Pharmacovigilance Amendments

Directive 2012/26/EU is a short, targeted follow-up to the 2010 pharmacovigilance package. It closes a gap exposed by the benfluorex (Mediator) scandal in France: a company could quietly withdraw or stop marketing a medicine for safety reasons without automatically triggering an EU-wide safety assessment.

Before this directive, voluntary action by a marketing-authorisation holder could leave a safety concern unexamined in other Member States where the same product was sold. Recital 1 points directly to "recent pharmacovigilance incidents" as the reason for an automatic Union-level procedure.

The holder must now notify the Member States and the EMA of the reasons for suspending marketing, withdrawing a product, requesting revocation, or not renewing an authorisation, and must declare whether the action rests on safety grounds, even when the action is taken in a third country (Article 123). The EMA forwards these notifications to all Member States and publishes an annual list of refused, revoked, suspended or withdrawn medicines with the reasons.

The urgent Union procedure now triggers automatically on safety grounds when a suspension, revocation, non-renewal or supply ban is considered, or when a new contraindication, a dose reduction or an indication restriction is needed (Article 107i). The PRAC always issues the recommendation when action is based on pharmacovigilance data; Member States and the Commission can take immediate interim measures pending the Union decision.

The directive clarifies the line between the Normal Procedure (Article 31, for Union-interest quality, safety or efficacy referrals) and the Urgent Union Procedure (Articles 107i to 107k, for pharmacovigilance-data-driven urgency), so the right machinery starts in the right case.

• EUR-Lex: Directive 2012/26/EU (CELEX 32012L0026)
• EMA: Pharmacovigilance Risk Assessment Committee (PRAC)
• EUR-Lex: National transposition measures

Part of the EU pharmaceutical law family in the Brubru Canon.