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MINISTRY OF
HEALTH OF VIETNAM
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SOCIALIST
REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
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No. 04/VBHN-BYT
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Hanoi, April 11,
2023
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CIRCULAR
GOOD
MANUFACTURING PRACTICES FOR PHARMACEUTICAL PRODUCTS AND PHARMACEUTICAL STARTING
MATERIALS
Circular No. 35/2018/TT-BYT dated November 22, 2018
of the Minister of Health of Vietnam on Goods Manufacturing Practices for pharmaceutical
products and pharmaceutical starting materials, effective as of January 10,
2019, is amended by:
Circular No. 29/2020/TT-BYT dated December 31, 2020
of the Minister of Health of Vietnam on amendments to and annulment of some
legislative documents promulgated or jointly promulgated by the Minister of
Health of Vietnam, effective as of February 15, 2021.
Circular No. 12/2022/TT-BYT dated November 21, 2022
of the Minister of Health of Vietnam on amendments to Circular No.
35/2018/TT-BYT dated November 22, 2018 of the Minister of Health of Vietnam
prescribing good manufacturing practices for pharmaceutical products and
pharmaceutical starting materials, effective as of January 5, 2023.
Pursuant to Law No. 105/2016/QH13 on Pharmacy
dated April 6, 2016;
Pursuant to Decree No. 54/2017/ND-CP dated May
8, 2017 of the Government of Vietnam elaborating on the Law on Pharmacy;
Pursuant to Decree No. 155/2018/ND-CP dated
November 12, 2018 of the Government of Vietnam on amendments to regulations
related to business conditions under state management of the Ministry of Health
of Vietnam;
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At the request of the Director of the Drug
Administration of Vietnam and the Director of the Traditional Medicine
Administration of Vietnam,
The Minister of Health of Vietnam hereby
promulgates a Circular on Goods Manufacturing Practices for pharmaceutical
products and pharmaceutical starting materials. [1]
Chapter I
GENERAL PROVISIONS
Article 1. Scope
This Circular provides for application and
promulgation of Good Manufacturing Practices for pharmaceutical products and
pharmaceutical starting materials (hereinafter referred to as “GMP”) and
inspection of GMP compliance.
Article 2. Interpretation of terms
For the purpose of this Circular, the following
terms shall be construed as follows:
1. “Good Manufacturing Practices” (GMP) means
a set of principles and standards for manufacture of pharmaceutical products
and pharmaceutical starting materials to ensure that pharmaceutical products
and pharmaceutical starting materials are consistently manufactured and controlled
to the quality standards appropriate to their intended use and as required by
the Marketing Authorization of pharmaceutical product and pharmaceutical
starting material.
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3. “Deficiency” means a deviation from GMP principles
or other applicable regulations on pharmacy management.
4. “GMP” stands for Good Manufacturing
Practices.
5. “WHO” stands for World Health
Organization.
6. “WHO - GMP” means Good Manufacturing
Practices of World Health Organization.
7. “PIC/S” stands for Pharmaceutical
Inspection Co-operation Scheme.
8. “PIC/S - GMP” means Good Manufacturing
Practices of Pharmaceutical Inspection Co-operation Scheme.
9. “EU” stands for European Union.
10. “EU - GMP” means Good Manufacturing
Practices of European Union.
11. “US” stands for United States.
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13.[2] “EU-GMP
equivalence” means GMP principles promulgated by pharmacy authorities of
SRA countries.
Chapter II
APPLICATION AND PROMULGATION OF GMP
Article 3. Documents about GMP principles
1.[3] The following GMP principles shall be
applied:
a) WHO GMP principles provided in the Appendix I
hereof and updated documents specified in Clause 4 of this Article;
b) Principles of WHO - GMP for biological medicinal
products derived from Human Blood or Plasma provided in the Appendix II hereof
and updated documents specified in Clause 4 of this Article;
c) GMP principles of Pharmaceutical Inspection
Co-operation Scheme provided in the Appendix I hereof and updated documents
specified in Clause 4 of this Article;
d) EU - GMP principles provided in the Appendix IV
hereof and updated documents specified in Clause 4 of this Article.
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2. The following GMP principles shall be
promulgated:
a) Principles of GMP for herbal pharmaceutical
products provided in the Appendix V hereof;
b) Principles of GMP for traditional pharmaceutical
products provided in the Appendix VI hereof;
c) Principles of GMP for prepared traditional
medicinal materials provided in the Appendix VII hereof.
3.[4] Application of other GMP principles:
a) For manufacturers of pharmaceutical products and
pharmaceutical starting materials other than excipients:
In addition to the GMP principles specified Clauses
1 and 2 of this Article, other GMP principles proved equivalent to EU - GMP
principles promulgated by pharmacy authorities of SRA countries may be applied.
Manufacturers of pharmaceutical products and pharmaceutical starting materials
that apply these GMP principles shall produce and certify translations in
accordance with regulations of law on notary and authentication; send these
transactions to Drug Administration of Vietnam for uploading onto its website
and the web portal of the Ministry of Health of Vietnam;
b) For manufacturers of excipients:
In addition to the GMP principles mentioned in
Point dd Clause 1 of this Article, manufacturers of may apply other GMP
principles of International Pharmaceutical Excipients Council (IPEC), the
Certification Scheme for Pharmaceutical Excipients (EXCiPACT), American
National Standards Institute (ANSI), United States Pharmacopeia (USP) or other
principles for manufacture of excipients applied by other excipient-related
international organizations or foreign regulatory authorities.
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a) If WHO makes any revision to GMP principles
(hereinafter referred to as “updated documents”) specified in Points a and b
clause 1 of this Article, within 3 months from the date on which updated
documents are published on WHO’s web portal; the Drug Administration of Vietnam
or the Traditional Medicine Administration of Vietnam shall, within its
jurisdiction, translate and publish the revisions on the web portal of the
Ministry of Health of Vietnam and the website of the Drug Administration of
Vietnam or Traditional Medicine Administration of Vietnam for retrieval,
updating and application by relevant entities;
b) If the Pharmaceutical Inspection Co-operation
System (PIC/S) or the European Union has the updated documents specified in
points c and d clause 1 of this Article, which have not been published on the
web portal of the Ministry of Health of Vietnam and the website of the Drug
Administration of Vietnam, manufacturers of pharmaceutical products and
pharmaceutical starting materials applying such documents shall do the
translation, certify translations in accordance with regulations of law on
notarization and authentication and send them to the Drug Administration of
Vietnam. Within 10 days from the date on which notarized and certified true
translations are received, the Drug Administration of Vietnam shall consider,
correct and publish them on the web portal of the Ministry of Health of Vietnam
and the website of the Drug Administration of Vietnam.
Article 4. Application of GMP principles
1. Manufacturers of pharmaceutical products and
pharmaceutical starting materials shall apply GMP principles specified in the
Appendix I or Appendix III or Appendix IV hereof and updated documents
specified in Clause 4 Article 3 hereof.
2. Manufacturers of biological medicinal products
derived from human blood or plasma shall apply GMP principles specified in the
Appendix II hereof and updated documents specified in Clause 4 Article 3
hereof.
3.[6] Manufacturers of herbal pharmaceutical
products and herbal pharmaceutical materials shall apply GMP principles
specified in Appendix V hereof.
4.[7] Manufacturers of traditional pharmaceutical
products in the form of extractions, pills, pellets, powders, medicinal liquor
or tinctures shall apply GMP principles specified in Part I – Appendix VI
hereof.
5. Manufacturers of traditional pharmaceutical
products in modern dosage forms (capsules, tablets, granules, liquid medicines
and other modern dosage forms) other than those specified in Clause 4 of this
Article shall apply GMP principles specified in Part II - Appendix VI hereof.
6. Manufacturers of prepared traditional medicinal
materials shall apply GMP principles specified in Appendix VII hereof.
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8. Manufacturers of herbal pharmaceutical products,
traditional pharmaceutical products and prepared traditional medicinal
materials shall apply GMP principles specified in the Appendix I or Appendix
III or Appendix IV hereof and updated documents specified in Clause 4 Article 3
hereof.
9.[8] Manufacturers of traditional pharmaceutical
products and prepared traditional pharmaceutical materials are permitted to
apply GMP principles specified in Part II Appendix VI or Appendix I or Appendix
III or Appendix IV or Appendix V hereof and updated documents specified in
Clause 4 Article 3 hereof.
10.[9] In addition to being manufactured by the
manufacturer applying corresponding GMP specified in this Article,
pharmaceutical products and pharmaceutical starting materials containing
beta-lactam antibiotics (Penicillins, Cephalosporins, Penems and equivalent),
cytotoxics, contraceptive sex hormones, vaccines, biologicals and
pharmaceutical products with special requirements specified in GMP (WHO-GMP,
PIC/S-GMP, EU-GMP and EU-GMP equivalence), must be manufactured at separate
facilities using separate equipment, and measures should be in place to prevent
the release of such pharmaceutical products, which is likely to affect the
environment and other pharmaceutical products manufactured in the same area.
For anti-cancer drugs, sex hormones and highly
active pharmaceutical ingredients that do not belong to the above groups of
pharmaceutical products, the necessity and level of segregation of facilities
and/or manufacturing equipment shall be determined on the basis of the risk
assessment and guidelines of the European Medicines Agency (EMA) or the World
Health Organization.
11.[10] Manufacturers of chemical
pharmaceutical products in the form of soft capsules, oral liquids and external
medicines (creams, gels, ointments and lotions) are entitled to manufacture
herbal pharmaceutical products from herbal extract, glue and granule which have
been standardized on production lines capable of producing the same dosage
forms, and must apply GMP principles specified in the Appendix I or Appendix
III or Appendix IV hereof and updated documents specified in Clause 4 Article 3
hereof.
12. Manufacturers of herbal pharmaceutical products
are entitled to manufacture herbal pharmaceutical products with added pure
ingredients extracted from essential oils, vitamins and minerals, and must
apply GMP principles specified in the Appendix V hereof.
13. Manufacturers of traditional pharmaceutical
products are entitled to manufacture traditional pharmaceutical products with
added pure ingredients extracted from essential oils, vitamins and minerals,
and must apply GMP principles specified in the Appendix VI hereof.
14. Manufacturers entering one or some stages of
the process of manufacturing pharmaceutical products and pharmaceutical
starting materials shall apply and comply with corresponding GMP principles
mentioned in Clauses 1, 2, 3, 4 and 5 of this Article.
15. Manufacturers of pharmaceutical products and
pharmaceutical starting materials shall apply updated documents specified in
Clause 3 Article 3 hereof within:
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b) 6 months in case of updates other than those
specified in Point a of this Clause, from the date on which updated documents
are published on the web portal of the Ministry of Health of Vietnam and the
website of the Drug Administration of Vietnam.
16.[11] Manufacturers of excipients
shall apply GMP principles and regulations of Appendix IIa hereof or other GMP
principles mentioned in Clause 3 Article 3 of this Circular and updated
documents mentioned in Clause 4 Article 3 of this Circular. In case WHO, IPEC,
EXCiPACT, ANSI, USP or other international organizations relevant to excipients
used for manufacture of drugs, cosmetics, foods publish updates to their GMP
principles (hereinafter referred to as “updated documents”) on their websites,
manufacturers of excipients shall apply the updated documents within:
a) 12 months in case of any change of premises or
manufacturing equipment, from the date on which updated documents are
published;
b) 6 months in case of updates other than those
specified in Point a of this Clause, from the date on which updated documents
are published.
Chapter III
INSPECTION OF GMP COMPLIANCE
Article 5. Documents used as basis for
inspection of GMP compliance
1. Documents used as basis for inspection of GMP compliance
by a pharmacy business establishment are those included in its application for
certificate of eligibility for pharmacy business (the establishment is not
required to submit these documents because they have been submitted when it
applies for the certificate of eligibility for pharmacy business) prescribed in
Article 38 of the Law on Pharmacy and Article 32 of the Government’s Decree No.
54/2017/ND-CP dated May 8, 2017 on guidelines for the implementation of the Law
on Pharmacy (hereinafter referred to as “the Decree No. 54/2017/ND-CP”).
Manufacturers of special-controlled pharmaceutical products must have the
documents prescribed in Article 38 of the Law on Pharmacy and Clause 31 Article
5 of the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on
amendments to some Articles related to business conditions under state
management of the Ministry of Health of Vietnam (hereinafter referred to as
“the Decree No.155/2018/ND-CP”).
Technical documents about a manufacturer shall be
prepared in accordance with guidelines for the site master file provided in the
Appendix VIII hereof or the site master file that is updated in the case of
change of scope of operation.
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3. If the manufacturer applying for certificate of
eligibility for pharmacy business sells pharmaceutical products and
pharmaceutical starting materials to wholesalers, retailers or health
facilities, documents about its technologies and personnel according to Clause
2 Article 32 of the Decree No. 54/2017/ND-CP are required when it applies for
both certificate of GDP compliance and certificate of eligibility for pharmacy
business. The receiving authority shall inspect its compliance with both GDP
and GMP in accordance with regulations on GDP.
Article 6. Sequence of inspection of GMP
compliance
1. Receipt of applications:
The manufacturer shall submit an application, which
includes the documents specified in Article 5 herein, accompanied by the
application fees in accordance with regulations of the Minister of Finance of
Vietnam to:
a) The Traditional Medicine Administration of
Vietnam if the manufacturer applies for the certificate for eligibility for
pharmacy business that allows manufacture of herbal materials, traditional
pharmaceutical products and prepared traditional medicinal materials at the
time of submission;
b) The Drug Administration of Vietnam if the
manufacturer applies for the certificate for eligibility for pharmacy business
that allows manufacture of pharmaceutical starting materials (excluding herbal
materials), chemical pharmaceutical products, herbal pharmaceutical products,
vaccines and biologicals;
c) The Drug Administration of Vietnam if the
manufacturer applies for the certificate for eligibility for pharmacy business
that allows manufacture of both one of the pharmaceutical products and
pharmaceutical starting materials specified in Point a of this Clause and one
of the pharmaceutical products and pharmaceutical starting materials specified
in Point b of this Clause at the time of submission.
2. Procedures for receiving and processing
applications:
Comply with Clause 2 and Clause 5 Article 33 of
Decree No. 54/2017/ND-CP and Clause 12 Article 5 of Decree No. 155/2018/ND-CP.
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Within 15 days from the date of issuing the
decision, the inspectorate shall carry out a site inspection of the
manufacturer.
Article 7. Procedures for inspection and
classification of GMP compliance
1.[12] Documents used during the inspection of GMP
compliance include: WHO - GMP or GMP documents specified in Clauses 2, 3, 4, 5
and 6 Article 4 of this Circular equivalent to the manufacturer’s manufacturing
operations.
2. Inspection procedures:
a) Step 1. The inspectorate shall publish the
decision on inspectorate establishment, purposes, contents and plan for the
inspection at the manufacturer;
b) Step 2. The manufacturer shall make a brief
introduction of its organizational structure, personnel and implementation or
application of GMP, or specific contents in conformity with the inspected
contents;
c) Step 3. The inspectorate shall carry out a site
inspection of the application of GMP at the manufacturer. If the manufacturer
enters one or some stages of the manufacturing process, only GMP applied to
such stages is inspected.
d) Step 4. The inspectorate shall have a talk with
the manufacturer about deficiencies found during the inspection (if any) and
assess the level of each deficiency; discuss with the manufacturer in case the
manufacturer does not agree with the inspectorate about the assessment of each
deficiency or level of GMP compliance;
dd) Step 5. An inspection record is prepared and
signed as follows:
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e) Step 6. The inspection record is completed as
follows:
The inspectorate shall make a GMP inspection report
using the Form No. 04 in the Appendix X hereof, list, analyze and classify
deficiencies that need to be rectified by the manufacturer, make a comparison
of corresponding regulations specified in legal documents and GMP, and assess
the level of GMP compliance. The deficiency classification and assessment of
level of GMP compliance (applied to each production line) are prescribed in the
Appendix IX hereof.
3. Level of GMP compliance:
The inspection of manufacturer's compliance with
GMP specified in Appendix IX hereof shall be carried out according to the
following 4 levels:
a) GMP level 1 manufacturer;
b) GMP level 2 manufacturer;
c) GMP level 3 manufacturer;
d) GMP level 4 manufacturer.
Article 8. Processing results of inspection of
GMP compliance
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Within 10 working days from the date of signing the
inspection record, the receiving authority shall request the Minister of Health
of Vietnam to issue the certificate of eligibility for pharmacy business and
issue the Certificate of GMP compliance according to Form No. 05 in the
Appendix X hereof if the manufacturer applies for both certificate of GMP compliance
and certificate of eligibility for pharmacy business.
2. If the GMP inspection report indicates that the
manufacturer complies with GMP at level 2 as prescribed in Point b Clause 3
Article 7 of this Circular:
a) Within 5 working days from the date of signing
the inspection record, the receiving authority shall send the GMP inspection
report to the manufacturer as prescribed in Point b Clause 6 Article 33 of the
Decree No. 54/2017/ND-CP.
b) Upon completion of deficiency rectification, the
manufacturer shall submit a rectification report including a plan and evidences
(such as documents, images, videos, certificates or other documentary
evidences) for completion of rectification of deficiencies specified in the GMP
inspection report.
c) Within 20 days from the receipt of the
rectification report, the receiving authority shall assess result of deficiency
rectification by the manufacturer and conclude the level of its GMP compliance.
To be specific:
- If the result of deficiency rectification makes
the manufacturer comply with GMP, the receiving authority shall request the
Minister of Health of Vietnam to issue the certificate of eligibility for
pharmacy business and the certificate of GMP compliance according to the Form
No. 05 in the Appendix X hereof if the manufacturer applies for both
certificate of GMP compliance and certificate of eligibility for pharmacy
business;
- If the result of deficiency rectification shows
that the manufacturer still fails to comply with GMP, the receiving authority
shall respond and provide explanation in writing.
d) Within 6 months from the date on which
additional documents are requested in writing by the receiving authority, the
manufacturer shall submit them as requested. If the manufacturer fails to
satisfy such request by the aforementioned deadline or the application is not
satisfactory within 12 months from the first time it is submitted, the
application will be rejected.
3. If the GMP inspection report indicates that the
manufacturer complies with GMP at level 3 as prescribed in Point c Clause 3
Article 7 of this Circular:
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Within 20 days from the receipt of the
rectification report, the receiving authority shall carry out a site inspection
of deficiency rectification at the manufacturer before concluding the level of
GMP compliance as prescribed in Point c Clause 2 of this Article.
4. If the GMP inspection report indicates that the
manufacturer complies with GMP at level 4 as prescribed in Point d Clause 3
Article 7 of this Circular:
Within 5 working days from the date of signing the
inspection record, the receiving authority shall send a notification of failure
to comply with GMP enclosed with a GMP inspection report to the manufacturer
and shall not issue the certificate of eligibility for pharmacy business.
5. In the cases where the manufacturer does not
agree with the deficiency stated by the inspectorate, within 30 days from the
date on which the inspectorate sends GMP inspection report or rectification
report, the manufacturer shall submit a written recommendation enclosed with
evidences (such as documents, images, videos and certificates) related to such
deficiency to the receiving authority.
Within 10 working days from the receipt of the
written recommendation, the receiving authority shall review GMP inspection
report and written recommendation submitted by the manufacturer, if necessary,
consult relevant exports and respond to the manufacturer in writing. The
written response must clearly specify agreements and disagreements with the
written recommendation submitted by the manufacturer and reasons for
disagreements. The abovementioned length of time shall not add to the time
limit for inspection.
6. Within 5 working days from the date of issuing
the certificate of eligibility for pharmacy business, the receiving authority
shall publish the following information on its website and web portal of the
Ministry of Health of Vietnam:
a) Name and address of the manufacturer;
b) Full name of the person in charge of pharmacy,
person in charge of quality assurance and number of his/her pharmacy practicing
certificate;
c) Number of the certificate of eligibility for
pharmacy business and Certificate of GMP compliance (if any);
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dd) Scope of operation of the manufacturer;
e) EU - GMP certificate number, validity period and
issuing authority if the manufacturer has its compliance with EU - GMP or
equivalent inspected by SRA.
Chapter IV
INSPECTION OF GMP COMPLIANCE AND MAINTENANCE THEREOF
Article 9. Periodic inspection of GMP compliance
1. GMP compliance by a manufacturer shall be
periodically inspected every 3 years from the date of signing the previous inspection
record (except surprise inspections or audits by the Ministry of Health of
Vietnam or the Department of Health).
2. In November, every receiving authority shall
publish the plan for periodic inspection of GMP compliance by manufacturers in
the succeeding year on its website and send it to manufacturers that are
mentioned in the plan. Regarding the manufacturer specified in Point c Clause 1
Article 6 of this Circular, the Drug Administration of Vietnam shall publish
and implement the periodic inspection plan, except in the cases where the
manufacturer applies for a particular inspection.
3. At least 30 days prior to the date of carrying
out periodic inspection of GMP compliance according to the published plan, the
manufacturer shall submit a report on its manufacture of pharmaceutical
products and pharmaceutical starting materials and GMP compliance (hereinafter
referred to as “operation and GMP compliance report”) according to the Form No.
2 in the Appendix X hereof enclosed with updated technical documents about
infrastructure, technologies and personnel of the manufacturer (in case any
change is made) to the receiving authority.
E.g.: If the estimated date of periodic inspection
of the manufacturer A is on August 18, 2018, the manufacturer A is required to
submit an operation and GMP compliance report to the receiving authority by
July 18, 2018.
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5. Within 45 days from the date on which the
operation and GMP compliance report is requested in writing by the receiving
authority, the manufacturer shall submit the report enclosed with a written
explanation for its delay in submission. By the aforementioned deadline, if the
manufacturer fails to submit the report, the receiving authority shall carry
out an surprise inspection or audit of GMP compliance by the manufacturer as
prescribed in Article 12 of this Circular.
6.[13] After submitting the operation and GMP
compliance report within the prescribed time limit, the manufacturer is
entitled to keep carrying out operations of the manufacturer of pharmaceutical
products and pharmaceutical starting materials under the Law on Pharmacy and
its related guiding documents until the result of periodic inspection of GMP
compliance is available, and shall ensure its maintenance of GMP compliance.
7.[14] Inspecting order and procedures for
inspecting and classifying results of inspection of GMP compliance are
prescribed in Articles 6 and 7 of this Circular.
If, in the event of any disaster, disease or war,
the receiving authority fails to carry out an inspection of GMP compliance as
prescribed, it shall verify the manufacturer’s GMP compliance status. Upon
completion of remedial actions, the receiving authority shall carry out an
inspection of maintenance of GMP compliance as prescribed in Articles 6 and 7
of this Circular.
Article 10. Processing of results of periodic
inspection of GMP compliance
1. If the GMP inspection report indicates that the
manufacturer complies with GMP at level 1 as prescribed in Point a Clause 3
Article 7 of this Circular:
Within 10 working days from the date of signing the
inspection record, the receiving authority shall update information about the
maintenance of GMP compliance by the manufacturer on its website and web portal
of the Ministry of Health of Vietnam as prescribed in Clause 6 Article 8 of
this Circular and issue the Certificate of GMP compliance according to Form No.
05 in the Appendix X hereof if the manufacturer applies for the certificate of
GMP compliance.
2. If the GMP inspection report indicates that the
manufacturer complies with GMP at level 2 as prescribed in Point b Clause 3
Article 7 of this Circular:
a) Within 5 working days from the date of signing
the inspection record, the receiving authority shall send the GMP inspection
report to the manufacturer so that it can rectify deficiencies and send a
rectification report to the receiving authority;
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c) Within 20 days from the receipt of the
rectification report, the receiving authority shall assess result of deficiency
rectification by the manufacturer and conclude the level of its GMP compliance.
To be specific:
- If the result of deficiency rectification makes
the manufacturer comply with GMP, the receiving authority shall update
information about the maintenance of GMP compliance by the manufacturer on its
website and web portal of the Ministry of Health of Vietnam as prescribed in
Clause 6 Article 8 of this Circular and issue the Certificate of GMP compliance
according to Form No. 05 in the Appendix X hereof if the manufacturer applies
for the certificate of GMP compliance;
- If the result of deficiency rectification shows
that the manufacturer still fails to comply with GMP, the receiving authority
shall request the manufacturer in writing to take more corrective actions
against deficiencies and submit an additional report. The manufacturer shall
have 45 days from the receipt of the written request to complete corrective
actions and send report thereof as requested.
d) Within 90 days from the date of signing the
inspection record, if the manufacturer fails to submit the rectification report
or still fails to comply with GMP after rectifying deficiencies, the receiving
authority shall send a notification of failure to comply with GMP and impose
one or some measures prescribed in Points a and b Clause 4 of this Clause
depending on the nature and level of non-compliance with GMP.
3. If the GMP inspection report indicates that the
manufacturer complies with GMP at level 3 as prescribed in Point c Clause 3
Article 7 of this Circular:
Processing order and time of result of inspection
of GMP compliance are specified in Clause 2 of this Article.
Within 20 days from the receipt of the
rectification report, the receiving authority shall carry out a site inspection
and supervision of deficiency rectification at the manufacturer before
concluding the level of GMP compliance as prescribed in Point c Clause 2 of
this Article.
4. If the GMP inspection report indicates that the
manufacturer complies with GMP at level 4 as prescribed in Point d Clause 3
Article 7 of this Circular:
Within 5 working days from the date of signing the
inspection record, according to the assessment of risks of deficiencies in the
quality of pharmaceutical products and pharmaceutical starting materials, and
pharmaceutical product user safety, the receiving authority shall send a notification
of failure to comply with GMP enclosed with a GMP inspection report. Depending
on the nature and level of non-compliance with GMP, the receiving authority
shall impose one or some of the following measures:
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b) Request the Minister of Health of Vietnam to
issue a decision on revocation of the certificate of eligibility for pharmacy
business as prescribed in Clause 2 Article 40 of the Law on Pharmacy and revoke
the certificate of GMP compliance (if any).
c) If the manufacturer is ineligible for one or
several business activities specified in its certificate of eligibility for
pharmacy business, the receiving authority shall:
- Request the Minister of Health of Vietnam to
issue a decision on revocation of the certificate of eligibility for pharmacy
business to remove the business activity for which the manufacturer is ineligible
and issue a new certificate of eligibility for pharmacy business which is
conformable with the business activity for which the manufacturer is eligible;
- Issue the certificate of GMP compliance which is
conformable with the business activity for which the manufacturer is eligible
if it so wishes.
5. Within 5 working days from the date of
concluding that the manufacturer maintains its compliance with GMP or issuing
the decision on revocation of the issued certificate of eligibility for
pharmacy business because of the manufacturer’s failure to maintain GMP
compliance, the receiving authority shall update GMP compliance status on its
website as prescribed in Clause 6 Article 8 of this Circular if the
manufacturer complies with GMP or information about the revocation of the
certificate of eligibility for pharmacy business or Certificate of GMP
compliance (if any) if the manufacturer fails to maintain its GMP compliance.
6. If it is concluded that a sample of
pharmaceutical product or pharmaceutical starting material collected by the
inspectorate during the inspection violates quality regulations, the receiving
authority shall handle it in accordance with applicable regulations.
Article 11. Control of changes
1. Before making one of the changes specified in
Points a and b of this Clause, a vaccine manufacturer shall send a notification
including the result of assessment of risks and effect of changes expected to
be made on the product quality and safety:
a) Changes specified in Points d, dd, e and g Clause
2 of this Article;
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Within 15 days, the Drug Administration of Vietnam
shall respond in writing in case it does not agree with the changes proposed by
the vaccine manufacturer.
2. After making any change, the manufacturer shall
apply for the certificate of eligibility for pharmacy business or submit a
report on its change using the Form No. 06 in the Appendix X hereof if:
a) Making one of the changes specified in Point b
Clause 1 Article 36 of the Law on Pharmacy; or
b) Changing the location of a factory at the same
business location; or
c) Opening a new factory at the same business
location; or
d) Expanding existing factory; or
dd) Repairing or having significant changes in
structure and floor plan of the premises and production line, which results in
changes to environmental conditions and manufacturing process; or
e) Changing important manufacturing equipment,
thereby affecting manufacturing process and quality of pharmaceutical products
and pharmaceutical starting materials; or
g) Changing auxiliary system or principle of
designing and operating utility systems, thereby affecting manufacturing
environment; or
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3. In case of changes specified in Point a Clause 2
of this Article, the manufacturer shall submit an application for the
certificate of eligibility for pharmacy business as prescribed in Clause 2 and
Clause 4 Article 38 of the Law on Pharmacy.
The order for inspecting, classifying, and
processing the result of inspection of GMP compliance is specified in Articles
6, 7 and 8 of this Circular.
4.[16] If the manufacturer makes one of the
changes prescribed in Point b, c or d Clause 2 of this Article or the
manufacturer of sterile pharmaceutical products and pharmaceutical starting
materials makes the change specified in Point dd, e or g Clause 2 of this
Article, the manufacturer is required to submit a report on its change, accompanied
by relevant technical documents, to the receiving authority.
a) The receiving authority shall carry out an
inspection at the manufacturing site. If the manufacturer complies with GMP,
the receiving authority shall grant a written consent to its changes;
b) The order for inspecting, classifying and
processing the result of inspection of GMP compliance in case of the change
specified in Point b Clause 2 of this Article is prescribed in Articles 6, 7
and 10 of this Circular;
c) Sequence of inspecting, classifying and
processing the result of inspection of GMP compliance in case of the change
made by the manufacturer specified in Point c or d Clause 2 of this Article or
the change made by manufacturer of sterile pharmaceutical products and
pharmaceutical starting materials specified in Point dd, e or g Clause 2 of
this Article is prescribed in Articles 6, 7 and 8 of this Circular.
5. In case of the change specified in Point h
Clause 2 of this Article, the manufacturer shall send a notification of change
of applied GMP and inspection by SRA at the manufacturer (name of SRA, date of
inspection, content/scope of inspection and inspection result) enclosed with
relevant technical documents, certificate of GMP compliance or GMP inspection
report issued by SRA.
a) The receiving authority shall review the
notification and enclosed documents and add/update information about compliance
with EU - GMP or equivalent by the manufacturer as prescribed in Clause 6
Article 8 of this Circular.
b)[17] (annulled).
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7.[19] If the manufacturer makes one of the
changes prescribed in Point dd, e or g Clause 2 of this Article (except for the
case specified in Clause 4 of this Article), the manufacturer is required to
submit a report on its change, accompanied by relevant technical documents, to
the receiving authority. The manufacturer shall keep carrying out manufacturing
operations in accordance with principles of GMP.
The receiving authority shall carry out a surprise
inspection and process the inspection result as prescribed in Article 12 of
this Circular if the change report on its change shows that the manufacturer
fails to maintain its GMP compliance.
Article 12. Unexpected inspection of GMP
compliance or audit of GMP compliance and maintenance thereof
1. Audit of GMP compliance and maintenance thereof
by manufacturers shall be conducted as prescribed by law.
2. A surprise inspection of GMP compliance and
maintenance thereof shall be carried out at the manufacturer in one of the
following cases:
a) The result of deficiency rectification by the
manufacturer shows it still fails to comply with GMP according to Sub-point 2
Point c Clause 6 Article 11 of this Circular;
b) The manufacturer that complies with GMP at level
3 or level 4 according to Points c and d Clause 3 Article 7 of this Circular
shall undergo an surprise inspection at least once within 3 (three) years from
the end of the previous inspection;
c) The manufacturer has at least 1 batch of
pharmaceutical products which is recalled because of first-degree violations;
d) The manufacturer has a pharmaceutical product
that is reported to have adverse effects, including serious ones;
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e) There is any complaint or denunciation that the
manufacturer seriously violates GMP;
g) The manufacturer fails to submit the operation
and GMP compliance report according to Clause 5 Article 9 of this Circular.
h) [20] The manufacturer produces
medicinal ingredients that are excipients.
3. The head of the receiving authority shall decide
on members of the inspectorate as prescribed in Article 15 of this Circular.
4. Order for conducting surprise inspections at a
manufacturer is mentioned in Article 7 of this Circular.
5. Results of surprise inspections or audits
conducted at a manufacturer shall be processed as prescribed by law.
Chapter V
INSPECTION OF GMP COMPLIANCE BY MANUFACTURERS NOT
REQUIRED TO OBTAIN CERTIFICATES OF ELIGIBILITY FOR PHARMACY BUSINESS AND
OVERSEAS MANUFACTURERS WHEN THEY APPLY FOR REGISTRATION OF PHARMACEUTICAL
PRODUCTS AND PHARMACEUTICAL STARTING MATERIALS IN VIETNAM
Article 13. Inspection of GMP compliance by
manufacturers not required to obtain certificates of eligibility for pharmacy
business
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2. The manufacturer not required to obtain the
certificate of eligibility for pharmacy business (except the health facility’s
division in charge of pharmaceutical product preparation) shall submit an
application form for inspection of GMP compliance using the Form No. 1 in the
Appendix X hereof and technical documents about the manufacturer, which shall
be prepared in accordance with guidelines for the site master file in the Appendix
VIII hereof in case of first inspection or manufacturing operation and GMP
compliance report enclosed with updated technical documents about the
manufacturer (if any change is made) according Clause 2 of Article 9 in case of
periodic inspection.
3. Inspecting orders and procedures for inspecting
and classifying results of inspection of GMP compliance, control of changes and
surprise inspection of GMP compliance by manufacturers of pharmaceutical
products and pharmaceutical starting materials not required to obtain
certificates of eligibility for pharmacy business are mentioned in Articles 6,
7, 9, 11 and 12 of this Circular.
4. Results of first inspection of GMP compliance by
a manufacturer of pharmaceutical products and pharmaceutical starting materials
not required to obtain the certificate of eligibility for pharmacy business
shall be processed as follows:
a) Sequence and time of processing result of first
inspection of GMP compliance by the manufacturer are mentioned in Article 8 of
this Circular.
b) The receiving authority shall send a
notification of status of GMP compliance by the manufacturer and publish it on
its website and web portal of the Ministry of Health of Vietnam as prescribed
in Clause 6 of this Article.
5. Results of surprise and periodic inspections of
GMP compliance by a manufacturer of pharmaceutical products and pharmaceutical
starting materials not required to obtain the certificate of eligibility for
pharmacy business shall be processed as follows:
a) If the inspection result shows that the
manufacturer complies with GMP at level 1 or level 2 or level 3 as prescribed
in Points a, b and c Clause 3 Article 7 of this Circular, the receiving
authority shall carry out inspection as prescribed in Clauses 1, 2 and 3
Article 10 of this Circular.
b) If the inspection result shows that the
manufacturer complies with GMP at level 4 as prescribed in Point d Clause 3
Article 7 of this Circular, the receiving authority shall carry out an
inspection and issue a decision on suspension of all manufacturing operations
or manufacturing operations that fail to comply with GMP until the result of
deficiency rectification by the manufacturer rectifies is satisfactory.
c) If it is concluded that a sample of
pharmaceutical product or pharmaceutical starting material collected by the
inspectorate during the inspection violates quality regulations, the receiving
authority shall handle it in accordance with applicable regulations on
management of quality of pharmaceutical products and pharmaceutical starting
materials. The head of the manufacturer shall be responsible to law for such
violation.
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a) Name and address of the manufacturer;
b) Full name of the person in charge of pharmacy,
person in charge of quality assurance and number of his/her pharmacy practicing
certificate;
c) Number of certificate of GMP compliance;
d) Expiry date of inspection of GMP compliance;
dd) Scope of operation of the manufacturer;
e) EU - GMP certificate number, validity period and
issuing authority if the manufacturer has its compliance with EU - GMP or
equivalent (if any) inspected by SRA.
Article 14. Inspection of GMP compliance by
overseas manufacturers when they apply for registration of pharmaceutical
products and pharmaceutical starting materials in Vietnam
1. Before submitting an application for inspection
of GMP compliance to the Ministry of Health of Vietnam (the receiving authority
specified in Clause 1 Article 6 of this Circular) shall have its GMP compliance
inspected and certified by a competent pharmacy authority of the home country.
2. Methods, contents, documentation, sequence,
procedures and power for inspection of GMP compliance by overseas manufacturers
are mentioned in Articles 96, 97, 98 and 99 of the Decree No. 54/2017/ND-CP.
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3.[21] Within 10 working days from the date on
which the result of inspection of GMP compliance by a manufacturer is obtained,
the receiving authority shall rely on the application for inspection of GMP
compliance, information obtained from the EMA’s database and websites of
pharmacy authorities around the world to update the result of inspection of GMP
compliance and publish the following information on its website and web portal
of the Ministry of Health of Vietnam:
a) Name and address of the manufacturer;
b) GMP principles (WHO-GMP, PIC/S-GMP, EU-GMP or
EU-GMP equivalence), period of validity of certificate of GMP compliance and
name of the regulatory authority competent to carry out assessment and
certification in the cases specified in Clauses 1 and 2 Article 96 of the Decree
No. 54/2017/ND-CP or date of GMP compliance inspection by the Vietnam Ministry
of Health of Vietnam, GMP documents applied and validity period of result of
inspection of GMP compliance in the case specified in Clause 3 Article 96 of
the Decree No. 54/2017/ND-CP;
c) Scope of operation of the inspected
manufacturer.
4.[22] Regulations on determination of the
validity period of certificate of GMP compliance specified in Point e Clause 6
of Article 13 and Point b Clause 3 of Article 14 during the Covid-19 pandemic
or in the event of a disaster, disease or war:
a) For the certificate of GMP compliance issued by
pharmacy authorities in countries in the European Economic Area - EEA:
- If the validity period of the manufacturer’s
certificate of GMP compliance is extended under the EMA’s Notice of regulatory
expectations for medicinal products for human use during the Covid-19 epidemic
or in the event of a disaster, disease or war: the validity period of the
certificate of GMP compliance shall comply with the EMA’s Notice;
- If the manufacturer has been issued with a new
certificate of GMP compliance, the validity period of the certificate of GMP
compliance is the same as that of the new one.
b) For the certificate of GMP compliance issued by
authorities other than those specified in Point a of this Clause: The validity
period of the certificate of GMP compliance during the Covid-19 epidemic or in
the event of a disaster, disease or war shall be determined under the notice
given by the pharmacy authority of each country which issued the certificate of
GMP compliance or is the same as that written on the certificate of GMP
compliance.
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INSPECTORATE CONDUCTING INSPECTIONS OF GMP COMPLIANCE
Article 15. Members and standards to be
satisfied by members of an inspectorate
1. An inspectorate includes:
a) The chief and 1 or 2 members of the receiving
authority. 1 or 2 members of the Traditional Medicine Administration of
Vietnam, regarding the manufacturer specified in Point c Clause 1 Article 6 of
this Circular;
b) 1 member: the representative of the National
Institute of Drug Quality Control or Institute of Drug Quality Control - Ho Chi
Minh City or National Institute for Control of Vaccine and Biologicals
(regarding the manufacturer of vaccines and biologicals);
c) 1 member: the representative of the Department
of Health of a province or centrally affiliated city (hereinafter referred to
as “the Department of Health”) where the factory is located.
d) Members of relevant authorities where necessary.
2. A member of the inspectorate must satisfy the
following standards:
a) He/she must obtain at least a bachelor’s degree
and has been provided with training medicine, pharmacy, biology, pharmaceutical
product quality management and pharmacy management;
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c) He/she must be honest, objective strictly comply
with regulations during the inspection and must not create any conflict of interest
with the inspected manufacturer as prescribed in Clause 3 of this Article;
d) The chief must have at least 3 (three) years of
experience in pharmacy management.
3. Rules for assessing the conflict of interest: A
member of the inspectorate shall be deemed to involve a conflict of interest
with the inspected manufacturer in one of the following cases:
a) He/she has worked or participated in providing
consulting services for the inspected manufacturer in the past 5 years;
b) He/she is receiving financial benefits
associated with the inspected manufacturer;
c) His/her spouse, child, parent, sibling or
parent-in-law is working for the inspected manufacturer.
Article 16. Rights and responsibilities of an
inspectorate
1. The inspectorate shall:
a) Inspect all operations of a manufacture
according to corresponding GMP prescribed in Article 3 of this Circular,
updated versions of GMP principles and relevant legislative documents and
regulations; clearly record inspection contents and deficiencies found, prepare
GMP inspection records and reports;
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c) Maintain confidentiality of all information
about the inspection and manufacturing operations, inspection of quality,
storage and distribution of pharmaceutical products (manufacturing, testing and
cleaning process, technological secrets, etc.) unless otherwise agreed upon by
the manufacturer or requested by the competent authority.
2. The inspectorate may:
a) Inspect all areas and premises of the
manufacturer and request inspection of other areas related to the manufacture,
storage and testing of pharmaceutical products and pharmaceutical starting
materials. Regarding manufacture of prepared traditional pharmaceutical
materials, inspect the prepared traditional pharmaceutical material processing
and manufacturing process.
b) Request the manufacturer to provide documents
concerning its quality management, manufacture, testing and storage of
pharmaceutical products and pharmaceutical starting materials;
c) Collect documentary evidences (by copying
documents, taking pictures or recording videos) of deficiencies found during
the inspection;
d) Take samples of pharmaceutical products, semi-finished
products and herbal materials to test their quality as regulated by law;
dd) Make inspection records and request the
manufacturer to suspend one, some or all of its manufacturing operations
related to violations. During the inspection, if the inspectorate finds that
the manufacturer commits a violation which seriously affects quality of one or
multiple pharmaceutical products and pharmaceutical starting materials, it is
required to notify the competent person thereof.
Chapter VII
IMPLEMENTATION PROVISIONS
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1. This Circular comes into force as of January 10,
2019.
2. The following documents and regulations shall
expire from the date this Circular comes into force:
a) Decision No. 3886/2004/QD-BYT dated November 03,
2004 of the Minister of Health of Vietnam;
b) Regulations on GMP specified in the Decision No.
27/2007/QD-BYT dated April 19, 2007 of the Minister of Health of Vietnam;
c) Regulations on GMP specified in the Circular No.
45/2011/TT-BYT dated December 21, 2011 of the Minister of Health of Vietnam;
Decision No. 2701/2001/QD-BYT dated June 29, 2001 of the Minister of Health of
Vietnam; Circular No. 06/2004/TT-BYT dated May 28, 2004; Decision No.
3886/2004/QD-BYT dated November 03, 2004 of the Ministry of Health of Vietnam;
Circular No. 13/2009/TT-BYT September 01, 2009 of the Ministry of Health of
Vietnam; Circular No. 22/2009/TT-BYT dated November 24, 2009 of the Ministry of
Health of Vietnam; Circular No. 2010/TT-BYT dated December 29, 2010.
d) Regulations on conditions for processing herbal
materials in the Circular No. 03/2016/TT-BYT dated January 21, 2016 of the
Minister of Health of Vietnam shall remain effective until December 31, 2020 according
to Clause 4 Article 19 of this Circular.
dd) Regulation: “If the test facility fails to
submit the application as prescribed, the Ministry of Health of Vietnam shall
revoke its certificate of eligibility for pharmacy business as prescribed in
Clause 2 Article 40 of the Law on Pharmacy” specified in Clause 5 Article 9 of
the Circular No. 04/2018/TT-BYT of the Minister of Health of Vietnam dated
February 09, 2018.
Article 18. Reference clause
If any legal document referred to this Circular is
amended, supplemented, or replaced, comply with its new edition.
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1. Any manufacturer of pharmaceutical products and
pharmaceutical starting materials that has been issued with the certificate for
eligibility for pharmacy business that allows manufacture of pharmaceutical
products and pharmaceutical starting materials or certificate of GMP compliance
before the effective date of this Circular is entitled to manufacture
pharmaceutical products and pharmaceutical starting materials until the expiry
date of such certificate.
If the certificate of eligibility for pharmacy
business expires, the manufacturer shall apply for the certificate of
eligibility for pharmacy business as prescribed by law.
If the certificate of GMP compliance expires before
the expiry date of the certificate of eligibility for pharmacy business, the
manufacturer shall apply for inspection of GMP compliance and maintenance
thereof according to Chapter IV of this Circular in order to keep operating as
prescribed.
2. Regarding the manufacturer of pharmaceutical
products and pharmaceutical starting materials that has been issued with the
indefinite term certificate for eligibility for pharmacy business that allows
manufacture of pharmaceutical products and pharmaceutical starting materials,
it shall, upon the expiry date of the certificate of GMP compliance, apply for
inspection of GMP compliance and follow relevant procedures as prescribed by
law.
3. Regarding applications for certificate of
eligibility for pharmacy business or applications for periodic inspection of
GMP compliance submitted to the receiving authority before the effective date
of this Circular, the receiving authority shall keep inspecting the
manufacturer according to GMP promulgated together with the Decision No.
3886/2004/QD-BYT dated November 03, 2004 of the Minister of Health of Vietnam
or regulations of this Circular if the manufacturer so requests.
4. If an herbal material trading establishment that
processes herbal materials has had its GMP compliance inspected and published
by the Traditional Medicine Administration of Vietnam on the web portal as
prescribed in the Circular No. 03/2016/TT-BYT dated January 21, 2016 of the
Minister of Health of Vietnam shall keep operating until December 31, 2020. By
January 01, 2021, every establishment manufacturing and processing herbal
materials and prepared traditional pharmaceutical materials shall submit an
application for the certificate of eligibility for pharmacy business that
allows processing of herbal materials and manufacture of and prepared
traditional pharmaceutical materials as prescribed in Article 5 of this
Circular and comply with manufacturing conditions prescribed in Articles 13,
14, 15, 16, 17, 18, 19 and 20 of the Circular No. 03/2016/TT-BYT dated January
21, 2016 of the Minister of Health of Vietnam. Documentation and procedures for
conducting inspections and processing inspection results are mentioned in
Articles 5, 6, 7 and 8 of this Circular.
5.[24] For any manufacturer issued with a
certificate of GMP compliance which covers the manufacture of herbal
pharmaceutical products and remains effective before the effective date of this
Circular, it is entitled to manufacture traditional pharmaceutical products.
Article 20. Implementation responsibilities
1. The Drug Administration of Vietnam shall:
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b) Within its jurisdiction, instruct Departments of
Health, health authorities and manufacturers of pharmaceutical products and
pharmaceutical starting materials to implement this Circular;
c) Consolidate and publish the list of
manufacturers that have been granted the certificate of eligibility for
pharmacy business and/or Certificate of GMP compliance, status of such
certificates, status of GMP compliance and other information on its website
according to Clause 6 Article 8 of this Circular within its jurisdiction;
d) Publish updated GMP documents on its website and
the web portal of the Ministry of Health of Vietnam;
dd) Take charge or cooperate with the Ministry
Inspectorate in inspecting and auditing GMP compliance and take actions against
violations within its power.
2. The Traditional Medicine Administration of
Vietnam shall:
a) Within its jurisdiction, instruct Departments of
Health, health authorities and manufacturers of pharmaceutical products and
pharmaceutical starting materials to implement this Circular;
b) Consolidate and publish the list of
manufacturers that have been granted the certificate of eligibility for
pharmacy business or Certificate of GMP compliance, status of such
certificates, status of GMP compliance and other information on its website
according to Clause 6 Article 8 of this Circular within its jurisdiction;
c) Take charge or cooperate with the Ministry
Inspectorate in inspecting and auditing GMP compliance and take actions against
violations within its power.
3. Departments of Health shall:
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b) Join the inspectorate conducting inspections of
GMP compliance; within their power, supervise and takes actions against
violations against regulations on GMP compliance by manufacturers of
pharmaceutical products and pharmaceutical starting materials within provinces.
4. The National Institute of Drug Quality Control,
Institute of Drug Quality Control - Ho Chi Minh City and National Institute for
Control of Vaccine and Biologicals shall join the inspectorate conducting
inspections of GMP compliance upon request.
5. Manufacturers of pharmaceutical products and
pharmaceutical starting materials shall:
a) Organize the implementation of this Circular;
b) Ensure their compliance with GMP during their
operation;
c) Carry out manufacturing operations within the inspected
and licensed scope according to regulations of law.
dd)[25] Manufacturers of drug
products and semi-finished products shall, on the basis for the purposes and
uses of the excipients at the manufacturing facility, carry out self-assessment
of compliance to GMP principles specified in Point dd Clause 1 Article 3 and
Point b Clause 3 Article 3 of this Circular regarding the recipients used at
the facility.
Difficulties that arise during the implementation
of this Circular should be reported to the Ministry of Health (Drug
Administration of Vietnam or Traditional Medicine Administration of Vietnam)
for consideration./.
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VERIFICATION OF
INTEGRATED DOCUMENT
PP. MINISTER
DEPUTY MINISTER
Do Xuan Tuyen
[1] Circular No. 29/2020/TT-BYT dated December
31, 2020 of the Minister of Health of Vietnam on amendments to and annulment of
legislative documents promulgated or jointly promulgated by the Minister of
Health of Vietnam has the following promulgation grounds:
“Pursuant to the Law on Promulgation of
Legislative Documents dated June 22, 2015 and the Law on Amendments to the Law
on Promulgation of Legislative Documents dated June 18, 2020;
Pursuant to the Law on Pharmacy dated April 6,
2016;
Pursuant to the Law on Tobacco Harm Prevention
and Control dated June 18, 2012;
Pursuant to Decree No. 54/2017/ND-CP dated May
8, 2017 of the Government of Vietnam elaborating on the Law on Pharmacy;
Pursuant to Decree No. 69/2018/ND-CP of the
Government of Vietnam dated May 15, 2018 on elaboration of the Law on Foreign
Trade Management;
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Pursuant to Decree No. 15/2018/ND-CP dated
February 2, 2018 of the Government of Vietnam on elaboration of some articles
of the Law on Food Safety;
Pursuant to Decree No. 34/2016/ND-CP of the
Government of Vietnam dated May 14, 2016 on elaboration of the Law on
Promulgation of Legislative Documents;
Pursuant to Decree No. 75/2017/ND-CP dated June
20, 2017 of the Government of Vietnam on functions, tasks, entitlements, and
organizational structure of the Ministry of Health of Vietnam;
At the request of the Director of Department of
Legal Affairs of Vietnam;
The Minister of Health of Vietnam hereby
promulgates a Circular on amendments to and abrogation of some legislative
documents promulgated or jointly promulgated by the Minister of Health of
Vietnam.
Circular No. 12/2022/TT-BYT dated November 21, 2022
of the Minister of Health of Vietnam on amendments to Circular No.
35/2018/TT-BYT dated November 22, 2018 of the Minister of Health of Vietnam
prescribing good manufacturing practices for pharmaceutical products and
pharmaceutical starting materials has the following promulgation grounds:
“Pursuant to the Law on Pharmacy No.
105/2016/QH13 dated April 6, 2016;
Pursuant to Decree No. 54/2017/ND-CP dated May
8, 2017 of the Government of Vietnam elaborating on the Law on Pharmacy;
Pursuant to Decree No. 155/2018/ND-CP dated
November 12, 2018 of the Government of Vietnam on amendments to regulations
related to business conditions under state management of the Ministry of Health
of Vietnam;
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At the request of the Director of the Drug
Administration of Vietnam and the Director of the Traditional Medicine
Administration of Vietnam; the Minister of Health of Vietnam hereby promulgates
a Circular on amendments to some Articles of the Circular No. 35/2018/TT-BYT
dated November 22, 2018 of the Minister of Health of Vietnam prescribing Good
Manufacturing Practices for pharmaceutical products and pharmaceutical starting
materials.”.
[2] This Clause is amended by Clause 1 Article 1
of Circular No. 12/2022/TT-BYT, effective as of January 5, 2023
[3] This Clause is amended by Point a Clause 6
Article 1 of Circular No. 29/2020/TT-BYT, effective as of January 1, 2021
[4] This Clause is amended by Point b Clause 6
Article 1 of Circular No. 29/2020/TT-BYT, effective as of January 1, 2021
[5] This Clause is amended by Clause 2 Article 1
of Circular No. 12/2022/TT-BYT, effective as of January 5, 2023
[6] This Clause is amended by Clause 3 Article 1
of Circular No. 12/2022/TT-BYT, effective as of January 5, 2023
[7] This Clause is amended by Clause 4 Article 1
of Circular No. 12/2022/TT-BYT, effective as of January 5, 2023
[8] This Clause is amended by Clause 5 Article 1
of Circular No. 12/2022/TT-BYT, effective as of January 5, 2023
[9] This Clause is amended by Clause 6 Article 1
of Circular No. 12/2022/TT-BYT, effective as of January 5, 2023
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[11] This Clause is amended by Point c Clause 6
Article 1 of Circular No. 29/2020/TT-BYT, effective as of January 1, 2021
[12] This Clause is amended by Clause 8 Article
1 of Circular No. 12/2022/TT-BYT, effective as of January 5, 2023
[13] This Clause is amended by Clause 9 Article
1 of Circular No. 12/2022/TT-BYT, effective as of January 5, 2023
[14] This Clause is amended by Clause 10 Article
1 of Circular No. 12/2022/TT-BYT, effective as of January 5, 2023
[15] This Point is amended by Clause 11 Article
1 of Circular No. 12/2022/TT-BYT, effective as of January 5, 2023
[16] This Clause is amended by Clause 12 Article
1 of Circular No. 12/2022/TT-BYT, effective as of January 5, 2023
[17] This Point is annulled by Clause 1 Article
2 of Circular No. 12/2022/TT-BYT, effective as of January 5, 2023
[18] This Clause is annulled by Clause 2 Article
2 of Circular No. 12/2022/TT-BYT, effective as of January 5, 2023
[19] This Clause is amended by Clause 13 Article
1 of Circular No. 12/2022/TT-BYT, effective as of January 5, 2023
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[21] This Clause is amended by Clause 14 Article
1 of Circular No. 12/2022/TT-BYT, effective as of January 5, 2023
[22] This Clause is amended by Clause 15 Article
1 of Circular No. 12/2022/TT-BYT, effective as of January 5, 2023
[23] Articles 3, 4, and 5 of Circular No.
29/2020/TT-BYT prescribe as follows:
“Article 3. Entry into force
1. This Circular comes into force as of February
15, 2021.
2. Regulations of Clauses 5, 6, 7, 8 and 11
Article 1 of this Circular come into force from January 1, 2021.
3. Regulations on online submission and access
of documents shall apply during Covid-19 pandemic until revised by the Ministry
of Health of Vietnam.
Article 4. Transitional provisions
1. The documents that are submitted before the
effective date of this and are still processed will apply relevant regulations
of this Circular or the regulations that are effective before the effective
date of this Circular, whichever is more convenient for enterprises,
organizations and individuals.
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Article 5. Implementation responsibilities
Director of the Legal Department, the Chief of the
Ministry Office, the Ministerial Chief Inspector, Directors of Departments of
the Ministry of Health of Vietnam, relevant organizations and individuals are
responsible for the implementation of this Circular./.”
Articles 3 and 4 of Circular No. 12/2022/TT-BYT
prescribe as follows:
“Article 3. Entry into force
This Circular comes into force as of January 5,
2023.
Article 4. Implementation responsibilities
Chief of the Ministry Office, Director General
of Drug Administration of Vietnam, Director General of Traditional Medicine
Administration of Vietnam, the Chief Inspector of the Ministry, heads of units
owned by or affiliated to the Ministry of Health of Vietnam; Departments of
Health of provinces and centrally affiliated cities; pharmacy business establishments
and organizations and individuals concerned are responsible for the
implementation of this Circular. Difficulties that arise during the
implementation of this Circular should be reported to the Ministry of Health of
Vietnam (through the Drug Administration of Vietnam or the Traditional Medicine
Administration of Vietnam) for consideration and resolution./.”
[24] This Clause is amended by Clause 16 Article
1 of Circular No. 12/2022/TT-BYT, effective as of January 5, 2023
[25] This Point is amended by Point dd Clause 6
Article 1 of Circular No. 29/2020/TT-BYT, effective as of January 1, 2021