EU: Updated explanatory notes on variation application form and implementation table for NPs

The CMD(h) together with the EMA released an updated revision 1 of the "Explanatory Notes on the Variation Applicaton Form (Human Medicinal Products)" which replaces revision 0 that has been released on 05-January-2010.

Revision 1 of the explanatory notes is available for download on the HMA website.

In addition, an updated table with information regarding implementation of the new variation regulation (1234/2008)in each EU Member State for medicinal products authorized by purely national procedures is available.

[Source: HMA website]

Related News:

 EU: Explanatory notes on the Variation Application Form released - 05.01.2010 17:09

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