art_38__para

In the case of veterinary medicinal products manufactured within the Community, the supervisory authorities shall be the competent authorities of the Member State or Member States which have granted the manufacturing authorization provided for in Article 24 of Directive 85/851/EEC in respect of the manufacture of the veterinary medicinal product concerned. In the case of veterinary medicinal products imported from third countries, the supervisory authorities shall be the competent authorities of the Member States in which the controls referred to in Article 30 (1) (b) of Directive 81/851/EEC are carried out unless appropriate arrangements have been made between the Community and the exporting country to ensure that those controls are carried out in the exporting country and that the manufacturer applies standards of good manufacturing practice at least equivalent to those laid down by the Community. A Member State may request assistance from another Member State or the Agency.

1 national measure recorded under this provision, in 1 form — sign in to view the analysis.

← Article 38 · All articles · Article 39 →

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