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Release of products arriving from third countries (outside EEA)

EEA RELEASE

ExtractumPharma Zrt. has the licence regarding the release of products arriving from the so-called third countries [countries outside the European Economic Area (EEA) and the so-called MRA (Mutual Recognition Procedure) countries (Canada, Switzerland, Australia, New-Zealand)]. In the European Union, the release and marketing of the medicinal products is regulated by Chapter IV of Directive 2001/83/EC.

  • A product can only be imported from a third country in possession of a pharmaceutical manufacturing licence issued by the GYEMSZI (the former OGYI).
  • The given member state has to ensure that a product is marketed according to the rules set out in the marketing authorisation.
  • A personnel condition of the manufacturing licence is a Qualified Person (QP) approved by the director general of OGYI, who ensures that the product is manufactured according to the rules set out in the marketing authorisation.
  • The Qualified Person
    • makes sure that the product is manufactured according to the GMP guidelines and the marketing authorisation
    • Evaluates the production documentations of the given production batch
    • Carries out on-site inspection
  • In the EU, a sample should be taken from each batch, and a complete analytical inspection should be carried out. The sample must be representative. A control report and a release certificate must be issued. The counter sample must be preserved at the location of the release.

Our company has all the necessary background to perform the release of products arriving from third countries and to make these released products available.

If you have further related questions, please contact us:

the medicinal products is regulated by Chapter IV of Directive 2001/83/EC.