This case raises important issues concerning the powers of the European Medicines Agency (EMA) and the powers and obligations of a national authority (in this case the Medicines and Healthcare products Regulatory Agency (the MHRA)) when conducting inspections relating to the adequacy of the pharmacovigilance systems of the holder of a marketing authorisation and whether it has complied with its obligations relating to the reporting of suspected adverse reactions associated with the use of its products, particularly where an infringement procedure relating to such matters is pending. In this case the infringement procedure relates to an investigation under the Penalties Regulation (EC) No 658/2007 (the Penalties Regulation)1 being conducted by the EMA; seemingly the first of its kind.
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