X.C.4. Creation and maintenance of the list

As defined in Article 23 of Regulation (EC) 726/2004 the Agency shall, in collaboration with the Member States, set up, maintain and make public a list of medicinal products that are subject to additional monitoring. This list will include the names and active substances of all medicinal products approved in the EU subject to additional monitoring irrespective of the approval procedure (i.e. centrally or nationally authorised). In addition, as defined in Article 106 of Directive 2001/83/EC, each Member State shall make publicly available on their national web-portal the list of medicinal product authorised in their territory that are subject to additional monitoring, and take all appropriated measures to encourage patients and health care professional to report any suspected adverse drug reactions.

X.C.4.1. Process for the creation of the list

The Agency in support of the European Commission will identify the centrally authorised products requiring additional monitoring. National competent authorities are responsible for identifying the nationally authorised products requiring additional monitoring.

Only medicinal products that fall under the mandatory scope according to Article 23(1) of Regulation (EC) 726/2004 will be automatically included in the list. For medicinal products that fall under the optional scope, consultation with the PRAC is required.

The Agency and the national competent authorities will maintain the information that is publicly available and ensure that it is up to date. While the Agency will have direct access to relevant data for centrally authorised products, for nationally authorised products, the Agency will rely on accurate and timely information provided by national competent authorities with regard to the inclusion or removal of medicinal products from the list and the provision of the electronic links to the national web-portals where the product information and the summary of the RMP are publicly available.

The Agency and the Members States will make the list available to the public.

X.C.4.2. Process for the maintenance of the list

The list will be updated monthly following each PRAC meeting, as appropriate.

X.C.4.2.1. Inclusion of medicinal products in the list

Mandatory scope

According to Article 23(1) of Regulation (EC) 726/2004 medicinal product that fall under the mandatory scope will be automatically included in the list on an ongoing basis In case of medicinal products approved through the mutual recognition or decentralised procedures, the Reference Member State (RMS) should inform the Agency once authorisation for such products has been granted. In addition, each national competent authority included in such procedures should inform the Agency, within 15 days of granting the marketing authorisation nationally, and provide the electronic links to their national web-portal where the product information and the summary of the RMP are publicly available. The Agency will include medicinal products in the list within the next update following receipt of the European Commission decision, in case of centrally authorised products, or following receipt of the national competent authorities’ notification.

Optional scope

According to Article 23(2) of Regulation (EC) No 726/2004 medicinal products that fall under the optional scope, consultation with the PRAC is required prior to inclusion in the list. In case of mutual recognition or decentralised procedures, the RMS should be the lead and consult the PRAC as soon as relevant conditions are considered necessary and before the finalisation of the procedure. In case of purely national procedures, the national competent authority should consult the PRAC as soon as relevant conditions are considered necessary and before the finalisation of the procedure. The Agency will include centrally authorised products in the list within 15 days of receipt of the European Commission decision. For non-centrally authorised products, once a procedure is finalised each national competent authority should inform the Agency within 15 days on those particular medicinal products that are to be included in the list and provide the electronic links to their national web-portal where the product information and the summary of the RMP are publicly available.