S.L. 458.36 Art. 11BDerogation from the requirement of an importers’ licence. S.L. 458.37. S.L. 458.33.

By way of derogation from sub-regulations 1(a) and (b) of regulation 3, until the 31st December 2024, the Licensing

Authority shall allow medicinal products to be imported from parts of the United Kingdom other than Northern Ireland by holders of a wholesale distribution authorisation as referred to in regulation 4 of the Wholesale Distribution and Brokering of Medicinal Products and Active Substances Regulations, that are not in possession of a relevant manufacturing authorisation provided that all of the following conditions are fulfilled:

(a) the medicinal products have undergone quality control testing, either in the Union, as provided for in regulation 12 or in parts of the United Kingdom other than Northern Ireland in compliance with regulation 11(1)(b);

(b) the medicinal products have been subject to batch release by a qualified person in the Union in accordance with regulation 11(1) or, for medicinal products authorised by the Licensing Authority and the United Kingdom in respect of Northern Ireland, in parts of the United Kingdom other than Northern Ireland applying quality standards that are equivalent to those laid down in regulation 11(1);

(c) the marketing authorisation for the medicinal product concerned has been granted in accordance with Union law, by the competent authority of a Member State or by the Commission or, as regards medicinal products placed on the market in Northern Ireland, by the competent authority of the United Kingdom in respect of Northern Ireland;

(d) medicinal products are only made available to patients or end-consumers in Malta;

(e) the medicinal products bear the safety features referred to in regulation 3(o) of the Medicinal Products

(Labelling and Packaging) Regulations.