Pharma meets Customs

On 21.08.2022, the new Annex 21 to the EU GMP Guideline came into force. Although this new document of the European Commission describes in the introduction that fiscal transactions are not to be the subject of this annex, there is a major impact on the practical customs clearance for the import of medicinal products into the European Economic Area. This is because both the physical import and the customs clearance in the customs territory of an EU/EEA state are a condition for the release of the imported batches by the Qualified Person according to §15 AMG.

Customs law and pharmaceutical law are not harmonised. Unfortunately, Annex 21 of the EU GMP Guideline missed the opportunity to bring both areas together. Practical implementation aids are still missing.  Either there are companies or people with expertise in customs law OR in pharmaceutical law. Grieshaber has and can do both!

Grieshaber's "Customs & Trade Solutions (CTS)" and "Quality & Regulatory Affairs (Q&RA)" departments work closely together in this regard and jointly develop practical implementation concepts for their customers. Both perspectives (customs law and pharmaceutical law) are taken into account.

We will be happy to advise you!


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