Rhone-Poulenc-sagen indgår i retspraksis i fortsættelse af sagerne De Peijper (dom af 20.5.1976, sag 104/75, Sml. s. 613), og Smith & Nephew og Primecrown (dom af 12.11.1996, sag C-201/94, Sml. I, s. 5819), hvilken retspraksis befordrede den frie bevægelighed for lægemidler inden for Fællesskabet ved at undtage en import fra en medlemsstat til en anden fra den tunge procedure, der er fastsat i direktiv 65/65, når det pågældende lægemiddel allerede var omfattet af en markedsføringstilladelse i den første medlemsstat, og den pågældende indførsel udgjorde parallelimport i forhold til et lægemiddel, som allerede var omfattet af en markedsføringstilladelse i importmedlemsstaten. I Rhone-Poulenc-sagen (dom af 16.12.1999, sag C94/98, Sml. I, s. 8789) var det pågældende produkt omfattet af en markedsføringstilladelse, der ikke længere havde virkning i importstaten og var en tidligere udgave af et lægemiddel, som i en senere udgave var omfattet af en markedsføringstilladelse i denne medlemsstat, og det var bestridt, at den tidligere udgave havde mulighed for at blive underkastet den forenklede procedure for parallelimport. Domstolen udtalte i dommen, at ingen af de tre grunde, der var fremført af indehaveren af markedsføringstilladelsen i importstaten, gjorde det muligt helt at udelukke muligheden for parallelimport. For det første blev det fremhævet, at de to udgaver af lægemidlet ikke var fremstillet efter samme formel, idet den udgave, der var omfattet af markedsføringstilladelsen i importlandet, blev fremstillet med andre hjælpestoffer og i en anden fremstillingsproces. Domstolen fastslog i denne forbindelse, at det påhvilede de kompetente myndigheder i importmedlemsstaten at sikre sig, at det parallelt indførte lægemiddel, selv om det ikke på alle punkter var identisk med det af myndighederne allerede 25
U9761 ECR 613 and Case C-2OI_BAR_94 Smith & Nephew and Primecrown U9961ECR I-5819. That case-law had facilitated the free movement of medicinal products within the Community by exempting imports from one Member State toanother from the onerous procedure laid down by Directive 65165 where the medicinal product in question was already covered by a marketing authorisationin the first Member State and was being imported as a parallel import of aproduct which was itself already covered by a marketing authorisation in the Member State of importation. In Rhöne-Poulenc the medicinal product at issuewas the subject of a marketing authorisation which had ceasedto have effect inthe Member State of importation, where a new version of that product wascovered by a marketing authorisation. It was disputed in that State that thesimplified procedure applicable to parallel imports could be used for the oldversion. In its judgment, the Court stated that none of the three grounds putforward by the holder of the marketing authorisation in the State of importationenabled the possibility of parallel importation to be ruled out in absolute terms.First, it was pointed out to the Court that the two versions of the medicinalproduct were not manufactured according to the sameformulation, given that theversion covered by a marketing authorisation in the State of importation wasmanufactured using different excipients and by a different manufacturing process.In that regard, the Court held that it was for the competent authorities of the Member State of importation to ensure that the medicinal product imported as aparallel product, even if not identical in all respectsto that already authorised bythem, had the same active ingredientand the same therapeutic effect and did notpose a problem of quality, efficacy or safety. Second, it was assertedthat thedrug monitoring ("pharmacovigilance") system would not work in the MemberState of importation because the holder of the marketing authorisation in that Statewas not obliged to submit information regularly in relation to the productimported in parallel. The Court found, however, that drug monitoring could beensured in particular through cooperation with the authorities of the other Member States. Finally, it was claimed that the particular benefit for public health whichwas provided by the new version, as compared with the old version, of themedicinal product could not be achieved if the old and new versions were bothavailable on the market of the State of importation at the same time. The Courtmet that third objection by stating that, even if the argument were well founded,it did not follow that, in circumstances such as those of the main case, thenational authorities were compelled to require parallel importers to follow theprocedure laid down in Directive 65165 if they took the view that, in normal 2525