MINISTRY OF HEALTH
No. 29/2020/TT-BYT

SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness

Hanoi, 31 December 2020

CIRCULAR

AMENDING, SUPPLEMENTING AND REPEALING A NUMBER OF LEGAL NORMATIVE DOCUMENTS PROMULGATED OR JOINTLY PROMULGATED BY THE MINISTER OF HEALTH

Reference translation note: This English translation is prepared for logistics, import-export and compliance reference. It is not an official legal translation. For binding application, the Vietnamese original published on the National Legal Database must prevail.

Pursuant to the Law on Promulgation of Legal Normative Documents dated 22 June 2015 and the Law amending and supplementing a number of articles of the Law on Promulgation of Legal Normative Documents dated 18 June 2020;

Pursuant to the Law on Pharmacy dated 06 April 2016;

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

Pursuant to Government Decree No. 54/2017/ND-CP dated 08 May 2017 detailing a number of articles and measures for implementation of the Law on Pharmacy;

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

Pursuant to Government Decree No. 96/2012/ND-CP dated 15 November 2012 on treatment of addiction to opioid substances using substitution medicines;

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

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

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

At the proposal of the Director of the Legal Department, the Minister of Health promulgates this Circular amending, supplementing and repealing a number of legal normative documents promulgated or jointly promulgated by the Minister of Health.

Article 1. Amendments and supplements to a number of legal normative documents in the fields of cosmetics, pharmacy, HIV/AIDS prevention and control, and food safety

1. Amendments and supplements to Circular No. 06/2011/TT-BYT on cosmetics management.

a) Clause 4 Article 4 is amended and supplemented regarding Certificate of Free Sale (CFS) for imported cosmetic products. CFS exemption applies to cosmetic products manufactured in a CPTPP member country where that country’s participation in the CPTPP has been approved and entered into force; cosmetic products circulated and exported from a CPTPP member country with documents proving circulation in that member country; and cosmetic products that have been granted a product notification receipt number in an ASEAN country.

For CPTPP/ASEAN proof documents, the enterprise responsible for placing the product on the market must submit the relevant document issued by the competent authority of the member country, consularly legalized as prescribed, except where the document is exempt from consular legalization under an international treaty or reciprocity principle, confirmed directly by a foreign diplomatic authority/competent cosmetics authority/issuing authority, or self-verified from the English website of the issuing authority with enterprise certification and a lookup link submitted to the Drug Administration of Vietnam. The enterprise is legally responsible for the legality and accuracy of the documents, information and self-lookup result.

Except for CFS-exempt cases, an imported cosmetic product notification dossier must include a CFS issued by the competent authority of the manufacturing or exporting country, still valid as an original or certified copy. If the CFS does not state its validity period, it must have been issued within 24 months before the date of submission. The CFS must be consularly legalized unless it is exempt under an international treaty/reciprocity principle or its information is confirmed to the Drug Administration of Vietnam by the issuing authority or a foreign diplomatic authority. The CFS must contain at least the information required under Article 36 of the Law on Foreign Trade Management and Clause 3 Article 10 of Decree No. 69/2018/ND-CP.

b) Appendix 01-MP issued together with Circular No. 06/2011/TT-BYT is amended and supplemented according to Appendix 1 attached to this Circular.

c) Article 33 is amended regarding CFS dossiers and procedures for domestically manufactured cosmetics for export. A CFS application dossier for exported cosmetics follows Article 11 of Decree No. 69/2018/ND-CP; the declared applicable standard may be replaced by a cosmetic product notification receipt already granted. The CFS issuance process follows Article 11 of Decree No. 69/2018/ND-CP. The CFS fee is calculated per product corresponding to one cosmetic product notification receipt. The provincial Department of Health where the manufacturing facility is located issues and manages CFS for exported cosmetics manufactured in its locality.

2. Appendix VII of Circular No. 20/2017/TT-BYT on drugs and medicinal ingredients subject to special control is supplemented with the rule that the list includes all salt forms, if any, of the substances named in the list.

3. Point dd Clause 2 Article 17 of Circular No. 02/2018/TT-BYT is amended: on a quarterly basis, the local authority shall report online the list of retail drug establishments granted certificates of eligibility for pharmacy business and their GPP compliance status on the Drug Administration of Vietnam website.

4. Point dd Clause 3 Article 18 of Circular No. 03/2018/TT-BYT is amended: on a monthly basis, the local authority shall report online the list of drug and medicinal ingredient distribution establishments granted certificates of eligibility for pharmacy business and their GDP compliance status on the Drug Administration of Vietnam website.

5. A number of articles of Circular No. 32/2018/TT-BYT on registration of drugs and medicinal ingredients are amended, supplemented or repealed. The amendments cover electronic legal documents; requirements for CPP/legal documents for new chemical drugs, imported biologicals and imported vaccines; self-assessment of GMP compliance for excipient manufacturers when certain documents are unavailable; minor variations requiring notification; temporary validity of GMP certificates during Covid-19; simplified CPP information requirements for applications submitted before 31 December 2021; online updating of information on excipients and empty capsules imported for domestically registered drugs; verification of legal documents; publication of websites of authorities issuing legal documents; and addition of Form 13/TT on declaration of GMP principles/standards applicable to excipient manufacture.

For electronic legal documents without full signature, signer name or official seal, the registrant must submit either the legalized legal document or a self-lookup result from the English website of the issuing authority, certified by the registrant and accompanied by a lookup link sent to the Drug Administration of Vietnam. The registrant is legally responsible for the legality and accuracy of the documents, information and self-lookup result.

For applications for marketing authorization of new chemical drugs and imported biologicals, except probiotic biologicals, a CPP issued by the competent authority of the manufacturing country must confirm that the drug has been licensed and actually circulated in that country. If that CPP is not issued by EMA, an additional legal document from one of the recognized regulatory authorities specified in Circular No. 32/2018/TT-BYT is required. Similar CPP/legal document requirements apply to imported vaccines.

Minor variations classified as notification-only, including MiV-N1, MiV-N2, MiV-N3, MiV-N4, MiV-N6 and MiV-N7 under Appendix II, may be implemented by the establishment from the date on the dossier receipt slip; within 15 working days, the Drug Administration of Vietnam publishes the notification-only changes on its website. Other notification-only minor variations are approved or responded to within 15 working days from the receipt date.

For drugs and medicinal ingredients whose marketing authorization expired between 01 January 2018 and 31 December 2021, including those already maintained, the validity may continue for 12 months if all applicable conditions are met. GMP certificates issued by EEA regulatory authorities may be recognized until 31 December 2021 if extended under EMA’s Covid-19 notice, unless a new EMA notice applies or a new GMP certificate has been issued. GMP certificates issued by non-EEA authorities are determined based on the issuing country authority’s notice or the validity stated on the certificate.

For domestically manufactured drugs and medicinal ingredients already granted marketing authorization before 31 December 2020 where the establishment needs to import excipients or empty capsules into Vietnam, before the first importation the registrant must update all information on those excipients or empty capsules in the approved dossier to the Drug Administration’s online public service system. Within 05 working days from the update, the Drug Administration must complete publication. The registrant is responsible for the accuracy of the updated information and is not required to repeat the update for subsequent importations.

6. A number of articles of Circular No. 35/2018/TT-BYT on Good Manufacturing Practice for drugs and medicinal ingredients are amended and supplemented. The Circular announces the application of WHO GMP, WHO GMP for biological medicinal products derived from human blood and plasma, PIC/S GMP, EU GMP, and WHO GMP for excipients; allows equivalent SRA-issued EU-GMP-standard GMP principles for non-excipient drug/medicinal ingredient manufacturers; and allows excipient manufacturers to apply GMP principles/standards of IPEC, EXCiPACT, ANSI, USP or other relevant internationally applied standards.

Excipient manufacturers must apply GMP under Appendix IIa or other permitted GMP principles/standards and updated documents. Where WHO, IPEC, EXCiPACT, ANSI, USP or another relevant international organization publishes updates to GMP principles/standards for excipients, the manufacturer must apply updated documents within 12 months if changes to premises or equipment are required, or within 06 months for other updates. Manufacturers of finished drugs and semi-finished products must self-assess the GMP compliance of excipient manufacturers based on the purpose and scope of use of the excipient.

7. Clause 6 Article 9 of Circular No. 36/2018/TT-BYT on Good Storage Practice is amended. After submitting the report on continued GSP compliance on time, the storage establishment may continue operating within the business scope stated in its pharmacy business eligibility certificate and may use that certificate until periodic assessment results are available, provided that GSP compliance is maintained throughout operations.

8. A number of articles of Circular No. 15/2019/TT-BYT on drug bidding at public health facilities are amended. Group 3 includes drugs granted marketing authorization or import permits for circulation in Vietnam and with bioequivalence study reports published by the Drug Administration of Vietnam. Group 5 includes drugs granted marketing authorization or import permits for circulation in Vietnam. Requirements on legal documents from SRA drug regulatory authorities, the bidder violation report form, and technical evaluation criteria in bidding appendices are also amended.

9. Point a Clause 2 Article 14 of Circular No. 14/2015/TT-BYT on Methadone management is amended. Patients must take all Methadone in the presence of medical staff, except where a health facility provides take-home Methadone according to Ministry of Health guidance.

10. A number of articles of Circular No. 18/2019/TT-BYT on GMP for manufacturing and trading health supplements are amended. Herbal/traditional medicine manufacturers already certified or assessed as meeting GMP for herbal/traditional medicines may manufacture health supplements in corresponding dosage forms without applying for a separate certificate of food safety eligibility meeting health supplement GMP. Imported health supplements must be manufactured at a facility granted one of the required certificates/confirmations by a competent authority of the manufacturing country, including GMP certificate or CFS showing GMP compliance.

Where a country or territory does not issue the required GMP certificate, written confirmation from the competent authority or official publication on its website is required. Certificates/confirmations must at least contain the issuing authority, date of issue, validity period, issuer’s name and signature, name and address of the certified establishment, and certified scope. If no validity is stated, there must be an assessment report/periodic inspection record or a validity/assessment interval under the exporting country’s law. Certain provisions are repealed, and where health supplements, herbal drugs and traditional medicines are manufactured on the same production line, appropriate controls must be in place to prevent mix-up, contamination and cross-contamination.

11. Circular No. 23/2015/TT-BYT on QCVN 16-1:2015/BYT for cigarettes is amended. The maximum tar and nicotine levels in QCVN 16-1:2015/BYT are reviewed periodically every 02 years and may be adjusted when necessary to meet tobacco harm prevention and control requirements.

Article 2. Repeal of a number of legal normative documents promulgated or jointly promulgated by the Minister of Health

The Circular repeals in full 28 legal normative documents and partially repeals 02 legal normative documents promulgated or jointly promulgated by the Minister of Health, as listed in Appendix 6 attached to this Circular.

Appendix 6 – List of wholly repealed legal normative documents:

Food safety: (1) Decision No. 01/2006/QD-BYT on food safety reporting regime and forms; (2) Decision No. 12/2006/QD-BYT on decentralization of food hygiene and safety management tasks in the health sector; (3) Circular No. 05/2007/TT-BYT on conditions and procedures for appointing organizations to conduct state inspection of imported food quality, hygiene and safety; (4) Circular No. 11/2013/TT-BYT on appointment and management of conformity certification organizations; (5) Circular No. 11/2014/TT-BYT on management of rapid test kits; (6) Joint Circular No. 13/2014/TTLT-BYT-BNNPTNT-BCT on assignment and coordination in state management of food safety.

Pharmacy – cosmetics: (7) Decision No. 47/2007/QD-BYT on application of good practices to establishments manufacturing, testing, trading, distributing, exporting, importing, storing and preserving vaccines and medical biologicals; (8) Circular No. 02/2007/TT-BYT guiding conditions for pharmacy business under the Law on Pharmacy and Decree No. 79/2006/ND-CP; (9) Circular No. 13/2015/TT-BYT amending Clause 2 Article 21 of Circular No. 47/2010/TT-BYT on import and export of drugs and packaging in direct contact with drugs; (10) Circular No. 44/2014/TT-BYT on drug registration; (11) Circular No. 32/2019/TT-BYT amending Clause 4 Article 4 and Appendix 01-MP of Circular No. 06/2011/TT-BYT on cosmetics management.

Planning – finance: (12) Joint Circular No. 09/TT-LB dated 21 July 1992 on organization of military-civilian medical boards and coordination in epidemic prevention/control and receiving wounded or sick persons; (13) Joint Circular No. 03/TT-LB dated 04 March 1994 on military-civilian medical coordination in emergency care and care for disaster victims.

Science, technology and training: (14) Circular No. 03/2012/TT-BYT on clinical drug trials.

Personnel organization: (15) Decision No. 3051/2000/QD-BYT on contents and forms of promotion examinations for health professional titles; (16) Joint Circular No. 08/2007/TTLT-BYT-BNV guiding staffing norms in public health establishments; (17) Joint Circular No. 02/2008/TTLT-BYT-BNV guiding implementation of Decree No. 43/2006/ND-CP on autonomy and accountability of public service units in the health sector; (18) Joint Circular No. 06/2010/TTLT-BYT-BNV-BTC guiding Decree No. 64/2009/ND-CP on policies for health officials and public employees working in extremely disadvantaged areas.

Medical equipment and works: (19) Circular No. 07/2002/TT-BYT guiding registration for circulation of medical device products; (20) Decision No. 1629/2001/QD-BYT promulgating 10 health-sector standards for medical devices; (21) Decision No. 326/2002/QD-BYT promulgating 09 health-sector standards for medical devices; (22) Decision No. 4380/2003/QD-BYT promulgating 08 health-sector standards for medical devices.

Medical environmental management: (23) Circular No. 05/1999/TT-BYT guiding declaration, registration and certificate issuance for use of substances subject to strict occupational hygiene requirements; (24) Directive No. 12/2001/CT-BYT on organizing the annual National Week of Occupational Safety and Hygiene and Fire/Explosion Prevention; (25) Circular No. 36/2010/TT-BYT repealing Decision No. 29/2005/QD-BYT on the form of certificate for circulation registration of insecticidal and disinfectant preparations for household and medical use; (26) Circular No. 02/2003/TT-BYT guiding implementation of the cooperation program to promote public health care and protection in the movement “All people unite to build cultural life”; (27) Decision No. 26/2007/QD-BYT repealing Decision No. 1635/2004/QD-BYT on regulations for recognition of “Healthy Family”, “Healthy Village”, “Healthy Quarter” and “Healthy Residential Area” titles.

Maternal and child health: (28) Joint Circular No. 10/2006/TTLT/BYT-BTM-BVHTT-UBDSGDTE guiding implementation of Decree No. 21/2006/ND-CP on trading and use of nutritional products for young children.

Appendix 6 – List of partially repealed documents: (1) Circular No. 52/2015/TT-BYT on state inspection of food safety for imported foods and control/certification of imported foods under the Ministry of Health: all provisions are repealed except those related to dossiers and procedures for issuance and revocation of health certificates for imported food products. (2) Decision No. 46/2007/QD-BYT on maximum limits of biological and chemical contamination in food: repeals the microbiological limit criteria for B. cereus applicable to certain dry foods and nutritional foods for children and special substitute foods under Section 6.9, and repeals related microbiological limit provisions in Part 6.

Article 3. Effect

1. This Circular takes effect from 15 February 2021.

2. The provisions at Clauses 5, 6, 7, 8 and 11 of Article 1 of this Circular take effect from 01 January 2021.

3. Provisions on online submission of dossiers, documents and lookup apply during the Covid-19 period until the Ministry of Health reviews and adjusts them in line with practical requirements.

Article 4. Transitional provisions

1. Dossiers submitted to the receiving authority before this Circular takes effect but still under processing may apply the relevant provisions of this Circular or the pre-effective provisions, in the direction more convenient for enterprises, organizations and individuals.

2. Provisions on online publication, updating, declaration and reporting under this Circular apply according to implementation by the competent state authority.

Article 5. Implementation responsibility

The Director of the Legal Department, Chief of the Ministry Office, Chief Inspector of the Ministry, directors of departments, directors-general of administrations under the Ministry of Health, and relevant agencies, organizations and individuals are responsible for implementing this Circular.

Minister
(Signed)
Nguyen Thanh Long

Cross-check note: Appendices 1 to 5 contain forms, GMP technical guidance and scoring tables with specific layout requirements. This article translates the operative legal content and Appendix 6 list for operational reference; for exact form fields, tables and signature layout, enterprises should open the original PDF/DOC using the buttons above.