SUPERA KVALITETA - legal representative for companies located outside the EU in the process of obtaining GMP Certificate Print

SUPERA KVALITETA offers legal representation to companies located outside the EU in the process of submitting the application for the Good Manufacturing Practice Certificate to the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) in Zagreb, Croatia as well as its services in communication with the HALMED in the process of obtaining the Good Manufacturing Practice Certificate.

In Europe, manufacturers of medicinal products and active pharmaceutical ingredients (APIs) are subject to monitoring by competent authorities with regard to compliance with the principles of Good Manufacturing Practices (GMP). Each EU Member State disposes of its own inspectorates. The location of the production is therefore crucial in order to decide which inspectorate is responsible.
The competent authority of each Member State carries out its inspections based on the requirements laid down in EU Directive 2003/94. The concrete interpretation of these requirements can be found in the EU GMP Guide and its Annexes.
If the manufacturing site is located outside the EU, it is important to verify into which country the medicinal product will be imported (the first entry to the EU market defines the competent authority).
To import a medicinal product or APIs, 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 or APIs (and in order to receive the import licence), the site located outside the EU has to be inspected by a competent EU authority. A GMP inspection by an EU authority will be performed when the manufacturing site outside the EU either has a valid marketing authorization for a medicinal product or APIs (issued by a competent EU authority or by EMA) or if it is referenced by an EU Marketing Authorization Holder for manufacturing.
In order to obtain a GMP certificate an Importer or a Marketing Authorization Holder should apply for a GMP inspection of a manufacturing site in a third country.
It may be possible to request an inspection on a voluntary basis. To explore this possibility, the authorities of the Member State into which the product will be imported into the EEA should be contacted.
If you do not have a permanent representative or Marketing Authorization Holder in Europe, you will need a legal representative in the EU to submit this application.