14.—(1) An application for a simple parallel import licence means an application for a parallel import licence in respect of a proposed importation of a medicinal product (“P”) which is similar to a medicinal product (“R”) in respect of which a marketing authorisation has already been granted in the United Kingdom.
(2) For the purposes of sub-paragraph (1) “similar” means—
(a)the manufacturer of P and the manufacturer of R are either the same company or belong to the same group of companies or, in the case of independent companies, agreements have been concluded with the same licensor; and
(b)product P and R are manufactured according to the same formulation, using the same active ingredients, have the same pharmaceutical form and have no differences that will result in a difference in the therapeutic effect.
(3) An application for a complex parallel import licence means an application for a parallel import licence which is not a simple parallel import licence and the application is in respect of a medicinal product—
(a)containing a new excipient;
(b)containing an active ingredient the manufacture of which involves a route of synthesis (or, in the case of a medicinal product not synthetically produced, a method of manufacture) different from that used in the manufacture of the active ingredient of any medicinal product which contains the same active ingredient as the product in question and in respect of which a marketing authorisation (other than a product licence of right) has previously been granted;
(c)which is a controlled release preparation;
(d)which is a sterile medicinal product the manufacture of which involves a method of sterilisation different from that used in the manufacture of any medicinal product which contains the same active ingredient as the product in question and in respect of which a marketing authorisation (other than a product licence of right) has previously been granted;
(e)which is a sterile medicinal product the container of which is directly in contact with the medicinal product and is made from different material from the container of any medicinal product which contains the same active ingredient as the product in question and in respect of which a marketing authorisation (other than a product licence of right) has previously been granted;
(f)containing an active ingredient which, unless that active ingredient is covered by a European Pharmacopoeia certificate of suitability, is not manufactured by a manufacturer of the active ingredient which is included in the medicinal product in respect of which a marketing authorisation (other than a product licence of right) has previously been granted;
(g)which is an influenza vaccine;
(h)which is to be delivered by way of a metered dose inhaler;
(i)which is in powder form and is to be delivered by inhalation;
(j)which falls within the description of the medicinal product set out in Article 10(3) of the 2001 Directive;
(k)where the sole or primary evidence for the safety and efficacy of that product consists of published scientific literature;
(l)in respect of which a marketing authorisation has not been made under Article 10, 10a or 10c of the 2001 Directive by the competent authority in the member State of exportation, and the application includes the results of pre-clinical tests or clinical trials within the meaning of Article 8(3)(i) of the 2001 Directive; or
(m)in respect of which a marketing authorisation to which the first sub-paragraph of paragraph 3 of Part II of Annex I to the 2001 Directive applied in the member State of exportation.
(4) An application for a standard parallel import licence means an application for a parallel import licence which is not a complex parallel import licence or a simple parallel import licence.
(5) An application shall not fall within the meaning of sub-paragraph (1), (3) or (4) where the applicant and the holder of the marketing authorisation in the member State of exportation in respect of which the medicinal product in question relates are a parent undertaking and subsidiary undertaking within the meaning of section 1162 (taken together with section 1161 of, and Schedule 7 to) the Companies Act 2006(1).