S.L. 437.47 Art. 31Procedure before submitting an application for mutual recognition of marketing practices.

(1) With a view to the granting of a marketing authorization for a veterinary medicinal product in more than one

Member State, the applicant shall submit an application based on an identical dossier in those Member States. The dossier shall contain all the administrative information and scientific and technical documentation described in regulations 12 to 14. The documents submitted shall include a list of Member States concerned by the application.

The applicant shall request one Member State to act as reference Member State and to prepare an assessment report in respect of the veterinary medicinal product in accordance with subregulation (2) or (3). Where appropriate, the assessment report shall contain an evaluation for the purposes of regulation 13(5) or regulation 13A(3).

(2) If the veterinary medicinal product has already received a marketing authorisation at the time of application, the concerned Member States shall recognize the marketing authorisation granted by the reference Member State. To this end, the marketing authorization holder shall request the reference Member State either to prepare an assessment report in respect of the veterinary medicinal product or, if necessary, to update any existing assessment report. The reference Member State shall prepare or update the assessment report within ninety days of receipt of a valid application. The assessment report together with the approved summary of product characteristics, labelling and package leaflet shall be forwarded to the concerned Member States and the applicant.

(3) If the veterinary medicinal product has not received authorisation by the time of application, the applicant shall request the reference Member State to prepare a draft assessment report and drafts of the summary of product characteristics, labelling and package leaflet. The reference Member State shall prepare these drafts within one hundred and twenty days of the receipt of a valid application and shall send them to the concerned Member States and the applicant.

(4) Within ninety days after receipt of the documents referred to in subregulations (2) and (3), the Member States concerned shall approve the assessment report, the summary of product characteristics, the labelling and the package leaflet and inform the reference Member State accordingly. The reference Member State shall record the agreement of all parties, close the procedure and inform the applicant accordingly.

(5) Each Member State in which an application following paragraph 1 has been submitted shall adopt a decision in conformity with the approved assessment report, summary of product characteristics, labelling and package leaflet within thirty days after acknowledgement of the agreement.