X.C.1. Criteria for including a medicinal product in the additional monitoring list

Location:
X.C.

X.C.1.1. Mandatory scope

According to Article 23(1) of Regulation (EC) No 726/2004 (REG), it is mandatory to include the following categories of medicinal products in the list:

  • medicinal products authorised in the EU that contain a new active substance which, on 1 January 2011, was not contained in any medicinal product authorised in the EU;
  • any biological medicinal product not covered by the previous category and authorised after 1 January 2011;
  • products for which a PASS was requested at the time of marketing authorisation (point (cb) of Article 9(4) of Regulation (EC) No 726/2004 and point( b) of Article 21a of Directive 2001/83/EC);
  • products authorised with specific obligations on the recording or suspected adverse drug reactions exceeding those referred to in Chapter 3 of Directive 83/2001/EC (point (cb) of Article 9(4) of Regulation (EC) No 726/2004 and point (c) of Article 21a of Directive 2001/83/EC);
  • products for which a PASS was requested following the grant of marketing authorisation (Article 10a(1) of Regulation (EC) No 726/2004 and point (a) of Article 22a (1) of Directive 2001/83/EC);
  • products which were granted a conditional marketing authorisation (Article 14(7) of Regulation (EC) No 726/2004));
  • products authorised under exceptional circumstances (Article 14(8) of Regulation (EC) No 726/2004) and Article 22 of Directive 2001/83/EC)).

X.C.1.2. Optional scope

As set out in Article 23(2) of Regulation (EC) No 726/2004 there is the possibility to include in the list medicinal products subject to conditions, not falling under the mandatory scope. This can be done at the request of the European Commission or a national competent authority, as appropriate, following consultation with the Pharmacovigilance Risk Assessment Committee (PRAC).

As reflected in Article 23(2) of Regulation (EC) No 726/2004 the situations that could form the basis for a request for inclusion in the list are:

  • When a marketing authorisation is granted subject to one or more of the following:
    • conditions or restrictions with regard to the safe and effective use of the medicinal product [REG Art 9(4)(c), DIR Art 21a(d)];
    • measures for ensuring the safe use of the medicinal product to be included in the risk management system [REG Art 9(4)(ca), DIR Art 21a(a)];
    • an obligation to conduct a post-authorisation efficacy study [REG Art 9(4)(cc)DIR Art 21a(f)];
    • the existence of an adequate pharmacovigilance system [DIR Art 21a(e)].

The scope of Article 23(2) of Regulation (EC) No 726/2004 does not only include medicinal products which are authorised or for which conditions are established after entry into force of the new pharmacovigilance legislation but also medicinal products which were authorised or made subject to conditions before such date, provided they fall within one or more of the above situations for the optional scope.

Pharmacovigilance rules in general and additional monitoring specifically take into account that the full safety profile of medicinal products can only be confirmed after products have been placed on the market. Due consideration should, therefore, be given to the merit of inclusion of a medicinal product in the list in terms of increasing awareness about the safe and effective use of a medicinal product and/or providing any additional information for the evaluation of the product. In this regard, the decision to include a medicinal product subject to conditions in the list should take account of the nature and scope of the conditions or obligations placed on the marketing authorisation including their potential public health impact. The decision should also consider the usefulness of the additional monitoring status in relation to other additional pharmacovigilance activities proposed in the risk management plan, for example in relation to the objectives of PASS.