Currently the Medicines and Healthcare Products Regulatory Agency (MHRA) has a responsibility to inspect marketing authorization holders (MAH) to ensure that they comply with the pharmacovigilance obligations established within the European Union (EU).
Currently the Medicines and Healthcare Products Regulatory Agency (MHRA) has a responsibility to inspect marketing authorization holders (MAH) to ensure that they comply with the pharmacovigilance obligations established within the European Union (EU). Any United Kingdom (UK) MAH or marketing authorization applicant (for any type of authorization procedure) may be subject to an MHRA GPvP inspection, which may also include any of their partners or service providers.
This Whitepaper will discuss the Preparing for a Good Pharmacovigilance Practice MHRA Inspection.