• • If the manufacturing site is located outside the EU it is important to verify in which country the medicinal product will be imported (the first entry to EU market defines the competent authority e.g. if the product first enters the German territory at the Frankfurt Airport, the competent authority in Darmstadt will be competent). To import a medicinal product, a company located outside the EU needs an import authorization (which includes a permanent representative in Europe). Prior to the first importation of medicinal products (and in order to receive the import license), the site located outside the EU has to be inspected by the competent EU authority. A GMP inspection from an EU Authority will only be performed when the manufacturing site outside the EU either has a valid marketing authorisation for a medicinal product (issued by a competent EU Authority or by EMA) or if it is referenced by a EU marketing authorization holder for manufacturing.

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