S.L. 458.34 Art. 4Authorisation for placing on the market.

(1)(a) Subject to the following provisions of this regulation, no medicinal product may be placed on the market in

Malta unless there is in respect of that product a valid marketing authorisation issued by the Licensing Authority in accordance with these regulations or in accordance with procedures laid down in Regulation

(EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency), read in conjunction with Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use, and Regulation (EC) No. 1394/2007 of the European Parliament and of the Council of the 13th November 2007 on advanced therapy medicinal products and such placing on the market is in accordance with the terms and conditions of such marketing authorisation.

(b) When a medicinal product has been granted an initial marketing authorisation in accordance with the preceding paragraph, any additional strengths, pharmaceutical forms, administration routes, presentations, as well as any variations and extensions shall only be granted an authorisation in accordance with the preceding paragraph or be included in the initial marketing authorisation. All these marketing authorisations shall be considered as belonging to the same global marketing authorisation, in particular for the purpose of the application of regulation 7(1).

(c) The provisions of paragraphs (a) and (b) shall also apply to radionuclide generators, kits, radionuclide precursor radiopharmaceuticals and industrially prepared radiopharmaceuticals.

(d) A marketing authorisation shall not be required in the case of a radiopharmaceutical prepared at the time of its use by a person or by an establishment duly authorised to use such medicinal products in an approved health care establishment exclusively from authorised radionuclide generators, kits or radionuclide precursors in accordance with the manufacturer’s instructions.

(e) The Licensing Authority may, in exceptional cases, subject to any condition it deems fit, allow the use of a medicinal product which does not have a marketing authorisation.

(f) The Licensing Authority may temporarily authorise the distribution of an unauthorised medicinal product in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation any of which could cause harm.

(g) The marketing authorisation holder shall be responsible for marketing the medicinal product and the designation of a representative shall not relieve the marketing authorisation holder of his legal responsibility. The holder of a marketing authorisation for a medicinal product and the distributors of the said medicinal product actually placed on the market in Malta shall, within the limits of their responsibilities, ensure appropriate and continued supplies of that medicinal product to pharmacies and persons authorised to supply medicinal products so that the needs of patients in Malta are covered.

(2) (a) In the absence of a marketing authorisation or of a pending application for a medicinal product which is authorised in another Member State in accordance with Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the community code relating to medicinal products for human use, and any amendments thereto, the Licensing Authority may for justified public health reasons authorise the placing of the said medicinal product on the market in Malta.

(b) The medicinal product referred to in paragraph (a) has to comply in particular with the requirements of the provisions regarding the classification of medicinal products, laid down in the Act, and any regulations made thereunder, and the following regulations:

(i) the Medicinal Products (Advertising)

Regulations;

(ii) the Medicinal Products (Labelling and

Packaging) Regulations;

(iii) the Pharmacovigilance Regulations; and

(iv) the Wholesale Distribution of Medicinal

Products Regulations. The Authority may decide that regulation 10(1) and (2) of the Medicinal Products (Labelling and Packaging) Regulations and Article 63(1) and (2) of Directive 2001/ 83/EC shall not apply to medicinal products authorised under paragraph (a).

(c) Any authorisation issued under this regulation shall for the purposes of articles 99 to 104 of the Act be deemed to be a marketing authorisation.

(d) Before granting such an authorisation the Licensing Authority shall:

(i) notify the marketing authorisation holder in the Member State in which the medicinal product concerned is authorised, of its intention to grant an authorisation under subregulation (2), and

(ii) request the competent authority in that Member State to furnish a copy of the assessment report, and of the marketing authorisation in force.

(e) (i) The medicinal product to be placed on the market in Malta shall be that authorised by the Member State referred to in paragraph (a).

(ii) An authorisation under this subregulation cannot be used as the basis for a licence in terms of the Parallel Importation of Medicinal Products Regulations.

(iii) An authorisation under this subregulation cannot be used as a reference for an application submitted in accordance with regulation 7.

(f) The holder of the authorisation in Malta granted in accordance with this subregulation, shall ensure that:

(i) the medicinal product is in accordance with the marketing authorisation issued by the Member State referred to above, and includes any variations in particular those affecting the summary of product characteristics, labelling and package leaflet of the medicinal product as approved in the said Member State, and submits the updated documentation to the Medicines Authority;

(ii) he implements without any delay actions relating to issues concerning the medicinal product which have resulted in a product or batch recall as may apply to the medicinal product authorised in the Member State referred to above.

(g) In the case of a medicinal product, where the wholesale distributor is not the authorisation holder for the medicinal product in Malta, the distributor shall, in respect of the product he is distributing in Malta, furnish to the Medicines Authority an authenticated copy of the said authorisation together with a letter of access issued by the authorisation holder granting the wholesale distributor the use of such an authorisation.