Two new GVP modules were published in December 2012, Module III – Pharmacovigilance Inspections and Module IV – Pharmacovigilance Audits, bringing the total of final modules to nine. It is expected that the remaining modules will be finalised and published in 2013.
The updated annex on GVP definitions was also published.
Module III- Pharmacovigilance Inspections – Member State competent authorities (CAs) must conduct pharmacovigilance (PV) inspections of marketing authorisation holders (MAH) and associated organisations to determine their compliance with EU PV obligations. The inspectors will be appointed by the national CA and they are empowered to inspect premises, records, documents and the Pharmacovigilance System Master File (PSMF) of the MAH or associated organisation. The inspectors will determine that the MAH has the personnel, systems and facilities to meet their PV obligations and to identify, record and address non-compliances that may pose a risk to public health. For non-centrally authorised products, the inspection should ensure that the legal requirements governing medicinal products are complied with. The inspections will consist of a risk based approach, and “for cause” inspections triggered by suspected non-compliance or potential risks. Sharing of information and communication between inspectors and assessors from PRAC and CHMP are key to ensuring the proper follow-up of inspections and actions to be taken. Where appropriate, the Member State concerned should ensure that a MAH is subject to effective, proportionate and dissuasive penalties for non-compliances.
Module IV – Pharmacovigilance Audits – this describes the legislative basis for the minimum requirements of the PV systems, quality system and the scope of risk-based audits for the Member State CAs, the EMA and the MAH. Guidance on planning and conducting legally required audits is provided. These align with internationally accepted auditing standards, supporting a risk-based approach to PV audits.
The two modules are available at: www.ema.europa.eu