S.L. 458.34 Art. 22Mutualrecognition and decentralised procedure.

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

Member State, including Malta, an applicant shall submit an application to the Authority, based on a dossier identical to that submitted in the other Member States. The dossier shall contain the information and documents referred to in regulations 5, 7 and 8. 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 on the medicinal product in accordance with paragraphs (b) and (c).

(b) Where the medicinal product has already received a marketing authorisation at the time of application, if Malta is a concerned Member State, the Authority shall recognise the marketing authorisation granted by the reference Member State. To this end, the marketing authorisation holder shall request the reference Member State either to prepare an assessment report on the medicinal product or, if necessary, to update any existing assessment report. If Malta is the reference Member State, the Authority 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 sent to the concerned Member States and to the applicant.

(c) In cases where the medicinal product has not received a marketing authorisation at the time of application, the applicant shall request the reference Member State to prepare a draft assessment report, a draft summary of product characteristics and a draft of the labelling and package leaflet. If Malta is the Reference Member State, the Authority shall prepare these draft documents within one hundred and twenty days after receipt of a valid application and shall send them to the concerned Member States and to the applicant.

(d) If Malta is a concerned Member State, within ninety days of receipt of the documents referred to in paragraphs (b) and (c), the Authority shall approve the assessment report, the summary of product characteristics and the labelling and package leaflet and shall inform the reference Member State accordingly. If Malta is the reference Member State, the Authority shall record the agreement of all parties, close the procedure and inform the applicant accordingly.

(e) The Authority shall adopt a decision in conformity with the approved assessment report, the summary of product characteristics and the labelling and package leaflet as approved, within thirty days after acknowledgement of the agreement.

(f) If, within the period laid down in paragraph (d), the Authority cannot approve the assessment report, the summary of product characteristics, the labelling and the package leaflet on the grounds of potential serious risk to public health, it shall give a detailed exposition of the reasons for its position to the reference Member State, to the other Member States concerned and to the applicant. The points of disagreement shall be forthwith referred to the co-ordination group. Within such co-ordination group, the Authority shall use its best endeavours to reach agreement on the action to be taken and it shall allow the applicant the opportunity to make his point of view known orally or in writing. If, within sixty days of the communication of the points of disagreement, all Member States reach an agreement, if Malta is the Reference Member State, the Authority shall record the agreement, close the procedure and inform the applicant accordingly and paragraph (e) shall apply: Provided that if Member States fail to reach an agreement within the co-ordination group, within such sixty-day period, and if the Authority has approved the assessment report, the draft summary of product characteristics and the labelling and package leaflet of the reference Member State, the Authority may, at the request of the applicant, authorise the medicinal product without waiting for the outcome of the procedure laid down in Article 32 of Directive 2001/ 83/EC as amended by Directive 2004/27/EC. In that event, the authorisation granted shall be without prejudice to the outcome of that procedure.