Thông tư 23/2021/TT-BYT sửa đổi một số văn bản quy phạm pháp luật

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.

Pursuant to Decree No. 75/2017/ND-CP dated June 20, 2017 of Government on functions, tasks, powers, and organizational structure of Ministry of Health of Vietnam;

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:

“e) Application for marketing authorization of imported modern drugs and biologicals other than probiotics:

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:

 “2a. The application for marketing authorization of the drug that meets urgent needs for prevention and control of epidemics is submitted before December 31, 2022:

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;

- 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;

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;

d) The drugs that have been declared as proprietary drugs by the Ministry of Health, 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 and produced with one or some stages on 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) 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;

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.”

e) The paragraph “2. Certificate of trademark registration for new drug name. In case of change of drug name due to intellectual property infringement on a protected trademark of another individual or organization, the registration establishment shall provide a document of the competent authority on intellectual property in order to confirm infringement with the above reason.” at regulation on Documents that must be submitted (D) Contents of changes 1 (MiV-PA1) Section 6 shall be annulled.  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;

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

The dossiers that have been submitted to the agency that receives the dossiers before the effective date of this Circular but are in the process of settlement shall be applied in accordance with the relevant regulations of this Circular or the regulations before the effective date of this Circular towards convenience for enterprises, organizations and individuals.

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.

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)

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