S.L. 458.34 Art. 23Referral to Committee for MedicinalProducts for Human Use.

(1) If two or more applications submitted in accordance with regulations 5, 7 and 8 have been made for marketing authorisation for a particular medicinal product, and if Member

States have adopted divergent decisions concerning the authorisation of the medicinal product or its suspension or revocation, the Authority, the Commission or the applicant or the marketing authorisation holder may refer the matter to the Committee for Medicinal Products for Human Use, hereinafter referred to as the Committee, for the application of the procedure laid down in Articles 32, 33 and 34 of Directive 2001/83 as amended by Directive 2004/27.

(2) In order to promote harmonisation of authorisations for medicinal products authorised in the Community, the Authority shall, each year, forward to the coordination group a list of medicinal products for which a harmonised summary of product characteristics should be drawn up.

(3) The Authority or the Commission, in agreement with the Agency and taking into account the views of interested parties, may refer these products to the Committee in accordance with subregulation (1).

(4) The Member States, the Commission, the applicant or the marketing authorisation holder shall, in specific cases where the interests of the European Union are involved, refer the matter to the Committee for application of the procedure laid down in Articles 32, 33 and 34 of Directive 2001/83/EC as amended before any decision is reached on an application for a marketing authorisation or on the suspension or revocation of a marketing authorisation, or on any other variation of the marketing authorisation which appears necessary. Where the referral results from the evaluation of data relating to pharmacovigilance of an authorised medicinal product, the matter shall be referred to the Pharmacovigilance Risk Assessment Committee and Article 107j(2) of Directive 2001/83/ EC may be applied. The Pharmacovigilance Risk Assessment Committee shall issue a recommendation according to the procedure laid down in Article 32 of Directive 2001/83/EC as amended. The final recommendation shall be forwarded to the Committee for Medicinal Products for Human Use or to the coordination group, as appropriate, and the procedure laid down in regulation 65 of the Pharmacovigilance Regulations shall apply. However, where one of the criteria listed in regulation 57(1)(a)(i) of the Pharmacovigilance Regulations is met, the procedure laid down in regulation 57 thereof applies.

(5) The Authority or the Commission shall clearly identify the question which is referred to the Committee for consideration and shall inform the applicant or the marketing authorisation holder.

(6) The Authority and the applicant or the marketing authorisation holder shall supply the Committee with all available information relating to the matter in question.

(7) (a) Where the referral to the Committee concerns a range of medicinal products or a therapeutic class, the Agency may limit the procedure to certain specific parts of the authorisation. In that event, regulation 24 shall apply to those medicinal products only if they were covered by the authorisation procedures referred to in regulations 22 and 23.

(b) Where the scope of the procedure initiated under regulations 22 and 23 concerns a range of medicinal products or a therapeutic class, medicinal products authorised in accordance with Regulation (EC) No 726/2004 which belong to that range or class shall also be included in the procedure.

(8) Without prejudice to sub-regulation (4), the Licensing Authority may, where urgent action is necessary to protect public health at any stage of the procedure, suspend the marketing authorisation and prohibit the use of the medicinal product concerned in Malta until a definitive decision is adopted. It shall inform the Commission, the Agency and the other Member States, no later than the following working day, of the reasons for its action.

(9) Where the scope of the procedure initiated in accordance with sub-regulation (7) includes medicinal products authorised in accordance with Regulation (EC) No 726/2004, the Commission may, where urgent action is necessary to protect public health, at any stage of the procedure, suspend the marketing authorisations and prohibit the use of the medicinal products concerned until a definitive decision is adopted. The Commission shall inform the Agency and the Licensing Authority no later than the following working day of the reasons for its action.