Circular No. 23/2021/TT-BYT amending and supplementing certain regulatory legal documents issued by the Minister of Health

CIRCULAR

AMENDMENTS AND SUPPLEMENTS TO CERTAIN LEGAL REGULATIONS

 ISSUED BY THE MINISTER OF HEALTH

Pursuant to the Medicine Law dated April 6, 2016;

Pursuant to the Population Ordinance dated January 9, 2003;

Pursuant to the Ordinance amending Article 10 of the Population Law dated December 27, 2008,

Pursuant to Decree No. 75/2017/NĐ-CP dated June 20, 2017 of the Government stipulating the functions, tasks, authorities, and organizational structure of the Ministry of Health;

Pursuant to Decree No. 98/2021/NĐ-CP dated November 8, 2021 of the Government on management of medical equipment;

Pursuant to the Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government detailing some provisions and measures for implementing the Medicine Law;

Pursuant to the Government's Decree No. 75/2017/NĐ-CP dated June 20, 2017 stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Legal Department, the Director of the Medical Equipment and Construction Department, the Director of the Drug Administration, and the Director General of the National Population and Family Planning Agency.

The Minister of Health promulgates this Circular to amend and supplement certain legal regulations issued by the Minister of Health.

Article 1. Amendments and supplements to certain legal regulations issued by the Minister of Health regarding medical equipment, drugs, and population control

"1. In vitro diagnostic self-testing medical equipment belonging to category B and in vitro diagnostic self-testing HIV medical equipment."

"1. For drugs and raw materials for drug production applying for a registration certificate: At the time of submitting the registration application, the drug quality standards must comply with the pharmacopoeia and meet one of the following two conditions:"

3. Amend and supplement certain articles of Circular No. 32/2018/TT-BYT dated November 12, 2018, of the Minister of Health on the registration of drug circulation and raw materials for drug production as follows:

a) Amend and supplement Points e and g of Clause 4 of Article 23 as follows:

"e) For new chemical drug registration applications and imported biological products, except probiotics (digestive enzymes):

A marketing authorization must be obtained from the competent authority of the producing country, confirming that the drug has been approved and is actually marketed in that country. If the marketing authorization is not issued by the European Medicines Agency (EMA), additional legal documents must be provided by the competent authority of another country confirming that the drug has been approved and is actually marketed in that country, including at least the following information: drug name, active ingredient, concentration or amount of active ingredient, dosage form, name and address of the manufacturing facility. The issuing authority of the marketing authorization or the issuing authority of the additional legal document must be one of the authorities specified in Clause 9 or Clause 10 of Article 2 of this Circular;

g) For vaccine import registration applications:

A marketing authorization must be obtained from the competent authority of the producing country, confirming that the vaccine has been approved and is actually marketed in that country. If the marketing authorization is not issued by the European Medicines Agency (EMA), additional legal documents must be provided by the competent authority of another country confirming that the vaccine has been approved and is actually marketed in that country, including at least the following information: vaccine name, active ingredient, concentration or amount of active ingredient, dosage form, name and address of the manufacturing facility. The issuing authority of the marketing authorization or the issuing authority of the additional legal document must be one of the authorities specified in Clause 9 of Article 2 of this Circular."

b) Amend and supplement Clause 5 of Article 23 as follows:

"5. The registration application and other administrative documents in the application dossier must be signed and stamped, and electronic signatures shall not be used. The registering entity and manufacturer may use digital signatures to sign relevant documents of the registering entity and manufacturer. The registration and use of digital signatures shall be carried out in accordance with the provisions of Government Decree No. 130/2018/NĐ-CP dated September 27, 2018, detailing the implementation of the Electronic Transactions Law on digital signatures and digital signature certification services. These documents must be signed by one of the following positions:

a) Chairman of the Board of Members, Board of Directors; General Director; Executive Director; Director of the registering entity and manufacturer;

b) A person designated according to the company's charter, work assignment documents, or other documents proving the signing authority of the signer;

c) A person directly authorized by those specified in Point a or Point b of this Clause."

c) Supplement Clause 2a after Clause 2 of Article 25 as follows:

"2a. For drugs meeting urgent needs for epidemic prevention submitted before December 31, 2022:

Accept pre-existing stability study data at the time of submission for consideration of the drug's shelf life based on the opinion of the Advisory Council for Drug Registration and Raw Material Certification, in cases where the duration of the drug's stability study data does not meet the minimum research period requirements as per ASEAN guidelines.

After obtaining the registration certificate, the entity must continue to submit finished product stability study reports until the actual research period meets the minimum stability study period requirements as per ASEAN guidelines to the Drug Administration through a change or supplementary provision in Appendix II of Circular No. 32/2018/TT-BYT for review and update of the shelf life as required.

In case the drug fails to meet the stability study results outlined in the registration dossier, the entity must immediately report to the Drug Administration for the Advisory Council for Drug Registration and Raw Material Certification to consider the drug's shelf life.

Based on the advisory opinion of the Advisory Council for Drug Registration and Raw Material Certification, the Drug Administration will decide on the shelf life of the drug, including batches already produced, based on actual stability study data."

d) Amend and supplement Clause 4 of Article 47 as follows:

"4. The updating of the classification of original brand-name drugs for drugs that have already been registered for circulation shall be carried out as follows:"

a) A drug that has been announced by the Ministry of Health as an original brand-name drug, produced entirely in a country with a regulatory authority listed in Clause 9 or Clause 10, Article 2 of this Circular, shall continue to be classified as an original brand-name drug if it falls under any of the following circumstances:

- The drug has a registration certificate for circulation that remains valid or has been renewed or amended and does not fall within the provisions of point b, Clause 2, Article 55 of the Medicine Law;

- The drug is issued a new registration certificate for circulation according to the re-registration procedure prescribed in Circular No. 44/2014/TT-BYT and has the same formulation, production process, quality standards for raw materials, and finished product quality standards as the original brand-name drug that has been announced, or has changes related to the above content approved by the Vietnamese Regulatory Authority or the competent authority of the country where the drug is manufactured. The applicant must submit an updated classification application for the original brand-name drug in accordance with Appendix II attached to this Circular;

- The drug changes its manufacturing facility and is issued a new registration certificate for circulation and meets the provisions of Clause 3, Article 9 of this Circular. The applicant must submit an updated classification application for the original brand-name drug in accordance with Appendix II attached to this Circular.

b) A drug produced outside the country that has been announced by the Ministry of Health as an original brand-name drug, which is not produced entirely in a country with a regulatory authority listed in Clause 9 or Clause 10, Article 2 of this Circular but is permitted to circulate in a country with a regulatory authority listed in Clause 9 or Clause 10, Article 2 of this Circular, shall continue to be classified as an original brand-name drug if it falls under any of the following circumstances:

- The drug has a registration certificate for circulation that remains valid or has been renewed or amended and does not fall within the provisions of point b, Clause 2, Article 55 of the Medicine Law;

- The drug is issued a new registration certificate for circulation according to the re-registration procedure prescribed in Circular No. 44/2014/TT-BYT and has the same formulation, production process, quality standards for raw materials, and finished product quality standards as the original brand-name drug that has been announced, or has changes related to the above content approved by the Vietnamese Regulatory Authority or the competent authority of the country where the drug is manufactured;

- The drug changes its manufacturing facility and is issued a new registration certificate for circulation and meets the provisions of Clause 3, Article 9 of this Circular;

The applicant must submit an updated classification application for the original brand-name drug in accordance with Appendix II attached to this Circular for the three cases mentioned above.

c) A drug that has been announced by the Ministry of Health as an original brand-name drug, produced entirely in Vietnam or produced one or several stages in Vietnam and the remaining production stages carried out entirely in a country with a regulatory authority listed in Clause 9 or Clause 10, Article 2 of this Circular, shall continue to be classified as an original brand-name drug if it falls under any of the following circumstances:

- The drug has a registration certificate for circulation that remains valid or has been renewed or amended and does not fall within the provisions of point b, Clause 2, Article 55 of the Medicine Law;

- The drug is issued a new registration certificate for circulation according to the re-registration procedure prescribed in Circular No. 44/2014/TT-BYT and has the same formulation, production process, quality standards for raw materials, and finished product quality standards as the original brand-name drug that has been announced, or has changes related to the above content approved by the Vietnamese Regulatory Authority or the competent authority of the country where the drug is manufactured. The applicant must submit an updated classification application for the original brand-name drug in accordance with Appendix II attached to this Circular;

- The drug changes its manufacturing facility and is issued a new registration certificate for circulation and meets the provisions of Clause 3, Article 9 of this Circular. The applicant must submit an updated classification application for the original brand-name drug in accordance with Appendix II attached to this Circular.

d) A drug that has been announced by the Ministry of Health as an original brand-name drug, produced one or several stages in Vietnam and the remaining production stages not carried out entirely in a country with a regulatory authority listed in Clause 9 or Clause 10, Article 2 of this Circular but is permitted to circulate in a country with a regulatory authority listed in Clause 9 or Clause 10, Article 2 of this Circular, shall continue to be classified as an original brand-name drug if it falls under any of the following circumstances:

- The drug has a registration certificate for circulation that remains valid or has been renewed or amended and does not fall within the provisions of point b, Clause 2, Article 55 of the Medicine Law;

- The drug is issued a new registration certificate for circulation according to the re-registration procedure prescribed in Circular No. 44/2014/TT-BYT and has the same formulation, production process, quality standards for raw materials, and finished product quality standards as the original brand-name drug that has been announced, or has changes related to the above content approved by the Vietnamese Regulatory Authority or the competent authority of the country where the drug is manufactured;

- The drug changes its manufacturing facility and is issued a new registration certificate for circulation and meets the provisions of Clause 3, Article 9 of this Circular;

The applicant must submit an updated classification application for the original brand-name drug in accordance with Appendix II attached to this Circular for the three cases mentioned above.

đ) A drug that has been announced by the Ministry of Health as an original brand-name drug, produced entirely in a country with a regulatory authority listed in Clause 9 or Clause 10, Article 2 of this Circular, and transferred technology for production in Vietnam, if the transferred technology for production is one, several, or all stages of production in Vietnam and a new registration certificate for circulation is issued, the drug will continue to be classified as an original brand-name drug if it meets the provisions of Clause 2, Article 9 of this Circular. The applicant must submit an updated classification application for the original brand-name drug in accordance with Appendix II attached to this Circular;

e) A drug that has been announced by the Ministry of Health as an original brand-name drug, not produced entirely in a country with a regulatory authority listed in Clause 9 or Clause 10, Article 2 of this Circular but permitted to circulate in a country with a regulatory authority listed in Clause 9 or Clause 10, Article 2 of this Circular, and transferred technology for production in Vietnam, if the transferred technology for production is one, several, or all stages of production in Vietnam and a new registration certificate for circulation is issued, the drug will continue to be classified as an original brand-name drug if it meets the provisions of Clause 2, Article 9 of this Circular. The applicant must submit an updated classification application for the original brand-name drug in accordance with Appendix II attached to this Circular;

g) A drug that has not been announced by the Ministry of Health as an original brand-name drug, if it meets the provisions of Clause 1, Article 9 of this Circular, shall be classified as an original brand-name drug. The applicant must submit an updated classification application for the original brand-name drug in accordance with Appendix II attached to this Circular."

đ) Supplement point p, Clause 1, Article 50 as follows:

"p) The Drug Administration of Vietnam shall publish on its electronic information website a list of drugs classified as original brand-name drugs."

e) Repeal the provision "2. Trademark registration certificate for the new name of the drug. In case the name of the drug is changed due to infringement of the trademark rights of another individual or organization, the applicant must provide a written confirmation from the competent authority regarding the infringement as stated." in the section on Documents to be submitted (D) Part Content Change 1 (MiV-PA1) Item 6. Minor Changes (MiV-PA) requiring approval before implementation of Appendix II. Major and minor changes apply to drugs and medicinal ingredients that have already been granted registration certificates for circulation.

g) Amend and supplement Section MiV-PA 38 in Section 6. Minor changes (MiV-PA) requiring approval before implementation in Appendix II. Major and minor changes apply to medicines and medicinal ingredients that have been granted registration numbers for circulation under Circular No. 32/2018/TT-BYT according to the provisions in Appendix 01 issued together with this Circular;

h) Add to Circular No. 32/2018/TT-BYT forms 14A/TT, 14B/TT, 14C/TT as stipulated in Appendix 02 issued together with this Circular;

i) Amend and supplement the Application for Extension Registration (Form 6B/TT) and the Report on Medicines and Medicinal Ingredients Circulation Process (Form 11/TT) in Appendix 03 issued together with this Circular.

4. Amend and supplement Clause 2 Article 7 of Circular No. 01/2021/TT-BYT dated January 25, 2021, issued by the Minister of Health guiding certain contents for localities to issue policies rewarding and supporting collectives and individuals who perform well in population work as follows:

"2. Based on the guidance provided in this Circular, the Department of Health shall take the lead and coordinate with relevant departments, agencies, and units to advise the People's Committee of the province to submit to the Provincial People's Council for promulgation of incentives, rewards, and financial or material support levels for collectives and individuals who perform well in population policies of the locality."

Article 2. Effective Date

1. This Circular takes effect from January 25, 2022.

2. Repeal Point c Clause 5 Article 1 of Circular No. 29/2020/TT-BYT dated December 31, 2020, issued by the Minister of Health amending, supplementing, and abolishing some legal documents issued by the Minister of Health and jointly issued.

Article 3. Transitional Provisions

Applications submitted to the receiving authority before the date this Circular takes effect but are still under processing shall be governed by the relevant provisions in this Circular or the provisions prior to the date this Circular takes effect, in a manner convenient for businesses, organizations, and individuals.

Article 4. Responsibilities for Implementation

The Head of the Legal Affairs Department, the Director of the Ministry's Office, the Inspector General of the Ministry, Heads of Departments, Directors of Agencies, and General Directors of the Departments, Agencies, and General Departments under the Ministry of Health, and related agencies, organizations, and individuals are responsible for implementing this Circular./.