Amendments to the EU’s pharmacovigilance (PV) legislation, most of which entered into force in July this year, have recently been adopted in the form of a Directive[1] and a Regulation[2]. The amended rules impose new significant notification requirements on marketing authorisation (MA) holders and include a broader application of the Urgent Union Procedure.

The new rules, adopted on October 25, require MA holders to notify and present reasons to the European Medicines Agency (EMA) and competent national authorities when a product ceases to be placed on the market of a Member State, either temporarily or permanently. These requirements also apply to “any action” taken by the MA holder to (i) suspend marketing of a medicinal product, (ii) request withdrawal of a MA, or (iii) not apply for renewal of a MA. The obligation to notify also applies to certain actions taken in third countries.

The Urgent Union Procedure (involving an EU-wide safety evaluation and possible withdrawal) will apply automatically when a Member State, based on concerns arising from its review of PV data:

  • considers suspending or revoking a MA, refusing its renewal or banning the supply of a medicinal product; or 
  • is informed by the MA holder that, on the basis of safety concerns, the holder has interrupted the placing on the market of a medicinal product or has taken action to have a MA withdrawn, or that the holder intends to do so. 

 Under the current rules, the Urgent Union Procedure is only triggered “when urgent action is considered necessary.”

The Directive must be implemented into national law by October 28, 2013. The Regulation will apply directly in all EU Member States from June 5, 2013, without a need for national implementation.

To facilitate the implementation of the new PV rules and discuss the lessons learned since the legislation entered into force, the EMA has hosted several stakeholder meetings. These include the EMA’s 6th Forum on Pharmacovigilance and the EMA Implementation Working Group (IWG) with EU Pharmaceutical Industry Associations on the implementation of Article 57(2).

We recommend that stakeholders review immediately the amending Directive and Regulation and assess their implications.