Article 14

The person responsible for marketing shall modify the control test method provided for in point 9 of Article 5 in accordance with technological and scientific progress, if such modification is needed to enable the veterinary medicinal product to be controlled with a greater degree of security. The person responsible for marketing shall forthwith inform the competent authorities of any new information which might entail amendment of the particulars and documents referred to in Article 5 or further examination and, in particular, of any prohibition or restriction imposed by the competent authorities of the States in which the veterinary medicinal product is marketed. The person responsible for marketing shall immediately inform the competent authorities, with a view to authorization, of any alteration he proposes to make to the particulars and documents referred to in Article 5.

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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.