Vietnam reforms pharmaceutical labelling requirements
Vietnamese ministry issues new guidelines for medicine product labels, raw materials of drugs and usage instructions
New regulations issued by the Ministry of Health (MoH) of Vietnam came into force on June 01 2018 replacing existing guidance on the labelling of pharmaceuticals.
The labelling guidelines (Circular No. 1: 01/2018/TT-BYT), issued in January this year, provide direction on labels of finished product drugs and drug raw materials, package inserts of finished drugs and the changing the shelf life specified on the label of finished drugs for special cases.
The reform does not apply to drugs and drug raw material that is imported for non-commercial purposes including epidemic control, national defense and security and disaster recovery in addition to pharmaceutical ingredients intended for export which is not yet registered in Vietnam.
Key takeaways from Vietnam’s pharmaceutical labelling reforms
Package inserts of finished drugs
Under new labelling guidelines the package insert should include just one section replacing the two under earlier regulations. Prior to the regulatory enforcement in June, information for the recipient was provided in the first section and for healthcare professional in the second.
It is hoped by simplifying the labelling process, the time spent preparing the language for the package insert and preparing packaging samples when registering drugs will be significantly reduced.
Package insert replacement following import of finished drugs
New guidelines now permit replaced or supplemented package inserts in Vietnam. However, this only applies to imported drugs with Marketing Authorization (MA) licenses and pharmaceuticals that have Vietnamese language package inserts within the product.
Entities in charge of imported drug labelling
Further drug changes will affect entities in charge of imported drug labelling. Under new guidelines, offshore manufacturers will effectively be freed from labelling responsibility
In the past, the entity was both the manufacturer and the holder of the MA license. This will change under new rules and allow entities for a product with a MA license to be the importer and the MA holder.
In addition, the responsible entity for a product with an import license will only be the importer. Previously, responsible entities have been both the manufacturer and the importer.
Provisions for a smooth transition
Following the commencement of the new regulation, the Vietnamese Ministry of Health set about providing a number of transitional provisions, these include:
- Drugs granted registration numbers before June 1, 2018, may be sold with Ministry of Health approved labels and package inserts until the expiry date of the MA license.
- In the case of drugs for which the MA/import license dossiers were submitted to the DAV before June 1, 2018, and are awaiting the DAV’s approval, the following will apply:
- The applicant may submit updated labels and updated package insert s for the drug in accordance with the new regulation or,
- If no updated documents are submitted to the DAV, the applicant’s label and PI may be considered by the DAV under current regulations. However, within six months from the date on which an MA license is issued, the MA holder must submit updated labels and package insert in the form of a variation registration to comply with Circular 01. Circular 01 is silent on the duty of the import license holder in this situation.