The Queen, ex parte Rhône-Poulenc Rorer Ltd and May & Baker Ltd v The Licensing Authority established by the Medicines Act 1968 (represented by the Medicines Control Agency).
Date: 1999-12-16
23 The first point to note is that notwithstanding the Treaty rules on the free movement of goods no medicinal product may be placed on the market in a Member State unless a marketing authorisation has been issued in accordance with the Directive by the competent authority of that State. An application for a marketing authorisation for a medicinal product submitted by the person responsible for placing it on the market must contain the information and be accompanied by the documents listed in Article 4 of the Directive even where the medicinal product concerned is already the subject of an authorisation issued by the competent authority of another Member State.
25 Accordingly, point 8 of Article 4 of Directive 65/65/EEC, as amended by Council Directive 87/21/EEC of 22 December 1986 (OJ 1987 L 15, p. 36), establishes an `abridged' procedure which, subject to certain conditions, relieves the manufacturers of medicinal products which are essentially similar to medicinal products already authorised from having to provide the results of pharmacological and toxicological tests and of clinical trials, thus saving the time and expense necessary to assemble such data, and avoiding the repetition of tests on humans or animals where these are not absolutely necessary (see Case C-368/96 Generics (UK) and Others [1998] ECR I-7967, paragraphs 2 to 4).
26 The other exception, which is relevant in this case, is defined in De Peijper. In that case, the Court held, at paragraphs 21 and 36, in the context of Articles 30 and 36 of the Treaty, that if, as a result of importation on a previous occasion which gave rise to the grant, by them, of a marketing authorisation, the public health authorities of the Member State of importation are already in possession of all the particulars necessary for checking that the product is effective and safe, it is not necessary, for the purpose of protecting the health and life of humans, for those authorities to require a second trader who has imported a medicinal product which is in every respect the same or which has no differences altering the therapeutic effect, to submit the abovementioned particulars to them again.
27 In Case C-201/94 Smith & Nephew and Primecrown [1996] ECR I-5819, paragraph 21, the Court stated again that the Directive cannot apply to a medicinal product covered by a marketing authorisation in one Member State which is being imported into another Member State as a parallel import of a product already covered by a marketing authorisation in that other Member State, because the imported medicinal product cannot, in such a case, be regarded as being placed on the market for the first time in the Member State of importation.
28 The Court went on to state, in paragraphs 25 and 26 of that judgment, that in order to ascertain whether imports of a medicinal product constitute parallel imports the competent authority in the Member State of importation must verify that the two medicinal products have a common origin and, if not identical in all respects, have at least been manufactured according to the same formulation, using the same active ingredient, and have the same therapeutic effect.
40 Next, it should be noted that although, as the Court held in De Peijper and Smith & Nephew and Primecrown, it follows from Articles 30 and 36 of the Treaty that national authorities must not obstruct parallel imports by requiring parallel importers to satisfy the same requirements as those which are applicable to undertakings applying for the first time for a marketing authorisation for a medicinal product, that principle is subject to the condition that an exception of that kind to the rules normally applicable to marketing authorisations for medicinal products does not undermine the protection of public health. As is clear from the first recital in the preamble to the Directive, the primary purpose of any rules concerning the production and distribution of medicinal products must be to safeguard public health. The criteria which must be met by a product imported as a parallel import for the parallel importer to be under no obligation to supply the particulars referred to in the Directive must not, therefore, lead to a relaxation of safety requirements (see, to that effect, Generics (UK), paragraph 22).
43 Although, as the United Kingdom Government has submitted, differences in the excipients used in medicinal products do not normally have any effect on safety, it is not disputed that such effects can exist. It is possible for a medicinal product imported as a parallel import, which contains the same active ingredients and has the same therapeutic effect but does not use the same excipients as the medicinal product which is the subject of the marketing authorisation in the Member State of importation, to show significant differences from the authorised product in terms of safety, given that modifications to the formulation of a medicinal product in respect of the excipients may have an effect on the shelf-life and the bioavailability of the product, for example in relation to the rates at which the medicinal product dissolves or is absorbed (see also, to that effect, Generics (UK), paragraph 32).
45 The national authorities are required to authorise, in accordance with the rules relating to parallel imports, a medicinal product imported as a parallel product where they are convinced that that product, in spite of differences relating to the excipients, does not pose a problem for public health. Accordingly, the competent authorities of the Member State of importation must ensure, at the time of import and on the basis of information in their possession, that the medicinal product imported as a parallel product, even if not identical in all respects to that already authorised by them, has the same active ingredient and the same therapeutic effect and does not pose a problem of quality, efficacy or safety (see, to that effect, Case C-100/96 British Agrochemicals Association [1999] ECR I-1499, paragraph 40).
46 As regards the problem raised in relation to pharmacovigilance, it is sufficient that pharmacovigilance satisfying the relevant requirements of Directive 75/319 as amended can be ensured for medicinal products imported as parallel imports, like those in this case, through cooperation with the national authorities of the other Member States by means of access to the documents and data, produced by the manufacturer or other companies in the same group, relating to the old version in the Member States in which that version is still marketed on the basis of a marketing authorisation still in force. In addition, it is possible to compel the holder of the marketing authorisation in the Member State of importation, who belongs to the group of companies which is in possession of the marketing authorisations for the old version in the other Member States, to supply the necessary information (see, to that effect, De Peijper, paragraphs 26 and 27).