GMP at foreign facilities for medicine circulation in Vietnam

When drugs and medicinal ingredients have not been granted a circulation registration certificate

At that time, the establishment registering for drug circulation in Vietnam needs to submit a GMP assessment dossier when submitting the circulation registration dossier for drugs and medicinal ingredients for the following cases:

• A facility that produces drugs and medicinal ingredients has a drug registered for circulation in Vietnam for the first time.
• Drugs produced by foreign drug and drug raw material manufacturers on production lines have not been evaluated by the Ministry of Health.
• Medicinal ingredients (or pharmaceutical substances) are registered for circulation in Vietnam for the first time.
• Medicinal ingredients produced by a foreign manufacturer registered for the first time in Vietnam.

When drugs and medicinal ingredients have been granted circulation registration before Decree 54/2017/ND-CP was issued

When a drug manufacturing facility has not been evaluated for GMP by the Ministry of Health but has a certificate of registration for circulation of its drug products, the registration facility needs to submit an application for GMP evaluation to the drug manufacturing facility foreign countries in the following cases:

• Submit an application to extend the registration for circulation of drugs and medicinal ingredients according to the provisions of Clause 4, Article 55 of the Law on Pharmacy (extension when the registration for circulation expires, including products with administrative changes at the time of submission). extend).
• Submit an application for a marketing registration certificate due to a change in the manufacturer’s location according to the provisions of Point b or c, Clause 2, Article 55 of the Pharmacy Law (the drug has a marketing registration certificate but has a change in pharmaceutical composition), substance, medicinal ingredient, concentration, content, volume of medicinal substance, medicinal ingredient; change of dosage form, route of administration; change of production facility, except in the case of changing the secondary packaging facility or factory such as the place of release; medicinal ingredients have a certificate of circulation but the production facility has been changed, except for the case of changing the secondary packaging facility or factory as well as the factory location).

When many establishments produce drugs and medicinal ingredients, many stages are involved

At that time, the registration facility needs to submit an application for assessment of all manufacturing facilities participating in the production process of that drug or medicinal ingredient.

Form of evaluating GMP documents for foreign manufacturers when registering to circulate drugs in Vietnam

Recognize and acknowledge the results of the inspection by the Pharmaceutical Management Agency

The following cases are recognized and acknowledged the results of the State Pharmaceutical Management agency’s inspection and testing to meet GMP:

• Drug and raw material manufacturing facilities belonging to countries on the list announced by the Ministry of Health that Vietnam has signed must acknowledge GMP inspection results, except in cases of inspection when making repairs or doubting the authenticity of information, or having Medicines produced violate level 1 quality, or when the facility has insufficient records to prove that it meets GMP.
• The manufacturing facility belongs to one of the ICH members, Australia and the manufacturing facility is approved by one of the European Union drug management agencies EU, EMA, Austrakia, US drug management agency FDA, Japan PMDA, or Canada inspects and evaluates compliance with GMP practices, except for inspections when making repairs or doubting the authenticity of information, or when a drug is produced with level 1 quality violations, or when the facility has inconsistent records. Sufficient evidence to prove compliance with GMP.

Inspection and inspection at establishments producing medicinal raw materials and foreign drugs

For some cases that need to be checked and inspected, specifically as follows:

• Establishments manufacturing drugs and medicinal ingredients whose registration documents show signs of alteration or have doubts about the authenticity of information and data.
• Establishments producing drugs and medicinal ingredients have drugs that violate quality at level 1 (according to the conclusion of the Ministry of Health).
• A facility manufacturing drugs and medicinal ingredients whose application for GMP assessment is concluded by the Ministry of Health does not have enough evidence to prove that it meets good drug manufacturing practices.

Appraisal of documents related to conditions for production of drugs and medicinal ingredients

The appraisal of documents related to drug and drug raw material production conditions for foreign drug manufacturers is applied to the remaining cases that do not fall under the two items mentioned above (recognition – recognition and inspection). Check at the production facility).

Thus, GMP assessment applies to cases where there is no application for GMP assessment in Vietnam when registering for circulation of drugs and medicinal ingredients of foreign manufacturers. To learn more about drug circulation registration services, contact Medgate  via Hotline:  098.546.1894  or email:  medgatevn@gmail.com  for Medgate to receive advice.