FAQs for variations submitted after 1 January 2010

This section gives answers to frequently asked questions on variations submitted after 1 January 2010.

General FAQs

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Answers to general questions about variations submitted after 1 January 2010.

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Quality FAQs

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Answers to quality questions in reference to variations submitted after 1 January 2010.

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Experience to date

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Our experience of the new Variations Regulation (EC/1234/2008) which was implemented on 1 January 2010.  

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Administrative FAQs

Law books
Answers to administrative questions about variations submitted after 1 January 2010.

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Safety, efficacy, pharmacovigilance FAQs

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Answers to questions on safety, efficacy and pharmacovigilance in reference to variations submitted after 1 January 2010.

Go to Safety, efficacy, pharmacovigilance FAQs page

Audit of new Type IA variations

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Details of the June 2010 audit of new Type IA variations.

Go to Audit of new Type IA variations page

Page last modified: 19 August 2010