Caronna (Medicinal products for human use) [2012] EUECJ C-7/11 (28 June 2012)

Caronna (Medicinal products for human use) [2012] EUECJ C-7/11 (28 June 2012)

Article 77(2) of Directive 2001/83/EC requires pharmacists who are authorised under domestic law to operate as wholesalers in medicinal products to obtain the relevant authorisation for wholesale distribution. Such pharmacists must also satisfy all requirements imposed on applicants and holders of wholesale distribution authorisation under Articles 79 to 82 of the Directive. However, this interpretation of EU law cannot, by itself and without national implementing legislation, give rise to or aggravate criminal liability for pharmacists lacking such authorisation.

Citation
[2012] EUECJ C-7/11
Parties
Defendant: Mr Caronna; Prosecutor: Tribunale di Palermo (Public Prosecutor's Office)
Jurisdiction
European Union
Judgment Date
28 June 2012
Procedural Posture
Preliminary Ruling (reference for Interpretation) / Judgment on Reference From National Court
Outcome
Preliminary ruling issued; interpretation of Directive provided to national court.
Legal Topics
Interpretation of Directive 2001/83/ec, Wholesale Distribution of Medicinal Products, Requirement for Authorisation, Criminal Liability for Unauthorised Distribution
European Union Law Criminal Law Pharmaceutical Law Interpretation of Directive 2001/83/ec Wholesale Distribution of Medicinal Products Requirement for Authorisation Criminal Liability for Unauthorised Distribution

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Parties

Mr Caronna

Defendant

Tribunale di Palermo (Public Prosecutor's Office)

Prosecutor

Procedural Posture

Preliminary Ruling (reference for Interpretation) / Judgment on Reference From National Court

Legal Issues

  1. 1 Whether Article 77(2) of Directive 2001/83/EC requires pharmacists to obtain authorisation for wholesale distribution of medicinal products
  2. 2 Whether pharmacists must satisfy all requirements for wholesale distribution authorisation under Articles 79 to 82 of the Directive
  3. 3 Whether EU law can independently give rise to or aggravate criminal liability for pharmacists lacking authorisation

Ratio Decidendi

Article 77(2) of Directive 2001/83/EC requires pharmacists who are authorised under domestic law to operate as wholesalers in medicinal products to obtain the relevant authorisation for wholesale distribution. Such pharmacists must also satisfy all requirements imposed on applicants and holders of wholesale distribution authorisation under Articles 79 to 82 of the Directive. However, this interpretation of EU law cannot, by itself and without national implementing legislation, give rise to or aggravate criminal liability for pharmacists lacking such authorisation.

Court Disposition

Preliminary ruling issued; interpretation of Directive provided to national court.

Orders

  • Article 77(2) of Directive 2001/83/EC requires pharmacists authorised under domestic law to operate as wholesalers to obtain wholesale distribution authorisation.
  • Such pharmacists must satisfy all requirements in Articles 79 to 82 of the Directive.