Q&A: Transparency

  • Email
  • Help

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”.

This guidance provides an overview for a number of procedures that occur frequently and addresses a number of questions which Marketing Authorisation Holders (MAHs) may have.
More information on this post-authorisation procedural advice Q&A.

Additional information

Back to top

1. Which transparency policy does the EMA apply for post-authorisation activities? Rev. July 2015

The EMA has published redacted agendas and minutes of the Committee for Medicinal products for Veterinary Use since December 2013. Information is made available in line with the Principles for publication of agendas and minutes of EMA scientific committees.

The published agendas and minutes will include full information on the post-authorisation procedures concerned, irrespective if the procedure is finalised or not. This covers variations including extensions of indication, extensions of marketing authorisation (such as a new pharmaceutical form, a new route of administration, a new strength, a new presentation), with the exception of quality variations. In addition the assessment reports for extension and major Type II variations will be made public after redaction to remove information of a commercially confidential nature.

As previously, the following information is also made publicly available:

  • CVMP Press Releases which are published on a monthly basis after each CVMP meeting.
  • CVMP Monthly Reports which are published on a monthly basis after each CVMP meeting.
  • CVMP Summaries of opinions which are product specific and published shortly after adoption of the relevant CVMP opinion.
  • EPARS, which are product specific and updated upon completion of post-authorisation procedures.
  • EMA Annual Reports and Work programmes

References

How helpful is this page?

Average rating:

 Based on 3 ratings

Add your rating:

See all ratings
3 ratings
0 ratings
0 ratings
0 ratings
0 ratings
    

Tell us more