Patel & Anor, R. v [2009] EWCA Crim 2311 (12 November 2009)

Patel & Anor, R. v [2009] EWCA Crim 2311 (12 November 2009)

The applicants' conduct did not constitute 'placing on the market' under paragraph 1 of Schedule 3 to the 1994 Regulations, as the products were not intended for sale to consumers within the EEA but for export outside the EEA. The convictions based on the judge's ruling were legally unsustainable.

Source-derived case information.

Citation
[2009] EWCA Crim 2311
Parties
Prosecution: Regina; Applicant: Hitendra Patel; Applicant: Shaan Hussain
Jurisdiction
England and Wales
Judgment Date
12 November 2009
Procedural Posture
Criminal Appeal / Appeal Against Conviction
Outcome
convictions set aside
Legal Topics
Marketing Authorisation, Medicinal Products, Interpretation of 'placing on the Market', Directive 2001/83/ec, Medicines for Human Use (marketing Authorisations Etc.) Regulations 1994
Criminal Law Pharmaceutical Regulation European Union Law Marketing Authorisation Medicinal Products Interpretation of 'placing on the Market' Directive 2001/83/ec Medicines for Human Use (marketing Authorisations Etc.) Regulations 1994

Source-derived case record

Summary, issues, holding and outcome

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Parties

Regina

Prosecution

Hitendra Patel

Applicant

Shaan Hussain

Applicant

Procedural Posture

Criminal Appeal / Appeal Against Conviction

Legal Issues

  1. 1 Whether the applicants' conduct amounted to 'placing on the market' under paragraph 1 of Schedule 3 to the 1994 Regulations
  2. 2 Proper interpretation of 'placing on the market' in the context of EC and UK pharmaceutical law
  3. 3 Whether convictions based on the judge's ruling were legally sustainable

Ratio Decidendi

The applicants' conduct did not constitute 'placing on the market' under paragraph 1 of Schedule 3 to the 1994 Regulations, as the products were not intended for sale to consumers within the EEA but for export outside the EEA. The convictions based on the judge's ruling were legally unsustainable.

Court Disposition

convictions set aside

Orders

  • permission to appeal granted
  • convictions of Hitendra Patel and Shaan Hussain set aside