Union Procedure on the Follow-up of Pharmacovigilance Inspections

On 30 April 2020 the EMA published this guideline effective 1 May 2020.

According to Article 19 of Regulation (EC) No 726/2004 and Article 111 of Directive 2001/83/EC, the competent authority of a Member State where medicinal products are authorised, in cooperation with the European Medicines Agency (hereinafter 'the Agency'), shall ensure that the legal requirements governing medicinal products are complied with by means of inspections. The competent authority may inspect the premises, records, documents and pharmacovigilance system master file (PSMF) of the marketing authorisation holder (MAH) or any firms employed by the MAH to perform the activities described in Title IX of Directive 2001/83/EC.

After every inspection, the competent authority is required to report on whether the MAH complies with the requirements laid down in Title IX of Directive 2001/83/EC and the content of those reports shall be communicated to the inspected entity. According to Article 111(8) of Directive 2001/83/EC, if the outcome of the pharmacovigilance inspection is that the MAH does not comply with the pharmacovigilance system as described in the PSMF and with Title IX of Directive 2001/83/EC, the competent authority of the Member State concerned shall bring the deficiencies to the attention of the MAH and give him the opportunity to submit comments, and shall also inform the other Member States, the Agency and the Commission. Any non-compliance identified should be rectified by the MAH in a timely manner through the implementation of a corrective and preventive action (CAPA) plan.

Some pharmacovigilance inspections will require significant follow-up and management due to the nature of the findings identified. Regulation (EC) No 658/2007 empowers the Commission to impose financial penalties on the holders of marketing authorisations for medicinal products granted in accordance with Regulation (EC) No 726/2004, and Article 111(8) of Directive 2001/83/EC states that, where appropriate, the Member State concerned shall take the necessary measures to ensure that a MAH is subject to effective, proportionate and dissuasive penalties. A variety of enforcement and infringement options exist within the Member States and are not further described in this guideline.

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