Variations regulation: regulatory and procedural guidance

Practical questions and answers to support the implementation of the variations guidelines in the centralised procedure - superseded

Reference Number: EMA/427505/2013 Rev.3

Practical questions and answers to support the implementation of the variations guidelines in the centralised procedure: document with track changes - superseded

Reference Number: EMA/427505/2013 Rev. 3

Transitional provisions for implementation of Commission Regulation (EU) No 712/2012 amending Variations Regulation (EC) No 1234/2008

Reference Number: EMA/626908/2012Summary:

Commission Regulation (EU) No 712/2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products entered into force on 24th August 2012.

Questions and answers on variations to an existing pharmacovigilance system as described in the detailed description of the pharmacovigilance system

AdoptedReference Number: EMA/456003/2013

Annex B Word template

Annex B PDF template

Template letter of intent work sharing procedure

Reference Number: EMA/293212/2017Summary:

Letter of intent for the submission of a work sharing procedure to the European Medicines Agency according to article 20 of Commission Regulation (EC) no 1234/2008

Template cover letter for worksharing procedures including centrally authorised products and nationally authorised products

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

Reference Number: EMEA-H-19984/03 Rev. 109

• Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products
• Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products
• Variations guidelines - Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products and on the documentation to be submitted pursuant to those procedures
• Electronic variation application form
• Variation application form
• European Medicines Agency/CMDh explanatory notes on Variation Application Form
• eCTD Variation Q&A document