Regulation (EU) 2019/6 of the European Parliament and of the CouncilShow full title

Article 128 Proof of the product quality specific for immunological veterinary medicinal products

1. For the purposes of application of Article 127(1), competent authorities may require the holder of a marketing authorisation for immunological veterinary medicinal products to submit to the competent authorities the copies of all the control reports signed by the qualified person in accordance with Article 97.

2. The holder of a marketing authorisation for immunological veterinary medicinal products shall ensure that an adequate number of representative samples of each batch of veterinary medical products is held in stock at least up to the expiry date, and provide samples promptly to the competent authorities on request.

3. Where necessary for reasons of human or animal health, a competent authority may require the holder of a marketing authorisation for an immunological veterinary medicinal product to submit samples of batches of the bulk product or of the immunological veterinary medicinal product for control by an Official Medicines Control Laboratory before the product is placed on the market.

4. On the request of a competent authority, the marketing authorisation holder shall promptly supply the samples referred to in paragraph 2, together with the control reports referred to in paragraph 1, for control testing. The competent authority shall inform the competent authorities in other Member States in which the immunological veterinary medicinal product is authorised, as well as the EDQM and the Agency in case the immunological veterinary medicinal product is authorised under the centralised procedure, of its intention to control batches of the immunological veterinary medicinal product.

5. On the basis of the control reports referred to in this Chapter, the laboratory responsible for the control shall repeat, on the samples provided, all the tests carried out by the manufacturer on the finished immunological veterinary medicinal product, in accordance with the relevant specifications in its dossier for marketing authorisation.

6. The list of tests to be repeated by the laboratory responsible for the control shall be restricted to justified tests, provided that all competent authorities in the relevant Member States, and, if appropriate, the EDQM, agree to such a restriction.

For immunological veterinary medicinal products authorised under the centralised procedure, the list of tests to be repeated by the control laboratory may be reduced only upon agreement of the Agency.

7. The competent authorities shall recognise the results of the tests referred to in paragraph 5.

8. Unless the Commission is informed that a longer period is necessary to conduct the tests, the competent authorities shall ensure that the control is completed within 60 days of receipt of the samples and control reports.

9. The competent authority shall notify the competent authorities of other relevant Member States, the EDQM, the marketing authorisation holder and, if appropriate, the manufacturer, of the results of the tests within the same period of time.

10. The competent authority shall verify that the manufacturing processes used in the manufacture of immunological veterinary medicinal products are validated and that batch-to-batch consistency is ensured.