X.C.3. Roles and responsibilities

Location:

X.C.

X.C.3.1. The European Commission

The European Commission decides, based on a recommendation from the PRAC:

if a particular centrally authorised medicinal product subject to conditions as set out in Article 23(2) of Regulation (EC) 726/2004 should be included in the list.

The Agency:

is responsible for publishing the list of medicinal products that are subject to additional monitoring on the European web-portal with an electronic link(s) to a webpage where the product information and the summary of the RMP are publicly available;
will coordinate the gathering of information that should be sent by the competent authorities within the EU network in order to set up, maintain and publish the list;
is responsible for removing medicinal products from the list after a pre-determined time period;
will take into account the list of centralised medicinal products subject to additional monitoring in determining the frequency and processes of its signal detection activities;
will inform the relevant MAH when a centralised medicinal product has been included to the list of additional monitored products;
will support the process of consultation of the PRAC on the inclusion of medicinal products on the list.

National competent authorities should:

inform the Agency which nationally authorised medicinal products are to be included in the list and provide the electronic links to the national webpage where the product information and the summary of the RMP are publicly available;
decide, based on a recommendation from the PRAC, if a particular nationally authorised medicinal product subject to conditions as set out in Article 23(2) of Regulation (EC) 726/2004 should be subject to additional monitoring and therefore included in the list;
make publicly available in their national web-portal the list of medicinal products authorised in their territory that are subject to additional monitoring. The list shall include an electronic link to a webpage where the product information and the summary of the RMP are publicly available;
inform the Agency of any update that needs to be made for nationally authorised medicinal products included in the list that is published by the Agency;
take into account the list of nationally authorised medicinal products subject to additional monitoring in determining the frequency and processes of their signal detection activities;
inform the relevant MAH when a nationally medicinal product has been included to the list of additional monitored products.

The PRAC:

recommends, upon request of the European Commission or a national competent authority, as appropriate, if a medicinal product which is subject to conditions as set out in Article 23(2) of Regulation (EC) 726/2004 should be included in the list.

The marketing authorisation holder:

shall include in the SmPC and Package leaflet of their medicinal products subject to additional monitoring the black triangle symbol and the and the standardised explanatory statement on additional monitoring;
should include information on the status of additional monitoring in any material to be distributed to healthcare professionals and patients and should make all efforts to encourage reporting of adverse reactions, as agreed with national competent authorities;
should provide evidence to the competent authorities concerned on the status of any conditions imposed by the national competent authorities or the European Commission;
should submit the relevant variation to include/remove the black symbol, the statement, and the standardised explanatory sentence from the SmPC and PL, where applicable.