EU: CMD(h) releases revision 2 of the Q&A to variation applications

The CMD(h) released a new revision (revision 2) of the Questions & Answer (Q&A) document regarding submission of variation applications for human medicinal products in the context of the new EU variation regulation (Commission Regulation (EC) 1234/2008).

Meanwhile, the list comprises 30 Q&As covering the following topics

1. General questions
2. Questions relating to the submission of variations
3. Questions relating to the classification of a variation
4. Questions relating to grouping or worksharing
5. Questions regarding the approval and implementation of variations

The Q&A list is available for download (see link below) from the CMD(h) website.

[Source: CMD(h) website]

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