EU Variations General Information

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EU Variations General Information

Current EU Variations Regulation

Regulation 1234/2008/EC

NEW Regulation 712/2012/EC amending Regulation 1234/2008/EC

European Medicines Agency post-authorisation procedural advice for users of the centralised procedure:

http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500003981.pdf

New Variations Regulation 1234/2008/EC:

The new variations regulation came into effect for all CP and MRP products as of January 1st, 2010.

Since 4 August 2013, the scope was extended to all MAH in EU, this means the inclusion of the national registered products.

Variation regulation_1234_2008_EC.pdf

Download PDF • 100KB

Useful links:

· EMA

http://www.emea.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000090.jsp&mid=WC0b01ac0580023398

Q&A on EMA post-authorisation procedural advice for users of the centralised procedure -

https://www.ema.europa.eu/en/human-regulatory/post-authorisation/variations

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