In the field of veterinary medicinal products, the Commission shall adopt acts implementing Regulations 2019/6 on veterinary medicinal products and No 37/2010 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin. It also adopts implementing acts on centralised marketing authorisations, determination of maximum residue limits and arbitrations on the basis of an opinion of the Committee for the assessment of Veterinary Medicinal Products (CVMP) of the European Medicines Agency (EMA).
Comitology
Comitology committees are set up by the legislator (Council and European Parliament or Council alone). They are composed of one representative from each EU Member State and are chaired by a Commission official.
The Committee for Veterinary Medicinal Products at the European Commission is set up by Article 145 of Regulation 2019/6.
Each committee shall determine its operating rules on the basis of the standard rules of procedure for the committees.
The Commission services shall submit draft implementing acts to the competent committees for their opinion. Most committees meet several times a year on Commission premises (usually in Brussels).
The Committee for Veterinary Medicinal Products is primarily referred to the Commission in accordance with the written voting procedure in accordance with Article 3(5) of Regulation 182/2011. In the event of disagreement, a Member State may request a plenary meeting. The meeting of the Committee shall be organised by the Commission within 15 days of the request.
Before each meeting, the Commission shall send the invitation, the agenda and the draft implementing act to the national authorities.
In order to adopt the text, the Commission shall follow the examination procedure laid down in Article 5 of Regulation No 182/2011:
- If a qualified majority (55 % of EU countries representing at least 65 % of the total EU population) votes in favour of the proposed implementing act, the Commission must adopt it;
- If a qualified majority votes against the proposed act, the Commission may not adopt it;
- If there is no qualified majority for or against the proposed act, the Commission may adopt it or present a new amended version.
After the meeting, it publishes the results of the vote and the summary record of the meeting in the Comitology Register (europa.eu).
The Anses-ANMV participates in the Committee for the assessment of Veterinary Medicinal Products at the EMA. Anses-ANMV experts serving on this committee may act as rapporteur or co-rapporteur on certain files.
The draft act shall be forwarded to the Member States by the European Commission. The Anses-ANMV is responsible for following up the written procedure.
At the meeting of the Standing Committee on Veterinary Medicinal Products, the Anses-ANMV participates as an expert in the delegation of the French authorities alone or in support of the line ministries.
Where the Commission decision is published, the Anses-ANMV shall be the competent authority responsible for its implementation.
For more information, consult the document on the standing committee by following this link (PDF).