- Y Diweddaraf sydd Ar Gael (Diwygiedig)
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Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products
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1. If two or more applications submitted in accordance with Articles 12 to 14 have been made for marketing authorisation for a particular veterinary medicinal product and Member States have adopted divergent decisions concerning the authorisation of that veterinary medicinal product, or suspension or revocation of authorisation, a Member State, or the Commission, or the marketing-authorisation holder may refer the matter to the Committee for Medicinal Products for Veterinary Use, hereinafter referred to as ‘ the Committee ’ , for the application of the procedure laid down in Articles 36, 37 and 38.
2. With a view to promoting the harmonisation of veterinary medicinal products authorised in the Community, and to strengthening the efficiency of the provisions of Articles 10 and 11, Member States shall send to the coordination group, no later than 30 April 2005, a list of veterinary medicinal products for which a harmonised summary of product characteristics should be prepared.
The coordination group shall agree on a list of medicinal products, on the basis of proposals sent by Member States, and shall forward the list to the Commission.
The medicinal products on the list shall be subject to the provisions in paragraph 1 in accordance with a timetable established in cooperation with the Agency.
The Commission, acting in collaboration with the Agency, and taking into consideration the views of the interested parties, shall agree the final list and timetable.]
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