# C_2012258EN.01000501.xml

| 25.8.2012 | EN | Official Journal of the European Union | C 258/5 |
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25.8.2012

EN

Official Journal of the European Union

C 258/5

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Judgment of the Court (Second Chamber) of 28 June 2012 (reference for a preliminary ruling from the Tribunale di Palermo — Italy) — Criminal proceedings against Fabio Caronna

(Case C-7/11) (1)

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(Medicinal products for human use - Directive 2001/83/EC - Article 77 - Wholesale distribution of medicinal products - Mandatory special authorisation for pharmacists - Conditions for granting)

2012/C 258/07

Language of the case: Italian

Referring court

Referring court

Tribunale di Palermo

Party in the main proceedings

Party in the main proceedings

Fabio Caronna

Re:

Re:

Reference for a preliminary ruling — Tribunale di Palermo –Interpretation of recital 36 and Articles 76 to 84 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67) — Wholesale distribution of medicinal products — Conditions under which authorisation may be granted for the wholesale distribution of medicinal products — National legislation which makes the wholesale distribution of medicinal products by pharmacists and persons authorised or entitled to supply medicinal products to the public subject to the requirement to obtain an authorisation imposed on wholesale distributors — Whether permissible

Operative part of the judgment

Operative part of the judgment

| 1. | Article 77(2) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by Commission Directive 2009/120/EC of 14 September 2009, 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. |
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1.

Article 77(2) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by Commission Directive 2009/120/EC of 14 September 2009, 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.

| 2. | 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. |
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2.

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.

| 3. | That interpretation cannot, of 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 in medicinal products without the requisite authorisation. |
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3.

That interpretation cannot, of 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 in medicinal products without the requisite authorisation.

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(1)  OJ C 80, 12.3.2011.

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