S.L. 437.47 Art. 30Instances when the marketing authorisation shall be withheld.

The marketing authorisation shall be refused if the file submitted to the Veterinary Services does not comply with regulations 12 to 13D and regulation 15.

The authorisation shall also be refused if, after examination of the documents and particulars listed in regulations 12 and 13(1), it is clear that -

(a) the risk-benefit balance of the veterinary medicinal product is, under the authorised conditions of use, unfavourable; when the application concerns a veterinary medicinal product for zootechnical use, particular regard shall be had to the benefits for animal health and welfare and to consumer safety; or

(b) the product has no therapeutic effect or the applicant has not provided sufficient proof of such effect as regards the species of animal which is to be treated; or

(c) its qualitative or quantitative composition is not as stated; or

(d) the withdrawal period recommended by the applicant is not long enough to ensure that foodstuffs obtained from the treated animal do not contain residues which might constitute a health hazard to the consumer, or is insufficiently substantiated; or

(e) the labelling or the package leaflet proposed by the applicant does not comply with these regulations; or

(f) the veterinary medicinal product is offered for sale for a use prohibited under other European Union provisions. However, when a European Union legislative framework is in the course of being adopted, the Veterinary Services may refuse authorisation for a veterinary medicinal product where such action is necessary for the protection of public health, consumer or animal health.

The applicant or marketing authorisation holder shall be responsible for the accuracy of documents and data submitted.

CHAPTER 4 Mutual recognition procedure and decentralized procedure