Subject matter and scope
1. This Regulation sets out the rules for the cooperation of Member States in:
(a)
the selection of safety assessing Member States in accordance with Article 3;
(b)
the assessment of information submitted on suspected unexpected serious adverse reactions and of information contained in annual safety reports in accordance with Articles 6 and 7;
(c)
the development of recommendations for the reporting Member States, referred to in Article 5 of Regulation (EU) No 536/2014, and the Member States concerned, aimed at addressing safety concerns emerging from the assessments referred to in point (b) and suggesting corrective measures and other actions for safety oversight related to the active substance;
(d)
the involvement of the safety assessing Member States in the assessment of substantial modifications to the reference safety information in accordance with Article 5(1), point (c), and Article 9(2), point (c);
(e)
the coordination between the reporting Member States and the Member States concerned in the implementation of recommended corrective measures and risk mitigating actions in accordance with Article 8;
(f)
the cooperation between safety assessing Member States, reporting Member States and Member States concerned in clinical trials using the same active substance, in accordance with Articles 5, 8 and 9.
2. This Regulation applies to all active substances that are used in investigational medicinal products in clinical trials authorised in at least two Member States, in accordance with Article 8 of Regulation (EU) No 536/2014, regardless of whether the clinical trial in question was authorised under that Regulation or initially under Directive 2001/20/EC ( 3 ) and subsequently under Regulation (EU) No 536/2014.
3. This Regulation does not apply to mono-national active substances, to active substances in investigational medicinal products used as reference products, including as a placebo, or to active substances used in auxiliary medicinal products.
Definitions
1. For the purposes of this Regulation, the definitions of ‘medicinal product’, ‘active substance’ and ‘adverse reaction’, set out in Article 1, points (2), (3a) and (11), of Directive 2001/83/EC, respectively, apply.
2. For the purposes of this Regulation, the following definitions also apply:
(a)
‘Multi-national clinical trial’ means a clinical trial for which the sponsor submitted an application dossier to more than one Member State through the EU portal.
(b)
‘Reference safety information’ means the safety information contained in the latest approved version of the clinical trial dossier, which serves as the basis to determine the expectedness of an adverse reaction by the sponsor.
(c)
‘Safety assessing Member State’ means the Member State that assesses the information submitted as suspected unexpected serious adverse reactions in accordance with Article 42 of Regulation (EU) No 536/2014, and the information contained in annual safety reports submitted in accordance with Article 43 of that Regulation, for clinical trials involving investigational medicinal products that contain the same active substance, regardless of the pharmaceutical form and strength or indication investigated and regardless of whether they are used in one or several clinical trials managed by the same or different sponsors.
(d)
‘Lead safety assessing Member State’ means the safety assessing Member State, which coordinates the safety assessments for different active substances in a clinical trial or for several clinical trials, performed by several safety assessing Member States.
(e)
‘New active substance for safety cooperation’ means an active substance, which has not been previously used in an investigational medicinal product in any clinical trial authorised in the Union under Regulation (EU) No 536/2014, and therefore does not have an assigned safety assessing Member State.
(f)
‘Safety concern in relation to an investigational medicinal product’ means information on the safety of the investigational medicinal product with potential negative impact on its benefit-risk ratio or with a public health implication.
(g)
‘Mono-national active substance’ means an active substance, which is used in an investigational medicinal product in clinical trial(s) authorised in only one Member State.
(h)
‘Multi-national active substance’ means an active substance, which is used in an investigational medicinal product in clinical trial(s) authorised in more than one Member State.
(i)
‘Screening of suspected unexpected serious adverse reactions’ means the systematic identification of suspected unexpected serious adverse reactions that require an assessment leading to a decision on the need to notify the reporting Member States and Member States concerned.
