S.L. 437.47 Art. 82VeterinaryServices to inform Agency on decisions which grant or refuse marketing authorisation.

(1) The Veterinary Services shall take all appropriate measures to ensure that the Agency is informed immediately of decisions granting marketing authorisation and of all decisions refusing or withdrawing marketing authorisation, cancelling a decision refusing or withdrawing marketing authorisation, prohibiting supply or withdrawing a product from the market, together with the reasons on which such decisions are based.

(2) (a) The marketing authorisation holder shall be obliged to notify the Veterinary Services forthwith of any action taken by him to suspend the marketing of a veterinary medicinal product or to withdraw a product from the market, together with the reasons for such action if it concerns the effectiveness of the veterinary medicinal product or the protection of public health. The Veterinary Services shall ensure that this information is brought to the attention of the Agency.

(b) The marketing authorisation holder shall implement a system for recording and reviewing complaints together with an effective system for recalling promptly and at any time the veterinary medicinal products in the distribution network.

(c) record and investigate any complaint concerning a quality defect.

(d) The Veterinary Services shall be informed by the Marketing Authorisation holder of any quality defect that could result in a recall or abnormal restriction on the supply. In so far as possible, the countries where the products are marketed shall also be indicated.

(3) The Veterinary Services shall ensure that appropriate information about actions taken pursuant to subregulations (1) and

(2) which may affect the protection of health in third countries is forthwith brought to the attention of the relevant international organisations, with a copy to the Agency.