lexiara

Article 10

Member States shall take all appropriate measures to ensure that: 1. the competent authorities ascertain that the manufacturers and importers of veterinary medicinal products from third countries are able to manufacture them in compliance with the details supplied pursuant to point 4 of the second paragraph of Article 5 and/or to carry out control tests in accordance with the methods described in the application documents under point 9 of the second paragraph of Article 5; 2. the competent authorities may authorize manufacturers and importers of veterinary medicinal products from third countries, where (1) See page 16 of this Official Journal. circumstances so justify, to have certain stages of manufacture and/or certain of the control tests referred to in paragraph 1 carried out by third parties ; in such cases checks by the competent authorities shall also be carried out in the establishments concerned.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.