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S.L. 437.47 · Veterinary Medicinal Products (S.L. 437.47)

S.L. 437.47 Art. 84Certificationonthe possession of a manufacturing authorisation.

TITLE XIV

In KraftAmtlicher Text

(1) At the request of the manufacturer or exporter of veterinary medicinal products, or the authorities of an importing third country, the Director shall certify that such manufacturer is in possession of the manufacturing authorisation. When issuing such certificates, the Veterinary Services shall comply with the following conditions:

(a) they shall have regard to the prevailing administrative arrangements of the World Health Organisation;

(b) for veterinary medicinal products intended for export which are already authorised in the territory, they shall supply the summary of the product characteristics as approved in accordance with regulation 25 or, in the absence thereof, an equivalent document.

(2) Where the manufacturer is not in possession of an authorisation to place the product on the market, he shall provide the authorities responsible for establishing the certificate referred to in subregulation (1) with a declaration explaining why such authorisation is not available.