Brussels, 29/06/2012 (Agence Europe) - A pharmacist who is also authorised under national law to operate as a wholesaler in medicinal products must obtain authorisation for wholesale distribution under EU law (Directive 2001/83/EC). “On the other hand, that interpretation of EU law cannot, in itself and independently of a law adopted by a member state, give rise to, or aggravate liability in, criminal law on the part of a pharmacist who has engaged in activity as a wholesale distributor without such authorisation” ruled the European Court of Justice in Case C-7/11 on 28 June.
The European Court of Justice was answering a query from an Italian court about whether this special authorisation requirement applied to pharmacists who are already authorised under Italian legislation to provide medicines to the general public, and whether pharmacists had to be meet all the wholesale conditions or whether it was enough for them to meet the requirements set out in Italian retail sales rules for medicines.
The Court of Justice ruled that under the directive, member states are required to ensure that wholesale distribution of medicinal products is subject to possession of authorisation to engage in such activity, even where persons entitled to supply medicinal products to the public are also authorised under national law to engage in wholesale business. The medicines retail sales rules vary from one member state to the next, but the directive harmonises the wholesale rules at EU level. The Court ruled that the “requirement under the directive 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.” “If the referring court were to reach the conclusion that national law, in the version applicable at the material time, did not require pharmacists to obtain special authorisation for the wholesale distribution of medicinal products and did not provide that pharmacists were subject to criminal liability, the principle that criminal penalties must have a proper legal basis4 would prohibit the imposition of criminal penalties for such conduct, even if the national rule were contrary to EU law.” (FG/transl.fl)