IX.C.7. Recommendations on signals from the PRAC

Location:
IX.C.

PRAC recommendations are adopted after prioritisation and after each plenary discussion during the assessment of the signal. The recommendations may include any or a combination of the following conclusions:

  • the marketing authorisation holder should provide additional data for assessment within a signal procedure;
  • the marketing authorisation holder should provide a review of additional data on the signal in the following PSUR or submit an ad-hoc PSUR (see GVP Module VII);
  • the marketing authorisation holder should update the product information through an application for a variation to the terms of the marketing authorisation;
  • the marketing authorisation holder should be requested to submit an RMP or to update the RMP (see GVP Module V);
  • the marketing authorisation holder should implement additional risk minimisation measures such as educational materials (see GVP Module XVI) or the dissemination of a Direct Healthcare Professional Communication (DHPC) (see GVP Module XV);
  • the marketing authorisation holder should sponsor a post-authorisation study according to an agreed protocol and submit the final results of that study (see GVP Module VIII);
  • the Member States or the European Commission should consider a referral procedure in accordance with Articles 31 or 107i of Directive 2001/83/EC, or Article 20 of Regulation (EC) No 726/2004, as appropriate (22);
  • the Agency or Member States should collect further information (e.g. via the pharmacovigilance non-urgent information system of the EU regulatory network) or perform additional analyses;
  • other EMA scientific committees or EMA expert groups should be consulted;
  • an inspection should take place in order to verify that the marketing authorisation holder for the medicinal product satisfies the pharmacovigilance requirements laid down in Titles IX and XI of Directive 2001/83/EC;
  • any other appropriate action that is not listed above;
  • no action is required at this point in time, other than routine pharmacovigilance.

PRAC recommendations to provide additional data are communicated directly to concerned marketing authorisation holders by the Agency. PRAC recommendations for regulatory action such as variation are submitted to the Committee for Medicinal Products for Human Use (CHMP) for endorsement when centrally authorised medicinal products are involved, and to the Co-ordination Group for Mutual Recognition and Decentralised procedures – Human (CMDh) for information in the case of nationally authorised medicinal products. The national competent authorities of Member States should take the appropriate measures at national level subsequently.

PRAC recommendations on signals are published on the Agency’s website (see IX.C.9.).