Request for follow-up

The marketing authorisation holder (MAH) for a medicinal product is responsible for updating its product information in light of new knowledge or recommendations, and for implementing the amendments without receiving a reminder.

A request for follow-up is a formal request from the Swedish MPA to the MAH to provide something that is linked to the authorisation of a medicinal product. The MAH is obliged to submit an application for a variationof the authorisation in accordance with the applicable agreement, and to submit agreed studies or other information if this is stipulated as a conditional in the authorisation.

Failure to respond to a request for follow-up may result in the issuing of an order and eventually consequences in the form of a withdrawal of the medicinal product.

Updating of product information

The MAH is also responsible for regularly monitoring relevant sources of new information and recommendations. All the sources below are links to websites in English

CMDh press release

The Co-ordination group for Mutual recognition and Decentralised procedures (CMDh) meets once a month, and a week later publishes a press release summarising what has been discussed and decided.

 PRAC recommendations on safety signals

• Overviews of PRAC recommendations on safety signals are published monthly by EMA.
• A cumulative list of all safety signals discussed by PRAC since 2012 is also published on the EMA website.
• PRAC recommendations for updates of product information are translated into all official EU languages and published by EMA.
• MAH's have a legal obligation to ensure that their product information is kept up to date with the PRAC recommendations published on the EMA website, in line with Article 11 of Commission Implementing Regulation (EU) No 520/2012.

Arbitration cases (referrals) – various regulatory principles

• Ongoing and closed arbitration cases.
• The MAH's affected by a procedure are notified by the EMA.

Referrals – decisions and texts

Decisions on referrals can be found on the European Commission’s website.

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.

PSUSA procedure

PSUSA – centrally authorised products (CAP)

EMA communicates directly with all undertakings that were part of a PSUSA CAP. Generic undertakings themselves monitor the publication of results in the European Commission’s Community register.

For the CAP, implementation at product level is managed in connection with the CPLR for the relevant PSUSA.

There are therefore no separate PSUSA texts for the CAP on the EMA’s website. However, in order to see which PSUSAs have been implemented in the CAP, it is possible to search by product name and scroll down to ‘Assessment history’ under European public assessment reports (EPAR).

PSUSA – nationally authorised products

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

Some purely national PSUSA NAPs are also published on the Commission’s website.

Paediatric Worksharing – procedure