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Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance)

article  141

CELEX:  02019R0006-20220128

1. The Committee shall have the following tasks:
(a) carry out the tasks conferred on it under this Regulation and Regulation (EC) No 726/2004;
(b) prepare scientific opinions of the Agency on questions relating to the evaluation and use of veterinary medicinal products;
(c) prepare opinions on scientific matters concerning the evaluation and use of veterinary medicinal products on the request of the Executive Director of the Agency or the Commission;
(d) prepare opinions of the Agency on questions concerning the admissibility of applications submitted in accordance with the centralised procedure, and on granting, varying, suspending or revoking marketing authorisations for centrally authorised veterinary medicinal products;
(e) take due account of any request made by Member States for scientific opinions;
(f) provide guidance on important questions and issues of general scientific nature;
(g) give a scientific opinion, in the context of cooperation with the World Organisation for Animal Health, concerning the evaluation of certain veterinary medicinal products intended exclusively for markets outside the Union;
(h) advise on the maximum limits for residues of veterinary medicinal products and biocidal products used in animal husbandry which may be accepted in foodstuffs of animal origin in accordance with Regulation (EC) No 470/2009;
(i) provide scientific advice on the use of antimicrobials and antiparasitics in animals in order to minimise the occurrence of resistance in the Union, and update that advice when needed;
(j) provide objective scientific opinions to the Member States on the questions which are referred to the Committee.
Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance)

article  141

CELEX:  02019R0006-20220128

2. The members of the Committee shall ensure that there is appropriate coordination between the tasks of the Agency and the work of competent authorities.
3. When preparing opinions, the Committee shall use its best endeavours to reach a scientific consensus. If such consensus cannot be reached, the opinion shall consist of the position of the majority of members and divergent positions, with the grounds on which they are based.
4. If there is a request for re-examination of an opinion where this possibility is provided for in the Union law, the Committee shall appoint a different rapporteur and, where necessary, a different co-rapporteur from those appointed for the opinion. The re-examination procedure may deal only with the points of the opinion initially identified by the applicant and may be based only on the scientific data available when the Committee adopted the opinion. The applicant may request that the Committee consult a scientific advisory group in connection with the re-examination.