Article 5
1. The European Medicines Agency shall, at the request of the Commission, ensure that the Committee for Medicinal Products for Veterinary Use carries out a scientific evaluation of any draft amendment to the list set out in the Annex. Within 210 days of receiving such a request, the European Medicines Agency shall deliver an opinion to the Commission on the scientific suitability of the amendment. Where appropriate, the European Food Safety Authority shall also be consulted. 2. When Member States or veterinary professional associations ask the Commission to amend the list set out in the Annex they shall duly substantiate their request and include any relevant scientific data available.