Q&A: Type II variations vs Extension applications
Once a veterinary product has received approval from the Commission (the “Commission Decision”) all further procedures connected with the product will fall under “Post-Authorisation Procedures”.
The guidance published under Post-authorisation procedural Q&A provides an overview for different types of post-authorisation procedures that occur frequently and, in each case, addresses a number of questions which marketing authorisation holders (MAHs) may have.
- The Rules governing Medicinal Products in the European Union, Volume 6, Notice to Applicants
- Community Legislation
- Commission Regulation (EC) No 1234/2008 - referred to as the ‘Variations Regulation’
- Commission Regulation (EU) No 712/2012 amending Regulation (EC) No 1234/2008
- Commission 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 and on the documentation to be submitted pursuant to those procedures (2013/C 223/01) - referred to as the ‘Variations Guidelines’, and also as the ‘Classification Guideline’ or the ‘Procedural Guideline’