Withdrawals of Application - Medicinal Products for Veterinary Use

Background

The EMEA publishes information on the products assessed by the Committee for Medicinal Products for Veterinary Use (CVMP). If a company withdraws its application before the assessment is completed, i.e. before the Committee has reached an opinion, the EMEA will make this information available as a ‘withdrawal of application’.

The legal basis for publishing information on withdrawals of application is contained in Article 36 of Regulation (EC) No 726/2004, and detailed in a reflection paper published on the EMEA website.

The information made available comprises information included in the CVMP press release and the letter from the company giving their reason for withdrawing the application.

Assessment Reports, after deletion of commercially confidential information, are also made available for applications withdrawn in the later stages of the assessment (after day 120). All together, these documents constitute a Withdrawal European Public Assessment Report, or WEPAR.

WEPARs are made available for withdrawals of application for first authorisation (initial application) and for withdrawals of applications for new indications and changes to or additions of non-food target species as well as applications for extensions of marketing authorisations as set out in Annex II to Regulation (EC) 1085/2003 when they are linked to a new indication or target species.