DBP-Uses DMF Dossier Manufacturer Supplier Licensing Vietnam

  • DBP-Uses DMF Dossier Manufacturer Supplier Licensing Vietnam
  • DBP-Uses DMF Dossier Manufacturer Supplier Licensing Vietnam
  • DBP-Uses DMF Dossier Manufacturer Supplier Licensing Vietnam
  • What are the requirements for importing and distributing drugs in Vietnam?
  • Drug Registration: Before importing and distributing drugs in Vietnam, the drug product must be registered with MOH. Local Representative: Foreign drug manufacturers and importers are required to appoint a local representative or a licensed distributor in Vietnam.
  • Who manages pharmaceutical products and medical devices in Vietnam?
  • In Vietnam, pharmaceutical products (including drugs and biologicals) and medical devices are under the overall management of the Ministry of Health (www.moh.gov.vn).
  • How do I get a product registration certificate in Vietnam?
  • Respond to queries and receive the product registration certificate. The application dossier must include the following documents: The application dossier must be submitted in Vietnamese. However, the CPP can be submitted in English. The review period for the application dossier is 60 days for domestic drugs and 90 days for imported drugs.
  • How do you get a drug license in Vietnam?
  • Generally, there are three steps to obtaining marketing authorization for a drug. First, a company established in Vietnam must obtain either a drug manufacturing license or a drug trading license from the DAV.
  • Who is responsible for drug approval in Vietnam?
  • Pharmaceutical Regulatory Authority in Vietnam The Drug Administration of Vietnam (DAV), the Vietnamese regulatory authority is responsible for the drug approval process in the country. The DAV is a decentralized body under the Ministry of Health (MOH), also called “Bộ Y Tế” in Vietnamese which literally means ‘Medicine’.
  • How long is a drug license valid in Vietnam?
  • Typically, the validity for a drug is granted for 12 months post which the continued validity of the old license shall be granted upon successful re-review. Drug Registration: Before importing and distributing drugs in Vietnam, the drug product must be registered with MOH.

Recommended hot-selling products