Refusals - Medicinal Products for Veterinary Use

Background

The EMEA publishes information on the products assessed by the Committee for Medicinal Products for Veterinary Use (CVMP). A negative opinion given by the Committee will result in a refusal of the marketing authorisation.

The legal basis for publishing information on refusals of marketing authorisation is contained in Article 37(3) of Regulation (EC) No 726/2004, and detailed in a reflection paper published on the EMEA website.

The information is made available in stages:

• The negative opinion will be announced in the Press Release of the CVMP meeting during which the opinion is adopted. A negative Summary of Opinion will be attached.
• In the case of a request for re-examination of the opinion, the Applicant’s request will be published. If the re-examination is followed by a negative CVMP opinion, the European Commission publishes the Commission Decision and grounds for refusal in all languages. If the re-examination is followed by a positive CVMP opinion recommending a marketing authorisation, the negative Summary of Opinion, published at the time of the initial opinion, will be immediately removed and replaced by a (positive) Summary of Opinion.
• Following a negative opinion and Commission Decision, a Refusal EPAR will normally be published 2-3 months later. In the case of a request for re-examination of the opinion, where the re-examination confirms the refusal, the re-examination steps will be clearly identified and described in the Refusal EPAR.

Information is made available for refusals of marketing authorisation for first authorisation (initial authorisation) and for refusals of applications to changes to or the addition of a non-food target species, new indications and applications under Annex II (extensions) of Commission Regulation (EC) No. 1085/2003.