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8 Jul 2015

Rx-360 Summary of EMA Concept Paper on New Guidance for Importers of Medicinal Products

Rx-360 has provided a summary of European Medicines Agency (EMA) concept paper on new guidance for importers of medicinal products.To clarify requirements for importers of finished medicinal products.

 

EMA is planning to draft a new annex to the GMP Guidelines (Annex 21). In preparation, EMA has released a Concept paper on new guidance for importers of medicinal products.  This concept paper discusses some of the issues it intends to address in the new guideline, which is expected to be adopted by the EC in March 2016. 

 

To view or download the EMA Concept Paper, click here

To view or download the Rx-360 Summary of the Concept Paper, click here

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