It must also be borne in mind that there would be a real obstacle to intra-Community trade if importers of the old versionof Zimovane, which is still authorised in other Member States and lawfully marketed there, were not able to use the simplified procedure open to parallel importers in accordance with MAL 2 (PI).
42.
As is clear from paragraph 35 of this judgment, the competent authorities in the United Kingdom considered it possible to authorise the placing on the market of those medicinal products imported as parallel imports by using as a parent marketing authorisation the authorisation for the new version of Zimovane and they have taken the view that, on the basis of the information in their possession, in spite of the different excipients used, the old version of Zimovane clearly remained effective and safe.
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).
44.
However, the possibility of such effects on safety does not mean that as a consequence of differences relating to the excipients used the national authorities may never resort to simplified procedures for the licences granted to parallel importers.
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).
47.
Finally, it is necessary to examine the argument put forward by M & B and RPR that the particular benefit to public health provided by the new version of Zimovane as compared with the old version would not be achieved if the old version of Zimovane were present on the United Kingdom market. In that regard, it is sufficient to state that, even if the argument were well founded, it does not follow that, in circumstances such as those of the main case, the national authorities are compelled to require parallel importers to follow the procedure laid down in the Directive if they take the view that, in normal conditions of use, as referred to in Article 5 of the Directive, the medicinal product imported as a parallel import does not pose a risk as to quality, efficacy or safety.
48.
In the light of the foregoing, the answer to the questions referred for a preliminary ruling must be that where it is sought to import medicinal product X from Member State A into Member State B, it is permissible for the person who proposes to place the imported product upon the market in Member State B to seek and obtain a parallel import licence from the competent authority in Member State B without complying with all the requirements of the Directive if:
-medicinal product X is the subject of a marketing authorisation granted in Member State A and was the subject of a marketing authorisation which has ceased to have effect in Member State B;
-medicinal product Y is the subject of a marketing authorisation granted in Member State B, but is not the subject of a marketing authorisation granted in Member State A;
-medicinal product X has the same active ingredients and therapeutic effect as medicinal product Y, but does not use the same excipients and is manufactured by a different manufacturing process, where the competent authority in Member State B is in a position to verify that medicinal product X complies with the requirements relating to quality, efficacy and safety in normal conditions of use and is in a position to ensure normal pharmacovigilance;
-the marketing authorisations referred to above were granted to different members of the same group of companies and the manufacturers of medicinal products X and Y are also members of that group of companies; and
-companies within the same group as the holder of the marketing authorisation for product X which has been withdrawn in Member State B continue to manufacture and market product X in Member States other than Member State B.
-In such a situation, the competent authority is not required to take into consideration the fact that medicinal product Y was developed and introduced in order to provide a particular benefit to public health which medicinal product X does not provide and/or that that particular benefit to public health would not be achieved if product X and product Y were both on the market in Member State B at the same time.