Assess manufacturing plant

There are 2 cases:

Case 1:

Finished product’s manufacturers are in countries declared by the Ministry of Health on the list of countries where Vietnam has signed an international agreement on mutual recognition of the results of the inspection of good manufacturing practice. (ASEAN’s countries which have PICs GMP)

Or manufacturers are in countries of ICH members, Australia and are inspected, assessed the implementation of good manufacturing practice by one of the Drug Administration Agency of United Stated (US Food and Drug Administration (USFDA), by countries is European Union (European Union, European Medicines Agency (EMA), by Australia (Therapeutic Goods Administration, TGA), Japan (Pharmaceuticals and Medical devices Agency, PMDA) or by Canada (Health Canada)

Case 2: The manufacturers are not including in case 1.

Documents required in dossier for evaluating manufacturer:

For case 1

1. a) Certificate of Good Manufacturing Practice or inspection report of Good Manufacturing Practice or Manufacturing license with full information about pharmaceutical dosage form of medicinal products, raw materials issued by competent authority in country of origin.
2. b) Site master file of manufacturer according to guideline about site master file of European Union (EU) or Pharmaceutical Inspection Co-operation Scheme (PIC/S) or World Health Organization.

For case 2:

1. Certificate of Good Manufacturing Practice or inspection report of Good Manufacturing Practice or Manufacturing license with full information about pharmaceutical dosage form of medicinal products, raw materials issued by competent authority in country of origin; GMP or testing report of GMP issued by Drug Administration of member countries in EU or PIC/S (if possible).
2. Site master file according to guideline about site master file of European Union (EU) or Pharmaceutical Inspection Co-operation Scheme (PIC/S) or World Health Organization.
3. List of GMP testing phase performed by Drug Administration of local or foreign countries within 03 years from the date of submitting dossiers and GMP testing reports of the latest inspection with inspection scope including medicinal products, medicinal raw materials or dosage form of registered drugs.
4. List of drugs with dosage form of medicinal products, medicinal raw materials have provided or supposed to be provided into Vietnam.
5. Drug releasing procedure for medicinal products, medicinal raw materials supposed to register in Vietnam.
6. Periodic qualitative inspection reports for medicinal products, medicinal raw materials supposed to register in sterile form.