Circular No. 29/2020/TT-BYT amending the Minister of Health's legal documents

CIRCULAR

On amending, supplementing and repealing a number of legal documents promulgated and jointly promulgated by the Minister of Health

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            Pursuant to the Law on Promulgation of Legal Documents dated June 22, 2015 and the Law on Amending and Supplementing the Law on Promulgation of Legal Documents dated June 18, 2020;

Pursuant to the Law on Pharmacy dated April 06, 2016;

Pursuant to the Law on Prevention and Control of Tobacco Harms dated June 18, 2012;

Pursuant to the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017, detailing a number of articles of and providing measures for implementing the Pharmacy Law;

Pursuant to the Government's Decree No. 69/2018/ND-CP dated May 15, 2018, on detailing a number of articles of the Law on Foreign Trade Management;

Pursuant to the Government's Decree No. 96/2012/ND-CP dated November 15, 2012, on treatment of opioid addiction with opioid substitution;

Pursuant to the Government's Decree No. 15/2018/ND-CP dated February 02, 2018, detailing a number of articles of the Law on Food Safety;

Pursuant to the Government’s Decree No. 34/2016/ND-CP dated May 14, 2016, detailing a number of articles of and providing measures for implementing the Law on Promulgation of Legal Documents;

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

At the request of the Director of the Legal Affairs Department,

The Minister of Health hereby promulgates the Circular on amending, supplementing and repealing a number of legal documents promulgated and jointly promulgated by the Minister of Health.

Article 1. To amend and supplement a number of legal documents in the fields of cosmetics, pharmacy, HIV/AIDS prevention and control and food safety

1. To amend and supplement a number of articles of the Minister of Health’s Circular No. 06/2011/TT-BYT dated January 25, 2021 on cosmetic management (hereinafter referred to as the Circular No. 06/2011/TT-BYT) as follows:

a) To amend and supplement Clause 4, Article 4 as follows:

“4. Certificate of free sale (CFS) for imported cosmetic products is prescribed as follows:

a) Cases of exempted from CFS include:

- Cosmetic products manufactured in a member state of the Comprehensive and Progressive Agreement for Trans-Pacific Partnership whose participation in this Agreement has been ratified and entered into force by a competent agency of that country (hereinafter referred to as the CPTPP member state);

- Cosmetic products circulated and exported from the CPTPP member states: Enterprises in charge of delivering products to the market must submit documents proving such products are allowed to be circulated in the CPTPP member states granted by the competent agencies of the CPTPP member states (licenses for cosmetic product circulation or the notification  of cosmetic products which already granted the receipt number or other legal document certifying that the products are circulated in the CPTPP member states) and consularly legalized in accordance with the law, except for the case legal documents fall into one of the following cases:

+ Being exempted from consular legalization according to the treaties to which the Socialist Republic of Vietnam (hereinafter referred to as Vietnam) is a contracting party or according to the principle of reciprocity between Vietnam and the issuing country;

+ Legal documents are certified by a document or e-mail sent from the foreign diplomatic missions or a competent state management agency in charge of cosmetics or the agency issuing legal documents of the CPTPP member state to the Drug Administration of Vietnam;

+ An enterprise in charge of delivering products to the market sends the results of self-checking of legal documents from the website (English website) of the legal document issuing agency of the CPTPP member state with a stamp of confirmation of the enterprise and documents providing information on the search link to the Drug Administration of Vietnam. The enterprise shall take responsibility before law for the lawfulness and accuracy of such documents, information and its self-checking results;

- Cosmetic products have been granted the cosmetic product notification receipt number in the countries of the Association of Southeast Asian Nations (ASEAN): The enterprise in charge of delivering products to the market must submit the notification of cosmetic products which have been granted the receipt number in the ASEAN countries and consularly legalized as prescribed by law, except the notification of cosmetic products falling into one of the following cases:

+ Being exempted from consular legalization according to the treaties to which the Socialist Republic of Vietnam is a contracting party or according to the principle of reciprocity between Vietnam and the issuing country;

+ The notification of cosmetic products is certified by a document or e-mail sent from the foreign diplomatic missions or a competent state management agency in charge of cosmetics or the agency issuing notification of cosmetic products of the ASEAN member state to the Drug Administration of Vietnam;

+ An enterprise in charge of delivering products to the market sends the results of self-checking of the notification of cosmetic products from the English website of the cosmetic product notification receipt number issuing agency of the ASEAN member state with a stamp of confirmation of the enterprise and documents providing information on the search link to the Drug Administration of Vietnam. The enterprise shall take responsibility before law for the lawfulness and accuracy of such documents, information and its self-checking results;

b) Apart from cases exempted from CFS specified at Point a of this Clause, a dossier of imported cosmetic product notification must contain a CFS which satisfies the following requirements:

- A CFS granted by the competent agency of the manufacturing country or the country exporting cosmetics to Vietnam which remains valid (an original or certified copy). In case CFS does not specify the expiry day, it must be a certificate which has just been granted within 24 months;

- The CFS must be consularly legalized in accordance with law provisions, except for the case the CFS satisfies one of the following requirements:

+ Being exempted from consular legalization according to the treaties to which Vietnam is a contracting party or according to the principle of reciprocity between Vietnam and the issuing country;

+ CFS’s information is confirmed by a written document or e-mail sent from the agency competent to grant CFSs or the foreign diplomatic missions to the Drug Administration of Vietnam;

- The CFS must contain at least information specified in Article 36 of the Law on Foreign Trade Management and Clause 3, Article 10 of the Government's Decree No. 69/2018/ND-CP dated May 15, 2018, detailing a number of articles of the Law on Foreign Trade Management (hereinafter referred to as the Decree No. 69/2018/ND-CP).”;

b) To amend and supplement Appendix No. 01-MP attached to the Circular No. 06/2011/TT-BYT according to Appendix 1 attached to this Circular;

c) To amend and supplement Article 33 as follows:

“Article 33. Dossiers and procedure for granting CFS with regard to cosmetics domestically manufactured for export

1. A dossier of request for grant of CFS with regard to exported cosmetics shall comply with Article 11 of the Decree No. 69/2018/ND-CP. Particularly, the declared standards applicable to products and goods may be replaced by the notification of cosmetic products which has been granted the receipt number (01 copy with the trader's stamp).

2. The procedures for grant of CFS with regard to exported cosmetics shall comply with Article 11 of the Decree No. 69/2018/ND-CP.

3. Charges for grant of CFS shall be calculated according to the products corresponding to 01 notification of cosmetic products which has been granted the receipt number.

4. The provincial-level Departments of Health of provinces and centrally run cities shall grant and manage CFS with regard to exported cosmetics which are manufactured in the area where the manufacturing establishment is placed.

2. To amend and supplement Appendix VII of the Ministry of Health’s Circular No. 20/2017/TT-BYT dated May 10, 2017, detailing a number of articles of the Law on Pharmacy and the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017, on drugs and drug materials subject to special control as follows:

To add to the end of Appendix VII. The List of drugs and pharmaceutical ingredients prohibited from use in a number of sectors and fields as follows: “This List contains all types of salt (if any) of substances stated in the List.”.

3. Amending and supplementing the Circular No. 02/2018/TT-BYT dated February 09, 2020 of the Minister of Health on good practices of drug retailing establishments as follows:

dd) On a quarterly basis, to make online report on the list of drug retailing establishments in the area which have been granted a certificate of eligibility for pharmaceutical business and their degrees of fulfillment of GPP requirements as prescribed in Clause 4, Article 8 of this Circular on the Drug Administration of Vietnam’s website.”.

4. To amend and supplement the Minister of Health’s Circular No. 03/2018/TT-BYT dated February 09, 2019, on good practices of distribution of drugs or drug materials as follows:

“dd) On an monthly basis, to make online report on the list of distributors that have been granted the certificate of eligibility for pharmaceutical business and their degrees of fulfillment of GPP requirements according to Clause 4, Article 8 of this Circular on the Drug Administration of Vietnam’s website.”.

5. To amend, supplement and repeal a number of articles of the Minister of Health’s Circular No. 32/2018/TT-BYT dated November 12, 2018, on registration for circulation of drugs and drug materials (hereinafter referred to as the Circular No. 32/2018/TT-BYT) as follows:

a) To amend and supplement Point c, Clause 3, Article 23 as follows:

“c) In case where the granted legal document is an electronic version, including the absence of sufficient signatures, name of the signing persons and certification marks of the competent state management agency of the country granting the legal document, the registration agency must submit one of the following documents:

- Legal documents consularly legalized as prescribed (originals or certified copies);

- The registration agency sends the results of self-checking of legal documents from the English website of the legal document issuing agency with a stamp of confirmation and documents providing information on the search link to the Drug Administration of Vietnam. The registration agency shall take responsibility before law for the lawfulness and accuracy of such documents, information and its self-checking results.

b) To repeal Point c, Clause 4, Article 23;

c) To amend and supplement Points e and g, Clause 4, Article 23 as follows:

“e) With regard to the dossier of granting the certificate of registration for circulation of new pharmacochemical drugs, imported biological products, except for probiotics:  Must have CPP granted by the competent agency of the manufacturing country and a confirmation that such drugs already licensed and actually circulated in that country. In case where this CPP is not granted by EMA, it is required to have legal documents granted by one of other management agencies as prescribed in Clause 9 or Clause 10, Article 2 of this Circular. A legal document must contain at least the following information: the drug’s name, active ingredients, concentration or content of active ingredients, formulation, name and address of the manufacturing establishment, a confirmation that such drugs already licensed and actually circulated in that country;

g) With regard to the dossier of granting the certificate of registration for circulation of imported vaccines: Must have CPP granted by the competent agency of the manufacturing country and a confirmation that such drugs already licensed and actually circulated in that country. In case where this CPP is not granted by EMA, it is required to have legal documents granted by one of other management agencies as prescribed in Clause 9, Article 2 of this Circular. A legal document must contain at least the following information: the drug’s name, active ingredients, concentration or content of active ingredients, formulation, name and address of the manufacturing establishment, a confirmation that such drugs already licensed and actually circulated in that country.”;

d) To add Point dd to Clause 12, Article 23 as follows:

“dd) With regard to excipients in the dossier of registration for finished drugs and drug materials that are semi-finished products:

In case of failing to provide papers specified at Point a or b or d of this Clause, the establishment manufacturing finished and semi-finished drugs shall conduct a self-assessment of the compliance with good manufacturing practices for establishment manufacturing excipients according to Point dd, Clause 1, Article 3, Point b, Clause 3, Article 3 and Point dd, Clause 5, Article 20 of the Minister of Health's Circular No. 35/2018/TT-BYT dated November 22, 2018, on good manufacturing practices of drugs and drug materials and self-declaration in the dossier of drug registration on principles and standards of good manufacturing practices that the establishments manufacturing excipients meets and undertakes to take responsibility before the law on this declaration according to Form 13/TT attached to this Circular”;

dd) To amend and supplement Clause 3, Article 40 as follows:

“3. For minor changes when modifying and supplementing the certificates of registration for circulation of drugs or drug materials, only notification is required:

a) For minor changes, only notifications MiV-N1, MiV-N2, MiV-N3, MiV-N4, MiV-N6 and MiV-N7 specified in Appendix II attached to this Circular are required: The establishment shall be entitled to make and take responsibility for the changes and supplements requested by the establishment from the date stated on the receipt of dossier. Within 15 working days from the date stated on the receipt of dossier, the Drug Administration of Vietnam shall publicize on its website minor changes that only require notification submitted by the establishment;

b) Minor changes only require other notifications provided in Appendix II attached to this Circular other than the cases specified at Point a of this Clause: Within 15 working days from the date stated on the receipt of dossier, the Drug Administration of Vietnam shall approve modification and supplementation of the certificate of registration for circulation for the satisfactory dossier or reply in writing for the dossier appraised as unsatisfactory or unqualified, clearly stating reasons; publicize on the Drug Administration of Vietnam's website minor changes that only require notifications submitted by the establishment and the results of processing dossier.”;

e) To amend and supplement the title of Clause 2, Article 47 as follows: “2. With regard to drugs and drug materials whose certificates of circulation registration expire from January 01, 2018 to December 31, 2021, including drugs and drug materials whose certificates of circulation registration have been maintained, their certificates of circulation registration may maintain the validity for 12 months if all of the following requirements are satisfied:”;

g) To add Clause 5 to Article 47 as follows:

“5. Regulations on validity of the GMP certificate as follows:

a) With regard to the GMP certificate granted by the pharmaceutical management agency of the European Economic Area (EEA):

- In case where the validity of the GMP of the manufacturing establishment is extended according to the Notice of EMA dated April 10, 2020, on the policy applicable to drugs for human during the COVID-19 pandemic: The GMP certificate shall be valid until December 31, 2021. If the EMA has new notice, the new notice shall be applied;

- In case where the manufacturing establishment is granted a new GMP certificate, its validity shall be confirmed according to the new one;

b) With regard to the GMP certificate granted by agencies other than those specified at Point a of this Clause: The determination of the GMP certificate's validity during the COVID-19 pandemic shall be implemented according to the notice of the pharmaceutical management agency of each country which has granted the GMP certificate or according to the validity stated in the GMP certificate.”;

h) To amend Clause 3, Article 48 as follows:

“3. With regard to the dossier of grant, extension, change or supplementation of circulation registration certificate submitted before December 31, 2021: The CPP is not required to have sufficient information on the finished drug standards; standards of pharmaceutical ingredients or medicinal materials; name and address of the establishment manufacturing pharmaceutical ingredients or medicinal materials.”;

i) To add Clauses 5 and 6 to Article 48 as follows:

“5. With regard to domestically manufactured drugs and drug materials that already have been granted the circulation registration certificate before December 31, 2020 and establishments wish to import drug materials that are excipients and capsules to Vietnam: Before importing to Vietnam for the first time, the registration establishment shall update all information on drug materials that are excipients and capsules in the dossier approved on the online public service system of the Drug Administration of Vietnam. Within 05 working days from the date on which the information is updated on the system by the establishment, the Drug Administration of Vietnam shall complete the announcement. The registration establishment shall take responsibility for the accuracy of updated information compared to information stated in the approved registration dossier, and such information is not required to be updated in the next import.

6. Provisions on authentication of legal papers for the dossier of request for grant, extension, change or supplementation of the certificate of registration for drug circulation submitted before December 31, 2021: The result of checking the authentication of legal papers specified in Clause 1, Article 12 off this Circular is not required before the time of grant, extension, change or supplementation of the certificate of registration for drug circulation, except for the cases the granted legal papers are electronic versions and do not satisfy requirements specified in Clause 1 and Points a, b, Clause 3, Article 23 of this Circular; in such case, the result of checking the authentication of legal papers is required before the time of grant, extension, change or supplementation of the certificate of registration for drug circulation.

After the drugs are granted, extended, changed or supplemented the certificate of circulation registration, if the diplomatic agency or a competent authority in the country or abroad has a written confirmation that the legal paper in the dossier of registration of drugs or drug materials does not ensure the authenticity, the Drug Administration of Vietnam shall consider handling it according to the Clause 5, Article 42 and Point h, Clause 1, Article 50 of this Circular.”;

k) To add Point o to Clause 1, Article 50 as follows:

“o) To publicize the list of websites of agencies granting legal papers as prescribed at Point c, Clause 3, Article 23 of this Circular.”;

l) To add to the Circular No. 32/2018/TT-BYT the form 13/TT - Declaration of principles and standards of GMP or principles and standards for the production of excipients that have been applied by the competent agencies of other countries or international organizations according to Appendix 2 attached to this Circular.

6. To amend and supplement a number of articles of the Minister of Health's Circular No. 35/2018/TT-BYT dated November 22, 2018, good manufacturing practices of drugs and drug materials as follows:

a) To amend and supplement Clause 1, Article 3 as follows:

“1. The following principles and standards of good manufacturing practices of drugs and drug materials shall be applied:

a) Principles and standards of good manufacturing practices of drugs of the World Health Organization provided in Appendix I attached to this Circular and updated documents specified in Clause 4 of this Article;

b) Principles and standards of good manufacturing practices of bio-drugs that are human blood and plasma derivatives of the World Health Organization provided in Appendix II attached to this Circular and updated documents specified in Clause 4 of this Article;

c) Principles and standards of good manufacturing practices of drugs of the Pharmaceutical Inspection Co-operation Scheme provided in Appendix III attached to this Circular and updated documents specified in Clause 4 of this Article;

d) Principles and standards of good manufacturing practices of drugs of the European Union provided in Appendix IV attached to this Circular and updated documents specified in Clause 4 of this Article.

dd) Principles and standards of good manufacturing practices of drugs of the World Health Organization for drug materials being excipients provided in Appendix IIa attached to this Circular and updated documents specified in Clause 4 of this Article.”;

b) To amend and supplement Clause 3, Article 3 as follows:

“3. Application of other GMP principles and standards:

a) With regard to a establishment manufacturing drugs or drug materials other than excipients:

In addition to GMP principles and standards specified in Clauses 1 and 2 of this Article, other GMP principles and standards equivalent to EU - GMP principles and standards promulgated by pharmaceutical management agencies of SRA countries may be applied. A drug or drug material manufacturing establishment that apply such principles and standards shall be responsible for translating and certifying the translation version in accordance with law provisions on notarize and authentication and send to the Drug Administration of Vietnam in order to post on the websites of the Drug Administration of Vietnam and the Ministry of Health;

b) With regard to an establishment manufacturing drugs or drug materials that are excipients:

In addition to GMP principles and standards specified at Point dd, Clause 1 of this Article, the establishment manufacturing excipients may apply other GMP principles and standards of the International Pharmaceutical Excipients Council (IPEC), the Certification Scheme for Pharmaceutical Excipients (EXCiPACT), American National Standards Institute (ANSI), United States Pharmacopeia (USP) or other principles and standards on manufacturing excipients that have been applied by the management agency of the country or other international organizations involved in excipients used to manufacture drugs, cosmetics and food.”;

c) To add Clause 16 to Article 4 as follows:

“16. The establishment manufacturing drug materials being excipients shall apply GMP and comply with regulations provided in Appendix IIa attached to this Circular or other GMP principles and standards specified in Clause 3, Article 3 of this Circular and updated documents as prescribed in Clause 4, Article 3 of this Circular. In case where the World Health Organization, and IPEC, EXCiPACT, ANSI, USP organizations or other international organizations related to excipients used to manufacture drugs, cosmetics, food have declared to amend or supplement the good manufacturing practices of drug materials being excipients (hereinafter referred to as the updated documents) on their websites, the establishment manufacturing drug materials being excipients shall apply the updated GMP documents within the following periods:

a) Within 12 months, for the case of requesting for change to factories, production equipment, from the time the updated document is published;

b) Within 06 months, for updates other than those specified at Point a of this Clause, from the time the updated document is published.”;

d) To add Point h to Clause 2, Article 12 as follows:

“h) A establishment manufacturing drug materials that are excipients.”;

dd) To add Point dd to Clause 5, Article 20 as follows:

“dd) A establishment manufacturing finished or semi-finished drugs shall, based on objectives and scope of using excipients at the manufacturing establishment, conduct self-assessment of compliance with the GMP principles and standards specified at Point dd, Clause. 1 Article 3 and Point b, Clause 3, Article 3 of this Circular for excipients used at the establishment.”;

e) To add Appendix IIa. Principles and standards for good manufacturing practices of drug materials being excipients of the World Health Organization after Appendix II attached to the Circular No. 35/2018/TT-BYT according to Appendix 3 attached to this Circular.

7. To amend and supplement Clause 6, Article 9 of the Minister of Health’s Circular No. 36/2018/TT-BYT dated February 09, 2019, on good practices of storage of drugs or drug materials as follows:

“6. After submitting reports on operation - maintain the compliance with the GMP according to the prescribed period, the storage establishment may continue to operate according to the scope of business stated in the granted certificate of eligibility for pharmaceutical business, be entitled to use this certificate until the result of the periodic evaluation on the maintenance of compliance with the GMP is available and must ensure to maintain the compliance with the GMP during its operation.”.

8. To amend and supplement a number of articles of the Minister of Health’s Circular No. 15/2019/TT-BYT dated November 07, 2019, on bidding for drugs at public health establishments as follows:

a) To amend and supplement Clause 3, Article 7 as follows:

“3. Group 3 includes of drugs granted with the certificate of registration for circulation or import permit to be circulated in Vietnam and have a bioequivalence study report published by the Drug Administration of Vietnam.”;

b) To amend and supplement Clause 5, Article 7 as follows:

“5. Group 5 includes of drugs granted with the certificate of registration for circulation or import permit to be circulated in Vietnam.”;

c) To amend and supplement Point a, Clause 8, Article 50 as follows:

“a) Legal documents issued by a pharmaceutical management agency of the country in the List of SRA, with full signatures, name of the signing persons, certification marks of the competent state management agency of the country issuing that legal documents. Such legal document must be consularly legalized as prescribed (originals or certified copies).

In case where the issued legal documents are electronic versions, including the absence of sufficient signatures, name of the signing persons and certification marks of the competent state management agency of the country issuing the legal documents, the establishment shall send the result of self-checking of legal documents from the English website of the legal document issuing agency with the establishment's stamp enclosed with documents providing information on the online search link to the Drug Administration of Vietnam. The registration agency shall take responsibility before law for the lawfulness and accuracy of such documents, information and its self-checking results.

A legal document must contain at least the following information: the drug’s name, active ingredients, concentration or content of active ingredients, formulation, name and address of the manufacturing establishment, a confirmation that such drugs already licensed and circulated in that country.”;

d) To amend and supplement Appendix 3 - Report template on violations of the contractors during the bidding or providing drugs of the Circular No. 15/2019/TT-BYT according to Appendix 4 attached to this Circular;

dd) To amend and supplement Clause 1 of Section I. Criteria to evaluate the quality of drugs and Clause 13 of Section II. Criteria to evaluate the packing, storage and delivery in Part 4 provided in Appendix - Standards for technical evaluation of Appendices 7 and 8 of the Circular No. 15/2019/TT-BYT according to Appendix 5 attached to this Circular.

9. To amend and supplement Point a, Clause 2, Article 14 of the Minister of Health’s Circular No. 14/2015/TT-BYT dated June 25, 2015, on Methadone management as follows:

“a) Drink all methadone in the presence of health staff, unless it is provided for use at home by a health establishment under the guidance of the Ministry of Health;”.

10. To amend and supplement a number of articles of the Minister of Health’s Circular No. 18/2019/TT-BYT dated July 17, 2019, on providing guidance on good manufacturing practices in manufacturing and trading health supplements as follows:

a) To amend and supplement Clause 3, Article 3 as follows:

“3. The establishment manufacturing drugs from medicinal materials and traditional drugs which have been granted a certificate of eligibility or assessment of the satisfaction of good manufacturing practices of drugs or drug materials (GMP)
by the Drug Administration of Vietnam - the Ministry of Health, for drugs from medicinal materials and traditional drugs that are still valid under the provisions of the law on pharmacy and are allowed to produce health supplements with formulation equivalent to the certified formulation and are not required to carry out the procedures for granting the  certificate of food safety eligibility and meeting the requirements of GMP in health supplements.”;

b) To amend and supplement the title of Clause 1, Article 4 as follows:

“1. Imported health supplements must be manufactured at establishments granted one of the following certificates or confirmations by the competent agencies of the manufacturing countries (including the state management agency in charge of food safety or organizations indicated or approved by the state management agency in charge of food safety or organizations and agencies of other countries as approved by the state management agencies of the manufacturing countries:”;

c) To amend and supplement Point a, Clause 1, Article 4 as follows:

“a) A certificate of good manufacturing practices (GMP) of an establishment manufacturing health supplements or a certificate of free sale (CFS) includes contents stating that the products are manufactured by an establishment satisfying requirements for good manufacturing practices (GMP);”;

d) To amend and supplement Point c, Clause 1, Article 4 as follows:

“c) With regard to countries or territories that do not grant certificates specified at Points a and b of this Clause, a written confirmation on not granting GMP certificates for establishments manufacturing health supplements of the competent agency or such confirmation announced on the official website of the competent agency shall be required;”;

dd) To amend Clause 2, Article 4 as follows:

“2. A certificate or confirmation specified at Points a and b, Clause 1 of this Article (excluding CFS with contents prescribed at Point a, Clause 1 of this Article) must include at least the following information:

a) Name of the organization or agency competent to issue;

b) Date of issuance;

c) Validity (in case where the certificate or GMP confirmation does not state the validity, the evaluation report or record on periodic examination ensuring that the manufacturing establishment maintains food safety conditions shall be required or the time limit for examination and evaluation must be prescribed at the legal document of the country of origin of the product);

d) Full name, and signature of the issuing person;

dd) Name and address of the granted establishment;

e) Scope of certification.”;

e) To repeal Clause 2, Article 5 and the provision “the time of applying this Point shall comply with Clause 2, Article 5 of this Circular” as prescribed at Point b, Clause 1, Article 4;

g) To amend and supplement Clause 3.7 of Section III. Manufacturing establishment and equipment provided in Appendix attached to the Circular No. 18/2019/TT-BYT as follows:

“3.7. In case where health supplements, drugs from medicinal materials and traditional drugs are manufactured in the same line: An appropriate to prevent and avoid the risks of confusion, contamination and cross-contamination (Section 6.19).”.

11. To amend and supplement the regulation “The maximum amount of Tar and Nicotine specified in the QCVN 16-1:2015/BYT shall be applied until December 31, 2020.” in Article 2 of the Minister of Health’s Circular No. 23/2015/TT-BYT dated August 20, 2015, on promulgating the National Technical Regulation on cigarettes as follows:

“The maximum amount of Tar and Nicotine specified in the National Technical Regulation QCVN 16-1:2015/BYT shall be reviewed every two years and considered adjusting in case of necessity in order to meet the requirements of prevention and control of tobacco harms”.

Article 2. To annul a number of legal documents promulgated and jointly promulgated by the Minister of Health

To annul all 28 legal documents and partially repeal 02 legal documents promulgated and jointly promulgated by the Minister of Health in Appendix 6 attached to this Circular.

Article 3. Effect

1. This Circular takes effect on February 15, 2021.

2. Particularly, provisions in Clauses 5, 6, 7, 8 and 11, Article 1 of this Circular takes effect on January 01, 2021.

3. Provisions related to submission of dossiers, documents and online searching shall be applied during the COVID-19 pandemic until the time the Ministry of Health considers and adjusts according to practical conditions.

Article 4. Transitional provisions

1. For dossiers already submitted to the agency receiving dossiers before the effective date of this Circular but are awaiting processing, relevant provisions of this Circular or provisions promulgated before the effective date of this Circular may be applied, according to the direction of convenience for enterprises, organizations and individuals.

2. Provisions on online disclosure, updating, declaration of information and report specified in this Circular shall be applied according to competent state agencies’ instructions.

Article 5. Implementation responsibility

Director of the Legal Affairs Department, Chief of the Ministry Office, Chief of the Ministry Inspector, Directors and Directors General of Departments, Agencies, Directorates of the Ministry of Health and relevant agencies, organizations and individuals shall be responsible for the implementation of this Circular./.

* All Appendices are not translated herein.