Chapter II, Article 6 · Commission Implementing Regulation (EU) 2022/20

Contents

Article 6Screening and assessment of suspected unexpected serious adverse reactions#

1.The screening of the EudraVigilance database referred to in Article 5(1), point (a), shall take place at least once every 15 calendar days.

2.For investigational medicinal products with a marketing authorisation in the Union, the safety assessing Member State may decide to decrease the screening frequency referred to in paragraph 1 to at least once every 30 calendar days.

3.When the state of knowledge about the safety profile of the active substance or the degree of deviation in the use of the active substance from normal clinical practice so requires, the safety assessing Member State shall apply a higher screening frequency than that set out in paragraphs 1 and 2. The safety assessing Member State shall record the outcome and the date of the screening in the information systems referred to in Article 11.

4.In case concerns regarding the safety of the active substance arise from the screening of reported suspected unexpected serious adverse reactions, the safety assessing Member State shall:

(a)assess the information about the suspected unexpected serious adverse reactions and submit an initial assessment as soon as possible but no later than 15 days after the screening;

(b)update the initial assessment as soon as possible after additional information from the sponsor has become available in accordance with Article 42(2) of Regulation (EU) No 536/2014 or in accordance with Article 5(1), point (d), of this Regulation;

(c)notify without undue delay the identified safety concerns in relation to an investigational medicinal product to all reporting Member States and Member States concerned by clinical trials involving the active substance in question.

The submission and sharing of the assessment referred to in points (a) and (b) and the notification referred to in point (c) shall be done through the information systems referred to in Article 11.

5.The safety assessing Member State shall increase the extent and shorten the timelines of the assessment referred to in paragraph 4 if the risk to safety of participants in a clinical trial so requires.

6.If additional information is requested pursuant to Article 5(1), point (d), in the context of the assessment of suspected unexpected serious adverse reactions, and the sponsor does not acknowledge receipt of the request for information by (i) the deadline set by the safety assessing Member State or (ii) 7 days after the request was sent, whichever is the later, the safety assessing Member State shall notify all reporting Member States and Member States concerned by a clinical trial using the active substance to consider taking corrective measures in accordance with Article 77 of Regulation (EU) No 536/2014.

7.Where the safety assessing Member State considers it necessary, based on its assessment(s), it shall submit general recommendations related to the safety of the active substance to the reporting Member States and the Member States concerned enabling them to take corrective measures and other actions for safety oversight related to the active substance.