Chapter II, Article 5 · Commission Implementing Regulation (EU) 2022/20

Contents

Article 5Role and tasks of the safety assessing Member State#

1.The safety assessing Member State shall have the following tasks as regards the assigned active substance contained in investigational medicinal products that are used in clinical trials authorised in the Union:

(a)to screen and assess information about all suspected unexpected serious adverse reactions reported in the EudraVigilance database in accordance with Article 42 of Regulation (EU) No 536/2014, regardless of whether they occurred in Member States or in third countries, as well as information contained in annual safety reports, in accordance with Articles 6 and 7 following a risk based approach;

(b)to identify safety concerns in relation to the active substance and the investigational medicinal product, based on the assessments referred to in point (a);

(c)to support, upon request of the reporting Member State, the assessment of aspects related to the reference safety information in the initial application referred to in Articles 5 and 11 of Regulation (EU) No 536/2014 or in an application for substantial modification referred to in Article 16 of that Regulation;

(d)to request missing or further information from sponsors, which is necessary for the assessments or for the cooperation in the safety assessment;

(e)to submit assessment reports and other records related to the safety assessment in accordance with Articles 6, 7 and 11 in order to ensure that all reporting Member States and Member States concerned receive appropriate information on clinical trials using the same active substance;

(f)to prepare and submit recommendations to the reporting Member States and Member States concerned related to the safety of the active substance, so that corrective measures and other actions for safety oversight related to the active substance can be taken if necessary, in accordance with Article 8;

(g)to provide assistance on any additional safety matter related to the particular active substance when requested by the reporting Member States or the Member States concerned.

2.The safety assessing Member State shall carry out its tasks until three months after the end of the last clinical trial with the active substance in all Member States concerned. It shall submit the final assessment report of the last annual safety report for the active substance without undue delay.

3.The responsible ethics committees shall be involved in the safety assessments performed by the safety assessing Member State, when such involvement is provided for in the national law of the safety assessing Member State.

Defined terms · 9

Show every defined term

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.
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.
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.
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.
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.
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.
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.
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.
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.