What is European GMP certificate ?

The GMP certificate declares that the manufacturer complies with GMP, and the certificate includes a reference to the most recent date of the actual inspection, as well as which activities and under which
legislation they have been inspected.

A GMP certificate is issued to a site and refers to one specific address

For each site, one GMP certificate can be issued per domain that has been inspected.

GMP certificates are issued in a common EU format defined by the European Medicines Agency (EMA)

A GMP certificate is valid for three years from the most recent date of inspection, but the period of validity can be shortened under special circumstances.

Who can obtain EU GMP Certificate?

MIA (Manufacturing and Importation Authorization for medicines and intermediate products)

• Issued for complete or partial manufacture, import and/or analysis of intermediate products and medicinal products.
• The authorization includes wholesale distribution of own finished and released medicinal products.
• Registration as a broker of medicinal products
• Registration is required for companies brokering medicinal products for human or veterinary use with a marketing authorization within the EU/EEA

How it works?

Vietnam company need inside EU MIA partner

• Company from third country mustn’t sell any medical product to EU
  directly. Vietnam product must be released by EU MIA partner
• All EU countries have to some right for it
• Vietnam company selling product do EU thru MIA partner 
• Produce semi-product, in-bulk product or final product for MIA partner

What we do

• Find a pharmaceutical industry business partner (MIA partner)
• Licence for drug products
• Registration in EU
• Preparation of contracts and agreements with a business partner responsible to release drug products to EU market.