PHARMACOVIGILANCE PROCEDURES OUTCOME

Referral procedures Art. 31 and 107i

Referral decisions and new product information changes can be found on:

  • the European Commission website - (EU languages only) this includes (Union) referral procedures (in accordance with articles 29(4); 30; 31(1); 31(2) or 107i of Directive 2001/83.
  • EMA website – (EU and EEA languages) all procedures, including CMDh positions on PRAC (Union) referrals for solely nationally authorised products (including MRP/DCP products) for which there is consensus within the CMDh

All European Commission decisions from the last 6 months can be find at EC website,

More information on referrals can be found at EMA website

Periodic safety update reports (PSURs)

More information on PSURs can be found at EMA website

PSUSA procedures (PSUR single assessment)

Changes to product information following the outcome of PSUSA procedures (PSUR single assessment) can be found on:

  • for centrally authorised products (CAPs) - a Decision will be published per product for the CAPs and the Decisions are identified by the word PSUSA in the procedure number. The European Commission’s website. 
  • for mix of centrally authorised products and nationally authorised products (NAPs, including MRP/DCP products) - PSUSAs are listed under both “Procedures for centrally authorised medicinal products” and “Procedures for nationally authorised medicinal products”. A Decision will be published per product for the CAPs; a single Commission Decision will be published per active substance for the NAPs. The Decisions are identified by the word PSUSA in the procedure number.
  • for NAPs only (including MRP/DCP products) for which there is no CMDh consensus - PSUSA are listed under  “Procedures for nationally authorised medicinal products”.
  • for NAPs only (including MRP/DCP products) for which there is consensus within the CMDh - EMA website. Published results from PSUSA NAP (MRP + NP) can be searched by substance name and category or procedure number on the EMA’s website as follows: Categories – Human Medicine – Periodic safety update report single assessments. EMA publishes the lists of nationally authorised medicines involved in PSUR single assessments for active substances contained only in nationally authorised medicines, together with the outcomes of assessments that lead to a variation of marketing authorisations EMA Website.

Other considerations (e.g. extrapolation) resulting from PSUSA procedures are published in CMDh Press Release or CMDh minutes

PSUR Follow up procedures (PSUFU + variations)

Outcome and changes to product information for PSUR Follow-up procedures (PSUFU + variations) can be found on:

  • Assessment Reports of PSUR Follow-up procedures are listed in alphabetical order according to substance at CMDh website

    More information on PSUR follow-up can be found at CMDh website

Outcome of informal PSUR work-sharing procedures

PSUR Summaries of Assessment Reports after PSUR Work sharing

  • CMDh lists in alphabetical order according to substance, summaries of evaluation reports. The list is updated once a PSUR procedure has been concluded.
    CMDh - PSUR Work sharing procedure

Safety signals

Post-authorisation safety studies (PASS)

Changes to product information following the outcome of imposed non-interventional post-authorisation safety studies (PASS) can be found on:
 

  • for centrally authorised products (CAPs) - the outcomes of imposed non-interventional PASS final study results assessments are published as part of each medicine's European public assessment report (EPAR) and the Decision will be published per product for the CAPs at EC website 
    The Decisions are identified by the word PSR in the procedure number.
     
  • for mix of centrally authorised products and nationally authorised products (NAPs, including MRP/DCP products) –PASS  are listed under “Procedures for centrally authorised medicinal products” as well as “Procedures for nationally authorised medicinal products”
    A Decision will be published per product for the CAPs; a single Commission Decision will be published per active substance for the NAPs. The Decisions are identified by the word PSR in the procedure number
     
  • for NAPs only (including MRP/DCP products) for which there is no CMDh consensus – the outcomes of imposed non-interventional PASS final study results assessments are published at "Procedures for nationally authorised medicinal products"
  • for NAPs only (including MRP/DCP products) for which there is consensus within CMDh – the outcomes of imposed non-interventional PASS final study results assessments are published at EMA website

More information on PASS can be found at EMA website

Outcome of PRAC advice

At the request of a Member State the PRAC may issue an advice concerning risk management plans/systems, renewals or safety type II variations that can affect the product information

PhVWP recommendations

The CHMP Pharmacovigilance Working Party (PhVWP) was responsible for evaluating and monitoring safety issues for human medicines until 2012; it was then replaced by the Pharmacovigilance Risk Assessment Committee (PRAC) with the entry into force of Directive 2010/84/EU.