Q&A: Changing the (invented) name of a centrally authorised medicinal product
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