Patel & Anor, R. v

Patel & Anor, R. v

The applicants' conduct did not amount to 'placing on the market' within the meaning of paragraph 1 of Schedule 3 to the 1994 Regulations because the transactions were not intended to, nor did they, release the medicinal products into a distribution system leading to sale to end users within the EEA. The market referenced in the Regulations is one in which consumers within the EEA can purchase the product. Therefore, the convictions were unsustainable in law and must be set aside.

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
Medicinal Products Regulation, Interpretation of 'placing on the Market', Marketing Authorisation, Community Law Implementation
Criminal Law Regulatory Law European Union Law Medicinal Products Regulation Interpretation of 'placing on the Market' Marketing Authorisation Community Law Implementation

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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 Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994
  2. 2 Whether the convictions were sustainable in law based on the facts and the proper construction of the Regulations

Ratio Decidendi

The applicants' conduct did not amount to 'placing on the market' within the meaning of paragraph 1 of Schedule 3 to the 1994 Regulations because the transactions were not intended to, nor did they, release the medicinal products into a distribution system leading to sale to end users within the EEA. The market referenced in the Regulations is one in which consumers within the EEA can purchase the product. Therefore, the convictions were unsustainable in law and must be set aside.

Court Disposition

Convictions set aside

Orders

  • Permission to appeal granted
  • Convictions of both applicants set aside