Implementation of agreed wording product information

European agreements on modifying product information for medicinal products are made regularly. The MEB strives to harmonise product information across all medicinal products with the same active substance.

The responsibility for up-to-date product information lies with the marketing authorisation holder (see article 23.3 of Directive 2001/83/EC). The implementation of these European agreements by marketing authorisation holders occurs via variation procedures that must be submitted by the marketing authorisation holders.

There are various reasons for submitting such variations, including:

  • Referral procedures
  • PSUSA (Single Assessment for a PSUR per active substance by the Member States) assessments (and, temporarily, PSUR Worksharing procedures)
  • PRAC recommendations based on monitoring
  • Paediatric worksharing procedures (articles 45 or 46)

Actions after completion of a European procedure or a national MEB decision

If the decision is made to suspend or withdraw marketing authorisation, the MEB informs the marketing authorisation holders.

In all other cases, the marketing authorisation holder is responsible for up-to-date product information. A variation can be submitted if changes in the product information are required. More information is available in the Procedural Guidance: Variation Procedure on the HMA website.

For a number of procedures (referrals, PSUSAs, PRAC signals), a timetable is published on the CMDh/PRAC/European Commission website. The company submits this variation in accordance with the European timetable (see also: CMDh Recommendation for implementation of Commission Decisions or CMDh agreements following Union referral procedures where the marketing authorisation is maintained or varied).

For medicinal products with an approved text, the MEB will eventually check whether the text has been implemented. If this is not the case, the company will be asked in writing to implement the agreed wording.

Publication of EU agreed wording

European Commission website

The following Commission Decisions are published on the European Commission website:

  • The outcomes of referrals: this includes (Union) referral procedures (in accordance with articles 29(4); 30; 31(1); 31(2) or 107i of Directive 2001/83). Outcomes of referrals for only nationally authorised products (including MRP/DCP products) for which there is consensus within the CMDh, are published on the EMA website.
  • The outcomes of PSUSA procedures (single assessment of a PSUR per active substance by the member states) using only centrally authorised products (CAPs) or a mix of centrally authorised products and nationally authorised products for which there is no CMDh consensus (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. Outcomes of PSUSAs using only NAPs for which there is consensus within the CMDh are published on the EMA website.

EMA website

Various PRAC/CMDh recommendations/positions for PSUSAs/monitoring signals and referrals may be found on the EMA website, such as:

  • The outcomes of referrals: these are CMDh positions on PRAC (Union) referrals for solely nationally authorised products (including MRP/DCP products) for which there is consensus within the CMDh.
  • CMDh positions on PSUSA procedures for nationally authorised products (including MRP/DCP products) for which there is consensus within the CMDh. These are products for which there has been a change to the marketing authorisation (modification of the product information and/or suspension or withdrawal of the marketing authorisation). The variations for the product information include translations. This overview also lists procedures that do not require a change to the marketing authorisation as a result of the PSUR assessment.
  • PRAC recommendations based on monitoring (including translations).

CMDh website

The outcomes of article 45 and 46 paediatric worksharing procedures.

Note: The PSUR worksharing procedure no longer applies, and the final ongoing procedures were completed in August 2015. For a PSUR submission made after 10 January 2013, please refer to the summary assessment report on the CMDh website. The implementation of these PSUR worksharing procedures must be submitted no later than 90 days after publication of the summary assessment report on the (see CMDh Best Practice Guide for Transitional Arrangements for PSUR Worksharing).

Dutch translations of CMDh agreed wording

In the context of European harmonisation, the CMDh in some cases agrees on a single SmPC and/or package leaflet wording for a specific group of medicinal products. To facilitate a harmonised implementation of this wording, the MEB publishes the Dutch translation of some of these texts.

Overview of agreed wording

The MEB published an overview of agreed wording for the product information per active substance for most of the agreed wording (in Europe) between 2008 and May 2015. This overview has not been kept updated since May 2015.

The agreed wording is now only published on European websites. MEB decisions about changes to the text are usually approved in a European context. If the product information only needs to be adjusted in The Netherlands, this is published via a separate news item on the MEB website.