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MINISTRY OF HEALTH OF VIETNAM
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THE SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
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No. 23/2021/TT-BYT
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Hanoi, December 09, 2021
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CIRCULAR
AMENDMENTS TO SOME LEGISLATIVE DOCUMENTS ISSUED BY THE
MINISTER OF HEALTH;
Pursuant to the Law on
Pharmacy dated April 06, 2016;
Pursuant to Population
Ordinance dated January 09, 2003;
Pursuant to Ordinance
on amendments to Article 10 of the Population Ordinance dated December 27,
2008;
Pursuant to the
Government’s Decree No. 104/2003/ND-CP dated September 16, 2003 on elaboration
of some Articles of the Population Ordinance;
Pursuant to the
Government’s Decree No. 98/2021/ND-CP dated November 08, 2021 on medical device
management;
Pursuant to the
Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 providing guidelines
for some articles and implementation of the Law on Pharmacy.
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At the request of the
Director of Department of Legal Affairs, the Director of Department of Medical
Equipment and Construction, the Director of Drug Administration of Vietnam, the
General Director of General Office for Population and Family Planning.
The Minister of Health
promulgates a Circular on amendments to some legislative documents issued by the
Minister of Health;
Article 1. Amendments
to some legislative documents on medical equipment, pharmacy and population
issued by the Minister of Health;
1. Amendments to Clause 1, Appendix III - List of type B, C, D
medical equipment that may be traded as if normal goods without submission of
declaration of eligibility to trade in medical equipment, issued together with
Circular No. 46/2017/TT-BYT dated December 15, 2017 of the Minister of Health
on guidelines for the Government's Decree No. 36/2016/ND-CP dated May 15, 2016
on management of medical equipment
“1. Type B home-use in
vitro diagnostic devices and HIV home-use in vitro diagnostic devices
2. The quote at Clause 1 Article 6 of Circular No.
11/2018/TT-BYT dated May 04, 2018 of the Minister of Health on drug/drug
ingredient quality shall be amended as follows:
“1. When applying for
marketing authorization of a drug/drug ingredient: The quality standards of
that drug/drug ingredient must conform to one of the following pharmacopeias at
the time of application:
3. Some Articles of Circular No. 32/2018/TT-BYT dated November
12, 2018 of the Minister of Health on marketing authorization of drugs and
medicinal ingredients shall be amended as follows:
a) Points e, g Clause 4
Article 23 shall be amended as follows:
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The CPP issued by the
competent authority in the country of origin certifies that the drug is granted
marketing authorization and has been marketed in reality. If this CPP is
not issued by the EMA, it is required to have legal documents issued by the
competent authority of the second country. The legal documents confirm that the
drug is granted marketing authorization and has been marketed in reality with
contents including: drug name, active ingredient, content, concentration
thereof, dosage form, name and address of the production establishment.
The competent authority in the country of origin (that have issued the
CPP) and the competent authority of the second country (that have issued the
legal documents) which confirm that the drug is granted marketing authorization
and has been marketed in reality shall be one of the competent authorities
specified in Clause 9 or Clause 10 Article 2 of this Circular;
g) Application for
marketing authorization of imported vaccines:
The CPP issued by the
competent authority in the country of origin certifies that the vaccine is
granted marketing authorization and has been marketed in reality. If this
CPP is not issued by the EMA, it is required to have legal documents issued by
the competent authority of the second country. The legal documents confirm that
the vaccine is granted marketing authorization and has been marketed in reality
with contents including: vaccine name, active ingredient, content,
concentration thereof, dosage form, name and address of the production
establishment. The competent authority in the country of origin (that
have issued the CPP) and the competent authority of the second country (that
have issued the legal documents) which confirm that the vaccine is granted
marketing authorization and has been marketed in reality shall be one of the
competent authorities specified in Clause 9 Article 2 of this Circular;
b) Clause 5 Article 23
shall be amended as follows:
“5. The application form
and other administrative documents shall bear the signature and seal. The
signature stamp is not acceptable). The registration and production
establishments may use digital signatures to sign their relevant documents. The
registration and use of digital signatures shall comply with the regulations of
Decree No. 130/2018/ND-CP dated September 27, 2018 of the Government on
guidelines for of the law on e-transactions of digital signatures and digital
signature authentication. The above documents shall be signed by:
a) President of the
Member Assembly, Board of Directors, General Director or Executive Director;
Directors of the registration and production establishments
b) Assigned person
according to regulations of the company's charter, the document on assignment
of work or other documents that prove the authority to sign of the signer;
c) A person authorized by
persons specified in Point a or Point b of this Clause.”
c) Clause 2a shall be
added to Clause 2 Article 25 as follows:
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The existing stability
studies at the time for submission of application shall be approved to consider
the expiry date of the drugs according to the opinions of the Marketing
Authorization Advisory Board in case the time for stability studies fails to
meet the requirements of the minimum time of study according to guidelines of
the ASEAN.
After issuance of the
marketing authorization, the establishment shall continue to submit the
stability study document (drug product) until the actual minimum time for
stability studies meets requirements of ASEAN on the Drug Administration in the
form of changes and amendments to regulations in Appendix II of Circular No.
32/2018/TT-BYT for consideration and update on the expiry date according to
regulations.
In case the drugs fail to
achieve the results of stability studies according to the outline in the
application, the establishment shall immediately report it to the Drug
Administration of Vietnam for submission to the Marketing Authorization
Advisory Board for consideration of the expiry date of the drugs.
According to the opinions
of the Marketing Authorization Advisory Board, the Drug Administration of
Vietnam shall consider and decide the expiry date of the drugs, including the
batches of drugs that have been produced according to the actual stability
studies.”
d) Clause 4 Article 47
shall be amended as follows:
“4. The classification of
proprietary drugs of drugs that have been granted market authorization shall be
updated as follows:
a) The drugs that have
been declared as proprietary drugs by the Ministry of Health and entirely
manufactured in the country with the management agency on the list specified in
Clause 9 or Clause 10, Article 2 of this Circular shall continue to be
classified as proprietary drugs in one of the following cases:
- The marketing
authorization is still valid, extended or amended that falls outside cases
specified at Point b, Clause 2, Article 55 of the Law on Pharmacy;
- The drugs granted new
marketing authorization in the form of re-registration specified in Circular
No. 44/2014/TT-BYT have the same formula, production process, raw material
quality standards, standards for the quality of the drug product as the
proprietary drugs that have been declared or changed relevant to the above
contents which have been approved by the management agency of Vietnam or the
host country. The registration establishment shall submit the dossier on update
on classification of proprietary drugs according to the regulations of Appendix
II issued with this Circular;
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b) The drugs that have
been produced at foreign countries, declared as proprietary drugs by the
Ministry of Health and granted marketing authorization in the country with the
management agency on the list specified in Clause 9 or Clause 10, Article 2 of
this Circular without being entirely manufactured in that country shall
continue to be classified as proprietary drugs in one of the following cases:
- The marketing
authorization is still valid, extended or amended that falls outside cases
specified at Point b, Clause 2, Article 55 of the Law on Pharmacy;
- The drugs granted new
marketing authorization in the form of re-registration specified in Circular
No. 44/2014/TT-BYT have the same formula, production process, raw material
quality standards, standards for the quality of the drug product as the
proprietary drugs that have been declared or changed relevant to the above
contents which have been approved by the management agency of Vietnam or the
host country.
- The drugs that have
change of the production establishment and have been granted new marketing
authorization meet the requirements specified in Clause 3 Article 9 of this
Circular;
The registration
establishment shall submit the dossier on update on classification of
proprietary drugs for three above cases according to the regulations of
Appendix II issued with this Circular;
c) The drugs that have
been declared as proprietary drugs by the Ministry of Health; entirely produced
in Vietnam or produced with one or some stages in Vietnam and the remaining
stages in the country with the management agency on the list specified in
Clause 9 or Clause 10, Article 2 of this Circular shall continue to be
classified as proprietary drugs in one of the following cases:
- The marketing
authorization is still valid, extended or amended that falls outside cases
specified at Point b, Clause 2, Article 55 of the Law on Pharmacy;
- The drugs granted new
marketing authorization in the form of re-registration specified in Circular
No. 44/2014/TT-BYT have the same formula, production process, raw material
quality standards, standards for the quality of the drug product as the
proprietary drugs that have been declared or changed relevant to the above contents
which have been approved by the management agency of Vietnam or the host
country. The registration establishment shall submit the dossier on update on
classification of proprietary drugs according to the regulations of Appendix II
issued with this Circular;
- The drugs that have
change of the production establishment and have been granted new marketing
authorization meet the requirements specified in Clause 3 Article 9 of this
Circular. The registration establishment shall submit the dossier on
update on classification of proprietary drugs according to the regulations of
Appendix II issued with this Circular;
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- The marketing
authorization is still valid, extended or amended that falls outside cases
specified at Point b, Clause 2, Article 55 of the Law on Pharmacy;
- The drugs granted new
marketing authorization in the form of re-registration specified in Circular
No. 44/2014/TT-BYT have the same formula, production process, raw material
quality standards, standards for the quality of the drug product as the
proprietary drugs that have been declared or changed relevant to the above
contents which have been approved by the management agency of Vietnam or the
host country.
- The drugs that have
change of the production establishment and have been granted new marketing
authorization meet the requirements specified in Clause 3 Article 9 of this
Circular;
The registration
establishment shall submit the dossier on update on classification of
proprietary drugs for three above cases according to the regulations of
Appendix II issued with this Circular;
dd) If the drugs have
been declared as proprietary drugs by the Ministry of Health, entirely produced
in the country with the management agency on the list specified in Clause 9 or
Clause 10, Article 2 of this Circular; then one, some or all technology for
production of the drugs is transferred to Vietnam and meets requirements
specified in Clause 2 Article 9 of this Circular, the drugs shall continue to
be classified as proprietary drugs when granted new marketing authorization The
production technology transfer drug register establishments at Vietnam shall
submit the dossiers on update on classification of proprietary drugs according
to the regulations of Appendix II issued with this Circular;
e) If the drugs have been
declared as proprietary drugs by the Ministry of Health, granted new marketing
authorization without being entirely produced in the country with the
management agency on the list specified in Clause 9 or Clause 10, Article 2 of
this Circular; then one, some or all technology for production of the drugs is
transferred to Vietnam and meets requirements specified in Clause 2 Article 9
of this Circular, the drugs shall continue to be classified as proprietary
drugs The production technology transfer drug register establishments at
Vietnam shall submit the dossiers on update on classification of proprietary
drugs according to the regulations of Appendix II issued with this Circular;
g) If the drugs that have
not been declared as proprietary drugs by the Ministry of Health meet
requirements specified in Clause 1 Article 9 of this Circular, the drugs shall
be classified as proprietary drugs The registration establishment shall submit
the dossier on update on classification of proprietary drugs according to the
regulations of Appendix II issued with this Circular;
dd) Point p Clause 1
Article 50 shall be amended as follows:
“p) The Drug
Administration of Vietnam shall declare the list of drugs classified as
proprietary drugs on the website of the Drug Administration.”
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g)
Section MiV-PA 38 at Section 6 shall be amended. Small changes (MiV-PA) shall
be approved before implementation of Appendix II. Big changes and small changes shall be applied to drugs and
medicinal ingredients that have been granted marketing authorization numbers of
Circular No. 32/2018/TT-BYT according to regulations at Appendix 01 issued with
this Circular;
h) Forms 14A/TT, 14B/TT,
14C/TT shall be added to Circular No. 32/2018/TT-BYT as prescribed in Appendix
02 issued together with this Circular;
i) The application for
renewal (Form 6B/TT) and the report on the circulation of drugs and medicinal
ingredients (Form 11/TT) shall be amended in Appendix 03 issued together
with this Circular.
4. Clause 2 Article 7 of Circular No. 01/2021/TT-BYT dated
January 25, 2021 of the Minister of Health on provision of guidance on some
contents for the local authorities to issue policies on commendation and
assistance for collectives and individuals who well perform population
work shall be amended as follows:
“2. According to the
guidance in the Circular, the Department of Health shall take charge and
cooperate with relevant provincial authorities and units in advising the
People's Committee of province to submit to the People's Council of provinces
for promulgation of the policies on encouragement, commendation, support in
cash or in kind to collectives and individuals who well perform the population
policies of the local authorities”.
Article 2: Entry into
force
1. This Circular comes
into force as of January 25, 2022.
2. Point c, Clause 5,
Article 1 of Circular No. 29/2020/TT-BYT dated December 31, 2020 of the
Minister of Health on amendments to and abrogation of some legislative
documents promulgated or jointly promulgated by the Minister of Health shall be
annulled.
Article 3. Transition
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Article 4.
Responsibility of implementation
Director of Department of
Legal Affairs, The Chief of the Ministry Office, Ministerial Chief Inspector,
Directors of Departments, General Directors of General Departments affiliated
to the Ministry of Health and relevant entities shall be responsible for the
implementation of this Circular.
PP. MINISTER
DEPUTY MINISTER
Do Xuan Tuyen
APPENDIX NO. 01
CONTENTS OF CHANGES 38 (MIV-PA38)
(Issued together with Circular No. 23/2021/TT-BYT dated December 09, 2021 of
the Minister of Health)
Contents of changes
38 (MiV-PA38)
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Conditions that must be
satisfied (C)
The drugs proposed for
classification of proprietary drugs shall fall into one of the cases
specified in Clause 4, Article 47 of this Circular.
Documents that must be
submitted (D)
1. The drugs have been
declared as proprietary drugs by the Ministry of Health, entirely produced in
the country with the management agency on the list specified in Clause 9 or
Clause 10, Article 2 of this Circular, granted new marketing authorization
in the form of re-registration specified in Circular No. 44/2014/TT-BYT under
the provisions of Point a, Clause 4, Article 47 of this Circular:
- Commitments made
according to Form 14A/TT on the proposed drugs and the declared proprietary
drugs.
2. The drugs have been
declared as proprietary drugs by the Ministry of Health, entirely produced in
the country with the management agency on the list specified in Clause 9 or
Clause 10, Article 2 of this Circular, granted new marketing authorization
according to regulations of Point a, Clause 4, Article 47 of this Circular
and have change of the production establishments:
- Commitments made
according to Form 14C/TT on the proposed drugs and the declared proprietary
drugs.
3. The drugs have been
produced at foreign countries, declared as proprietary drugs by the
Ministry of Health without being entirely produced in the country with the
management agency on the list specified in Clause 9 or Clause 10, Article 2
of this Circular and the marketing authorization of which is still valid,
extended or amended that falls outside cases specified in Point b, Clause 2
Article 55 of the Law on Pharmacy according to regulations at Point b, Clause
4 Article 47 of this Circular:
- CPP granted marketing
authorization by one of the competent authorities specified in Clause 9 or
Clause 10 Article 2 of this Circular;
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- CPP granted marketing
authorization by one of the competent authorities specified in Clause 9 or
Clause 10 Article 2 of this Circular;
- Commitments made
according to Form 14A/TT on the proposed drugs and the declared proprietary
drugs.
5. The drugs have been
produced at foreign countries, declared as proprietary drugs by the Ministry
of Health, without being entirely produced in the country with the management
agency on the list specified in Clause 9 or Clause 10, Article 2 of this
Circular, granted new marketing authorization according to regulations
of Point a, Clause 4, Article 47 of this Circular and have change of the
production establishments:
- CPP granted marketing
authorization by one of the competent authorities specified in Clause 9 or
Clause 10 Article 2 of this Circular;
- Commitments made
according to Form 14C/TT on the proposed drugs and the declared proprietary
drugs.
6. If the drugs have
been declared as proprietary drugs by the Ministry of Health, entirely
produced in Vietnam or produced with one or some stages in Vietnam and the
remaining stages in the country with the management agency on the list
specified in Clause 9 or Clause 10, Article 2 of this Circular, granted new
marketing authorization in the form of re-registration specified in Circular
No. 44/2014/TT-BYT under the provisions of Point b, Clause 4, Article 47 of
this Circular.
- Commitments made
according to Form 14A/TT on the proposed drugs and the declared proprietary
drugs.
7. The drugs have been
declared as proprietary drugs by the Ministry of Health, entirely produced in
Vietnam or produced with one or some stages in Vietnam and the remaining
stages in the country with the management agency on the list specified in
Clause 9 or Clause 10, Article 2 of this Circular, granted new marketing
authorization according to regulations of Point c, Clause 4, Article 47 of
this Circular and have change of the production establishments:
- Commitments made
according to Form 14C/TT on the proposed drugs and the declared proprietary
drugs.
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- CPP granted marketing
authorization by one of the competent authorities specified in Clause 9 or
Clause 10 Article 2 of this Circular;
9. The drugs have been
declared as proprietary drugs by the Ministry of Health, produced with one or
some stages in Vietnam (the remaining stages are not carried out in the
country with the management agency on the list specified in Clause 9 or
Clause 10, Article 2 of this Circular), granted new marketing authorization
in the form of re-registration specified in Circular No. 44/2014/TT-BYT
according to regulations of Point d, Clause 4, Article 47 of this Circular.
- CPP granted marketing
authorization by one of the competent authorities specified in Clause 9 or
Clause 10 Article 2 of this Circular;
- Commitments made
according to Form 14C/TT on the proposed drugs and the declared proprietary
drugs.
10. The drugs have been
declared as proprietary drugs by the Ministry of Health, produced with one or
some stages in Vietnam (the remaining stages are not carried out in the
country with the management agency on the list specified in Clause 9 or
Clause 10, Article 2 of this Circular), granted new marketing authorization
according to regulations of Point d, Clause 4, Article 47 of this Circular
and have change of the production establishments:
- CPP granted marketing
authorization by one of the competent authorities specified in Clause 9 or
Clause 10 Article 2 of this Circular;
- Commitments made
according to Form 14C/TT on the proposed drugs and the declared proprietary
drugs.
11. The drugs have been
declared as proprietary drugs by the Ministry of Health, entirely produced in
the country with the management agency on the list specified in Clause 9 or
Clause 10, Article 2 of this Circular, granted new marketing
authorization according to regulations of Point d, Clause 4, Article 47 and
the technology for production of the drugs is transferred to Vietnam:
- Commitments made
according to Form 14B/TT on the drugs that the technology for production is transferred
to Vietnam and the drugs that have been declared before the technology for
production is transferred to Vietnam.
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12. The drugs have been
declared as proprietary drugs by the Ministry of Health without being
entirely produced in the country with the management agency on the list
specified in Clause 9 or Clause 10, Article 2 of this Circular, granted new
marketing authorization according to regulations of Point e, Clause 4,
Article 47 and the technology for production of the drugs is transferred to
Vietnam:
- CPP of the drugs
before transfer of technology granted marketing authorization by one of the
competent authorities specified in Clause 9 or Clause 10 Article 2 of this
Circular;
- Commitments made
according to Form 14B/TT on the drugs that the technology for production is
transferred to Vietnam and the drugs that have been declared before the
technology for production is transferred to Vietnam.
- The proving documents
according to Appendix II of this Circular shall correspond to changes in
formulation, production process, standards for the quality of raw materials
and drug products to prove that the drugs that have been produced in Vietnam
are equivalent in the quality to the proprietary drugs before transfer (in
case of change of one of these contents).
13. The drugs have not
been declared, proposed for classification as proprietary drugs by the
Ministry of Health according to regulations at Point g, Clause 4 Article 47
of this Circular:
- CPP granted marketing
authorization by one of the competent authorities specified in Clause 9 or
Clause 10 Article 2 of this Circular for the drugs that have not been
entirely produced in the country with the management agency on the list
specified in Clause 9 or Clause 10, Article 2 of this Circular (except for
the drugs that have been produced in Vietnam)
- Preclinical and
clinical documents (attached to the approved instruction papers), except for
the drugs that have been granted marketing authorization according to the
ACTD or ICH-CTD including the clinical documents.