Circular 12/2022/TT-BYT amending Circular 35/2018/TT-BYT good practices of manufacturing drugs, drug materials

CIRCULAR

Amending and supplementing a number of articles of the Minister of Health's Circular No. 35/2018/TT-BYT dated November 22, 2018, on good practices of manufacturing drugs or drug materials

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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, detailing a number of articles of and providing measures for implementing the Pharmacy Law;

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 proposal of the Director of the Drug Administration of Vietnam and the Director of the Traditional Medicine Administration;

The Minister of Health hereby promulgates the Circular amending and supplementing a number of articles of the Minister of Health's Circular No. 35/2018/TT-BYT dated November 22, 2018, on good practices of manufacturing drugs or drug materials.

Article 1. Amending and supplementing a number of articles of the Minister of Health's Circular No. 35/2018/TT-BYT dated November 22, 2018, on good practices of manufacturing drugs or drug materials

1. To add Clause 13 Article 2 as follows:

“13. EU-GMP equivalents mean GMP principles and standards issued by stringent regulatory authorities.”

2. To amend and supplement Clause 4 Article 3 as follows:

“4. Updated documents on GMP principles and standards:

a) In case where the World Health Organization amends and supplements the principles or standards for good practices of manufacturing drugs or drug materials (hereinafter referred to as updated documents) specified at Points a and b Clauses 1 of this Article, within 03 months from the date on which the updated documents are publicized on the World Health Organization’s portal, the Drug Administration of Vietnam or the Traditional Medicine Administration shall, within the state management, organize to translate and publicize such amendments and supplementations on the Ministry of Health's portal and its website, for search, update and application;

b) In case where the Pharmaceutical Inspection Co-operation Scheme (PIC/S), or the European Union issues updated documents specified at Points c and d Clause 1 of this Article that have not yet been publicized on the Ministry of Health's portal and the website of the Drug Administration of Vietnam, the drug or drug material manufacturing establishment applying such documents shall be responsible for translating and certifying the translations in accordance with the law on notarization and certification and send them to the Drug Administration of Vietnam. Within 10 days from the date of receiving the notarized, certified translations sent by the drug or drug material manufacturing establishment, the Drug Administration of Vietnam shall review, modify and publicize them on the Ministry of Health’s portal and its website.”

3. To amend and supplement Clause 3 Article 4 as follows:

3. Establishments manufacturing drugs from medicinal materials and drug materials from medicinal materials shall apply GMP principles and standards provided in Appendix V to this Circular.”

4. To amend and supplement Clause 4 Article 4 as follows:

“4. Establishments manufacturing traditional drugs that only manufacture traditional drugs in the form of extracts, pellets, pills, powders, tinctures or medicinal liquor shall apply GMP standards and principles provided in Part I - Appendix VI to this Circular”.

5. To amend and supplement Clause 9 Article 4 as follows:

“9. Establishments manufacturing traditional drugs and traditional medicaments are allowed to apply GMP standards and principles provided in Part II of Appendix VI or Appendix I or Appendix II or Appendix IV or Appendix V to this Circular, and updated documents prescribed in Clause 4 Article 3 of this Circular.”

6. To amend and supplement Clause 10 Article 4 as follows:

“10. For drugs and drug materials containing beta-lactam antibiotics (Penicillins, Cephalosporins, Penems and the like), cytotoxic drugs, drugs containing sexual hormones belonging to the group of contraceptives, vaccines, biological products and specific drugs with separate manufacture requirements as specified in GMP principles and standards (WHO-GMP, PIC/S-GMP, EU-GMP and EU-GMP equivalents), in addition to the requirement to be manufactured at the manufacturing establishment applying relevant GMP principles and standards specified in this Article, they must be manufactured in separate facilities which have particular equipment and measures to prevent spreading and polluting the environment and other drug products manufactured in the same area.

For anti-cancer drugs, sexual hormone drugs and highly active drugs that do not belong to the above-mentioned drug group, the need and degree of segregation of facilities and/or production 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. To amend and supplement Clause 11 Article 4 as follows:

“11. Manufacturers of chemical pharmaceutical products in the form of soft gelatin capsules, oral liquids and external medicines (creams, gels, ointments and topical solutions) are entitled to manufacture drug from medicinal materials from herbal extracts, pastes, oil and granules that have been standardized on the production line and have the corresponding form, and must apply GMP standards and principles specified in Appendix I or Appendix III or Appendix IV to this Circular and updated documents specified in Clause 4 Article 3 of this Circular.”

8. To amend Clause 1 Article 7 as follows:

“1. Documents used in the assessment of the satisfaction of GMP standards and principles: Documents on WHO-GMP standards and principles, or documents on GMP standards and principles specified in Clauses 2, 3, 4, 5 and 6 Article 4 of this Circular, corresponding to production activities of the manufacturers.”

9. To amend Clause 6 Article 9 as follows:

“6. After submitting the reports on operation and compliance with GMP standards and principles within the prescribed time limit, the manufacturer is entitled to keep operations of the drug or drug material manufacturing establishment as prescribed in the Law on Pharmacy and relevant guiding documents until the result of periodic assessment of GMP standard and principle compliance is available and shall ensure its maintenance of GMP standard and principle compliance.”

10. To amend Clause 7 Article 9 as follows:

“7. Order for assessment and procedures for assessment and classification of results of assessing the GMP standard and principle compliance are prescribed in Articles 6 and 7 of this Circular.

In case the receiving agency fails to assess the maintenance and compliance with GMP standards and principles as prescribed due to the occurrence of natural disasters, epidemics or war, it shall certify the state of maintaining the GMP standards and principles for the manufacturer. After remedying the state of natural disasters, epidemics or war, the receiving agency shall assess the maintenance and compliance with GMP standards and principles in accordance with Articles 6 and 7 of this Circular.”

11. To amend Point h Clause 2 Article 11 as follows:

“h) The manufacturer’s supplementation of the applicable GMP standards and principles is assessed and certified compliance with EU-GMP standards and principles or EU-GMP equivalents, and such compliance is recommended to be publicized by stringent regulatory authorities.”

12. To amend Clause 4 Article 11 as follows:

“If the manufacturer has one of the changes prescribed at Points b, c or d Clause 2 of this Article or the sterile drug or drug material manufacturing establishment has the change specified at Points dd, e and g Clause 2 of this Article, it is required to submit a report on its changes, accompanied by relevant technical documents, to the receiving agency.

a) The receiving agency shall carry out a field assessment at the manufacturer. If the manufacturer complies with requirements, the receiving agency shall grant written consent to its changes;

b) Order for assessing, classifying results and processing the assessment results of the manufacturer with changes specified at Point b Clause 2 of this Article shall comply with Articles 6, 7 and 10 of this Circular;

b) Order for assessing, classifying results and processing the assessment results of the manufacturer with changes specified at Point c or d Clause 2 of this Article, or the sterile drug or drug material manufacturing establishment with changes specified at Points dd, e and g Clause 2 of this Article shall comply with Articles 6, 7 and 8 of this Circular.”

13. To amend Clause 7 Article 11 as follows:

“7. If the drug or drug material manufacturing establishment has one of the changes prescribed at Points dd, e or g Clause 2 of this Article (except for the cases specified in Clause 4 of this Article), it is required to submit a report on its changes, accompanied by relevant technical documents, to the receiving agency. The manufacturer must maintain its operations in compliance with GMP standards and principles.

The receiving agency shall carry out an irregular assessment, process the assessment results in accordance with Article 12 of this Circular if the report on changes fails to prove the maintenance and compliance with GMP standards and principles by the manufacturer.”

14. To amend Clause 3 Article 14 as follows:

“3. Within 10 working days from the date on which the result of assessing the GMP standard and principle compliance, the receiving agency shall, based on documents in the application for assessing the GMP standard and principle compliance, information from the European Medicines Agency and stringent regulatory authorities’ websites, update assessment results and publicize the following information on the Ministry of Health’s portal and its website:

a) Name and address of the manufacturer;

b) GMP standards and principles (WHO-GMP, PIC/S-GMP, EU-GMP or EU-GMP equivalents) that have been complied with; the validity period for compliance with GMP standards and principles, name of the management agency competent to conduct the assessment and certification for the cases specified in Clauses 1 and 2 Article 96 of Decree No. 54/2017/ND-CP, or the date of assessing the compliance with GMP standards and principles of the Ministry of Health of Vietnam, applicable documents on GMP standards and principles, the validity period of the results of assessing GMP standards and principles, for the cases specified in Clause 3 Article 96 of Decree No. 54/2017/ND-CP;

c) Scope of operation of the assessed manufacturer.”

15. To add Clause 4 Article 14 as follows:

“4. Regulations on the determination of the validity period for compliance with GMP standards and principles mentioned at Point e Clause 6 Article 13 and Point b Clause 3 Article 14 amidst the Covid-19 pandemic, or in the occurrence of natural disasters, epidemics or war:

a) For GMP certificates issued by the medicines agency of the European Economic Area (EEA):

- In case where the manufacturer's GMP certificate validity is extended under the EMA's notice on policies applicable to human drugs amidst the Covid-19 pandemic or in the occurrence of natural disasters, epidemics or war: the validity period shall comply with EMA's notice;

- In case where the manufacturer has been granted a new GMP certificate, the validity period shall be determined according to the new one;

b) For GMP certificates issued by agencies other than those mentioned at Point a of this Clause: The determination of the validity period of the GMP certificate amidst the Covid-19 pandemic or in the occurrence of natural disasters, epidemics or war shall comply with the notice issued by the medicines agency of the country that has issued the GMP certificate, or comply with the validity period stated on the GMP certificate.”;

16. To add Clause 5 Article 19 as follows:

“5. Manufacturers granted a GMP certificate with the scope of manufacturing drugs from medicinal materials that remains valid before the effective date of this Circular are entitled to manufacture traditional drugs.”

17. To amend Section 4.1.14 in Form No. 05 provided in Appendix X as follows:

“4.1.14. Traditional medicament”.

18. To add Section 4.1.15 in Form No. 05 provided in Appendix X as follows:

“4.1.15. Others”.

Article 2. Repealing a number of phrases, points and clauses of the Minister of Health's Circular No. 35/2018/TT-BYT dated November 22, 2018, on good practices of manufacturing drugs or drug materials

1. To repeal Point b Clause 5 Article 11.

2. To repeal Clause 6 Article 11.

3. To repeal the phrase “or PIC/S-GMP or EU-GMP” in Form No. 01 provided in Appendix X.

4. To repeal the phrase “or the Pharmaceutical Inspection Co-operation Scheme (PIC/S) or European Union (EU)” in Form No. 05 provided in Appendix X.

Article 3. Effect

This Circular takes effect from January 05, 2022.

Article 4. Implementation responsibility

Chief of the Ministry Office, Director of the Drug Administration of Vietnam, Director of the Traditional Medicine Administration, Chief Inspector of the Ministry, heads of units affiliated to the Ministry of Health; Departments of Health of provinces and centrally-run cities, pharmaceutical business establishments, and relevant agencies, organizations and individuals shall implement this Circular.

Any difficulties arising in the course of implementation should be promptly reported to the Ministry of Health (the Drug Administration of Vietnam, the Traditional Medicine Administration) for consideration and settlement./.