CMDv releases latest report for release as well as guidance on aquaculture products, VMP labeling and PSURs

Aquaculture veterinary medicines available for salmon and other fish in Europe
20 November, 2018

The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMDv) Report for Release from the monthly meetings which took place in July and September 2018 (no CMDv meeting takes place in August) is now available to download (Link). The documents discussed at these meetings and other recent updates from the CMDv are summnarised below.

CMDv Report for Release (July - September 2018)

Brexit: the ongoing Brexit Q & A document has been updated (Link) with answers added relating to the deputy QPPV (Q3a) and inspections (Q17). To complement the Q & A, a practical guidance document has been released, which is based on the EMA equivalent relating to centrally authorised VMPs (Link).

Following a recent referral procedure there was a discussion regarding the Maximum Residue Limit (MRL) status of flavouring agents in VMPs. The European Commission has now been formally asked to consider how approved flavouring agents  could be added to Table 1 of the Annex to Regulation (EU) 37/2010.

The CMDv has responded to two new questions from Applicants relating to:

  • Making reference to an autogeneric VMP during an application for a new generic product
  • Marketing authorisations held by more than one company in different member states

As in all CMDv Reports for Release, a list of other recently updated CMDv guidance documents is also included. The CMDv has also recently published a number of documents which were not discussed in the July and September meetings, as listed below.

VMPs for fish

The CMDv has updated its section on special VMPs, to include an Excel listing of “Veterinary Medicinal Products intended for fish” (Link). This adds to the existing lists for products intended for bees and for rabbits.

VMP labelling and packaging

The recommendations document for labelling and packaging of VMPs has been revised (Link). This document is a new version of the previous recommendation of 2008 and gives a comprehensive overview covering multilingual provisions, the use of pictograms and QR codes, acceptable abbreviations, correct use of the blue box and considerations for small packaging.

Periodic Safety Update Reports (PSURs)

The CESP website has issued a clarification on the requirements for submission of PSURs for mutually recognised and decentralised VMPs (Link). It has been clarified that the CESP delivery file needs to include all national product names with the corresponding Member State (MS) and the procedure number and that these details should also be included in the covering letter. For Workshare PSURs, the active substance also needs to be stated, as well as the year and month of the Data Lock Point (DLP) and the PSUR Reference Member State (RMS).

National Fees

On the CMDv webpage of general information for applicants, the section on national fees charged by each MS has been updated with current links for all the national agency websites (Link).

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