News about GMP/cGMP

18.03.2016

Importation of APIs: Version 6 of Q&A Document

The European Commission has published a revised Version 6 of its Question and Answers Document that sets out frequently asked questions on importation of active substances for medicinal products for human use.

 

Question 3 Do the rules on the written confirmation apply to active substances for medicinal products intended for research and development trials? was updated to clarify the application of the rules on APIs used in the manufacture of authorized investigational medicinal products.

Active substances imported to be used in the manufacture of authorised medicinal products intended for research and development trials are expected to fulfil the requirements of Directive 2001/83/EC and be accompanied by a written confirmation, unless there is proof that the full amount of the imported API will be used for the manufacture of batches/units of an authorized medicinal product exclusively intended for research and development trials. In the latter case, those batches/units of an authorised medicinal product fall outside the scope of Directive 2001/83/EC and the API used in their manufacture is exempted from the rules on the written confirmation.


Source:

EC: Medicinal Products for Human Use

 



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