Delfarma Sp. z o.o. v Prezes Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych.
Date: 2019-07-03
18


In that connection, it should be noted, that, under Article 6(1), first subparagraph, of Directive 2001/83, no medicinal product may be placed on the market of a Member State for the first time unless a marketing authorisation has been issued by the competent authorities of that Member State in accordance with that directive, or an authorisation has been granted in accordance with Regulation No 726/2004. Applications for marketing authorisations must be accompanied by the information and documents listed in Article 8(3) 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 (see, to that effect, judgments of 12 November 1996, Smith & Nephew and Primecrown, C‑201/94, EU:C:1996:432, paragraph 19; of 16 December 1999, Rhône-Poulenc Rorer and May & Baker, C‑94/98, EU:C:1999:614, paragraph 23; and of 10 September 2002, Ferring, C‑172/00, EU:C:2002:474, paragraph 19).
19


However, it is clear from the case-law of the Court that Directive 2001/83 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 medicinal 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. Such a situation therefore falls under the provisions of the FEU Treaty on the free movement of goods (see, to that effect, judgments of 12 November 1996, Smith & Nephew and Primecrown, C‑201/94, EU:C:1996:432, paragraph 21, and of 16 December 1999, Rhône-Poulenc Rorer and May & Baker, C‑94/98, EU:C:1999:614, paragraph 27; see also, as regards plant protection products, judgment of 6 November 2014, Mac, C‑108/13, EU:C:2014:2346, paragraph 27 and the case-law cited, and, as regards veterinary medicinal products, judgment of 27 October 2016, Audace and Others, C‑114/15, EU:C:2016:813, paragraph 51 and the case-law cited).
20


It should be recalled that, according to settled case-law, all measures of a Member State which are capable of hindering, directly or indirectly, actually or potentially, trade within the European Union are to be considered as measures having an effect equivalent to quantitative restrictions within the meaning of Article 34 TFEU (see, to that effect, judgments of 20 May 1976, de Peijper, 104/75, EU:C:1976:67, paragraph 12, and of 23 December 2015, Scotch Whisky Association and Others, C‑333/14, EU:C:2015:845, paragraph 31 and the case-law cited).
21


The free movement of goods means that an operator who has bought a medicinal product lawfully marketed in one Member State under a marketing authorisation issued in that State can import that medicinal product into another Member State where it already has a marketing authorisation, without having to obtain such an authorisation in accordance with Directive 2001/83 and without having to provide all the information and documentation required by the directive for the purpose of determining whether the medicinal product is effective and safe (see, to that effect, judgment of 10 September 2002, Ferring, C‑172/00, EU:C:2002:474, paragraph 21 and the case-law cited).
22


It follows from Articles 34 and 36 TFEU that a Member State must not obstruct parallel imports of a medicinal product 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. However that is subject to the condition that the import of that medicinal product does not undermine the protection of public health (see, to that effect, judgment of 16 December 1999, Rhône-Poulenc Rorer and May & Baker, C‑94/98, EU:C:1999:614, paragraph 40).
23


Accordingly, the competent authorities of the Member State of importation must ensure, at the time of import and on the basis of the information in their possession, that the medicinal product imported as a parallel product and the medicinal product which is the subject of a marketing authorisation in the Member State of importation, even if not identical in all respects, have at least been manufactured according to the same formulation, have the same active ingredient and have the same therapeutic effect, and that the imported medicinal product does not pose a problem of quality, efficacy or safety (see, to that effect, judgments of 12 November 1996, Smith & Nephew and Primecrown, C‑201/94, EU:C:1996:432, paragraph 26, and of 16 December 1999, Rhône-Poulenc Rorer and May & Baker, C‑94/98, EU:C:1999:614, paragraph 45).
24


If, on completion of its examination, the competent authority of the Member State of importation finds that all the criteria mentioned in the preceding paragraph of the present judgment are satisfied, the medicinal product to be imported must be regarded as having already been placed on the market in that Member State and, consequently, must be entitled to benefit from the marketing authorisation issued for the medicinal product already on the market, unless there are countervailing considerations relating to the effective protection of the life and health of humans (see, to that effect, judgments of 12 November 1996, Smith & Nephew and Primecrown, C‑201/94, EU:C:1996:432, paragraph 29; see also, as regards plant protection products, judgments of 11 March 1999, British Agrochemicals Association, C‑100/96, EU:C:1999:129, paragraph 36, and of 6 November 2014, Mac, C‑108/13, EU:C:2014:2346, paragraph 28). Thus, that authority is required to authorise a medicinal product imported as a parallel product which satisfies those criteria where it is convinced that that product, in spite of differences relating to the excipients, does not pose a problem of quality, efficacy or safety (judgment of 16 December 1999Rhône-Poulenc Rorer and May & Baker, C‑94/98, EU:C:1999:614, paragraph 45).
29


In that connection, although it is true that, among the goods or interests protected by Article 36 TFEU, the protection of health and life of humans is ranked in first position and that it is for the Member States, within the limits imposed by the FEU Treaty, to decide the level of protection they wish to afford, in particular, as regards how strict the checks to be carried out are to be, the fact remains that, in accordance with settled case-law, a measure having equivalent effect to a quantitative restriction on imports can be justified, for example, on grounds of the protection of the health and life of humans, within the meaning of that article, only if that measure is appropriate for securing the achievement of the objective pursued and does not go beyond what is necessary in order to attain it (see, to that effect, judgments of 20 May 1976, de Peijper, 104/75, EU:C:1976:67, paragraphs 15 to 17, and of 23 December 2015, Scotch Whisky Association and Others, C‑333/14, EU:C:2015:845, paragraph 33).
30


Article 36 TFEU cannot be relied on to justify rules or practices which, even though they are beneficial, contain restrictions which are explained primarily by a concern to lighten the administration’s burden or reduce public expenditure, unless, in the absence of the said rules or practices, this burden or expenditure clearly would exceed the limits of what can reasonably be required (judgment of 20 May 1976, de Peijper, 104/75, EU:C:1976:67, paragraph 18).
33


Moreover, as regards the information necessary for the examination of an application for a parallel import licence for a medicinal product, the Court has already observed that the competent national authorities have available to them legislative and administrative means of compelling the manufacturer or his duly appointed representative to supply information in their possession which the authorities consider necessary and that simple cooperation between the authorities of the Member States would enable them to obtain the necessary substantiating documents on a reciprocal basis (see, to that effect, judgments of 20 May 1976, de Peijper, 104/75, EU:C:1976:67, paragraphs 26 and 27, and of 12 November 1996, Smith & Nephew and Primecrown, C‑201/94, EU:C:1996:432, paragraphs 27 and 28; see also, as regards plant protection products, judgment of 6 November 2014, Mac, C‑108/13, EU:C:2014:2346, paragraph 36 and the case-law cited).
34


The Court states that when the applicant does not have access to all the necessary information but provides data that make it at least plausible that the two medicinal products do not differ significantly for the purpose of assessing their safety and efficacy, the competent authorities must act in such a way that their decision as to whether to extend to the second medicinal product the marketing authorisation granted to the first one is taken on the basis of the fullest information possible, including information which is available to them or which they could have obtained through cooperation with the health authorities in other Member States (judgment of 1 April 2004, Kohlpharma, C‑112/02, EU:C:2004:208, paragraph 20).