Section VI.C of this Module highlights the EU specific requirements, as defined in Directive 2001/83/EC [DIR] and Regulation (EC) No 726/2004 [REG] in relation to the collection, management and submission of reports of suspected adverse reactions (serious and non-serious) associated with medicinal products for human use authorised in the EU, irrespective of the products conditions of use within or outside the terms of the marketing authorisation in the EU. These requirements are applicable to competent authorities in Member States and/or to marketing authorisation holders in the EU.

The definitions and general principles detailed in Sections VI.A. and VI.B. should be applied in conjunction with the guidance provided in this Section. The requirements provided in Chapters IV, V and IX of the Commission Implementing Regulation (EU) No 520/2012 [IR] on the use of terminology, formats and standards, on the submission of reports of suspected adverse reactions, and on the processing of personal data shall also be followed.

In accordance with Article 107 of Directive 2001/83/EC, marketing authorisation holders have to submit in addition to information on adverse reactions that occur in the EU, information on serious suspected adverse reactions that occur in third countries. Given that a medicinal product is authorised with a defined composition, all the adverse reactions suspected to be related to any of the active substances being part of a medicinal product authorised in the EU should be managed in accordance with the requirements presented in this Module. This is valid irrespective of the strengths, pharmaceutical forms, routes of administration, presentations, authorised indications, or names of the medicinal product (see VI.C.2.2. for detailed requirements applicable to marketing authorisation holders). For the definition of the name and strength of a medicinal product, refer to Article 1(20) and 1(22) of Directive 2001/83/EC.

  • The guidance provided in this Module also applies to homeopathic and herbal medicinal products with the exception of homeopathic medicinal products authorised under the special simplified registration procedure detailed in Article 14 (1) of Directive 2001/83/EC [DIR Art 16 (3) and Art 16g], and to
  • medicinal products supplied in the context of compassionate use as defined in Article 83(2) of Regulation (EC) No 726/2004, subject to and without prejudice to the applicable national laws of EU Member States. As the case may be, this guidance may also apply to named patient use as defined under Article 5(1) of Directive 2001/83/EC (see VI.C.1.2.2. for ICSRs management in compassionate use and named patient use).

For devices containing active substances, the procedure to be followed for the submission of individual reports of suspected adverse reactions and/or incidents varies depending if these devices have been authorised in the EU as an integral part of medicinal products (products covered by the second paragraph of Article 1(3) of Directive 93/42/EEC) or CE marked as medical devices. With regard to this, devices authorised as an integral part of medicinal products follow the pharmacovigilance requirements provided in Directive 2001/83/EC and Regulation (EC) No 726/2004, whereas devices CE marked as medical devices follow the requirements for medical device vigilance given in Directive 90/385/EEC and Directive 93/42/EEC. As detailed in the Guidelines on a Medical Devices Vigilance System16, a medical device incorporating a medicinal product or substance, where the action of the medicinal product or substance is ancillary to that of the device, follows the legal requirements of Directive 90/385/EEC and Directive 93/42/EEC.