EU 'Special' Authorization for Wholesale Distribution of Medicines Applies to Pharmacists
On 28 June 2012, the Court of Justice of the European Union (CJEU) issued a ruling in a case referred to by an Italian court (Case C-7/11 Criminal proceedings against Fabio Caronna), regarding an Italian pharmacist who was licensed to retail medicinal products to the public in Italy, and who also engaged in wholesale distribution of these products. The CJEU confirms that a retail-licensed pharmacist who is authorized to engage in wholesale distribution of medicinal products under national law – as was the case here under Italian law – must also satisfy the requirements imposed on applicants for, and holders of, a special authorization for the wholesale distribution of medicinal products under EU law (Directive 2001/83/EC on the Community code relating to medicinal products for human use, “the Medicinal Products Directive”).
The CJEU, nevertheless, reminds that a court’s interpretation of national rules in conformity with EU law must not go so far as making criminally liable a pharmacist who sold medicinal products at wholesale in accordance with national rules – e.g. the Italian pharmacist in the present case – yet did not obtain the requisite EU ‘special’ authorization due to inconsistencies between national law and EU law at the time.
The CJEU’s ruling offers two important clarifications for the EU pharmaceutical industry: first, rules for wholesale distribution of medicinal products are widely harmonized at EU level under the Medicinal Products Directive, whereas national rules for retail sale may vary from one Member State to another. Second, it cannot be presumed from the simple fact that a pharmacist satisfies the conditions laid down by national rules for retail sale of medicinal products that the pharmacist also complies with the requirements set out under EU law for the wholesale distribution of such products.
The EU Life Sciences Practice of Sidley Austin LLP For further information on the EU Life Sciences Practice, please contact: Maurits Lugard (+32.2.504.6417,
), Maarten Meulenbelt (+32.2.504.6467,
) or Prof. Vincenzo Salvatore (+32.2.504.6478,
).
Sidley Global Life Sciences Practice For further information on the Global Life Sciences Practice, please contact: Scott Bass (+1.202.736.8684/+1.212.839.5613,
) or James C. Stansel (+1.202.736.8092,
).
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