CIRCULAR

AMENDMENTS TO SOME ARTICLES OF THE CIRCULAR NO. 35/2018/TT-BYT DATED NOVEMBER 22, 2018 OF THE MINISTER OF HEALTH PRESCRIBING GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICAL PRODUCTS AND PHARMACEUTICAL STARTING MATERIALS

Pursuant to the Law on Pharmacy No. 105/2016/QH13 dated April 06, 2016;

Pursuant to the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 providing guidelines for implementation of the Law on Pharmacy;

Pursuant to the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to some Articles related to business conditions under state management of the Ministry of Health;

Pursuant to the Government’s Decree No. 95/2022/ND-CP dated November 15, 2022 defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the request of the Director General of the Drug Administration of Vietnam and the Director General of the Traditional Medicine Administration of Vietnam;

The Minister of Health hereby promulgates a Circular on amendments to some Articles of the Circular No. 35/2018/TT-BYT dated November 22, 2018 of the Minister of Health prescribing Good Manufacturing Practices for pharmaceutical products and pharmaceutical starting materials.

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1. Clause 13 is added to Article 2 as follows:

“13. “EU-GMP equivalence” means GMP principles promulgated by pharmacy authorities of SRA countries.”

2. Clause 4 of Article 3 is amended as follows:

“4. Updated documents on GMP principles:

a)  If WHO makes any revision to GMP principles (hereinafter referred to as “updated documents”) specified in Points a and b clause 1 of this Article, within 03 months from the date on which updated documents are published on WHO’s web portal; the Drug Administration of Vietnam or the Traditional Medicine Administration of Vietnam shall, within its jurisdiction, translate and publish the revisions on the web portal of the Ministry of Health and websites of the Drug Administration of Vietnam or Traditional Medicine Administration of Vietnam for retrieval, updating and application by relevant entities;

b) If the Pharmaceutical Inspection Co-operation System (PIC/S) or the European Union has the updated documents specified in points c and d clause 1 of this Article, which have not been published on the web portal of the Ministry of Health and website of the Drug Administration of Vietnam, manufacturers of pharmaceutical products and pharmaceutical starting materials applying such documents shall do the translation, certify translations in accordance with regulations of law on notarization and authentication and send them to the Drug Administration of Vietnam. Within 10 days from the date on which notarized and certified true translations are received, the Drug Administration of Vietnam shall consider, correct and publish them on the web portal of the Ministry of Health and website of the Drug Administration of Vietnam.”

3. Clause 3 of Article 4 is amended as follows:

“3. Manufacturers of herbal pharmaceutical products and herbal pharmaceutical materials shall apply GMP principles specified in Appendix V hereof.”

4. Clause 4 of Article 4 is amended as follows:

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5. Clause 9 of Article 4 is amended as follows:

“4. Manufacturers of traditional pharmaceutical products and prepared traditional pharmaceutical materials are permitted to apply GMP principles specified in Part II Appendix VI or Appendix I or Appendix III or Appendix IV or Appendix V hereof and updated documents specified in Clause 4 Article 3 hereof.”

6. Clause 10 of Article 4 is amended as follows:

“10. In addition to being manufactured by the manufacturer applying corresponding GMP specified in this Article, pharmaceutical products and pharmaceutical starting materials containing beta-lactam antibiotics (Penicillins, Cephalosporins, Penems and equivalent), cytotoxics, contraceptive sex hormones, vaccines, biologicals and pharmaceutical products with special requirements specified in GMP (WHO-GMP, PIC/S-GMP, EU-GMP and EU-GMP equivalence), must be manufactured at separate facilities using separate equipment, and measures should be in place to prevent the release of such pharmaceutical products, which is likely to affect the environment and other pharmaceutical products manufactured in the same area.

For anti-cancer drugs, sex hormones and highly active pharmaceutical ingredients that do not belong to the above groups of pharmaceutical products, the necessity and level of segregation of facilities and/or manufacturing equipment shall be determined on the basis of the risk assessment and guidelines of the European Medicines Agency (EMA) or the World Health Organization.”

7. Clause 11 of Article 4 is amended as follows:

“11. Manufacturers of chemical pharmaceutical products in the form of soft capsules, oral liquids and external medicines (creams, gels, ointments and lotions) are entitled to manufacture herbal pharmaceutical products from herbal extract, glue and granule which have been standardized on production lines capable of producing the same dosage forms, and must apply GMP principles specified in the Appendix I or Appendix III or Appendix IV hereof and updated documents specified in Clause 4 Article 3 hereof.”

8. Clause 1 of Article 7 is amended as follows:

“1. Documents used during the inspection of GMP compliance include: WHO - GMP or GMP documents specified in Clauses 2, 3, 4, 5 and 6 Article 4 of this Circular equivalent to the manufacturer’s manufacturing operations.”

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“6. After submitting the operation and GMP compliance report within the prescribed time limit, the manufacturer is entitled to keep carrying out operations of the manufacturer of pharmaceutical products and pharmaceutical starting materials under the Law on Pharmacy and its related guiding documents until the result of periodic inspection of GMP compliance is available, and shall ensure its maintenance of GMP compliance.”

10. Clause 7 of Article 9 is amended as follows:

“7. Sequence of inspecting and procedures for inspecting and classifying results of inspection of GMP compliance are prescribed in Articles 6 and 7 of this Circular.

If, in the event of any disaster, disease or war, the receiving authority fails to carry out an inspection of GMP compliance as prescribed, it shall verify the manufacturer’s GMP compliance status. Upon completion of remedial actions, the receiving authority shall carry out an inspection of maintenance of GMP compliance as prescribed in Articles 6 and 7 of this Circular.”

11. Point h Clause 2 of Article 11 is amended as follows:

“h) changing applied GMP principles and undergoing inspection of compliance with EU-GMP principles or EU-GMP equivalence by an SRA and being recommended by an SRA to make the declaration of compliance with GMP.”

12. Clause 4 of Article 11 is amended as follows:

“If the manufacturer makes one of the changes prescribed in Point b, c or d Clause 2 of this Article or the manufacturer of sterile pharmaceutical products and pharmaceutical starting materials makes the change specified in Point dd, e or g Clause 2 of this Article, the manufacturer is required to submit a report on its change, accompanied by relevant technical documents, to the receiving authority.

a) The receiving authority shall carry out an inspection at the manufacturing site.  If the manufacturer complies with GMP, the receiving authority shall grant a written consent to its changes;

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c) Sequence of inspecting, classifying and processing the result of inspection of GMP compliance in case of the change made by the manufacturer specified in Point c or d Clause 2 of this Article or the change made by manufacturer of sterile pharmaceutical products and pharmaceutical starting materials specified in Point dd, e or g Clause 2 of this Article is prescribed in Articles 6, 7 and 8 of this Circular.”

13. Clause 7 of Article 11 is amended as follows:

“7. If the manufacturer makes one of the changes prescribed in Point dd, e or g Clause 2 of this Article (except for the case specified in Clause 4 of this Article), the manufacturer is required to submit a report on its change, accompanied by relevant technical documents, to the receiving authority. The manufacturer shall keep carrying out manufacturing operations in accordance with principles of GMP.

The receiving authority shall carry out a surprise inspection and process the inspection result as prescribed in Article 12 of this Circular if the change report on its change shows that the manufacturer fails to maintain its GMP compliance.”

14. Clause 3 of Article 14 is amended as follows:

“3. Within 10 working days from the date on which the result of inspection of GMP compliance by a manufacturer is obtained, the receiving authority shall rely on the application for inspection of GMP compliance, information obtained from the EMA’s database and websites of pharmacy authorities around the world to update the result of inspection of GMP compliance and publish the following information on its website and web portal of the Ministry of Health:

a) Name and address of the manufacturer;

b) GMP principles (WHO-GMP, PIC/S-GMP, EU-GMP or EU-GMP equivalence), period of validity of certificate of GMP compliance and name of the regulatory authority competent to carry out assessment and certification in the cases specified in Clauses 1 and 2 Article 96 of the Decree No. 54/2017/ND-CP or date of GMP compliance inspection by the Vietnam Ministry of Health, GMP documents applied and validity period of result of inspection of GMP compliance in the case specified in Clause 3 Article 96 of the Decree No. 54/2017/ND-CP;

c) Scope of operation of the inspected manufacturer.”

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“4. Regulations on determination of the validity period of certificate of GMP compliance specified in Point e Clause 6 of Article 13 and Point b Clause 3 of Article 14 during the Covid-19 pandemic or in the event of a disaster, disease or war:

a) For the certificate of GMP compliance issued by pharmacy authorities in countries in the European Economic Area - EEA:

- If the validity period of the manufacturer’s certificate of GMP compliance is extended under the EMA’s Notice of regulatory expectations for medicinal products for human use during the Covid-19 pandemic or in the event of a disaster, disease or war: the validity period of the certificate of GMP compliance shall comply with the EMA’s Notice;

- If the manufacturer has been issued with a new certificate of GMP compliance, the validity period of the certificate of GMP compliance is the same as that of the new one.

b) For the certificate of GMP compliance issued by authorities other than those specified in Point a of this Clause: The validity period of the certificate of GMP compliance during the Covid-19 pandemic or in the event of a disaster, disease or war shall be determined under the notice given by the pharmacy authority of each country which issued the certificate of GMP compliance or is the same as that written on the certificate of GMP compliance.”;

16. Clause 5 is added to Article 19 as follows:

“5. For any manufacturer issued with a certificate of GMP compliance which covers the manufacture of herbal pharmaceutical products and remains effective before the effective date of this Circular, it is entitled to manufacture traditional pharmaceutical products”.

17. 4.1.14 in the Form No. 05 of the Appendix X is amended as follows:

“4.1.14. Prepared traditional pharmaceutical materials”.

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“4.1.15. Other”.

Article 1. Abrogation of some phrases, Points and Clauses of the Circular No. 35/2018/TT-BYT dated November 22, 2018 of the Minister of Health prescribing Good Manufacturing Practices for pharmaceutical products and pharmaceutical starting materials

1. Point b Clause 5 of Article 11 is abrogated.

2. Clause 6 of Article 11 is abrogated.

3. The phrase “hoặc PIC/S - GMP hoặc EU - GMP” (“or PIC/S - GMP or EU - GMP”) is removed from the Form No. 01 in the Appendix X.

4. The phrase “hoặc Hệ thống hợp tác thanh tra dược phẩm (PIC/S) hoặc Liên minh Châu Âu (EU)” (“or Pharmaceutical Inspection Co-operation Scheme (PIC/S) or European Union (EU)” ) is removed from the Form No. 05 in the Appendix X.

Article 3. Effect

This Circular comes into force as of January 05, 2023.

Article 4. Responsibility for implementation

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Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health (through the Drug Administration of Vietnam or the Traditional Medicine Administration of Vietnam) for consideration and resolution./.

PP. THE MINISTER
THE DEPUTY MINISTER




Do Xuan Tuyen