CIRCULAR

Amending, supplementing, and abolishing certain regulatory legal documents

issued by the Minister of Health, jointly issued

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Pursuant to the Law on Legislative Regulatory Documents dated June 22, 2015 and the Law Amending and Supplementing Certain Provisions of the Law on Legislative Regulatory Documents dated June 18, 2020;

Pursuant to the Law on Medicines dated April 6, 2016;

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

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

Pursuant to Decree No. 69/2018/NĐ-CP dated May 15, 2018 of the Government detailing certain provisions of the Law on Foreign Trade Management;

Pursuant to Decree No. 96/2012/NĐ-CP dated November 15, 2012 of the Government on treatment for drug addiction with substitute drugs;

Pursuant to Decree No. 15/2018/NĐ-CP dated February 2, 2018 of the Government detailing certain provisions of the Food Safety Law;

Pursuant to Decree No. 34/2016/NĐ-CP dated May 14, 2016 of the Government detailing certain provisions and implementing measures of the Law on Legislative Regulatory Documents;

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

At the request of the Director of the Legal Department,

The Minister of Health hereby issues this Circular amending, supplementing, and abolishing certain regulatory legal documents issued by the Minister of Health, jointly issued.

Article 1. Amending and supplementing certain regulatory legal documents in the cosmetics, pharmaceuticals, HIV/AIDS prevention and control, and food safety sectors

1. Amending and supplementing certain articles of Circular No. 06/2011/TT-BYT dated January 25, 2011 of the Minister of Health on cosmetics management (hereinafter referred to as Circular No. 06/2011/TT-BYT) as follows:

a) Amending and supplementing Clause 4 of Article 4 as follows:

"4. Free Circulation Certificate (CFS) for imported cosmetic products shall be regulated as follows:

a) Cases exempted from CFS include:

- Cosmetic products produced in member countries of the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) where the agreement has been ratified and entered into force by the competent authority of that country (hereinafter referred to as CPTPP member countries);

- Cosmetic products circulating and exported from CPTPP member countries: The enterprise responsible for bringing the product to market must submit documentation proving the product's circulation in the CPTPP member country issued by the competent authority of the CPTPP member country (cosmetic product circulation permit or declaration of cosmetic product registration number received or other legal document certifying the product's circulation in the CPTPP member country), legalized according to the law, except in the following cases:

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

+ The foreign diplomatic mission or the competent state agency for cosmetics management or the issuing agency of the CPTPP member country sends a letter or email to the Drug Administration confirming the legal document;

+ The enterprise responsible for bringing the product to market submits the result of self-searching for the legal document from the English-language website of the issuing agency of the CPTPP member country with the enterprise's stamp of confirmation attached, along with a document providing information about the search link to the Drug Administration. The enterprise is liable under the law for the legality and accuracy of these documents, information, and the self-search results;

- Cosmetic products already registered with a declaration number in a country belonging to the Association of Southeast Asian Nations (ASEAN): The enterprise responsible for bringing the product to market must submit the declaration of cosmetic product registration number from an ASEAN country, legalized according to the law, except in the following cases:

+ Exempted from legalization according to international treaties to which Vietnam is a party or under the principle of reciprocity between Vietnam and the issuing country;

+ The foreign diplomatic mission or the competent state agency for cosmetics management or the issuing agency of the ASEAN member country sends a letter or email to the Drug Administration confirming the declaration of cosmetic product registration;

+ The enterprise responsible for bringing the product to market submits the result of self-searching for the declaration of cosmetic product registration from the English-language website of the competent authority of the ASEAN member country issuing the declaration number with the enterprise's stamp of confirmation attached, along with a document providing information about the search link to the Drug Administration. The enterprise is liable under the law for the legality and accuracy of these documents, information, and the self-search results;

b) In addition to the cases exempted from CFS as specified in point a of this clause, the declaration dossier for imported cosmetic products must include a CFS meeting the following requirements:

- The CFS must be issued by the competent authority of the producing country or exporting country to Vietnam and still valid (original or certified copy). If the CFS does not specify an expiration date, it must have been issued within 24 months from the date of issuance;

- The CFS must be legalized according to the law, except if the CFS meets one of the following conditions:

+ Exempted from legalization according to international treaties to which Vietnam is a party or under the principle of reciprocity between Vietnam and the issuing country;

+ There is a letter or email from the issuing authority of the CFS or the foreign diplomatic mission sent to the Drug Administration confirming the information on the CFS;

- CFS must contain at least the information prescribed in Article 36 of the Law on Foreign Trade Management and Clause 3 of Article 10 of Decree No. 69/2018/ND-CP dated May 15, 2018 of the Government detailing certain provisions of the Law on Foreign Trade Management (hereinafter referred to as Decree No. 69/2018/ND-CP).

b) Amend and supplement Appendix No. 01-MP issued together with Circular No. 06/2011/TT-BYT according to the provisions of Appendix 1 issued together with this Circular;

c) Amend and supplement Article 33 as follows:

"Article 33. Documents and procedures for issuing CFS for domestically produced cosmetics for export

1. The application documents for issuing CFS for exported cosmetics shall be carried out in accordance with the provisions of Article 11 of Decree No. 69/2018/ND-CP. However, the Standard Declaration for Application may be replaced by a copy of the Cosmetic Product Declaration that has been assigned a registration number (one certified copy stamped by the trader).

2. The procedure for issuing CFS for exported cosmetics shall be carried out in accordance with the provisions of Article 11 of Decree No. 69/2018/ND-CP.

3. The fee for issuing CFS shall be calculated based on each product corresponding to one Cosmetic Product Declaration that has been assigned a registration number.

4. Provincial Health Departments shall implement the issuance and management of CFS for cosmetics exported from domestic production facilities located within their jurisdiction.".

2. Amend and supplement Appendix VII of Circular No. 20/2017/TT-BYT dated May 10, 2017 of the Minister of Health detailing certain provisions of the Drug Law and Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government on special control drugs as follows:

Add to the end of Appendix VII. List of drugs and pharmaceutical substances included in the list of prohibited substances for use in certain sectors and fields as follows: "This list includes all salts (if any) of the substances listed in the List."

3. Amend and supplement Point d Clause 2 Article 17 of Circular No. 02/2018/TT-BYT dated January 22, 2018 of the Minister of Health on Good Pharmacy Practice as follows:

“d) Quarterly, report online the list of retail pharmacies in the locality that have obtained a Certificate of Compliance for Pharmaceutical Business Conditions, and the status of compliance with GPP of retail pharmacies according to the contents stipulated in Clause 4 Article 8 of this Circular on the website of the Drug Administration Department.”

4. Amend and supplement Point d Clause 3 Article 18 of Circular No. 03/2018/TT-BYT dated February 9, 2018 of the Minister of Health on Good Distribution Practices for Drugs and Pharmaceutical Ingredients as follows:

“d) Monthly, report online the list of distributors in the locality that have obtained a Certificate of Compliance for Pharmaceutical Business Conditions, and the status of compliance with GDP according to the contents stipulated in Clause 4 Article 8 of this Circular on the website of the Drug Administration Department.”

5. Amend, supplement, and abolish certain articles of Circular No. 32/2018/TT-BYT dated November 12, 2018 of the Minister of Health on Registration and Circulation of Drugs and Pharmaceutical Ingredients (Circular No. 32/2018/TT-BYT) as follows:

a) Amend and supplement Point c Clause 3 Article 23 as follows:

“c) In cases where the legal documents issued are electronic versions, including cases where they do not have sufficient signatures, names of signatories, and stamps of competent state management agencies of the issuing country, the registrant must submit one of the following documents:

- Legal documents legalized by consular certification (original or certified true copy);

- The registrant sends the results of self-searching legal documents from the English-language website of the issuing agency, accompanied by a confirmation stamp of the registrant and a letter providing the search link to the Drug Administration Department. The registrant shall bear legal responsibility for the legality and accuracy of these documents and the search results.”

b) Abolish Point c Clause 4 Article 23;

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

“e) For new chemical drug and imported biological product registration applications (excluding probiotics), except for probiotics: must have a Certificate of Pharmaceutical Product (CPP) issued by the competent authority of the producing country with confirmation that the drug is approved and actually marketed in that country. If the CPP is not issued by the European Medicines Agency (EMA), additional legal documents issued by other regulatory authorities specified in Clause 9 or Clause 10 Article 2 of this Circular must also be provided. Legal documents must include at least the following information: name of the drug, active ingredient, concentration or content of the active ingredient, dosage form, name and address of the manufacturing facility, with confirmation that the drug is approved and actually marketed in that country;

g) For imported vaccine registration applications: must have a CPP issued by the competent authority of the producing country with confirmation that the drug is approved and actually marketed in that country. If the CPP is not issued by the European Medicines Agency (EMA), additional legal documents issued by other regulatory authorities specified in Clause 9 Article 2 of this Circular must also be provided. Legal documents must include at least the following information: name of the drug, active ingredient, concentration or content of the active ingredient, dosage form, name and address of the manufacturing facility, with confirmation that the drug is approved and actually marketed in that country.”

d) Supplement Point đ into Clause 12 Article 23 as follows:

"đ) For excipients in the registration dossier for finished products and pharmaceutical ingredients as semi-finished products:

In case it is not possible to provide the documents prescribed in any of Points a, b, or d of this Clause, the manufacturer of finished products and semi-finished products shall conduct a self-assessment of the compliance with good manufacturing practices (GMP) of the excipient manufacturer according to the provisions of Point đ Clause 1 Article 3, Point b Clause 3 Article 3, and Point đ Clause 5 Article 20 of Circular No. 35/2018/TT-BYT dated November 22, 2018 of the Minister of Health on Good Manufacturing Practices for Drugs and Pharmaceutical Ingredients and declare in the registration dossier the principles and standards of GMP that the excipient manufacturer complies with and commit to legal responsibility for this declaration according to Model 13/TT issued together with this Circular;"

đ) Amend and supplement Clause 3 Article 40 as follows:

"3. Amending and supplementing the drug circulation registration certificate for minor changes that only require notification (Notification):

a) Minor changes that only require notification MiV-N1, MiV-N2, MiV-N3, MiV-N4, MiV-N6, MiV-N7 as stipulated in Appendix II issued together with this Circular: The entity implementing and responsible for the changes and supplements proposed by the entity shall be effective from the date recorded on the Application Form. Within 15 working days from the date recorded on the Application Form, the Drug Administration of Vietnam will publish on its official website the minor changes that only require notification submitted by the entity.

b) Other minor changes that only require notification as stipulated in Appendix II issued together with this Circular, except for the cases specified in point a of this clause: Within 15 working days from the date recorded on the Application Form, the Drug Administration of Vietnam will approve the amendments and supplements to the drug circulation registration certificate for applications meeting the requirements or issue a written response for applications not meeting the requirements, clearly stating the reasons; and publish on its official website the minor changes that only require notification submitted by the entity and the results of the application processing."

e) Amend the title of Clause 2 Article 47 as follows: "2. Drugs and drug raw materials whose circulation registration certificates have expired during the period from January 1, 2018 to December 31, 2021, including those whose circulation registration certificates were maintained, may continue to maintain the validity of their circulation registration certificates for 12 months if they meet all the following provisions:"

g) Add Clause 5 to Article 47 as follows:

"5. Provisions regarding the validity of Good Manufacturing Practice (GMP) certificates as follows:

a) For GMP certificates issued by pharmaceutical management agencies of countries within the European Economic Area (EEA):

- In the case where the GMP of the production facility is extended in accordance with the EMA announcement dated April 10, 2020 concerning the policy for medicines used during the COVID-19 pandemic: the validity of the GMP certificate is extended until December 31, 2021. If EMA issues a new announcement, it will be implemented according to the new announcement;

- In the case where the production facility has been issued a new GMP certificate, the validity of the GMP certificate is confirmed according to the new certificate;

b) For GMP certificates issued by agencies other than those specified in point a of this Clause: Determination of the validity of GMP certificates during the COVID-19 pandemic will be carried out according to the announcements of the pharmaceutical management agencies of the respective countries that issued the GMP certificates or according to the validity period recorded on the GMP certificate."

h) Amend Clause 3 Article 48 as follows:

"3. For applications for issuance, extension, amendment, and supplementation of drug circulation registration certificates submitted before December 31, 2021: It is not mandatory for the Common Technical Document (CTD) to contain complete information about finished drug product standards; active substance and herbal medicine standards; name and address of the manufacturing facility for active substances and herbal medicines."

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

"5. For domestically produced drugs and drug raw materials that have been issued circulation registration certificates before December 31, 2020 and entities requiring the import of excipients and capsule shells into Vietnam: Before the first import into Vietnam, the entity must update all information about the imported excipients and capsule shells in the approved application file onto the online public service system of the Drug Administration of Vietnam. Within five working days from the date the entity updates the information onto the system, the Drug Administration of Vietnam must complete the publication. The entity applying is responsible for the accuracy of the updated information compared to the information in the previously approved application file and is not required to update the information again at subsequent imports.

6. Provisions on verifying legal documents for applications for issuance, extension, amendment, and supplementation of drug circulation registration certificates submitted before December 31, 2021: It is not mandatory to have the verification results of legal documents as stipulated in Clause 1 Article 12 of this Circular prior to the issuance, extension, amendment, and supplementation of the drug circulation registration certificate, except when the legal documents are electronic versions that do not comply with the provisions of Clause 1 and points a and b of Clause 3 Article 23 of this Circular, then the verification results of legal documents must be obtained prior to the issuance, extension, amendment, and supplementation of the drug circulation registration certificate.

In the event that after the issuance, extension, amendment, and supplementation of the drug circulation registration certificate, the diplomatic agency or competent authority in Vietnam or abroad provides a written confirmation that the legal documents in the drug registration application file are not authentic, the Drug Administration of Vietnam will consider handling the matter in accordance with Clause 5 Article 42 and point h of Clause 1 Article 50 of this Circular."

k) Add point o to Clause 1 Article 50 as follows:

"o) Publish the list of websites of agencies issuing legal documents as stipulated in point c of Clause 3 Article 23 of this Circular."

l) Supplement Model 13/TT of Circular No. 32/2018/TT-BYT with the announcement of GMP principles and standards or principles and standards for excipient production applied by the management agency of another country or international organization as stipulated in Appendix 2 issued together with this Circular.

6. Amend and supplement some articles of Circular No. 35/2018/TT-BYT dated November 22, 2018 of the Minister of Health on Good Manufacturing Practices for Drugs and Drug Raw Materials as follows:

a) Amending and supplementing Clause 1 of Article 3 as follows:

"1. Announce the application of the following Good Manufacturing Practices for Drugs and Drug Raw Materials:

a) World Health Organization's Good Manufacturing Practices for Drugs as stipulated in Appendix I issued together with this Circular and updated documents as stipulated in Clause 4 of this Article;

b) World Health Organization's Good Manufacturing Practices for Biological Medicines Derived from Human Blood and Plasma as stipulated in Appendix II issued together with this Circular and updated documents as stipulated in Clause 4 of this Article;

c) The principles and standards of Good Manufacturing Practice (GMP) for drug production set forth in Appendix III issued together with this Circular and updated materials as provided in Clause 4 of this Article;

d) The principles and standards of Good Manufacturing Practice (GMP) for drug production of the European Union set forth in Appendix IV issued together with this Circular and updated materials as provided in Clause 4 of this Article;

đ) The principles and standards of Good Manufacturing Practice (GMP) for drug excipient production of the World Health Organization set forth in Appendix IIa issued together with this Circular and updated materials as provided in Clause 4 of this Article.";

b) Amend and supplement Clause 3 of Article 3 as follows:

"3. Apply other GMP principles and standards:

a) For drug manufacturing facilities and non-excipient drug raw material manufacturing facilities:

In addition to the GMP principles and standards stipulated in Clauses 1 and 2 of this Article, equivalent GMP principles and standards to EU-GMP issued by drug regulatory authorities of SRA countries may be applied. Drug manufacturing facilities and non-excipient drug raw material manufacturing facilities implementing such application shall be responsible for translating and confirming the translation according to the laws on notarization and authentication, and submitting it to the Department of Medicine Management for publication on the Ministry of Health's electronic portal and the Department of Medicine Management's electronic portal;

b) For drug excipient manufacturing facilities:

In addition to the GMP principles and standards stipulated in Point đ of Clause 1 of this Article, drug excipient manufacturing facilities may apply other GMP principles and standards of the International Pharmaceutical Excipients Council (IPEC), the Certification Scheme for Pharmaceutical Excipients (EXCiPACT), the American National Standards Institute (ANSI), the United States Pharmacopeia (USP), or other GMP principles and standards applicable to drug excipient production from relevant regulatory agencies or international organizations related to drug, cosmetic, and food excipient production;

c) Supplement Clause 16 to Article 4 as follows:

"16. Drug excipient manufacturing facilities implementing GMP must comply with the provisions in Appendix IIa issued together with this Circular or other GMP principles and standards stipulated in Clause 3 of Article 3 of this Circular and updated materials as provided in Clause 4 of Article 3 of this Circular. In case the World Health Organization, IPEC, EXCiPACT, ANSI, USP, or other relevant international organizations have published updates or amendments to GMP principles and standards for drug excipient production (hereinafter referred to as updated materials) on their websites, drug excipient manufacturing facilities must implement the updated GMP materials within the following timeframes:

a) Within twelve months for cases requiring changes to the factory premises and production equipment, counted from the date of publication of the updated materials;

b) Within six months for updates not falling under the circumstances specified in Point a of this Clause, counted from the date of publication of the updated materials.";

d) Supplement Point h to Clause 2 of Article 12 as follows:

"h) Drug excipient manufacturing facilities.";

đ) Supplement Point đ to Clause 5 of Article 20 as follows:

"đ) Finished drug product and semi-finished drug product manufacturing facilities shall base on the purpose and scope of use of excipients at their facilities to conduct self-assessment to meet the GMP principles and standards stipulated in Point đ of Clause 1 of Article 3 and Point b of Clause 3 of this Circular for excipients used at their facilities.";

e) Supplement Appendix IIa. Principles and standards of Good Manufacturing Practice (GMP) for drug excipient production of the World Health Organization after Appendix II of Circular No. 35/2018/TT-BYT according to the provisions in Appendix 3 issued together with this Circular.

7. Amend and supplement Clause 6 of Article 9 of Circular No. 36/2018/TT-BYT dated November 22, 2018 of the Minister of Health regarding Good Storage Practice (GSP) for drugs and drug raw materials as follows:

“6. After submitting the activity report - maintaining compliance with GSP as prescribed, the storage facility may continue operations within the business scope recorded in the Drug Business License already issued, using this certificate until the periodic assessment results of maintaining compliance with GSP are available, and must ensure continuous compliance with GSP during the entire operation period.”.

8. Amend and supplement some articles of Circular No. 15/2019/TT-BYT dated July 11, 2019 of the Minister of Health regarding drug tendering at public health facilities as follows:

a) Amend and supplement Clause 3 of Article 7 as follows:

“3. Group 3 includes drugs that have been granted a registration certificate for circulation or import permit for circulation in Vietnam and have a bioequivalence study report published by the Department of Medicine Management.”;

b) Amend and supplement Clause 5 of Article 7 as follows:

“5. Group 5 includes drugs that have been granted a registration certificate for circulation or import permit for circulation in Vietnam.”;

c) Amend and supplement Point a of Clause 8 of Article 50 as follows:

“a) Legal documents issued by the drug regulatory authority of a country listed in the SRA list must bear sufficient signatures, names of signatories, and seals of the competent state management agency of the issuing country, and must be legalized consularly according to regulations (original or certified copy).

In cases where the legal document issued is an electronic version, including cases without sufficient signatures, names of signatories, and seals of the competent state management agency of the issuing country, the applicant must submit the result of self-searching the legal document from the English-language website of the issuing authority with a seal of confirmation from the applicant attached, along with a document providing information about the online search link to the Department of Medicine Management. The applicant must bear legal responsibility for the legality and accuracy of these documents, information, and the self-search results.

The legal documents must include at least the following contents: drug name, active ingredient, concentration or amount of active ingredient, dosage form, name and address of the production facility, with confirmation that the drug has been granted permission for circulation in that country.

d) Amend and supplement Appendix 3 Model report on violations by contractors during the bidding process and supply of drugs as stipulated in Appendix 4 issued together with this Circular, pursuant to Circular No. 15/2019/TT-BYT.

đ) Amend and supplement Clause 1 of Section I. Quality criteria for drugs and Clause 13 of Section II. Packaging, storage, and delivery criteria in Part 4 of the Technical Evaluation Standard Table of Appendices 7 and 8 of Circular No. 15/2019/TT-BYT as stipulated in Appendix 5 issued together with this Circular.

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

"a) Consuming all Methadone in the presence of healthcare staff, except in cases where the healthcare facility provides Methadone for take-home use in accordance with the guidelines of the Ministry of Health;"

10. Amend and supplement some provisions of Circular No. 18/2019/TT-BYT dated July 17, 2019 of the Minister of Health guiding Good Manufacturing Practices (GMP) in the production and business of health protection foods as follows:

a) Amending and supplementing Clause 3 of Article 3 as follows:

“3. A pharmaceutical herb medicine or traditional medicine manufacturing facility that has been granted a Certificate of Compliance or assessed as meeting the Good Manufacturing Practice (GMP) standards for pharmaceutical herb medicines or traditional medicines by the Department of Drug Administration under the Ministry of Health or the Department of Traditional Medicine Management under the Ministry of Health, and such certificates remain valid according to current pharmaceutical laws may produce health protection foods in the corresponding dosage forms without having to go through the procedures for obtaining a Food Safety Facility Certification Meeting GMP Standards for Health Protection Foods.”

“1. Imported health protection foods must be produced at facilities that have been authorized by the competent authority of the producing country (including national food safety management agencies or organizations designated, recognized, or approved by such agencies, or agencies or organizations from other countries recognized by the national management agency of the producing country) to issue one of the following certifications or confirmations:”

“a) Good Manufacturing Practice (GMP) Certificate for the production facility of health protection foods or Free Sale Certificate (Certificate of Free Sale - CFS) stating that the product is manufactured at a facility that meets GMP requirements;"

"c) For countries or regions that do not issue the certificates specified in points a and b of this clause, they must be confirmed in writing by the competent authority or published on the official website of the competent authority stating that the issuing of GMP Certificates for health protection food production facilities does not occur in that country;"

“2. The content of the certificates or confirmations specified in points a and b Clause 1 of this Article (excluding CFS as specified in point a Clause 1 of this Article) must include at least the following information:

a) Name of the competent authority or organization issuing the certificate;

b) Date of issuance;

c) Validity period (if the GMP certificate or confirmation does not specify a validity period, it must include a periodic inspection report or record ensuring the production facility maintains food safety conditions or the inspection and evaluation period is specified in the regulatory document of the product's exporting country);

d) Name and signature of the issuer;

đ) Name and address of the certified facility;

e) Scope of certification.”

e) Repeal Clause 2 Article 5 and provide that "The implementation date of the provision in this point shall be carried out in accordance with Clause 2 Article 5 of this Circular" in point b Clause 1 Article 4;

g) Amend and supplement Clause 3.7 of Section III. Production Facilities and Equipment in the attached Appendix of Circular No. 18/2019/TT-BYT as follows:

“3.7. In cases where health protection foods, pharmaceutical herb medicines, and traditional medicines are produced on the same production line: appropriate measures must be taken to prevent confusion, contamination, or cross-contamination (see Section 6.19).”

11. Amend and supplement the provision "The maximum Tar and Nicotine levels prescribed in QCVN 16-1:2015/BYT will be applied until December 31, 2020." in Article 2 of Circular No. 23/2015/TT-BYT dated August 20, 2015 of the Minister of Health on the issuance of National Technical Regulations for cigarette tobacco as follows:

"The maximum Tar and Nicotine levels prescribed in the National Technical Regulation QCVN 16-1:2015/BYT will be reviewed every two years and adjusted if necessary to meet the requirements for preventing and controlling the harmful effects of tobacco."

Article 2. Repeal certain regulatory legal documents issued by the Minister of Health, jointly issued.

Repeal entirely twenty-eight regulatory legal documents and repeal part of two regulatory legal documents issued by the Minister of Health, jointly issued, listed in Appendix 6 attached to this Circular.

Article 3. Effectiveness

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

2. Specifically, the provisions of Clauses 5, 6, 7, 8, and 11 of Article 1 of this Circular take effect from January 1, 2021.

3. Provisions related to submission of applications, documents, and online search shall be applied during the COVID-19 pandemic period until the Ministry of Health reviews and adjusts them in accordance with practical requirements.

Article 4. Transitional Provisions

1. Applications submitted to the receiving agency before the effective date of this Circular but still under processing shall be governed by relevant provisions of this Circular or previous regulations prior to the effective date of this Circular, in a manner that is convenient for businesses, organizations, and individuals.

2. Provisions on information disclosure, updates, declarations, and reports through online forms in this Circular shall be implemented according to the deployment by competent state agencies.

Article 5. Responsibilities for Implementation

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