CHAPTER VIII

INSPECTIONS AND CONTROLS

Proof of the product quality for veterinary medicinal products
Article 127
1
The marketing authorisation holder shall have at its disposal the results of the control tests carried out on the veterinary medicinal product or on the constituents and intermediate products of the manufacturing process, in accordance with the methods laid down in the marketing authorisation.
2
If a competent authority concludes that a batch of a veterinary medicinal product is not in conformity with the control report of the manufacturer or the specifications provided for in the marketing authorisation, it shall take measures in relation to the marketing authorisation holder and the manufacturer, and shall inform accordingly the competent authorities of other Member States in which the veterinary medicinal product is authorised, and also the Agency in case the veterinary medicinal product is authorised under the centralised procedure.