Amendments to the pharmacovigilance legislation: new notification requirements for marketing-authorisation holders

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05/06/2013

Amendments to the pharmacovigilance legislation: new notification requirements for marketing-authorisation holders

Marketing-authorisation holders of human medicines will now have to declare the reasons that lead them to take any of the actions below to the European Medicines Agency (EMA), in accordance with the amendments to the 2010 pharmacovigilance legislation of the European Union (EU):

  • temporary or permanent marketing cessation or suspension of marketing of a medicine;
  • withdrawal of a medicine from the market;
  • a request to withdraw a marketing authorisation;
  • the intention not to apply for the renewal of a marketing authorisation.

These amendments were adopted in October 2012. The new provisions apply to centrally authorised medicines from today, 5 June 2013, and will apply to nationally authorised medicines from 28 October 2013.

The amendments stipulate that, in addition to the notification of these actions, marketing-authorisation holders have a clear obligation to declare the reasons for taking them, in particular when these are based on any of the following grounds:

  • the medicine is harmful;
  • the medicine lacks therapeutic efficacy;
  • the risk-benefit balance of the medicine is not favourable;
  • the qualitative and quantitative composition of the medicine are not as declared;
  • manufacturing or inspection issues have been identified.

Most of these notification requirements already apply for centrally authorised medicines as part of the Agency’s guidance and processes.

The amendments contribute to the strengthening of the protection of patient health by allowing the Agency to take appropriate decisions, including triggering referral procedures, when necessary.

For centrally authorised medicines, marketing-authorisation holders should continue to follow the processes described in the current guidance on marketing and cessation notification. They should also continue to notify the Agency immediately, via the nominated product team leader, of:

  • withdrawal of a medicine from the market for safety reasons;
  • the intention to request the withdrawal of a marketing authorisation;
  • the intention not to apply for the renewal of a marketing authorisation.

Withdrawals due to quality, manufacturing or inspection issues should still be notified via the contact point for quality defects and recalls.

For nationally authorised medicines, the amendments to the legislation mean that marketing-authorisation holders will need to notify the EMA, in addition to the Member State where the medicine is authorised, when any of these actions are taken on the basis of any of the grounds listed above.

These obligations will also apply when action based on these grounds is undertaken in a third country (a country outside the European Economic Area).

The EMA is working together with the Member States to define a common notification process for centrally and nationally authorised medicines. The EMA's guidance documents will be updated to describe these new requirements and processes by 28 October 2013.

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