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News about GMP/cGMP

EC: Import of Active Substances

The European Commission has published the final template for the written confirmation for active substances exported to the European Union for medicinal products for human use. The new template has been published in Part III of EudraLex, Volume 4.

 

According to Article 46b(2) of Directive 2001/83/EC, active substances shall only be imported if, inter alia, the active substances are accompanied by a written confirmation from the competent authority of the exporting third country which, as regards the plant manufacturing the exported active substance, confirms that the standards of good manufacturing practice and control of the plant are equivalent to those in the Union.

In addition to the template an informative “Questions and Answers document” was published which responds to the most frequently asked questions in relation to the template. Actually listed on a list of third countries which have so far requested to be listed are Switzerland and Israel.

The new rules apply as of 2 July 2013.

Source:

EC: Reference Documents EudraLex - Volume 4

EC: Written Confirmation

EC: Q & A Document

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