What are regulations on processing results of inspection of Good Manufacturing Practices for pharmaceutical products and pharmaceutical starting materials (GMP) compliance in Vietnam?

What are regulations on processing results of inspection of Good Manufacturing Practices for pharmaceutical products and pharmaceutical starting materials (GMP) compliance in Vietnam? - image from internet

Pursuant to Article 8 of the Circular 35/2018/TT-BYT on Good Manufacturing Practices for pharmaceutical products and pharmaceutical starting materials by the Minister of Health stipulating regulations on processing results of inspection of GMP compliance in Vietnam:

1. If the GMP inspection report indicates that the manufacturer complies with GMP at level 1 as prescribed in Point a Clause 3 Article 7 of this Circular:

Within 10 working days from the date of signing the inspection record, the receiving authority shall request the Minister of Health to issue the certificate of eligibility for pharmacy business and issue the Certificate of GMP compliance according to Form No. 05 in the Appendix X hereof if the manufacturer applies for both certificate of GMP compliance and certificate of eligibility for pharmacy business.

2. If the GMP inspection report indicates that the manufacturer complies with GMP at level 2 as prescribed in Point b Clause 3 Article 7 of this Circular:

a) Within 05 working days from the date of signing the inspection record, the receiving authority shall send the GMP inspection report to the manufacturer as prescribed in Point b Clause 6 Article 33 of the Decree No. 54/2017/ND-CP.

b) Upon completion of deficiency rectification, the manufacturer shall submit a rectification report including a plan and evidences (such as documents, images, videos, certificates or other documentary evidences) for completion of rectification of deficiencies specified in the GMP inspection report;

c) Within 20 days from the receipt of the rectification report, the receiving authority shall assess result of deficiency rectification by the manufacturer and conclude the level of its GMP compliance. To be specific:

- If the result of deficiency rectification makes the manufacturer comply with GMP, the receiving authority shall request the Minister of Health to issue the certificate of eligibility for pharmacy business and the certificate of GMP compliance according to the Form No. 05 in the Appendix X hereof if the manufacturer applies for both certificate of GMP compliance and certificate of eligibility for pharmacy business;

- If the result of deficiency rectification shows that the manufacturer still fails to comply with GMP, the receiving authority shall respond and provide explanation in writing.

d) Within 06 months from the date on which additional documents are requested in writing by the receiving authority, the manufacturer shall submit them as requested. If the manufacturer fails to satisfy such request by the aforementioned deadline or the application is not satisfactory within 12 months from the first time it is submitted, the application will be rejected.

3. If the GMP inspection report indicates that the manufacturer complies with GMP at level 3 as prescribed in Point c Clause 3 Article 7 of this Circular:

Sequence and time of processing result of inspection of GMP compliance are specified in Clause 2 of this Article.

Within 20 days from the receipt of the rectification report, the receiving authority shall carry out a site inspection of deficiency rectification at the manufacturer before concluding the level of GMP compliance as prescribed in Point c Clause 2 of this Article.

4. If the GMP inspection report indicates that the manufacturer complies with GMP at level 4 as prescribed in Point d Clause 3 Article 7 of this Circular:

Within 05 working days from the date of signing the inspection record, the receiving authority shall send a notification of failure to comply with GMP enclosed with a GMP inspection report to the manufacturer and shall not issue the certificate of eligibility for pharmacy business.

5. In the cases where the manufacturer does not agree with the deficiency stated by the inspectorate, within 30 days from the date on which the inspectorate sends GMP inspection report or rectification report, the manufacturer shall submit a written recommendation enclosed with evidences (such as documents, images, videos and certificates) related to such deficiency to the receiving authority.

Within 10 working days from the receipt of the written recommendation, the receiving authority shall review GMP inspection report and written recommendation submitted by the manufacturer, if necessary, consult relevant exports and respond to the manufacturer in writing. The written response must clearly specify agreements and disagreements with the written recommendation submitted by the manufacturer and reasons for disagreements. The abovementioned length of time shall not add to the time limit for inspection.

6. Within 05 working days from the date of issuing the certificate of eligibility for pharmacy business, the receiving authority shall publish the following information on its website and web portal of the Ministry of Health:

a) Name and address of the manufacturer;

b) Full name of the person in charge of pharmacy, person in charge of quality assurance and number of his/her pharmacy practicing certificate;

c) Number of the certificate of eligibility for pharmacy business and Certificate of GMP compliance (if any);

d) Expiry date of inspection of GMP compliance;

dd) Scope of operation of the manufacturer;

e) EU - GMP certificate number, validity period and issuing authority if the manufacturer has its compliance with EU - GMP or equivalent inspected by SRA.

Above are regulations on processing results of inspection of GMP compliance in Vietnam. Please refer to the Circular 35/2018/TT-BYT for further information.

Best regards!