*R (on the application of Roche Registration Ltd) v Secretary of State for Health

Medicine – Product licence. The claimant issued judicial review proceedings on the basis that, when conducting a re-inspection, the Medicines and Health Care Products Regulatory Agency (the MHRA) was knowingly gathering evidence in the context and for the purpose of infringement proceedings which had been brought against it under Commission Regulation (EC) 658/2007. The Administrative Court, in dismissing the application, held that it could not declare that the MHRA's response to the European Medicines Agency's requests under art 8(3) of the Regulation had been unlawful or rule substantially rule on the contention that the material provided contained errors. Further, the MHRA's conduct had not been procedurally improper and unlawful in failing to advise the claimant of the potential use of the information.

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