GOVERNMENT
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No.
155/2018/ND-CP
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Hanoi,
November 12, 2018
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DECREE
ON AMENDMENTS TO CERTAIN REGULATIONS RELATING TO
BUSINESS CONDITIONS UNDER STATE MANAGEMENT OF THE MINISTRY OF HEALTH
Pursuant to the Law on
organization of the Government dated June 19, 2015;
At the request of the Minister
of Health;
The Government promulgates the
Decree on amendments to some certain regulations relating to business
conditions under state management of the Ministry of Health.
Chapter I
FOOD SAFETY
Article 1.
Annulment of some documents and regulations on food safety:
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2. Clause 2c, Article 5 of the
Government’s Decree No. 15/2018/ND-CP dated February 02, 2018 on elaboration of
some articles of the Law on Food Safety (hereinafter referred to as
"Decree No. 15/2018/ND-CP).
3. Circular No. 15/2012/TT-BYT
dated September 12, 2012 of the Minister of Health providing food safety
requirements applied to food manufacturers and sellers.
4. Circular No. 16/2012/TT-BYT
dated October 22, 2012 of the Minister of Health on food safety conditions
applicable to food manufacturers and sellers and food packing instruments and
materials under the management of the Ministry of Health.
5. Circular No. 26/2012/TT-BYT
dated November 30, 2012 of the Minister of Health on granting of food safety
certificates for manufacturers and sellers of functional food, food with
micronutrients, food additives and food processing aids; still mineral water,
bottled water; food packaging instruments and materials under the management of
the Ministry of Health.
6. Circular No. 30/2012/TT-BYT
dated December 05, 2012 of the Minister of Health on food safety conditions
applied to street food vendors.
7. Circular No. 47/2014/TT-BYT
dated December 11, 2014 of the Minister of Health providing guidance on
management of food safety of food and beverage establishments.
8. Clause 1 and 3, Article 14,
clause 1 of Article 15 of Circular No. 43/2014/TT-BYT dated November 24, 2014
of the Minister of Health on management of functional foods.
Article 2.
Amendments to some articles of the Government’s Decree No. 67/2016/ND-CP dated
July 01, 2016 on requirements for food manufacturing and trading under
specialized management of the Ministry of Health
1. Article 1, Chapter I is amended
as follows:
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2. Chapter II is amended as follows:
“Chapter
II
FOOD
SAFETY REQUIREMENTS FOR FOOD MANUFACTURERS AND SELLERS UNDER MANAGEMENT OF THE
MINISTRY OF HEALTH AND THE FOOD AND BEVERAGE ESTABLISHMENTS
Article 4. Food manufacturers
and sellers under management of the Ministry of Health
1. Comply with the regulations in
Articles 19, 20, 21, 22, 25, 26 and 27 of the Law on Food Safety and the
following specific requirements:
a. Food manufacturing process shall
be designed to provide an operational flow through pattern and follow a
sequence from raw materials to finished products.
b. Walls, ceilings and floors of
the production, trading and storage areas must be water-resistant, without
flaws and moisture-resistant.
c. Equipment and tools in direct
contact with food must be easy to clean, not release harmful substances into
the food and not contaminate it.
d. There must be boots, shoes or
sandals for personal use in the food production area.
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e. Do not display and sell
chemicals for other purposes in the facilities trading additives and food
processing aids.
2. The persons who directly produce
and trade food must be trained and provided with knowledge on food safety, as
well as be authorized by the facility owner and must not contract any of the
following diseases during food manufacturing and trading process: cholera,
hepatitis A and E, skin infection, tuberculosis and diarrhoea epidemic.
Article 5. Food and beverage
establishments
1. Comply with the regulations in
Articles 28, 29 and 30 of the Law on Food Safety and the following specific
requirements:
a. Carry out three-step food
checking and store food sample according to the guidelines of the Ministry of
Health.
b. Equipment and vehicle used for
food transport and preservation must ensure hygiene and must not contaminate
such food.
2. The persons directly processing
food must be trained in food safety, and confirmed by the establishment owner
that they does not contract any of the following diseases during food
manufacturing and trading process: cholera, dysentery, typhoid, hepatitis A and
E, skin infection, tuberculosis and acute diarrhea.”
3. Chapter III is amended as
follows:
“Chapter
III
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Article 6. Application documents
and procedures for and authority to issue the Certificates
1. Authority to issue the
Certificate:
The Ministry of Health shall issue
the Certificates for the facilities manufacturing different types of foods
under its management or decentralize or authorize another unit to issue such
Certificate according to the regulations in clause 5, Article 37 and in
Appendix II of Decree No. 15/2018/ND-CP .
2. The application for the
Certificate must be made in accordance with the regulations in clause 1,
Article 36 of the Law on Food Safety and must contain:
a. An application form for the
Certificate using form No.01 in Appendix I hereto.
b. A copy of the Business
Registration Certificate or the Enterprise Registration Certificate which
specifies the business suitable to the types of food manufactured by the
facility (must be confirmed by such facility).
c. A list of food producers and
food service providers who are trained and provided with food safety knowledge.
Such list must be confirmed by the facility owner.
3. The procedures for issuance of
the Certificate must be carried out in accordance with clause 2, Article 26 of
the Law on Food Safety and the following requirements:
a. Send the application specified
in clause 2 of this Article through the online public service system or by post
or in person at the receiving authority.
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After 30 days from the date on
which such notification is received, if the facility does not provide
additional documents and complete the application as requested, such
application will be invalidated. If needed, organizations and individuals shall
submit new application to receive the Certificate.
c. If the application is
satisfactory, within 15 working days from the date on which the complete
application is received, the receiving authority shall establish an appraisal
team or authorize another appraisal unit to write an appraisal document using
form No. 02 in Appendix hereto. If the receiving authority authorizes its
inferior competent agency, it must provide an authorization document.
The appraisal team, which receives
a Certificate from the competent agency or authorized by it to carry out the
appraisal tasks, shall be established with 03 to 05 members. At least 03
members must carry out food safety tasks (may invite experts who are suitable
for the food production of the facility to participate in the appraisal).
d. If the appraisal results satisfy
the requirements, within 05 working days from the date on which such results
are received, the receiving authority shall issue the Certificate by using form
No. 03 in Appendix hereto.
dd. If the appraisal results are
not satisfactory and the weaknesses are rectifiable, the appraisal team must
specify the necessary rectifications and allow a period of 30 days for
rectification.
After receiving the rectification
report from the facility, within 05 working days, the appraisal team must
evaluate such rectification result and write the conclusion in the appraisal
document. If the rectification result is satisfactory, the facility will be
granted a Certificate according to point d of this clause. If the rectification
result is not satisfactory, the receiving authority shall send a written
notification of the appraisal result to the facility and the local regulatory
agency.
e. If the appraisal result is not
satisfactory, the receiving authority shall send a written notification to the
local regulatory agency for it to carry out supervision and request the
facility not to operate until such facility receives the Certificate.
4. If the name of the enterprise,
the facility owner or the address is changed without changing the location and
the food manufacturing and service process, and the Certificate does not
expire, the facility must write a notification about the adjusted Certificate
and attach with it a legal copy specifying such changes, then send both of them
to the receiving authority through an online public service system or by post
or in person.
5. Any certificate issued before
this Decree comes into effect may be used until its expiry date.”
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1. Point a, clause 2, Article 5 is
amended as follows:
a. Organizations or individuals
shall announce the product declaration through mass media or post it on their
websites or publicly post it up at their offices and make public through the
food safety data system (if such system has not been established, organizations
or individuals shall send 01 application by post or in person to the regulatory
agency assigned by the People's Committees of provinces and central-affiliated
cities (hereinafter referred to as “receiving authority”), in order for it to
retain the application documents and post the self-declaration, including names
of organizations or individuals and product information, on its website. If the
organizations or individuals have more than 02 facilities which manufacture the
same product, they shall only submit the application at the regulatory agency
in their locality where the manufacturing facility is selected by them. After
selecting the regulatory agency for submitting the application, the next
self-declared documents must be submitted at the previously selected agency.)
2. Clause 6, Article 40 is amended
as follows:
“6. Issue the Certificate of
Eligibility for Food Safety to the facilities producing bottled water, still
mineral water, ready-to-use ice and ice used for food processing and the
facilities producing supplement food, medical food, food for special dietary
uses, nutrition products used for children of 36 months old, additives, food
processing aids and food micronutrients, other food manufacturing facilities
which are not specified in the list of the Ministry of Industry and Trade and
the Ministry of Agriculture and Rural Development, and the food and beverage
establishments.
Chapter II
PHARMACEUTICAL PRODUCTS
Article 4. Annulment
of the following regulations of the Government’s Decree No. 54/2017/ND-CP dated
May 08, 2017 providing guidelines on some articles on methods for implementing
the Law on Pharmacy
1. Clause 1c and Clause 1g, Article
3.
2. Clause 1b, Article 4.
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4. Clause 1, clause 3 and clause 4,
Article 14.
5. Clause 4, Article 19.
6. Points a, b, c, d, dd and e,
clause 2, Article 21.
7. Clause 2, Article 23.
8. Article 24.
9. Article 25.
10. Article 26.
11. Article 27.
12. Clause 1, Article 28.
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14. Clause 3, Article 32.
15. Clause 5, Article 38.
16. Clause 2, Article 40.
17. Clause 1d; Clause 2dd; Clause
3b and 3c; Clause 4d; Clause 5c; Clause 7d; Clause 10b and 10d; Clause 11b and
11c, Article 43.
18. The storage facility and
separate areas must have solid walls and ceilings which are made from solid
materials specified in Clause 1a, Clause 2a, Clause 5a and Clause 7a, Article
43.
19. Clause 1c; Clause 2c; Clause
3b; Clause 4b; Clause 5; Clause 6c; Clause 7; Clause 12b, Article 44.
20. Clause 2, Article 49.
21. Article 50.
22. Article 52.
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24. Clause 2b and 2c, Article 58.
25. Clause 3c, Clause 4a, and
Clause 5a, Article 60.
26. Clause 2c, Clause 4b, Article
62.
27. Clause 1c, Clause 2i, Article
65.
28. A report on the pharmacy
business results must be included in the application for Drug Import License.
The licensed drugs are specified in the List of Inhibited Drugs and Active
Ingredients in certain fields mentioned in Clause 2g, Article 65, Clause 2h,
Article 66, Clause 2e, Article 69.
29. The drug importer must include
a GMP Certificate in the application for Drug Import License as specified in
Clause 2h, Article 65, Clause 2i, Article 66, Clause 2g, Article 69, Clause 2h,
Article 71, Clause 2i, Article 72, if the Certificate of Pharmaceutical
Products confirms that the importer satisfies the GMP principles and standards.
30. Clause 2k, Article 66.
31. Clause 1a; Clause 2, Article
68.
32. If biologicals are imported,
there must be an original copy of the foreign exporter and manufacturer's
commitment to quality, safety and efficacy as specified in Clause 3e, Article
68.
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34. Clause 2b, Article 70.
35. Clause 2i, Article 71.
36. Clause 2dd, Article 73.
37. Clause 1b, Article 74.
38. Clause 3b and 3d, Article 75.
39. If drugs are imported as
specified in Article 72, there must be a separate purchase order as mentioned
in Clause 1, Article 76.
40. Clause 3b, Article 76.
41. The drug labels must be
consularly legalized according to Clause 3d, Article 76.
42. The Certificate of
Pharmaceutical Products must confirm that the drugs are licensed in the country
in which the Certificate is issued, according to Clause 4dd, Article 76.
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44. Clause 2b, Article 82.
45. Clause 1b and 1c, Article 84.
46. Clause 2dd, Article 85.
47. Clause 1b, Article 86.
48. The facility which provides
controlled drugs imported for testing, research and production of exported
drugs as specified in Article 80; provides imported medicinal materials
specified in Article 82, 83, 84, 85; and drugs as emergency aid or humanitarian
aid must implement the regulations specified in clause 15, Article 91.
49. If the drugs are imported in
accordance with the regulations in Clause 1a and 1b, Article 72, the importer
must submit an original copy or a certified true copy of the testing
certificate of the batch of imported drugs/medicinal materials.
50. There must be a copy bearing
the importer's seal of the authorization letter or the seller's license or the
certificate of partnership which are specified in point d, clause 2, Article
92, with regards to drugs as emergency aid or humanitarian aid.
51. There must be a copy bearing
the importer's seal of the authorization letter or the seller’s license or the
certificate of partnership which are specified in Clause 4dd, Article 92, with
regards to imported drugs specified in Article 68 and 72, controlled drugs
imported for production of exported drugs specified in Article 80, imported
medicinal materials specified in Article 84, 85.
52. Clause 1a, 1c, 1d and the
sentence “Minister of Health shall compile the list of herbal materials for
which registration is mandatory" in Article 93.
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54. Clause 2h, Article 100.
55. Procedures for re-exporting
medicinal materials specified in Clause 4, Article 104.
56. Clause 2 and Clause 3, Article
107.
57. Clause 1dd; Clause 2dd, Article
108.
58. Article 109.
59. Article 110.
60. Clause 4, Article 111.
61. Article 114.
62. Article 115.
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64. Clause 1dd and Clause 2dd,
Article 121.
65. Article 122.
66. Article 123.
67. Clause 4, Article 124.
68. Clause 4b, Article 130.
69. Clause 4dd, 4e, 4g of Article
131.
70. Clause 2, clause 3, clause 4,
Article 134.
71. Deadlines for the person in
charge of drug quality assurance of the manufacturer to obtain the pharmacy
practice certificate are specified in clause 1, clause 4, Article 140.
72. Forms No. 08, 09, 10, 11, 13,
14, 14, 16 and 17 in Appendix I.
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74. Forms No. 03 and 04 in Appendix
VI.
Article 5.
Amendments to some articles of the Government’s Decree No. 54/2017/ND-CP dated
May 08, 2017 providing guidelines for some articles on implementation of the
Law on Pharmacy
1. Clause 2, Article 2 is amended
as follows:
“2. Pharmaceutical conference
means a conference where a drug is introduced or drug-related issues are
discussed among medical or pharmaceutical practitioners.”
2. Clause 1a, Article 3 is amended
as follows:
“a. The application form for
the Pharmacy Practice Certificate must be made by using form No.02 in Appendix
I hereto."
3. Clause 1a, Article 4 is amended
as follows:
“a. The application form for
re-issuance of the Pharmacy Practice Certificate must be made by using form No.
04 in Appendix I hereto."
4. Clause 1a, Article 5 is amended
as follows:
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5. Clause 3a and 3c, Article 6 are
amended as follows:
a. Point a is amended as follows:
“a. The Pharmacy Practice
Certificate must be issued within 15 days from the date on which the
application is received; if the application is rejected, provide explanations
in writing."
b. Point c is amended as follows:
“c. Re-issue or amend the
Pharmacy Practice Certificate within 05 working days from the date on which the
application is received; if the application is rejected, provide explanations
in writing.
6. Article 8 is amended as follows:
“Article 8. Institutions
offering refresher training courses in pharmacy
1. The institutions offering
refresher training courses must be one of the following organizations: a
vocational education institution licensed to provide training in medicine or
pharmacy; an education institution licensed to provide training in health
science; a research institute licensed to provide training in medicine or
pharmacy; an institution licensed to provide training for health workers or a pharmacy
association.
2. The institutions providing
refresher training courses in pharmacy must develop their training programs
with the following principal contents:
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- Professional knowledge.
- Pharmacy law and management.
b. Duration of the refresher
course: at least 08 hours."
7. Clause 1a and Clause 2a, Article
15 are amended as follows:
Clause 1a is amended as follows:
“a. Inspect and supervise the
refresher training institutions specified in Article 8 hereof"
b. Clause 2a is amended as follows:
“a. Inspect, supervise and
cooperate with the pharmacy refresher training institutions in its provinces in
providing refresher trainings in pharmacy.
8. Clause 2, Article 21 is amended
as follows:
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a. 3/4 of the duration for holders
of PhDs or SL2 degrees in the field related to the specific internship.
b. 1/2 of the duration for holders
of Master Degrees or SL1 degrees in the field related to the specific
internship.”
9. Clause 3, Article 28 is amended
as follows:
“3. The Ministry of Health
shall assign the eligible examination centers specified in Article 23 hereof to
administer tests and issue the Pharmacy Practice Certificate if there are no
centers carrying out such tasks.”
10. Article 31 is amended as
follows:
a. Clause 5b, Article 31 is amended
as follows:
"b. The retailer has an
isolated and fixed store which is firmly built; the store area is suitable to
its scope of business, located in a high, dry, airy and safe area, at an
adequate distance from sources of pollution."
b. Clause 5c, Article 31 is amended
as follows:
“The storage area and
equipment must satisfy the storage requirements written on the labels.
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The retailer of herbal drugs,
traditional drugs or herbal materials shall have suitable storage areas to
store such drugs and materials or to store herbal materials and prepared
traditional medicinal materials.”
11. Clause 2a, Article 32 is
amended as follows:
“a. If the applicant is a
manufacturer of drugs or medicinal materials: documents about the location,
factory, testing laboratory, storage area, auxiliary systems, machinery for
manufacturing and storing drugs, quality control system, documents about
technologies and personnel according to Good Manufacturing Practice (GMP) for
drugs and medicinal materials.
If the applicant applies for a
Certificate of Eligibility for Pharmacy Business that allows sale and delivery
of drugs or medicinal materials manufactured by the applicant to wholesalers,
retailers and health facilities, documents on technologies and personnel
according to GDP for drugs and medicinal materials are required, unless such
products are delivered at the storage facility of the applicant.
12. Heading, Clause 3a and Clause 4
of Article 33 are amended as follows:
“3. The receiving authority
shall:
“a. Issue the Certificate of
eligibility for pharmacy business within 20 days from the date written on the
application receipt form without a site inspection at the applicant’s premises,
if the applicant’s facilities and personnel are conformable with relevant Good
Practice requirements.
4. If the application is deemed
unsatisfactory according to Clause 3a of this Article, within 07 working days
from the date written on the application receipt form, the receiving authority
shall request the applicant in writing to complete the application and specify
necessary additional documents.”
13. Clause 3a, Article 34 is
amended as follows:
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14. Clause 3, Article 40 is amended
as follows:
“3. Within 05 working days
from the date on which the notification from the applicant is received, the
Department of Health shall publish information about the mobile drugstore on
its website and inform the district health offices for supervision and
inspection.”
15. Clause 2, Article 41 is amended
as follows:
a. The heading of clause 2, Article
31 is amended as follows:
“2. Publication of the list
of drugs and active ingredients on the list of substances banned from certain
fields:
b. Clause 2b, Article 41 is amended
as follows:
“b. After receiving the list
of banned substances from the ministries and ministerial agencies, the Ministry
of Health shall promulgate the list of banned drugs and active ingredients in
certain fields on its website."
16. Clause 2, Article 42 is amended
as follows:
“2. If there are no
establishments trading controlled drugs in the province, the Department of
Health shall appoint a wholesaler or a retailer to conduct such trading or the
pharmacy department of the health facility to sell the controlled drugs in
order to ensure adequate supply of drugs for patients."
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“a. Have a separate storage
facility or area that meets GSP requirements. Such separate storage facility or
area must have robust doors with locks to store narcotic drugs, psychotropic
drugs, precursor drugs, medicinal materials that are narcotic active
ingredients, psychotropic active ingredients or drug precursors.”
18. Clause 6, Article 43 is amended
as follows:
“6. An exporter, importer or
wholesaler of radiopharmaceuticals shall have a documentary management system
according to the regulations of the Minister of Health.”
19. Clause 8a, Article 43 is
amended as follows:
“a. The narcotic drugs,
psychotropic drugs or precursors must be stored in a separate and locked
cabinet or drawer.”
20. Clause 12, Article 43 is
amended as follows:
“12. A provider of clinical trial
services, bioequivalence study services, controlled drug testing services,
except for those mentioned in Clause 11 of this Article, shall store the
narcotic drugs, psychotropic drugs, precursor drugs, medicinal materials that
are narcotic active ingredients, psychotropic active ingredients or drug
precursors, combination drugs that contain narcotic active ingredients,
psychotropic active ingredients or precursors in a separate and locked area or
separate and locked cabinets or drawers.”
21. Article 44 is amended as
follows:
Change the phrase “02 years” with
the phrase “12 months” in clauses 1, 2, 4, 6 and 10.
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“9. As for the retailer of
radiopharmaceuticals: the person responsible for retailing such drugs must have
at least an associate degree in pharmacy.”
23. Clause 2c, Article 46 is
amended as follows:
“c. An establishment that has
the Certificate of Eligibility for Pharmacy Business that allows export, import
and wholesaling of drugs may only sell drugs to other establishments that have
such Certificates, health facilities, research and testing establishments,
rehabilitation centers, establishments providing opioid substitution treatment,
establishments providing training in medicine or pharmacy, drugstores
nationwide; and may select 01 wholesaler in a province to sell all of its
products.”
24. Clause 2d, Article 46 is
amended as follows:
"d. A wholesaler may only sell
drugs to health facilities, research and testing establishments, rehabilitation
centers, establishments providing opioid substitution treatment, institutions
providing training in medicine or pharmacy, other non-commercial pharmacy
establishments and drugstores in the same province."
25. Clause 2dd, Article 46 is
amended as follows:
"dd. Health facilities,
rehabilitation centers and establishments providing opioid substitution
treatment may purchase drugs from the establishments specified in Points a, b,
c, d of this Clause based on their bidding results or according to the bidding
plan approved by the competent person. Private health facilities may purchase
drugs from the establishments specified in Points a, b, c, d of this Clause
based on the prescriptions approved by the competent authority.
26. Clause 2a, Article 48 is
amended as follows:
“a. The application shall be
sent in person or by post to the Ministry of Health if the applicant is a
manufacturer, exporter or importer, or to the Department of Health of the same
province if the applicant is a pharmacy business establishment other than the
aforesaid entities; or at the Military Medicine Department (Ministry of
National Defense) if the applicant is under the management of such Ministry.
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“c. If the application is
satisfactory, the receiving authority shall issue a written permission for
destruction within 20 days from the date on which the application is received.
d. If the application is not
satisfactory, the receiving authority shall request the applicant in writing to
complete the application within 20 days from the date on which the application
is received."
28. Clause 3, Article 48 is amended
as follows:
“3. The destruction of
narcotic drugs, psychotropic drugs, precursor drugs or medicinal materials that
are narcotic active ingredients, psychotropic active ingredients or drug
precursors may only be carried out after receiving the written permission from
the Ministry of Health or the Department of Health in the same province, or
from the Military Medicine Department (Ministry of National Defense).”
29. Clause 4b, Article 48 is
amended as follows:
“b. The destruction must be
witnessed by representatives of the Department of Health of the same province
or the Military Medicine Department (Ministry of National Defense) and be
recorded using form No. 16 in Appendix II hereto.
30. Clause 4c, Article 48 is
amended as follows:
“17. Within 10 days from the
date on which the destruction is done, a destruction report (using form No. 17
in Appendix II) enclosed with a destruction record shall be submitted to the
Ministry of Health or Department of Health or Military Medicine Department
(Ministry of National Defense).”
31. Clause 1, Article 49 is amended
as follows:
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32. Article 51 is amended as
follows:
"Article 51.
Procedures for issuance of the Certificate of Eligibility for Pharmacy Business
to traders of controlled drugs
1. The procedures for issuance of
the Certificate of Eligibility for Pharmacy Business to the traders of
controlled drugs shall be completed in accordance with Article 33 hereof.
2. If the trader already has such
Certificate or satisfies the Good Practice requirements according to Article 33
of the Law on Pharmacy and requests for the permission for trading controlled
drugs, the receiving authority shall only evaluate the application mentioned in
Article 49 of the Decree No. 54/2017/ND-CP.
33. Article 53 is amended as
follows:Clause 2a is amended as follows:
“a. 01 copy of the order for
medicinal materials that contain narcotic active ingredients, psychotropic
active ingredients or drug precursors using form No. 19 in Appendix II hereto.
b. Clause 3b is amended as follows:
“b. 01 copy of the sale order
for medicinal materials that are narcotic active ingredients, psychotropic
active ingredients or drug precursors using form No. 19 in Appendix II
hereto."
34. Clause 1, Article 54 is amended
as follows:
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"b. The Department of Health
of the same province if the applicant is a drug wholesaler, a retailer, a
private health facility, a research and testing institution, an institution
providing training in medicine or pharmacy, a rehabilitation center, an
establishment providing opioid substitution treatment and a non-commercial
pharmacy establishment.”
b. Clause 1c is added as follows:
“c. Military Medicine
Department (Ministry of National Defense) if the applicant is under the
management of the Ministry of National Defense."
35. Article 65 is amended as
follows:
a. Clause 1a and 1b, Article 65 are
amended as follows:
“a. The drug is licensed in
one of the following country: manufacturing country, reference country that is
a member state of The International Council for Harmonization of Technical
Requirements for Pharmaceuticals for Human Use (ICH) or Australia;
b. The drug falls into one of the
following cases:
- The drug is specified in the
guidelines for disease diagnosis, prevention and treatment which are
promulgated and approved by the Ministry of Health.
- The drug is used for emergency of
poison control and as an anti-rejection medication.
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b. Clause 2d and 2e, Article 65 are
amended as follows:
“d. The original copy of 01
set of specimens of the label and package insert from the drug production
country or the exporting country, unless such package insert or the summary of
product characteristics is attached to the Certificate of Pharmaceutical
Product.
e. Clinical data about the safety
and efficacy of the drug according to the regulations on drug registration of
the Minister of Health.
Documents specified in this point
are not required to be submitted in cases where the drug are licensed for
import according the regulations in this Article and no changes are made to the
information related to the indication, dosage and user.
36. Clause 2c, 2d and 2e, Article
66 are amended as follows:
“c. Quality documents
according to the regulations of the Minister of Health on the use of ASEAN
Common Technical Dossier (ACTD) in drug registration or quality standards and
results of bioequivalence study according to clause 7, Article 76 hereof.”
d. The original of 01 set of
specimens of the label and package insert from the drug production country or
the exporting country, unless both of them or the summary of product
characteristics are attached to the Certificate of Pharmaceutical Product.
e. Clinical document if required by
the regulations of the Minister of Health on drug registration.
Documents specified in this point
are not required to be submitted in cases where the drug has been licensed for
import according the regulations in this Article and no changes have been made
to the information about the indication, dosage and user.”
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“c. An original copy or a
copy bearing the issuer’s seal of the written request or approval issued by any
of the competent authorities specified in Clause 1a, 1b or 1c of this Article
which specifies: the active ingredients of the modern drug or biologicals or
herbal materials of the herbal drug or traditional drug, dosage form,
concentration of active ingredients of the modern drug or biologicals or
quantity of herbal materials of the herbal drug or traditional drug, package
contents, manufacturer and manufacturing country.”
38. Article 68 is amended as
follows:
Clause 1b, Article 68 is amended as
follows:
“b. The drug does not satisfy
the treatment requirements and is:
- Used for emergency of poison
control and as anti-rejection medication; or
- Included in the List of Rare
Drugs; or
- Specified in the guidelines on
prevention and treatment for anaphylactic shock promulgated and approved by the
Ministry of Health; or
- Used for a specific patient who
is receiving treatment at the health facility for: class-A communicable
disease, cancer, HIV/AIDS, tuberculosis, malaria and other fatal diseases
announced by the Minister of Health.”
b. Clause 3c, Article 68 is amended
as follows:
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c. Clause 3g, Article 68 is amended
as follows:
“g. The drug provider is not
required to implement the regulations in clause 15, Article 91 hereof, if it
has a copy of the Pharmacy Business License which is issued by the competent
agency of the home country and is certified and consularly legalized according
to the regulations.”
39. Clause 2d, Article 69 is
amended as follows:
“d. The original copy of 01
set of specimens of the label and package insert from the drug production
country or the exporting country, unless both of them are attached to the
Certificate of Pharmaceutical Product.”
40. Article 71 is amended as
follows:
Clause 1b, Article 71 is amended as
follows:
“b. The drug is licensed in one of
the following countries: the manufacturing country, the member state of the ICH
or Australia.”
b. Clause 2c, 2d and 2dd, Article
71 are amended as follows:
“c. Quality documents
according to the regulations of the Minister of Health on the use of ACTD in
drug registration or quality standards and results of bioequivalence study
according to Clause 7, Article 76 hereof.”
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The documents specified in this
point are not required to be submitted in cases where the drug has been
licensed for import according the regulations in this Article and no changes
have been made to the information about the indication, dosage and user.
dd. The original copy of 01 set of
samples of the label and package insert from the drug production country or the
exporting country, unless both of them are attached to the Certificate of
Pharmaceutical Product.”
41. Article 72 is amended as
follows:
a. Clause 1, Article 72 is amended
as follows:
“1. The import of such drug
shall only be licensed in the manufacturing country or the country which is the
member state of ICH or Australia, when:
a. The drug as an emergency aid is
carried by the foreign humanitarian medical team to use for their humanitarian
medical services.
b. The drug as an emergency aid is
used for treating a specific patient who is required to stay in the health
facility.
c. The drug as an emergency aid is
used for the state medical programs or projects.
d. The drug as an emergency aid is
not specified in points a, b and c of this clause and is not narcotic drug,
radiopharmaceutical or vaccine."
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“a. The import order using
form No. 24, 25 or 26 in Appendix III hereto.
c. The original copy or the
certified true copy of the written approval issued by a regulatory agency for
the use of foreign drugs as an emergency aid in state medical programs or
projects; if the drugs are imported, the original copy of the written approval
issued by the regulatory agency for humanitarian medical services is required,
according to Clause 1a of this Article.
dd. Quality documents according to
the regulations of the Minister of Health on the use of ACTD in drug
registration or quality standards and results of bioequivalence study according
to clause 7, Article 76 hereof."
e. Clinical document if required in
some cases by the regulations of the Minister of Health on drug registration.
The documents specified in this
point are not required to be submitted in cases where the drug has been
licensed for import according the regulations in this Article and no changes
have been made to the information about the indication, dosage and user.”
g. The original of 01 set of
specimens of the label and package insert from the drug production country or
the exporting country, unless both of them are attached to the Certificate of
Pharmaceutical Product.”
h. 02 sets of specimens of the
label and package insert in Vietnamese which bear the importer's seal.
k. The documents specified in
points d, dd, e, g, h and i are not required in cases where the drug is
imported in accordance with Clause 1a and 1b of this Article. However, there
must be a written commitment about the drug licensed in the manufacturing
country or the member state of ICH or Australia. Also, the written commitment
of the facility receiving humanitarian aids must clearly specify the list of
patients in need of the drug according to Clause 1b of this Article."
42. Article 76 is amended as
follows:
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“d. The package insert of the
drug licensed in the manufacturing country or the exporting country, except for
the cases specified in Clause 2d, Article 66, Clause 2d, Article 69, Clause
2dd, Article 71 and Clause 2g, Article 72 hereof.”
b. The heading of clause 5, point b
and c, clause 5, Article 76 are amended as follows:
“5. The specimens of the
label and package insert of a drug licensed in the manufacturing country or the
exporting country must satisfy the following requirements, except the drugs
that have the same trade name, active ingredients, concentration and dosage
form as those of a proprietary drug having the marketing authorization in
Vietnam, are manufactured by the same manufacturer of the proprietary drug or
by an authorized manufacturer and are sold at a lower price than that of the
proprietary drug sold in Vietnam according Article 70 hereof:
b. The specimens of the package
insert bearing the seal of the competent authority which issues the Certificate
of Pharmaceutical Product in the manufacturing country or the exporting
country, except for the cases specified in Clause 2d, Article 66, Clause 2d,
Article 69, Clause 2dd, Article 71 and Clause 2g, Article 72.
c. The original of the specimen of
package insert undergoing consular legalization.”
c. Clause 5d, Article 76 is amended
as follows:
“d. The specimen of the label
specified in Clause 2d, Article 65; samples of the label and the package insert
which are specified in Clause 2d, Article 66, Clause 2d, Article 69, Clause 2dd,
Article 71 and Clause 2g, Article 72 must bear the seal of the manufacturer or
the owner of the product or product license (stamped on the Certificate of
Pharmaceutical Product) and the importer.”
d. Clause 7, Article 76 is amended
as follows:
“7. Quality standards and
results of the bioequivalence study:
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b. Results of bioequivalence study
shall only be submitted if required by the regulations of the Minister of
Health on drug registration.
The documents specified in this
point are not required in cases where drugs are produced and licensed
(specified on the Certificate of Pharmaceutical Product) in the country that is
the permanent member or founder of ICH or Australia."
43. Article 77 is amended as
follows:
a. Heading of Clause 1, Clause 1g,
Article 77 are amended as follows:
“1. In cases of drug import
specified in Articles 65, 66, 69, 71, Clause 1c and 1d, Article 72 hereof:
g. In cases where drugs imported
for provision of humanitarian medical services are approved by the competent
authority and the documents specified in Points d, dd, e, g, h, i, clause 2, Article
72 hereof are not mentioned but the drugs are essential for the disease
treatment, the Minister of Health shall consider approving the application on
the basis of counsel given by the certification advisory council."
b. Heading of Clause 3, Article 77
is amended as follows:
“3. In cases of drug import
specified in Clause 1b and 1c, Article 68, Article 70, Clause 1a and 1b,
Article 72, 73, Clause 1, Article 74 hereof.”
c. Clause 4e, Article 77 is amended
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44. Clause 3, Article 78 is amended
as follows:
a. The heading of Clause 3, Article
78 is amended as follows:
“3. As for drugs used for
emergency treatment and poison control, and vaccines used in some special cases
with limited amounts and other drugs licensed for import according to Clause 1b
and 1c, Article 68 hereof:"
b. Clause 3c is added to Article 78
as follows:
“c. The regulations in clause
4, Article 103 of the Law on Pharmacy are not required to be implemented. The
importer of drugs requiring cold or deep freezing storage shall retain the data
sheets which record the storage conditions (cold chain) during the transport
process of imported batch of drugs (bearing the seal of the importer). Such
storage conditions are recorded by using the temperature data logger and from
the freeze indicator (if any).
45. Clause 3, Article 79 is amended
as follows:
“3. For the drugs specified
in the list of drugs and active ingredients banned from certain fields, a
written explanation enclosed with proof documents are required if the total
quantity of imported drugs and remaining drugs specified in the order form and
the quantity of drugs to be imported according to the issued Import License exceeds 150% of the total actual business demand in
01 year before the time of making the order.
46. Points a, d, dd, e, clause 1,
Article 80 are amended as follows:
“a. 01 original of the
purchase order using form No. 35, 36 or 41 in Appendix III hereto.
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The sale report specified in this
point is not required in cases where medicinal materials and reference
materials are imported for testing or research.
dd. The plan for production, use or
sale of imported medicinal materials and the plan for sale of semi-finished
drugs produced from imported medicinal materials other than toxic medicinal
materials.
The sale report specified in this
point is not required in cases where semi-finished drugs produced from
medicinal materials and reference materials which are imported for testing or
research.
For the imported drugs specified in
the list of drugs and active ingredients banned from certain fields,
documentary evidence is required if the total quantity of imported drugs and
remaining drugs specified in the order form and the quantity of imported
ingredients which have been granted the Import License exceeds 150% of the
total actual business demand in 01 year before the time of making the order.
e. If medicinal materials and
reference materials are imported for testing or research; toxic medicinal
materials and active ingredients specified in the List of Drugs and Active
Ingredients Banned from Certain fields are imported for production of exported
drugs; the medicinal materials are granted the marketing authorization in
Vietnam or the ingredients on the list of active ingredients, excipients or
semi-finished drugs used for production of drugs are granted the marketing
authorization in Vietnam, the documents specified in Points b and c of this
Clause are not required.”
47. Article 87 is amended as
follows:
a. Heading of Article 87 is amended
as follows:
“Article 87. Composition
of the application for licensing import of herbal materials in the cases other
than those specified in Articles 82 through 86 hereof”
b. Clause 1d and 1dd, Article 87
are amended as follows:
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dd. Certified true copy of the
manufacturer's certificate of GMP issued by the competent authority of their
home country."
48. Article 91 is amended as
follows:
a. Clause 5, Article 91 is amended
as follows:
“5. Representative offices in
Vietnam of manufacturers, holders of the certificates of free sale of drugs
undergoing clinical trial, bioavailability study or bioequivalence study;
providers of clinical trial, bioavailability study or bioequivalence study
services may import medicinal materials, primary packages of drugs and
reference materials for provision of the aforesaid services and register for
the license to perform testing and research on drugs and medicinal materials.
b. Clause 5a is added to clause 91
as follows:
“5a. The following agencies
and organizations, which satisfy the requirements in Article 35 of the Law on
Pharmacy, may:
a. Import drugs which are specified
in Article 67 hereof, if assigned by the Ministry of National Defense, Ministry
of Public Security or Ministry of Health in a written request.
b. Import drugs as emergency aid or
humanitarian aid, if approved by the regulatory agency.
c. Clause 8a, Article 91 is amended
as follows:
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d. Clause 15, Article 91 is amended
as follows;
“15. To be allowed to sign a
contract with the importer, the foreign supplier of drugs/medicinal materials
must be:
a. A manufacturer of imported
drugs/medicinal materials.
b. The owner of the product or
holder of the certificate of free sale of the imported drug or active
ingredient written on the Certificate of Pharmaceutical product, whether or not
the drug is granted the marketing authorization in accordance with the Law on
Pharmacy.
c. The applicant for registration
of the drug or medicinal ingredient has the marketing authorization in Vietnam
which does not expire at the time customs clearance is granted. This applicant
must be other than those mentioned in Points a and b of this Clause.
d. An establishment granted the
License to trade drugs, medicinal materials, vaccines, biologicals or
ingredients thereof in Vietnam.
dd. In cases specified in Points c,
d or h of this clause, they are required to be authorized in writing by the
entity mentioned in Point a or b of this Clause to supply drugs in Vietnam.
Except for those specified in points d and h of this clause, they are specified
in point a or b of this clause.
The authorization document may be
an authorization letter, seller's license or certificate of partnership. The
authorization document must be written in Vietnamese or English and contain:
name and address of the authorizing party and authorized party; scope of supply
of drugs/medicinal materials in Vietnam; authorization period or sale period;
responsibilities of the parties for the quality and origins of drugs/medicinal
materials supplied in Vietnam; signatures of the parties.
e. Regulations of this Clause do
not apply to suppliers of imported drugs specified in Articles 67, 73 and
Clause 1, Article 74 hereof.
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h. Establishments specified in
Clause 22 hereof.”
dd. Clause 16, Article 91 is
amended as follows:
“16. Regulations of Clause 15
of this Article do not apply to suppliers of imported excipients, capsule
shells, primary packages of drugs, reference materials and medicinal materials
used for producing controlled drugs which are imported for testing, research or
production of exported drugs according to Article 80 hereof; medicinal
materials used for producing imported drugs according to Articles 82, 83, 84,
85 hereof; drugs as emergency aid or humanitarian aid.
e. Clauses 22, 23, 24 are added to
Article 91 as follows:
“22. If the Ministry of
Health receives a written document from the competent authority of the
exporting country requesting the announcement of the list of manufacturers and
sellers which register for supplying drugs and medicinal materials in Vietnam,
the Ministry of Health shall:
a. Within 30 days from the date on
which the written request of the aforesaid competent authority is received, the
Ministry of Health shall post the list of foreign manufacturers and sellers
which register for supplying drugs and medicinal materials in Vietnam on its
website.
b. If the Ministry of Health
receives the written document from the aforesaid authority requesting it to
change the announced information about the foreign suppliers, the Ministry of
Health shall implement point a of this clause.
23. The competent authority of the
exporting country specified in clause 23 of this Article shall send a written
notification to the Ministry of Health as follows:
a. The written notification must be
sent within 01 month, from the date on which the written request for changes to
the name, address and business scope of the supplier is received.
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24. The written documents of the
competent authority specified in clauses 23 and 24 hereof must:
a. Clearly specify the name,
address and contact information of the competent authority of the exporting
country; information about the country or territory which register for
supplying drugs and medicinal materials in Vietnam; name of the supplier,
address, business scope and contact information of the manufacturer and seller;
b. Be the original copies which are
written in English or Vietnamese. If the copies cannot be written in English or
Vietnamese, provide the certified translated documents in one of these languages.
49. Article 92 is amended as
follows:
a. Clause 2dd, Article 92 is
amended as follows:
“dd. In case of import of a
drug or medicinal ingredient specified in Clause 1dd, Article 59 of the Law on
Pharmacy and such case does not require the import license, the importer shall
provide the bill of lading in order to prove that the shipment is sent from the
exporting country's port before the expiration date of the marketing
authorization to be granted customs clearance.”
b. Points e, g and h, clause 2, Article
92 are added as follows:
“e. In case of import of a
drug or medicinal ingredient specified in Clause 1dd, Article 59 of the Law on
Pharmacy and if such case does not require the import license, the importer
shall provide the bill of lading to prove that the shipment is sent from the
exporting country’s port before the expiration date of the marketing
authorization to be granted customs clearance.”
g. In case of import of medicinal
materials specified in the list of active ingredients, excipients,
semi-finished drugs used for production of drugs that are granted the marketing
authorization in Vietnam and if such case does not require the import license,
the importer shall provide the bill of lading to prove that the shipment is
sent from the exporting country’s port before the expiration date of the
marketing authorization which is used to declare the expired materials (if such
certificate is used to declare the expired materials during customs clearance).
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c. Clause 3e, Article 92 is amended
as follows:
“e. In case of import of
medicinal materials and semi-finished medicinal materials specified in Clause
1dd, Article 59 hereof and if such case does not require the import license,
the importer shall provide the bill of lading in order to prove that the
shipment is sent from the exporting country's port before the expiration date
of the marketing authorization.”
d. Clause 3h and 3i, Article 92 are
added as follows:
“h. In case of import of
medicinal materials and semi-finished medicinal materials specified in Clause
1dd, Article 59 of the Law on Pharmacy and if such case does not require the
import license, the importer shall provide the bill of lading in order to prove
that the shipment is sent from the exporting country's port before the
expiration date of the marketing authorization and the Import License to be
granted customs clearance.”
“i. In case of import of
medicinal materials and semi-finished products in the form of import license
but without a marketing authorization in Vietnam and such import license
expires by the time of customs clearance, the importer shall provide the bill
of lading in order to prove that the shipment is sent from the exporting
country's port before the expiration date of the Import License.”
dd. Clause 4e is added to Article
92 as follows:
“e. In case of import of drugs,
medicinal materials in the form of import license but without a marketing
authorization in Vietnam and such import license expires by the time of customs
clearance, the importer shall provide the bill of lading in order to prove that
the shipment is sent from the exporting country’s port before the expiration
date of the Import License.”
50. Clause 1dd, Article 93 is amended
as follows:
“dd. It is on the list of
herbal materials that can be domestically obtained with adequate quantity for
the treatment demand and at reasonable prices; or"
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“b. The certificate of GMP
and report on GMP inspection mentioned in Clause 1 through 4 of this Article
and the manufacturing license mentioned in Clause 1 through 3 of this Article
must be original copies or certified true copies and must be unexpired when the
application is submitted. If the expiration date is not specified, they must be
issued within the last 03 years, from the date on which the application is
submitted.
The Certificate of GMP or the
Manufacturing License are not required if they are posted on the website of the
pharmacy authority.
52. Clause 1a and 1b, Article 99
are amended as follows:
“a. Within 20 days from the
date on which the satisfactory application is received in case of mutual
recognition of GMP inspection.
b. Within 40 days from the date on
which the satisfactory application is received in case of document inspection.
53. Clause 2a, Clause 3c and Clause
4, Article 100 are amended as follows:
a. Clause 2a is amended as follows:
“a. Any of the violations
that result in revocation of the Certificate of Drug/Medicinal Ingredient
Registration specified in Points a, d, dd, Clause 1, Article 58 of the Law on
Pharmacy.”
b. Clause 3c is amended as follows:
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c. Clause 4 is amended as follows:
“4. Applications submitted by
applicants that commit any of the violations specified in Points a, b, d, dd,
e, Clause 2 of this Article before the violations are dealt with will be
invalidated. At the end of the periods specified in Clause 3 of this Article,
the application may be submitted in accordance with the Law on Pharmacy.”
54. Article 105 is amended as
follows:
“Article 105. Methods of
provision of drug information
Information shall be provided for
medical and pharmaceutical practitioners by using the following methods:
1. Provision of drug information
via sale representatives.
2. Publishing of documents
containing drug information.
3. Holding pharmaceutical
conferences.”
55. The heading of Article 107 is
amended as follows:
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56. Clause 1e and Clause 2e,
Article 108 are amended as follows:
“e. The license for
establishment of a representative office in Vietnam if the applicant is a
foreign establishment; or the Certificate of Eligibility for Pharmacy Business
if the applicant is a Vietnamese pharmacy business establishment. The
Certificate of Eligibility for Pharmacy Business is not required if the
applicant is a Vietnamese pharmacy business establishment.
57. Article 111 is amended as
follows:
a. The heading is amended as
follows:
“Article 111. Documents
included in the application for issuance of the Certification of Drug
Information”
b. Clause 2, clause 5 and clause 6,
Article 111 are amended as follows:
“2. Documents mentioned in
Clause 1d, Clause 1e, Clause 2d, Clause 2e of Article 108 shall be copies
bearing the seal of the applicant if they are issued by the Minister of Health
or certified true copies if they are not issued by the Ministry of Health.
5. Documents mentioned in Clause 1b
and Clause 2b of Article 108 hereof are 02 original copies and made into 02
copies.
6. Each application for issuance of
the Certification of Drug Information shall contain:
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“2. Within 10 days from the
date on which the satisfactory application is received, the receiving authority
shall issue the Certificate to the applicant by using Form No. 05 or Form No.06
in Appendix hereto. If the application is rejected, the receiving authority
must respond and provide explanation in writing.”
59. Clause 3, Article 113 is
amended as follows:
“3. If the application is not
satisfactory, within 10 days from the date on which the application is
received, the receiving authority shall request the applicant in writing to
complete the application. To be specific:
a. The written request shall
specify necessary adjustments and/or additions.
b. Within 10 days from the date on
which the amended application is received, the receiving authority shall issue
the Certificate by using form No. 05 or No. 06 in appendix VI hereto, or reject
the application and provide explanation.
c. Within 90 days from the date on
which the additional documents are requested in writing by the receiving
authority, the applicant shall submit additional documents as requested.
Otherwise, the application will be rejected.”
60. Article 116 is amended as
follows:
“Article 116. Power to
issue the Certification of Drug Information
1. The Ministry of Health has the
power to issue the Certification of Drug Information in cases specified in
clause 2, Article 105 hereof.
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61. The heading of Article 120 is
amended as follows:
“Article 120. Issuance of
the Certification of Drug Advertisement Contents”
62. Clause 1e, Clause 2e, Article
121 are amended as follows:
“e. The license for
establishment of a representative office in Vietnam if the applicant is a
foreign establishment; or the Certificate of Eligibility for Pharmacy Business
if the applicant is a Vietnamese pharmacy business establishment. The
Certificate of Eligibility for Pharmacy Business is not required if the
applicant is a Vietnamese pharmacy business establishment.”
63. Article 124 is amended as
follows:
a. Heading of Article 124 is
amended as follows:
“Article 124. Documents
included in the application for the Certification of Drug Advertisement
Contents"
b. Clause 2, clause 5 and clause 6,
Article 124 are amended as follows:
“2. Documents mentioned in
Clause 1d, Clause 1e, Clause 2d, Clause 2e of Article 121 must be copies which
bear the seal of the applicant if they are issued by the Ministry of Health or
certified true copies if they are not issued by such Ministry.
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6. Each application for issuance of
the Certification of Drug Advertisement Contents shall contain:”
64. Article 127 is amended as
follows:
Article 127. Procedures for
issuance of the Certification of Drug Advertisement Contents
1. The applicant for the
Certification of Drug Advertisement Contents shall submit an application to the
Ministry of Health.
2. Procedures for issuance of the
Certification of Drug Advertisement Contents are the same as the procedures in
Article 113 hereof.”
65. Article 128 is amended as
follows:
"Article 128. Power to
issue the Certification of Drug Advertisement Contents
The Ministry of Health has the
power to issue the Certification of Drug Advertisement Contents.”
66. Article 129a is added to
Article 129 as follows:
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1. If the information specified on
the Certification of Drug Information and Drug Advertisement is incorrect due
to the mistakes made by the issuer, the applicant must send a written notification
to the issuer and clearly specify the incorrect information that requires to be
modified. After receiving the written notification, the issuer must send a
written confirmation which specifies the contents to be adjusted to the
applicant. Such confirmation must be made by using form No. 07 in Appendix VI
hereto. The applicant may operate according to the adjusted contents and shall
be responsible for such contents.
2. If the amended contents are
granted the certification but this case is not specified in clause 1b, Article
107 or clause 1b, Article 120 of the Decree No. 54/2017/ND-CP , the applicant
shall notify the issuer of the adjusted contents in writing. The applicant may
change the contents themselves and shall be responsible for such changes.
67. Clause 3, Article 130 is
amended as follows:
“3. The declaration of drug
prices in case of change to the marketing authorization specified in Clause 2b,
Article 55 of the Law on Pharmacy shall be made in accordance with clause 1 of
this Article.”
68. Clause 1c, Article 131 is
amended as follows:
“c. A drug price declaration
shall be submitted when the marketing authorization specified in Clause 2b,
Article 55 of the Law on Pharmacy is adjusted, or the Drug Import License is
also adjusted and before the first shipment of imported drug is launched in
Vietnam.
If adjustment is made to the
marketing authorization unspecified in Clause 2b, Article 55 of the Law on
Pharmacy or to the Drug Import License without adjusting the expected sale and
retail prices of the drug according to the declaration, the declarant is not
required to submit the declaration of drug prices but shall submit the
application specified in clause 4, Article 130 hereof.”
69. Clause 2c, Article 131 is
amended as follows:
“c. A drug price declaration
shall be submitted when the marketing authorization specified in Clause 2b,
Article 55 of the Law on Pharmacy is adjusted and before the first batch of
drugs is launched in Vietnam.
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70. Clause 4b, 4c, 4d are amended
as follows:
“b. The receiving official
shall examine the application documents and their quantity if such application
is completed. He/she shall append a seal on the received documents, specify the
date of receipt and return 01 dossier in person or by post to the applicant. If
the Ministry of Health is the receiving authority, such dossier must be
enclosed with a receipt note, using form No.06 in Appendix VII hereto. If the
People’s Committees of provinces and central-affiliated cities are the
receiving authorities, the receipt note must be made by using form No. 07 in
Appendix VII hereto. Also, the receiving official shall send 01 dossier to the
heads of competent agencies and technical service sections.
If the application is rejected, the
receiving official shall provide explanation in writing, specify the required
additional contents and immediately return the application to the applicant in
person; or within 02 working days from the date on which the application is
received in paper form.
c. Within 07 days from the date on
which the complete declarations which specify the declared/re-declared drug
prices are received, the Ministry of Health shall announce such
declared/re-declared drug prices; and additional drug information on its
website.
d. As for the re-declarations of
domestic drug prices:
- Within 03 working days from the
date on which the complete application is received, the People's Committees of
provinces and central-affiliated cities must send reports on the re-declared
drug prices to the Ministry of Health, using form No.08 in Appendix hereto.
- Within 04 working days from the
date on which the reports from the People’s Committees of provinces and
central-affiliated cities are received, the Ministry of Health shall publish
the summarization of these reports on its website.
- After reviewing the prices, if
the People’s Committees of provinces and central affiliated cities request the
declaring establishment in writing to report about the declared prices which
are conformable with the changes of pricing elements, such establishment must
also send 01 report to the Ministry of Health.
71. Clause 1, Article
132 is amended as follows:
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72. Clause 2b, Article 132 is
amended as follows:
“b. Failure to adjust drug
prices and to send a written notification at the request of a drug pricing
authority; failure to report about the pricing elements.”
73. Clause 2, clause 3, clause 4,
Article 133 are amended as follows:
“2. A pharmacy business
establishment may sell a drug from the date on which its price is declared or
re-declared by the manufacturer, outsourcing entity or importer.
3. A pharmacy business
establishment must not sell a drug wholesale or retail at a price higher than
the price declared or re-declared by the manufacturer, outsourcing entity or
importer.
4. In cases where the competent
authority requests a pharmacy business establishment to report about a declared
or re-declared price of drug, within 60 days from the date on which the request
is issued, the applicant must send a written report about such declared price
which is conformable with the pricing elements or adjust such declared price as
requested by the competent authority. If no respond is made by the aforesaid
deadline, the application will be invalidated."
74. Clause 1, Article 134 is
amended as follows:
“1. Declared/re-declared drug
prices shall be reviewed on the following basis:
a. Such prices must not be higher
than those of ASEAN countries.
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c. Changes in costs constituting
drug prices, such as cost of materials, fuel, exchange rates, salaries and
other relevant costs, must be conformable with the price increase.”
75. Clause 5 and 6, Article 134 are
amended as follows:
“5. Drug pricing authorities
shall establish a Drug Pricing Department to review the accuracy of the
declared and re-declared drug prices.
6. The Minister of Health shall
establish a Drug Pricing Council, which consists of representatives of the
Ministry of Health, Ministry of Finance, Social Security Administration of
Vietnam and relevant organizations and units, in order to give counsel to the
Minister of Health on review of the declared and re-declared drug prices in the
following cases:
a. The concentrations/contents of
the drug are different from those of other drugs posted on the website of the
Ministry of Health.
b. The dosage form of the drug is
different from that of other drugs posted on the website of the Ministry of
Health.
c. The drug is a new drug.
d. The drug is on the list of drugs
undergoing price negotiation, the drug is a proprietary drug, a drug
manufactured according to EU-GMP or PIC/S-GMP standards by a manufacturer in a
member state of the ICH or Australia, a drug manufactured according to WHO-GMP
standards certified by the Ministry of Health of Vietnam and granted the
certificate of free sale in a member state of the ICH or Australia with the
following increase rates:
- Over 10% if the drug price is exceeding
5.000 VND but not exceeding 100,000 VND per smallest pack.
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- Over 5% if the drug price is
exceeding 1.000.000 VND."
76. Clause 2, Article 136 is
amended as follows:
The drug retailer within the
premises of a health facility may only buy drugs from suppliers that are
awarded contracts for supplying drugs to such health facility and drugs
selected at the health facilities in provinces and central-affiliated cities
within 12 months; drugs selected and procured in localities and nationwide
within the term of the contract or the centralized procurement framework before
the procurement. The buying prices are specified below:
a. The buying price for a drug on
the list of drugs supplied by successful bidders of the health facility must
not exceed the successful bid at the same time.
b. The buying price of a drug that
is not included in the list of drugs supplied by successful bidders of the
health facility must not exceed the successful bids at the health facilities in
provinces and central-affiliated cities within 12 months; the successful bids
of centralized procurements in localities and nationwide within the term of the
contract or according to the centralized procurement framework before the
procurement.
This regulation is not applicable
to drugs which are licensed for import according to Articles 67 and 68 of the
Decree No. 54/2017/ND-CP ; narcotic drugs, psychotropic drugs, precursor drugs
and new drugs according to clause 14, Article 2 of the Law on Pharmacy. Such
drugs are not supplied by successful bidders of the health facilities."
77. Clause 2, Article 140 is
amended as follows:
“2. Deadline for the person
in charge of drug quality assurance of manufacturers to obtain the pharmacy
practice certificate is on January 01, 2021.
78. Article 143 is amended as
follows:
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“3. Licenses to export or
import drugs/medicinal materials, orders for exported or imported drugs/
medicinal materials and relevant administration procedures shall be issued and
carried out according to the Law on Pharmacy No. 34/2005/QH11 and its
instructional documents shall remain effective until their expiration dates.
Drugs and medicinal materials
mentioned in this Clause are imported or exported and granted customs clearance
documents if they satisfy the requirements of the Law on Pharmacy No.
34/2005/QH11 and related instructional documents or according to this Decree, from
the date on which this Decree takes effect.”
b. Clause 5a is amended as follows:
“a. An establishment trading
controlled drugs specified in Clause 26a and 26b, Article 2 of the Law on
Pharmacy may keep operating until the end of June 30, 2019. After this day, it
shall obtain the Certificate of Eligibility for Pharmacy Business that permits
trading in controlled drugs in accordance with Section 4, Chapter III of this
Decree.”
c. Clause 7 is amended as follows:
“7. From January 01, 2021,
the marketing authorization or declaration of applied standards shall be
obtained in accordance with Clause 1 and Clause 2, Article 93 hereof before
herbal materials are sold in Vietnam."
d. Clause 11, Article 143 is
amended as follows:
“11. A foreign enterprise
whose license to trade in drugs and medicinal materials in Vietnam or license
to trade in vaccines, biologicals and ingredients thereof in Vietnam is granted
before the Decree No. 54/2017/ND-CP takes effect and is used until its expiry
date.”
79. Replace the phrase “Department
of Health of the province where the applicant's head quarters are located” in
Clause 1b Article 33, Clause 1b Article 34, Clause 1b Article 50, Clause 1b
Article 51, Clause 2b Article 55 with the phrase “Department of Health of the
province where the applicant's business location exists”.
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81. Amend Form No. 19 in Appendix
II hereto.
82. Amend Appendix III:
a. Amend forms No. 03, 04, 05, 15,
16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 30, 33, 34, 35, 36, 37, 38, 41,
43, 46, 47, 48, 49, 50.
b. Amend forms No. 03, 24, 25, 26,
38, 46.
83. Amend Appendix V: Add the
phrase “Narcotic drugs and finished products from narcotic drugs."
84. Amend form No. 06 in Appendix
VI hereto.
85. Add form No. 07 to Appendix VI.
86. Amend forms No. 01, 02, 03, 04
in Appendix VII hereto.
Chapter III
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Article 6.
Annulment of some Articles of the Government’s Decree No. 118/2016/ND-CP dated
July 22, 2016 on amendments to some Articles of the Government’s Decree No.
56/2008/ND-CP dated April 29, 2008 on organization and operation of the tissue
banks and the National Coordinating Center for Human Organ Transplantation
1. Subpoint 4 in Clause 2b of
Article 3a.
2. Sub-point 4 in Clause 2c of
Article 3a.
3. Subpoint 2 in Clause 1d of
Article 4.
Article 7.
Amendments to some Articles of the Government's Decree No. 118/2016/ND-CP dated
July 22, 2016 on amendments to some Articles of the Government's Decree No.
56/2008/ND-CP dated April 29, 2008 on organization and operation of the tissue
banks and the National Coordinating Center for Human Organ Transplantation
1. Article 3a is amended as
follows:
“Article 3a. Requirements
for operation and issuance of operating license to tissue banks
1. Operation requirements for
tissue banks: the tissue banks shall only operate after receiving the Operating
License issued by the Ministry of Health.
2. Requirements for issuance of
operating license to tissue banks:
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b. Appropriate facilities must
include:
- Technical room for receiving,
treating, storing and providing tissues.
- Laboratory. If the tissue bank is
under the management of the health facility, the testing can be conducted in
the testing department of the health facility.
- Administrative area which is used
for collecting and managing documents, as well as providing counseling.
c. Minimum quantity of personnel:
- The specialized manager of the
tissue bank must satisfy the requirements specified in clause 4, Article 35 of
the Law on Donation, Removal, Transplantation of Human Tissues and Organs and
Donation and Recovery of Cadavers.
- 01 general doctor who has a
laboratory practice certificate (Bio-chemistry or Hematology or Microorganism)
or 01 laboratory technician who has a bachelor degree and a medical laboratory
practice certificate.
- 01 medical technician or 01 nurse
who has a medical intermediate degree and a medical practicing certificate.
If the applicant is a tissue bank
under the management of the health facility, its personnel can hold several
positions, however, a medical technician or a nurse must perform special tasks.
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- If the tissue bank performs tasks
related to the cornea, it must satisfy the requirements in Clause 3 of this
Article.
- Administrative management
procedures.
- Technical procedures for
removing, storing and distributing each type of tissue registered by the bank.
3. Requirements for issuance of the
operating license for the cornea bank (if the tissue bank performs tasks
related to the cornea):
a. Facilities must be sufficiently
provided according to Clause 2b of this Article.
b. Equipment must be sufficiently
provided according to the regulations in Appendix I hereto.
c. Personnel:
- There must be sufficient
personnel according to Clause 2b of this Article.
- The technician removing the
cornea must have a high school diploma and must be trained in removing, storing
and transporting the cornea."
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“Article 4. Application
and procedures for issuance of the Operating License to tissue banks
1. Application for the Operating
License shall contain:
a. An application form for the
Operating License, using the form in Appendix II hereto.
b. A copy of the Establishment
Approval of the tissue bank or a copy of such Approval enclosed with an
original copy, or the Enterprise Business Certificate if the applicant is a
private tissue bank.
c. A declaration of the medical
facilities and equipment to prove the applicant’s eligibility according to
Article 3a hereof.
d. If the applicant is an
independent tissue bank, it shall submit a declaration of its personnel to
prove its eligibility according to Article 3a hereof. The specialized manager
must provide a certified true copy of his/her qualification or certificate.
If the applicant is a tissue bank
under the management of the health facility, it shall provide the practicing
certificate.
2. Application and procedures for
issuance of the Operating License to tissue banks:
a. Agencies, organizations or
individuals shall send 01 set of application to request for the Operating
License specified in Clause 1 of this Article to the Ministry of Health, in
administrative form or in person.
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c. Within 05 working days from the
date on which the complete application is received, the Ministry of Health
shall establish an Appraisal Council to issue the Operating License to tissue banks.
Such Council shall comprise at least 05 members who are the representatives of
related units of the Ministry of Health, and who are the medical and legal
experts.
d. Within 17 working days from the
date on which the Establishment Approval is received, the Appraisal Council
shall perform their tasks at the tissue bank, write a report on the appraisal
result and send it to the Minister of Health, in order for him to use it as a
basis for issuing the Operating License to the tissue bank, using the form in
Appendix III hereto.
Time limit for resolution: Within
30 days from the date on which the valid application is received until the date
on which the Certificate is issued by the Ministry of Health.”
Chapter IV
INSECTICIDAL AND GERMICIDAL CHEMICALS AND PREPARATIONS
FOR HOUSEHOLD AND MEDICAL USE
Article 8.
Annulments of the following articles of the Government’s Decree No.
91/2016/ND-CP dated July 01, 2016 on management of insecticidal and germicidal
chemicals for household and medical use
1. Clause 1, Article 4.
2. Clause 1c and Clause 2, Article
5.
3. Clause 1c, 1e, 1g and Clause 2c,
Article 7.
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5. Clause 1, Article 10.
6. Clause 2b; Clause 3b, 3d, 3dd
and 3e of Article 14.
7. Clause 5, Article 15.
8. Clause 1b, Article 40.
9. Clause 1 and Clause 3, Article
41.
10. Clause 3, Article 42.
Article 9.
Amendments to some Articles of the government’s Decree No. 91/2016/ND-CP dated
July 01, 2016 on management of insecticidal and germicidal chemicals and
preparations for household and medical use
1. Clause 1, Article 6 is amended
as follows:
“Satisfy the requirements in
Section 1, Chapter II, of the Government’s Decree No. 113/2017/ND-CP dated
October 09, 2017 providing guidelines on some Articles of the Law on Chemical.”
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“d. The documents specified
in Clause 1d and 1dd must be confirmed by the manufacturer."
3. Clause 4, Article 8 is amended
as follows:
"4. Within 03 working days
from the date on which the application is received, the Ministry of Health
shall publish the name, address and phone number of the manufacturer on its
website."
4. Clause 5a, Article 8 is amended
as follows:
“a. Changes of its personnel:
The written request for change of information relating to the declaration of
eligibility to produce preparations shall be submitted, enclosed with the
documents mentioned in Clause 1b, Article 7 hereof.” <0}
5. Clause 2, Article 10 is amended
as follows:
“2. Testing establishments
must meet requirements defined in ISO 17025:2005 or its editions certified by
the certification organization which has registered for the Certificate of
Eligibility to Conduct Evaluation Business according to the law."
6. Article 12 is amended as
follows:
“Article 12. Declaration
of eligibility to conduct testing
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2. Within 03 working days from the
date on which the application is received, the Ministry of Health shall post
the name, address and phone number of the testing establishment on its website,
as well as a list of chemicals tested by the establishment.
3. If the testing establishment
changes their testing conditions compared to the information declared in the
application sent to the Ministry of Health, within 05 working days from the
date on which the changes are made, such establishment shall send a written
notification enclosed with the documents mentioned in Article 11 hereof to the
Ministry of Health.
4. If the additional documents are
not satisfactory and the testing establishment cannot develop any remedies
within the time limit required by the Ministry of Health, such Ministry shall
stop posting information related to the aforesaid establishment and send it a
written notification about such termination. The testing establishment shall
not conduct the testing from the date on which the aforesaid notification is
received, due to the establishment's inability to satisfy the testing
requirements.
7. Clause 2a, Article 14 is amended
as follows:
“a. The person in charge of
managing the experiment division must have at least 03 years of experience in
the experiment on preparations.”
8. Clause 2a, Article 14 is amended
as follows:
“a. Have a laboratory which
is managed and operated under ISO 17025:2005 or ISO 15189:2012 or their
editions. If the testing is conducted, it must be registered in accordance with
the law on requirements for provision of conformity assessment services.”
9. Article 16 is amended as
follows:
“Article 16. Declaration
of eligibility to conduct experiment activities
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2. Within 03 working days from the
date on which the application is received, the Ministry of Health shall post
the name, address and phone number of the experiment establishment on its
website, as well as a list of experiment procedures carried out by the eligible
experiment establishment.
3. If the experiment establishment
changes their experiment conditions compared to the information declared in the
application sent to the Ministry of Health, within 15 working days from the
date on which the changes are made, such establishment shall send a written
notification enclosed with the documents mentioned in Article 15 hereof to the
Ministry of Health.
4. Within 03 working days from the
date on which the application is received according to Clause 3 of this
Article, the Ministry of Health shall update the information on its website.
5. If the additional documents are
not satisfactory and the experiment establishment cannot develop any remedies
within the time limit required by the Ministry of Health, such Ministry shall
stop posting information related to the aforesaid establishment and send it a
written notification about the termination. The testing establishment shall not
conduct the experiment from the date on which the aforesaid notification is
received, due to the establishment's inability to satisfy the experiment
requirements.
10. Clause 4d, Article 26 is
amended as follows:
“d. The original or valid
copy of the written notice of testing results for ingredients and the content
of active ingredients in preparations. Such written notice of testing results
must be made by an entity that is qualified to conduct testing as referred to
in Article 10 hereof. If the testing establishments in Vietnam cannot conduct
the testing, the applicant can use the testing results from the manufacturer or
an independent laboratory which satisfies ISO 17025:2005 or ISO 15189:2012 or
their editions. Also, such manufacturer or laboratory must take responsibility
before the law for the legality of their testing results.”
11. Clause 3, Article 40 is amended
as follows:
“3. Traders in common
insecticidal and germicidal preparations, consisting of: mosquito coil;
mosquito repellent tablets for household and medical use; insecticidal sprays;
insect poisons; insect repelling cream, patch and band for human use; liquid
mosquito repellents and killers; mosquito nets with mosquito repellents and
killers; and germicidal preparations for household use are not required to
satisfy the requirements in Clause 1 and Clause 2c of this Article."
12. Clause 2, Article 41 is amended
as follows:
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a. Be able to read the information
specified on the label of the preparation.
b. Be able to perform insecticidal
and germicidal works with skills that are suitable to the provided service.
c. Can use and dispose insecticidal
and germicidal preparations.”
13. Clause 2, Article 42 is amended
as follows:
“2. A declaration of
personnel which is confirmed by the provider."
14. Clause 1a is added to Clause 1,
Article 63 as follows:
“1a. Provide trainings for
the person directly performing insecticidal and germicidal works. If no
training is provided, the provider must assign such person to receive trainings
at the training units specified in Clause 2, Article 41 hereof."
15. Amend forms No. 01, 03, 04, 05,
06 and 08 in Appendix I; Appendix VI; Appendix VII and Appendix IX hereto.
Chapter V
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Article 10.
Annulment of the following regulations of the Government's Decree No.
109/2016/ND-CP dated July 01, 2016 on issuance of practice certificates to
healthcare practitioners and operating licenses to the health facilities
1. Clause 1dd, Article 7.
2. Clause 17, 18 and 19 of Article
22.
3. Clause 3a, Article 23.
4. Clause 5b, 5c and 5k of Article
23.
5. Clause 2b and 2c, Article 24.
6. Clause 3, clause 5, Article 24.
7. Clause 2a, 2c and 2d, Article
25.
8. Clause 3a, Article 25.
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10. Clause 1a, 1d, 1dd and 1e of
Article 26.
11. Sub-point 9, Clause 1c, Article
26.
12. Clause 2a, Article 26.
13. Clause 1a, 1d and 1dd, Article
27.
14. Second subpoint of Clause 2a,
Clause 3a, Article 27.
15. Subpoints 10 and 11 of Clause
1a, Clause 1b and Clause 1c of Article 28.
16. Clause 3a and subpoint 3 of
Clause 3b, Article 28.
17. Clause 1b and 1c of Article 29.
18. Clause 2, Article 29.
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20. Clause 1a, 1d and 1dd, Article
30.
21. Clause 2a, Article 30.
22. Clause 3a, Article 30.
23. Subpoints 2 and 3 of Clause 3b,
Article 30.
24. Clause 4a, Article 31.
25. Clause 5, Article 31.
26. Clause 2b, Clause 3b and Clause
4a, Article 32.
27. Article 33, 34, 35, 36, 37 and
38.
28. Clause 1b and 1c, Clause 2a,
Article 39.
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1. Clause 1b, Article 4 is amended
as follows:
“b. Issuance of a modified
practice certificate in case of change in contents of an issued practice
certificate, including:
- Supplement the practice scope
specified on the practice certificate when the practitioner applies for
supplementation of a practice scope of a speciality different from the one
specified in the practice certificate.
If the technical skills of one
speciality are different from those of the speciality specified in the practice
certificate, the practitioners may only practice these skills after receiving
the certificate of training in practicing such technical skills. This
certificate must be issued by a legal training institution. Also, these skills
must be approved in writing by the chief physician of the health facility
without the need to supplement the practice scope specified on the practice
certificate.
- Supplement the practice scope
specified on the practice certificate when the practitioner applies for a
change of a speciality different from the one specified on the practice
certificate.”
2. Article 7 is amended as follows:
“Article 7. Application
documents for modification of practice certificates
1. An application for
supplementation to the practice scope specified on the practice certificate
shall contain:
a. An application form using form No.
05 in Appendix I hereto.
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c. A valid of copy of a training
qualification or a certificate issued by a legal training institution. The
maximum training period is 6 months and must be conformable with the
supplemented practice scope.
3. Article 22 is amended as
follows:
"Article 22. Forms of
organization of health facilities
The health facilities must be
established in accordance with the law and must conform to one of the following
forms of organization:
1. Hospital, including general
hospital and specialized hospital.
2. Infirmaries of People's Public
Security Forces.
3. Polyclinic.
4. Specialized clinic, including:
a. General medicine clinic.
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c. Clinic providing healthcare
consultancy or clinic providing healthcare consultancy by using information
technology and telecommunications.
Specialized clinic, including:
dd. Antenatal clinic.
e. Clinic of andrology.
g. Clinic of odonto-stomatology.
h. Clinic of otolaryngology.
Clinic of ophthalmology.
k. Clinic of cosmetology.
l. Clinic of rehabilitation.
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n. Clinic of oncology.
o. Clinic of dermatology.
p. Clinic of traditional medicine;
q. Clinic of dietetics.
r. Clinic of drug rehabilitation.
s. Clinic of HIV/AIIDS treatment.
t. Laboratory.
u. Image diagnosis clinic, X-ray
room.
v. Opioid substitution treatment
clinic which implements the regulations specified in the Government's Decree
No. 90/2016/ND-CP dated July 01, 2016 on treatment for opioid substitution.
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y. Occupational health clinic.
z. Other specialized clinics.
5. Family medicine facilities (or
healthcare facilities operated in the principle of family medicine): pilot
establishment as prescribed by the Minister of Health.
6. Maternity ward.
7. Medical service providers,
including:
a. Injection, dressing change,
pulse counting and temperature and blood pressure measurement service provider.
b. Home healthcare service
provider.
c. Facilities providing emergency
and patient transportation services in Vietnam or abroad.
d. Optical glasses service
provider.
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e. Other healthcare service
providers.
8. Commune-level health stations,
infirmaries.
9. Medical assessment facility and
forensic examination facility providing medical examination and treatment shall
be organized as a health facility specified in Clause 3 of this Article. Mental
forensics examination facility providing medical examination and treatment
shall be organized as a health facility specified in Clause 1 and Clause 3, or
Clause 4m of this Article. Such facilities shall satisfy the applicable
requirements.
10. Any medical facility affiliated
to an agency, unit or organization which conducts healthcare must be operated
in a form specified in Clause 3 or Clause 4a of this Article and must comply
with the requirements applied to such form of organization.
11. Any medical center having a
function of conducting medical examination and treatment shall be issued with a
license to operate in form of a general hospital or a polyclinic and shall
comply with the requirements applied to such form of organization. If the
hospital is granted a license to operate in form of a general hospital, it
shall be ranked as level IV, if it is granted a license to operate in form of a
polyclinic, its rank shall correspond with its scale.
12. If the health facilities
satisfy the requirements for healthcare service providers specified in this
Decree, their scale and practice scope shall be supplemented accordingly.
4. Article 23a is added as follows:
“Article 23a. General requirements
for issuance of operating licenses to healthcare facilities
1. Facility requirements:
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b. Radiation safety and fire safety
are ensured in accordance with regulations of law.
c. There is a separated area for
sterilizing reusable medical instruments, unless there are no reusable
instruments or the healthcare facility has a contract with another healthcare
facility for sterilization of reusable instruments.
2. Medical equipment:
a. Sufficient medical equipment
must be provided and be suitable to the practice scope of the health facility.
b. An occupational health service
provider must have at least a Biochemistry Laboratory Department.
c. Clinic providing healthcare
consultancy or clinic providing healthcare consultancy by using information
technology and telecommunications is not required to have the medical equipment
specified in points a and b of this Clause. However, it must have sufficient
information technology and telecommunications which are suitable to the
registered practice scope.
3. Personnel:
a. Each health facility must have a
chief physician. The chief physician and the deans of specialized departments
of the health facility must:
- Be a doctor with a practicing
certificate which is suitable to the practice scope of such facility.
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- Any chief physician of the
following specialized clinics shall satisfy the corresponding conditions as
follows:
+ Clinic of rehabilitation: being a
doctor with a practice certificate relevant to physical therapy or
rehabilitation.
+ Clinic for drug rehabilitation:
being a psychiatric doctor or a general practitioner with a certificate of
training in psychiatry or a traditional medicine practitioner with a
certificate of training in drug rehabilitation using traditional medicine.
+ Clinic of HIV/AIDS treatment:
being a doctor of infectious disease speciality or a general practitioner with
a certificate of training in HIV/AIDS treatment.
+ Clinic of traditional medicine:
Being a traditional medicine practitioner.
+ Traditional medicine facility:
Being a herb doctor or a practitioner who is granted a certificate of
traditional medicine prescription and treatment.
+ Clinic of dietetics: being a
nutrition expert or a general practitioner with a certificate of training in
dieting, or a preventive medicine doctor with a certificate of training in
dieting or a bachelor in dieting; or a traditional medicine doctor with a
certificate of training in dieting or a bachelor in dieting; or a physician
with a certificate of training in dieting.
+ Clinic of cosmetic: Being a
plastic surgeon or a Cosmetological doctor or a cosmetic surgeon.
+ Clinic of andrology: Being an
adrological doctor or a general doctor with a certificate of training in
andrology.
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+ Laboratory: Being a doctor or a
physician specialized in testing with a bachelor degree or higher and a
practice certificate for testing; or a chemical or biological bachelor, or a
pharmacist with a bachelor degree. This requirement is applicable to those who
are recruited to work in the laboratory before this Decree takes effect and are
physicians who are granted practice certificates for testing.
+ Image diagnosis clinic, X-ray
room: Being an image diagnosis doctor or have a bachelor’s degree of X-ray
therapy or higher, or have a practice certificate.
- Have provided medical examination
and treatment for at least 36 months after being granted a practice
certificate, or have directly participated in providing medical examination and
treatment for at least 54 months. The chief physician of the health facility
must be assigned in writing to carry out the tasks.
- He/she must work on a full-time
basis at the health facility.
b. Aside from the chief physician,
other practitioners working in the health facility must have practice
certificates and shall only provide medical examination and treatment within
the assigned practice scope. The chief physician of the health facility shall
assign the practitioners in writing to undertake the specialized tasks based on
the practice scope, qualifications and certificates of training and the
potential of such practitioners.
c. A testing physician with a
bachelor degree is qualified for reading and signing the testing results. If
the health facility does not have any general doctor who conducts the testing
or a testing physician who has a bachelor degree, the doctor who recommends the
testing must read and sign the testing results.
d. The bachelor who specializes in
X-ray therapy is qualified to read and interpret medical images. If the health
facility does not have an image diagnosis doctor or a radiologist, the doctor
who recommends an imaging test must read and sign the image diagnostic results.
dd. Other entities that participate
in the provision of medical examination and treatment but are not required to
obtain practice certificates according to the Law on Medical Examination and
Treatment must be allowed to perform the tasks assigned by the chief physician
(medical physicists, radiation physicians, speech therapists, psychotherapists
and other entities). Such entities must be assigned tasks which are suitable to
their specialized qualifications.
4. Health facilities must satisfy
the following requirements:
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b. Have clinical and paraclinical
departments, as well as sufficient personnel and equipment used for providing
medical examination and detecting the health conditions of patients based on
the health standards and medical forms which are enclosed with the documented
guidelines on medical examination.
5. Cosmetological service providers
are not required to obtain operating licenses but shall have a proof document
proving their eligibility for providing Cosmetological services. Such document
must be made by using the form specified in Appendix VIII hereto. They shall
send this form to the Department of Health where their head office is located,
at least 10 days before the operation.
Any Cosmetological service which
involves the intervention of drugs, substances and equipment in human bodies
(surgery, operation, injection, augmentation, ray emission, wave, firing and
other types of intervention) that change the color of skin, shape, weight and
shortcomings of human bodies (skin, nose, eyes, lips, face, breasts, belly,
buttock and other body parts), or services of doing tattoos and microblading.
Anesthetic is injected to the human bodies while providing the aforesaid
services and is only used in hospitals having Cosmetological specialists or
Cosmetological clinics or healthcare facilities with the practice scope in
Cosmetological speciality approved by the competent authorities.”
5. Article 23 is amended as
follows:
“Article 23. Requirements
for issuance of the operating licenses to the hospitals
Aside from the requirements
specified in Article 23a hereof, the hospitals must also satisfy the following
requirements:
1. Scale of hospitals:
a. A general hospital must have at
least 30 patient beds.
b. A specialized or traditional
hospital must have at least 20 patient beds. Particularly, an ophthalmologic or
a psychiatric hospital must have at least 10 patient beds.
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Aside from the requirements
specified in Article 23a hereof and depends on the scale of the hospital, a
specialized or a general hospital must be designed and built in accordance with
the following requirements:
a. Departments, rooms and hallways
must be arranged conveniently for technique expertise under the interconnected
and self-contained complex model within the hospital premises.
b. As for a general and a
specialized hospital, there must be a minimum construction floor area of 50 m2
per patient bed; the hospital façade must be at least 10m.
c. There must be a stand-by
generator.
d. Requirements for medical waste
treatment must be satisfied according to the regulations on environment.
3. Medical equipment: There must be
sufficient emergency vehicles for transporting patients in and out of the
hospital. If there are no emergency vehicles providing out-of-hospital
treatment, a contract must be signed with a health facility which has been
granted an operating license and its practice scope includes the provision of
emergency transport services.
4. Organization:
a. Departments:
- There must be at least 02 of 04
departments of internal medicine, surgery, obstetrics and pediatrics,
applicable to general hospitals, or an appropriate clinical department,
applicable to specialized hospital.
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- The paraclinical department shall
have at least one unit for testing and one unit for image diagnostic. Any
ophthalmologic hospital having no image diagnostic unit must have a contract
concluded with a healthcare facility having an operating license and with an
image diagnostic unit.
- Pharmaceutical department.
- Other specialized departments and
sections must be suitable to the scale, functions and tasks of the hospital.
b. There must be departments of
general planning, organization and personnel, quality control, convalescence,
finance and accounting and other necessary departments.
5. Personnel:
a. The number of full-time
(tenured) practitioners in each department must account for at least 50% of the
total number of practitioners in such department.
b. The deans of specialized
departments of the hospital must have practice certificates which are suitable
to such departments and must be the full-time practitioners at the hospital.
c. Deans of other departments who
are not granted the practice certificates must have bachelor degrees in the
specialities suitable to the assigned tasks. Also, they must be full-time
practitioners at the hospital.
“Article 24. Requirements for
issuance of operating licenses to infirmaries affiliated to People’s Police
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1. Scale:
a. Have at least 10 patient beds.
b. Have at least 02 departments
specialized in internal medicine and surgery, including emergency rooms;
patient rooms; and a paraclinical department.
2. Facilities: Have consulting
rooms, emergency rooms, patient rooms and laboratories with an area sufficient
for the use of means and instruments serving the medical examination and
treatment."
7. Article 25 is amended as follows:
“Article 25. Requirements
for issuance of the operating license to polyclinics
Aside from the requirements
specified in Article 23a hereof, the polyclinics must also satisfy the
following requirements:
1. Scale of a polyclinic:
a. Have 02 of 04 specialized
departments of internal medicine, surgery, obstetrics and pediatrics.
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2. Facilities: Have emergency
rooms, patient rooms, specialized consulting rooms and minor surgery rooms (if
any minor surgery is carried out). The area of the rooms within the polyclinic
must be sufficient for performing specialized techniques.
3. Have anti-shock first aid kits
and sufficient specialized emergency drugs.
4. Personnel:
The number of full-time doctors
must account for at least 50% of the total number of doctors of the polyclinic.
The persons in charge of the specialized consulting rooms and the paraclinical
department (units of testing and image diagnostic) which are affiliated to the
polyclinic, must work on a full-time basis.
8. Article 26 is amended as
follows:
“Article 26. Requirements
for issuance of operating licenses to specialized clinics
Aside from the requirements
specified in Article 23a hereof and except those applied to the chief
physicians, the specialized clinics must also satisfy the following
requirements:
1. Facilities:
a. If any operation is conducted,
including implanting operation, acupuncture, massage or acupressure, the
operation room must be located in a separate area. The area of the operation
room must be sufficient for performing specialized techniques.
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c. There must be a biochemistry
department for diagnosing and treating occupational diseases.
2. Medical equipment: Have
anti-shock first aid kits and sufficient specialized emergency drugs.”
9. Article 30 is amended as
follows:
“Article 30. Requirements
for issuance of operating licenses to maternity wards
1. Aside from the requirements
specified in Article 23a hereof, the maternity wards shall satisfy the
following requirements:
a. Facilities:
- Functional rooms must be
interconnected and convenient for emergency and medical examination and
treatment.
- There must be rooms for pre-natal
and gynecological checkup and for lying-in women. These rooms must have
sufficient area for performing specialized techniques.
b. Medical equipment:
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- Have anti-shock first aid kits
and sufficient specialized emergency drugs.
2. The chief physician of the
maternity ward must:
a. Be a gynecological doctor or a
midwife who has a bachelor degree and a practice certificate.
- Have conducted examination and
treatment in gynecology for at least 36 months after being granted a practice
certificate, or have participated directly in providing medical examination and
treatment for at least 54 months. Such chief physician of the maternity ward
must be assigned in writing to carry out the aforesaid tasks.
3. Any maternity ward eligible for
providing pediatric healthcare services according to the regulations in Article
27 hereof or providing vaccines according to the law on immunization, may add
such specialities to its practice scope.”
10. Article 33a is added as
follows:
“Article 33. Requirements
for issuance of operating licenses for healthcare service providers
1. Facilities must satisfy the
requirements specified in Clause 1a, Article 23a hereof.
- If the healthcare service
provider also provides optical glasses service, its area must be at least 15 m2.
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2. Medical equipment:
Aside from the requirements
specified in Clause 2a, Article 23a hereof, if the healthcare service provider
also provides:
a. Injection, dressing change,
pulse counting and temperature and blood pressure measurement, then it must
have anti-shock first aid-kits.
b. Emergency transportation, then
it must have ambulances, anti-shock first aid kits and sufficient specialized
emergency drugs. In case of registration for patient transportation abroad,
such provider must have emergency transportation contracts signed with an
aviation service company.
3. Personnel:
Aside from the requirements
specified in Article 23a hereof and those applicable to the chief physician, if
the healthcare service provider also provides:
a. Emergency transportation, the
chief physician must satisfy the following requirements:
- Be a doctor with a practice
certificate.
- Have specialized qualifications
or certificates of recuperation and first aid.
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c. Optical glasses services, then
the chief physician must have an intermediate or higher degree in medicine, a
practice certificate and a certificate of training in ophthalmology or
refractive eye defect.
d. Cosmetological services, then
the person doing tattoos or embroidering pictures on the surface of the skin
without use of anesthetics in injection form at a Cosmetological service
provider, shall possess a certificate of study in the corresponding speciality
lawfully issued by a training institution or a vocational training facility.
dd. If the home healthcare service
providers also provide services including dressing change, suture removal,
physical therapy, rehabilitation, mother and baby care, collection of blood
samples for testing, result provision, care of patients with cancer and other
home nursing services, then the chief physician must have an intermediate or
higher degree in medicine and a practice certificate. Also, he/she must have
provided medical examination and treatment for at least 45 months."
11. Article 45b is added as follows:
“Article 45b. Issuance,
re-issuance and revocation of the certificates of traditional medicine
prescription and treatment
1. Application documents for
issuance or re-issuance of the Certificate of Traditional Medicine Prescription
and Treatment (hereinafter referred to as “Certificate”):
a. Application for the new
Certificate shall contain:
- An application form for the
Certificate using form No. 01 in Appendix XV hereto.
- A written interpretation of the
traditional medicine prescription and treatment, using form No. 02 in Appendix
XV hereto.
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- 2 color photos of 2 x 6 cm, with
a white background. Such photos must be taken within 06 months before the date
of submission.
b. Application documents
- An application form for
re-issuance of the Certificate, using form No. 04 in Appendix XV hereto.
- A medical certificate which is
made within 06 months, before the date of submission.
- 2 color photos of 2 x 6 cm, with
a white background. Such photos must be taken within 06 months before the date
of submission.
2. Procedures for issuance of the
Certificate of Traditional Medicine Prescription and Treatment:
a. The applicant shall send 01
application dossier to the Department of Health of the same province. After
receiving the application, the Department of Health shall issue the written
confirmation to the applicant, using form No. 05 in Appendix XV hereto.
b. If the application is deemed
unsatisfactory, within 05 working days from the date on which the application
is received, the Department of Health shall send a written notification to the
applicant to request for additional documents.
Within 60 days from the date on
which the written notification is received, if the applicant does not provide
additional documents, the application will be invalidated. If needed, the
applicant shall submit a new application for issuance of the new Certificate.
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c. Within 30 days from the date on
which the application from the Department of Health is received, the Oriental
Medicine Association shall respond in writing, using form No. 03 in Appendix XV
hereto.
d. After the written advice from
the Oriental Medicine Association is received, the Department of Health shall
organize a council meeting to appraise such application.
dd. Within 10 working days from the
date on which the meeting minute of the Appraisal Council is received, the
Department of Health shall issue the Certificate, using form No. 06 in Appendix
XV hereto, or reject the application and provide explanations in writing.
3. The Director of the Department
of Health shall issue, re–issue or revoke the Certificate.
4. Cases where the Certificate is
revoked:
a. The Certificate is issued ultra
vires.
b. The contents of the Certificate
violate the law regulations.
c. The Appraisal Council
established by the Department of Health concludes that the applicant makes
serious mistakes that cause negative effects to the health and lives of
patients.
d. The applicant who is granted the
Certificate falls into the cases mentioned in clause 4, Article 18 of the Law
on Medical Examination and Treatment."
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“The polyclinics within the
areas where inpatients stay and are established and operated before this Decree
takes effect shall implement the regulations hereof. This requirement also
applies to those within the mountainous areas and remote and isolated areas and
is approved in writing by the People’s Committees of provinces and Departments
of Health.
Chapter VI
COSMETIC PRODUCTS
Article 12.
Annulment of some documents and regulations on cosmetic products
1. Annul the following regulations
of the Government’s Decree No. 93/2016/ND-CP dated July 01, 2016 on
requirements for the manufacture of cosmetic products:
a. Clause 1, Article 3.
b. Clause 3c and 3e, Article 4.
c. Clause 1d, Article 7.
d. Clause 2b, Article 7.
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a. Clause 2, Article 4.
b. Clause 1b, 1d and 1g of Article
34.
c. Clause 1, Article 35.
Article 13.
Amendments to clause 3a, Article 4 of the Government's Decree No. 93/2016/ND-CP
dated July 01, 2016 on requirements for the manufacture of cosmetic products
“a. Raw materials, auxiliary
materials and semi-finished products which are used to manufacture cosmetic
products must satisfy the quality standards adopted by the manufacturer.”
Chapter VII
PREVENTION AND CONTROL OF COMMUNICABLE DISEASES
Article 14.
Annulment to some Articles on prevention and control of communicable diseases
1. Annul the following Articles of
the Government's Decree No. 103/2016/ND-CP dated July 01, 2016 on biosafety in
laboratories:
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b. Clause 1d, Article 4.
c. Clause 1a, 1c, 1d, 1dd and 1e of
Article 5.s
d. Clause 2b and 2c, Article 5.
dd. Clause 3b and 3d, Article 5.
e. Clause 4b, 4c, 4dd, 4e and 4g,
Article 5.
g. Clause 2c, Article 6.
h. Clause 4b, Article 6.
Clause 1dd, Article 7.
k. Clause 2c, Article 7.
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m. Clause 1d, 1e, 1h, Article 11.
n. Clause 4b, Article 11.
2. Annul the following Articles of
the Government’s Decree No. 104/2016/ND-CP dated July 01, 2016 on vaccination:
a. Clause 1c, Article 8.
b. Clause 1b, 1c, 1d, 1dd and 1e,
Article 9.
c. Clause 2b and 2d, Article 9.
d. Clause 1b, Article 10.
3. Annul Circular No.
43/2011/TT-BYT dated December 05, 2011 of the Ministry of Health on management
of infectious specimens.
Article 15.
Amendments to some Articles on prevention and control of communicable diseases
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Clause 1d, Article 4 is amended as
follows:
“d. If the testing facilities
specified in points a, b, c of this Clause have the equipment for storing the
specimens and satisfy the regulations on standard practice, they are allowed to
store, retain, use, research, exchange and dispose blood specimens, serum
specimens, urine samples, fecal samples, secretion specimens and other
specimens from human bodies which may or may not spread communicable diseases,
as well as other micro-organisms specimens which may cause communicable
diseases for people.”
b. Clause 1b, Article 5 is amended
as follows:
“b. Emergency eye wash kits
and first aid kits.”
c. Clause 1, Article 9 is amended
as follows:
“1. Level I, level II and
level III biosafety-testing facilities must comply with the requirements for
facilities, equipment, employees and practices; restoration, maintenance and
calibration of testing equipment and supervision of practices in the laboratory."
d. Clause 1, Article 10 is amended
as follows:
“1. The Minister of Health
shall conduct inspections, issue, re-issue or revoke the Certificates of
Satisfaction of Biosafety Standards for level III biosafety-testing facilities
(hereinafter referred to as "Certificate of Biosafety”), excluding testing
facilities under the management of the Ministry of National Defense.
dd. Clause 1b, Article 11 is
amended as follows:
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e. Clause 2c and 2dd, Article 11
are amended as follows:
“c. A report on changes in
employees (if any)."
“dd. A report on changes to
facilities.”
g. Clause 1, Article 17 is amended
as follows:
“1. The Ministry of Health
shall conduct regular or irregular inspections of testing facilities which have
obtained the Certificate of biosafety of level III and the testing facilities
which have declared themselves that they satisfy the biosafety standards of
level I or level II nationwide.”
h. Clause 2, Article 19 is amended
as follows:
“2. Annually, the level III
biosafety laboratories must organize rehearsal of prevention and remedy for
biosafety incidents according to the regulations of the Minister of Health.”
Clause 4, Article 20 is amended as
follows:
“4. If an incident happening
in a biosafety laboratory of level II and level III is spread widely, seriously
influence the population communities or national security, the handling and
remedy for such incident must comply with the provisions in section 2, Chapter
IV of the Law on Prevention and Control of Communicable Diseases."
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“1. The health quarantine
officer shall collect:
a. The Declaration of biological
products, tissues and human body organs which are imported for the purpose of
prevention, research, diagnosis and treatment of diseases.
b. The Ministry of Health’s
declaration and license for import of blood specimens, serum specimens, urine
samples, fecal samples, secretion specimens and other specimens from human
bodies which may or may not spread communicable diseases, as well as other
micro-organisms specimens which may cause communicable diseases for people.
These specimens and samples are imported for the purpose of prevention,
research, diagnosis and treatment of diseases.
2. The application for import shall
contain:
a. An application form for the
import license, using form No. 25 in Appendix hereto.
b. A copy of the written approval
from a competent agency which allows the execution of the research project or
topic. Such approval must still be effective. Or a copy of the approved outline
or approved document of the project, or a copy of an effective agreement, or
related documents on the import of specimens between domestic and foreign
facilities.
c. A copy of the self-declaration
about the ability to satisfy the biosafety standards. Such declaration is made
by the biosafety laboratory level I and II. Or a copy of the Certificate of
Biosafety-Testing Facility from the biosafety laboratory level III.
3. Procedures for issuance of the
import license:
a. The applicant shall send 01
application in person or by post to the Ministry of Health.
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c. If the application is deemed
unsatisfactory, within 10 days from the date on which the application is
received, the Ministry of Health shall send a written notification to the
applicant to request for additional documents.
d. Within 30 days from the date on
which the written notification from the Ministry of Health is received, the
applicant shall provide additional documents as required. If the aforesaid
period ends and the applicant does not provide additional documents, it shall
re-apply for the import license.
dd. If the additional documents are
deemed unsatisfactory, the Ministry of Health shall send a written notification
to the applicant as specified in point c of this clause. If the additional
documents are deemed satisfactory, the Ministry of Health shall issue the
import license according to point b of this clause.”
3. Amend some articles of the
Government’s Decree No. 104/2016/ND-CP dated July 01, 2016 on vaccination:
a. Clause 1d, Article 8 is amended
as follows:
“d. There must be equipment
for monitoring temperature of vaccines throughout the transport, storage and
handling of products. Temperatures shall be recorded during transport and
delivery. Storage temperatures shall be checked and recorded at least twice a
day.”
b. Clause 1a, Article 9 is amended
as follows:
“a. The vaccination area must
be protected from rain and sunlight. Also, it must be airtight and airy and be
arranged according to a flow pattern, including: welcoming patients, providing
them guidance and counsel, performing screening tests, giving vaccination,
monitoring and handling responses of post-vaccination."
c. Clause 3b, Article 9 is amended
as follows:
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d. Clause 1c, Article 10 is amended
as follows:
“c. It has adequate insulated
containers and anti-shock kits according to the regulations of the Minister of
Health.”
dd. Clause 2b, Article 10 is
amended as follows:
“b. Facilities must be
arranged according to a flow pattern, including: welcoming patients, providing
them guidance and counsel, performing screening tests, giving vaccination,
monitoring and handling responses of post-vaccination."
e. Clause 2c, Article 10 is amended
as follows:
“c. Equipment: Have insulated
containers and anti-shock kits according to the regulations of the Minister of
Health.”
g. Clause 2d, Article 10 is amended
as follows:
“d. Personnel: Have at least
02 health workers who satisfy the requirements specified in Clause 3b, Article
9 hereof.”
h. Clause 2, Article 11 is amended
as follows:
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Chapter VIII
PREVENTION AND CONTROL OF HIV/AIDS
Article 16.
Annulment of some Articles on prevention and control of HIV/AIDS
1. Annul the following regulations
of the Government’s Decree No. 75/2016/ND-CP dated July 01, 2016 on conditions
for HIV testing:
a. Article 3.
b. Clause 1b, Article 5.
c. Clause 2b, Article 5.
2. Annul the following regulations
of the Government's Decree No. 90/2016/ND-CP dated July 01, 2016 on treatment
for opioid substitution:
a. Clause 1b, 1c and 1d of Article
12.
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c. The sentence "The quantity
of full-time employees must reach 75% or above of the total quantity of
employees within the establishment" specified in Clause 3h, Article 12.
d. Clause 1b, Article 13.
3. Annul Circular No.
15/2013/TT-BYT dated May 24, 2013 on quality assurance and HIV testing
techniques.
Article 17.
Amendments to some Articles of the Government's Decree No. 75/2016/ND-CP dated
July 01, 2016 on conditions for HIV testing
1. Article 4 is amended as follows:
“1. HIV screening tests
conducted by the laboratories:
Personnel:
There must be testers who:
- Have specialized high school
diplomas or higher in one of the following majors: Medicine, Pharmacy, Biology
or Chemistry.
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b. The laboratory must have
equipment used for testing and storing biologicals and specimens and is
suitable to HIV testing techniques adopted by such laboratory.
c. Facilities: There must be a
permanent location.
2. HIV screening tests in the
community:
a. The testers must have knowledge
about counseling and HIV tests and shall conduct HIV tests in accordance with
the instructions of the manufacturer.
b. There must be equipment used for
testing and storing biologicals and is suitable to the HIV biological being
used."
2. Clause 1a, Article 5 is amended
as follows:
“1a. The chief technician
must have at least a bachelor’s degree in medicine, pharmacy, biology or
chemistry, as well as having experience in HIV testing for 06 months or
above."
3. Clause 3, Article 5 is amended
as follows:
“3. The facilities must
satisfy the following requirements:
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b. Testing tables must be easily
cleaned with common detergents, placed at sufficiently lighted and windless
positions.
c. Hand washing stations must be
available.
d. There must be equipment or
methods for treating wastes before they are moved to the common garbage
dump."
4. Clause 4c, Article 5 is amended
as follows:
“c. Receive accurate testing
results of reference samples from an HIV testing laboratory recognized by the
Ministry of Health.”
Chapter IX
REPRODUCTIVE HEALTH
Article 18.
Annulment of some Articles on reproductive health
1. Annul Article 7 of the
Government’s Decree No. 88/2008/ND-CP dated August 05, 2008 on sex
reassignment.
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3. Annul Circular No.
29/2010/TT-BYT dated May 24, 2010 on guiding some Articles of the Government’s
Decree No. 88/2008/ND-CP dated August 05, 2008 on sex reassignment.
Article 19.
Amendments to some Articles on reproductive health
1. Amendments to the Government’s
Decree No. 88/2008/ND-CP dated August 05, 2008 as follows:
a. Article 8 is amended as follows:
“Article 8. Requirements
for health facilities to be licensed to conduct medical intervention for sex
reassignment
A health facility will be licensed
to conduct medical intervention for sex reassignment if it satisfies the following
requirements:
1. Be a public general or
specialized hospital which has departments of surgery, obstetrics and
pediatrics and is located in a province or a central-affiliated city, or a
private hospital which has departments of surgery, obstetrics and pediatrics.
2. Its practice scope of medical
intervention for sex reassignment is approved a competent authority.”
b. Article 10 is amended as
follows:
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2. Amend the Government’s Decree
No. 10/2015/ND-CP dated January 28, 2015 on giving birth through in vitro
fertilization and conditions for altruistic gestational surrogacy
a. Clause 2, Article 7 is amended
as follows:
“2. Medical facilities,
equipment and personnel performing in vitro fertilization shall include:
a. Facilities:
- Have an intensive care unit.
- Conduct reproductive
endocrinology tests.
- Have a unit performing in vitro
fertilization and include the following sections: oocyte retrieval; sperm
collection; vitro culture; sperm testing and washing; such sections must
satisfy the standards established by WHO.
b. Medical equipment:
Have at least 02 CO2 incubators;
02 ovens for heat sterilizing; 01 sperm tank; 01 centrifuge; 01 embryo
cryopreservation tank; 01 vagina ultrasound machine; 01 inverted microscope; 02
stereo zoom microscopes; 01 laminar flow cabinet.
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The technicians directly perform in
vitro fertilization shall satisfy the following requirements:
- There must be 02 doctors who are
trained in performing in vitro fertilization and 02 employees who have
bachelor's degrees in medicine, pharmacy or biology and are trained in clinical
embryology.
- 02 clinical doctors must have
practice certificates according to the Law on Medical Examination and
Treatment.
- Employees must have
qualifications or certificates of training in in vitro fertilization. Such
certificates or qualifications must be granted by a domestic or foreign
training institution.
- The employees must be confirmed
in writing that they have provided fertility treatment by using in vitro
fertilization technology for at least 20 periods. Such written confirmation
must be issued by the Ministry of Health.
b. Amend form No. 02 (Appraisal
Document) of the laboratory eligible for performing in vitro fertilization and
storing sperm and eggs. Such form is enclosed with the Government’s Decree No.
10/2015/ND-CP dated January 28, 2015.
Chapter X
IMPLEMENTATION
Article 20.
Entry into force
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Article 21.
Transitional clauses
1. Transitional clauses for Decree
No. 89/2018/ND-CP:
a. The units granted the import and
export licenses before this Decree takes effect shall continue to import
specimens according to the contents specified in such licenses.
b. If the units applying for the
import and export licenses submit their applications before this Decree takes
effect but are not granted the licenses, they shall import the specimens
according to the regulations specified in this Decree.
2. Transitional clauses for Decree
No. 103/2016/ND-CP:
a. The testing facilities which are
granted the certificates shall continue maintaining the required conditions
within the effective period of such Certificates and shall submit
self-declarations or apply for the re-issuance of the certificates before the
expiration date as specified in the Decree No. 103/2016/ND-CP and this Decree.
b. The testing facilities which
have submitted self-declarations about their ability to satisfy the biosafety
standards shall continue maintaining the required conditions mentioned in the
Decree No. 103/2016/ND-CP and this Decree.
c. The testing facilities that are
newly built or upgraded after this Decree takes effect shall satisfy the
biosafety requirements suitable to each level, according to the regulations in
the Decree No. 103/2016/ND-CP and this Decree.
3. Transitional clauses for the
Decree No. 104/2016/ND-CP:
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b. The vaccination clinics which
have submitted the declarations about their eligibility for vaccination shall continue
maintaining the conditions mentioned in the Decree No. 104/2016/ND-CP and this
Decree.
c. The vaccination clinics, which
operate after this Decree takes effect, shall satisfy the requirements
specified in the Decree No. 104/2016/ND-CP and this Decree.
4. Transitional clauses for the
Decree No. 54/2017/ND-CP:
a. If the applications for the
practice certificates or the Certificates of Eligibility for Pharmacy Business
or the import and export licenses which are specified in the Decree No.
54/2017/ND-CP are submitted before this Decree takes effect, they shall be
processed according to the regulations in the aforesaid Decree.
b. The medicinal materials, which
are used for producing drugs and are licensed before this Decree takes effect,
shall continue to be imported until the expiration date of the license.
c. The drugs which are procured by
the retailers in the health facilities before this Decree takes effect shall
comply with the regulations in the Decree No. 54/2017/ND-CP .
5. Transitional clauses for the
Decree No. 109/2016/ND-CP:
The applications submitted to
request for the practice certificates or the operating licenses before this
Decree takes effect shall comply with the regulations in the Government’s
Decree No. 109/2016/ND-CP dated July 01, 2016.
Article 22. Responsibility
for implementation
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ON
BEHALF OF THE GOVERNMENT
THE PRIME MINISTER
Nguyen Xuan Phuc
APPENDIX
III
(to
the Decree No. 155/2018/ND-CP)
REVISION
OF SAMPLES ATTACHED TO THE DECREE NO. 91/2016/ND-CP DATED JULY 1, 2016
Appendix
VII
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1. Required information:
A letter of authorization must
comprise all of the following information:
- Name and address of the product’s
owner.
- Name and address of the
individual or institutional trustee.
- Scope of authorization (acting as
the bearer of registration of free sale of the product in Vietnam with respect
to authorization for product registration.)
- Trade name of the product held in
trust.
- Address of the manufacturer of
the product.
- Term of authorization.
- The product owner’s commitments
to providing the individual or institutional trustee with full product
information required for registration of free sale.
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2. If the product owner who
has already authorized an entity to register free sale of their product in
Vietnam and receive the number of registration for free sale wishes to
authorize another entity to do so in Vietnam before the expiry date of such
number, they must submit the new letter of authorization granted to the latter,
enclosing the written agreement on discontinuation of their role as the bearer
of registration for free sale, and the written request for withdrawal of the
number of registration for free sale from the former.
3. Consular legalization:
A letter of authorization issued by
a foreign entity requires consular legalization according to regulations in
force, except in case of exemption from consular legalization under a relevant
treaty of which Vietnam is a member.