Pharmacovigilance

Pharmacovigilance covers all activities relating to the detection, assessment, understanding and prevention of adverse effects of medicinal products after they have been placed on the market. It is governed by Title IX of Directive 2001/83/EC and, for medicinal products authorised under the centralised procedure, by Regulation (EC) No 726/2004, both substantially overhauled by the 2010 EU reform. Under French law, the Public Health Code entrusts its coordination to the ANSM, supported by a network of regional pharmacovigilance centres.

Obligations of the marketing authorisation holder

The holder of the marketing authorisation must operate a pharmacovigilance system described in a master file kept available to the authorities, and must have a qualified person responsible for pharmacovigilance who resides and operates in the Union. The holder collects and records suspected adverse reactions, reports them to the EudraVigilance database within time limits that depend on their seriousness, submits periodic safety update reports and monitors the scientific literature. It must inform the authorities without delay of any new information that may alter the assessment of the benefit-risk balance.

Signal assessment and public health measures

At Union level, the Pharmacovigilance Risk Assessment Committee, attached to the European Medicines Agency, analyses signals and issues recommendations. These may lead to an amendment of the summary of product characteristics and of the package leaflet, to the imposition of post-authorisation safety studies, or to the suspension or withdrawal of the authorisation. Certain medicinal products are subject to additional monitoring, indicated by an inverted black triangle in the package leaflet. European referral procedures allow a safety issue to be settled uniformly across the Union.

Litigation and competition implications

Pharmacovigilance data feed into claims based on product liability for health products, in which the holder’s knowledge of a signal and the speed of its response come under close scrutiny. Post-marketing data may reveal the value of a particular dosage regimen or patient population, which may be protected as a second medical use, and the dissemination of unfounded safety alerts targeting a competitor may amount to disparagement of generics. Finally, breaches of pharmacovigilance obligations expose the holder to financial penalties imposed by the national authority.

Key points

Pharmacovigilance obligations weigh on the holder throughout the life of the medicinal product, well beyond the grant of the authorisation. Breaches carry a regulatory cost, in the form of penalties or suspension measures, and a judicial one, since the data collected serve as evidence. On any acquisition of a product or a licence, it should be checked that a pharmacovigilance agreement allocates the obligations between the parties and that the pharmacovigilance system master file is compliant.

---

This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

Pharmaceutical patents and medicines regulation · Pharma case law · Tell us about your situation