# 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, Article 82

Extent: E+W+S+N.I.

1. Where it considers it necessary for reasons of human or animal health, a Member State may require the marketing authorisation holder for an immunological veterinary medicinal product to submit samples of batches of the bulk product and/or veterinary medicinal product for control by an Official Medicines Control Laboratory before the product is put into circulation.
2. On request by the competent authorities, the marketing authorisation holder shall promptly supply the samples referred to in paragraph 1, together with the reports of the control referred to in Article 81(2).
The competent authority shall inform all the other Member States in which the veterinary medicinal product is authorised as well as the European Directorate for the Quality of Medicines of its intention to control batches or the batch in question.
In such cases, the competent authorities of another Member State shall not apply the provisions of paragraph 1.
3. After studying the control reports referred to in Article 81(2), the laboratory responsible for the control shall repeat, on the samples provided, all the tests carried out by the manufacturer on the finished product, in accordance with the relevant provisions shown in the dossier for marketing authorisation.
The list of tests to be repeated by the laboratory responsible for the control shall be restricted to justified tests, provided that all Member States concerned, and if appropriate the European Directorate for the Quality of Medicines, agree to this.
For immunological veterinary medicinal products authorised under Regulation (EC) No 726/2004, the list of tests to be repeated by the control laboratory may be reduced only after agreement by the Agency.
4. All Member States concerned shall recognise the results of the tests.
5. Unless the Commission is informed that a longer period is necessary to conduct the tests, Member States shall ensure that this control is completed within 60 days of receipt of the samples.
The competent authority shall notify the other Member States concerned, the European Directorate for the Quality of Medicines, the marketing authorisation holder and, if appropriate, the manufacturer, of the results of the tests within the same period of time.
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 all the necessary measures vis-a-vis the marketing authorisation holder and the manufacturer, where appropriate, and shall inform accordingly the other Member States in which the veterinary medicinal product is authorised.

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Source: https://www.legislation.gov.uk/eudr/2001/82/article/82 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-82/article-82
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.