Fabio Caronna.
Date: 2012-06-28
28. Article 77(1) of the Directive imposes on the Member States a general obligation to make the wholesale distribution of medicinal products subject to the possession of a special authorisation. The same obligation is referred to in the first sentence of recital 36 in the preamble to the Directive, which states that ‘[a]ny person involved in the wholesale distribution of medicinal products should be in possession of a special authorisation’.
29. Article 77(2) of the Directive provides that that obligation also applies to persons authorised or entitled to supply medicinal products to the public if they may also engage in wholesale business.
35. In particular, while, under Article 40(1) of the Directive, the manufacture of medicinal products is subject in general to the requirement to obtain an authorisation, the second subparagraph of Article 40(2) of the Directive provides that the manufacturing authorisation is not required for preparation, dividing up, changes in packaging or presentation ‘where these processes are carried out, solely for retail supply, by pharmacists in dispensing pharmacies or by persons legally authorised in the Member States to carry out such processes’. It follows that, where such manufacturing processes are not carried out for the purpose of the retail supply of medicinal products, pharmacists are not exempt from the requirement to hold a manufacturing authorisation, which also covers the authorisation for the wholesale distribution of medicinal products.
37. The Court therefore finds that pharmacists are included in the wider class of persons authorised or entitled to supply medicinal products to the public within the meaning of Article 77(2) of the Directive and are required, if they are permitted under domestic law to engage in activity as wholesale distributors in medicinal products, to obtain the authorisation prescribed under Article 77(1).
40. In any event, the preamble to a European Union act has no binding legal force and cannot be relied on either as a ground for derogating from the actual provisions of the act in question or for interpreting them in a manner clearly contrary to their wording (Case C-308/97 Manfredi [1998] ECR I-7685, paragraph 30; Case C-136/04 Deutsche Milch-Kontor  [2005] ECR I-10095, paragraph 32; and Case C-134/08 Tyson Parketthandel  [2009] ECR I-2875, paragraph 16).
41. It follows from the foregoing that the answer to Question 1 is that Article 77(2) of the Directive must be interpreted as meaning that the requirement to obtain authorisation for the wholesale distribution of medicinal products is applicable to a pharmacist who, as a natural person, is also authorised under domestic law to operate as a wholesaler in medicinal products.
Question 2
43. As a preliminary point, it should be noted that the conditions applicable to the supply of medicinal products to the public are not harmonised under European Union law as it currently stands. Accordingly, Member States may impose conditions for supplying medicinal products to the public within the limits laid down in the FEU Treaty (see recital 21 in the preamble to Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (OJ 2011 L 174, p. 74)). Consequently, the regime applicable to persons entrusted with the retail supply of medicinal products varies from one Member State to another (Case C-531/06 Commission  v Italy [2009] ECR I-4103, paragraph 38).
44. On the other hand, the minimum requirements to be satisfied by applicants for and holders of authorisation for the wholesale distribution of medicinal products are harmonised by the Directive, in particular in Article 79 to 82 of the Directive. Question 2 must therefore be considered in the light of those provisions.
45. Thus, Article 79 of the Directive provides that the granting of authorisation to operate as a wholesaler in medicinal products is contingent on the existence of suitable premises, installations and equipment and qualified staff, so as to ensure proper conservation and distribution of the medicinal products.
46. Checks are carried out during the period in which that authorisation is held to ensure that the conditions for the granting thereof are satisfied. There are further requirements, set out in Articles 80 to 82 of the Directive, which the holder of the authorisation must comply with, including those relating to the documentation of transactions, the supply of medicinal products and compliance with the principles and guidelines relating to good distribution practice.
47. Given that the retail of medicinal products has different characteristics from the wholesale distribution of such products, it cannot be presumed from the simple fact that pharmacists satisfy the conditions governing retail supply in their respective Member States that they also satisfy the conditions laid down by harmonised rules at European Union level for wholesale distribution.
48. Accordingly, in order to ensure that the Directive’s objectives are achieved, in particular those relating to the protection of public health, the removal of barriers to trade in medicinal products within the European Union and the need to exercise control over the entire chain of distribution of medicinal products, referred to in recitals 2 to 5 and 35 in the preamble to the Directive, the minimum requirements for the wholesale distribution of medicinal products must be fulfilled in a uniform and effective manner by all persons who engage in that activity in all Member States.
49. That conclusion does not mean that a competent national authority cannot, when authorising pharmacists for the purposes of wholesale distribution of medicinal products, take into account any equivalent conditions relating to authorisation for the purposes of retail distribution of such products, in application of national rules.
50. Consequently, the answer to Question 2 is that a pharmacist who is also authorised under domestic law to operate as a wholesaler in medicinal products must satisfy all the requirements imposed on applicants for and holders of authorisation for the wholesale distribution of medicinal products in Articles 79 to 82 of the Directive.
The obligation to interpret national law in conformity with European Union law in criminal matters
52. As the Court has held, the principle of interpreting national law in conformity with European Union law is limited by general principles of law which form part of the European Union legal system, in particular, the principles of legal certainty and non-retroactivity. Thus, a directive cannot, of itself and independently of a national law adopted by a Member State for its implementation, have the effect of determining or aggravating the liability in criminal law of persons who act in contravention of the provisions of that directive (see, inter alia, Case C-60/02 X [2004] ECR I-651, paragraph 61 and the case-law cited).
54. However, it is not for the Court to interpret domestic law, that being exclusively a matter for the national court.