QPPV.COM KNOWLEDGE ASSESSMENT

EU Referral Mechanisms: Articles 20, 31, 107i and 30

Test your understanding of the concepts covered by EMA Referral Types Explained: Article 20, Article 31, Article 107i and Article 30.

Question 1 of 10Pass mark: 80%

Question 1 of 10 What is the main purpose of a question-to-evidence matrix during a referral response?

To replace the formal referral notification To organise evidence and responsibilities around the specific questions posed by the committee To demonstrate that the company has submitted the largest possible dossier To determine which committee has legal authority to initiate the procedure

Question 2 of 10 Under Article 31 pharmacovigilance, which combination correctly identifies potential initiators described in the article?

Only PRAC and CHMP A Member State, the European Commission or a marketing authorisation holder Only the CMDh and national courts Only healthcare professionals and patients

Question 3 of 10 What distinguishes Article 107i from an ordinary Article 31 pharmacovigilance referral?

Article 107i applies only to centrally authorised products Article 107i is selected whenever a safety issue is clinically serious Article 107i is linked to specified statutory circumstances in which urgent regulatory action is being considered Article 107i is assessed by CHMP without a PRAC recommendation

Question 4 of 10 Which shorthand pairing is most accurate as a first orientation tool?

Article 20: urgent action; Article 107i: harmonisation Article 31: CAP-only pharmacovigilance; Article 30: urgent Union safety action Article 20: CAP pharmacovigilance; Article 31: Union-interest pharmacovigilance; Article 107i: urgent action; Article 30: harmonisation Article 20: national divergence; Article 31: quality only; Article 30: routine signal management

Question 5 of 10 What is the most appropriate interpretation of a Member State suspension taken pending a Union referral outcome?

It is necessarily the final Union regulatory decision It is an interim protective measure that should not be confused with completion of the Union assessment It converts the procedure automatically into Article 30 It prevents the European Commission from initiating a procedure

Question 6 of 10 What is the committee sequence for an Article 20 pharmacovigilance procedure?

CHMP assessment followed by PRAC opinion CMDh assessment followed by CHMP position PRAC assessment and recommendation followed by a CHMP opinion European Commission assessment followed by CMDh recommendation

Question 7 of 10 Which situation most clearly supports consideration of an Article 30 referral rather than a pharmacovigilance referral?

A new signal is identified for a CAP-only product Different Member States have materially different indications and contraindications for the same nationally authorised medicine A Member State is considering suspension based on urgent safety information A therapeutic class is being monitored through routine signal management

Question 8 of 10 What is the principal regulatory problem addressed by Article 30?

An urgent pharmacovigilance concern requiring immediate Union action A safety concern limited to centrally authorised medicines Divergent national marketing authorisations requiring harmonisation A request by an MAH to change its risk-management plan

Question 9 of 10 For an Article 30 referral involving divergent national product information, what type of material should the MAH or applicant be prepared to provide?

Only an updated aggregate-reporting procedure A map of divergent national positions and a proposed harmonised product-information package Only the original spontaneous case reports A request to transfer all national authorisations to the centralised procedure

Question 10 of 10 Which proposed regulatory action is most relevant to determining whether Article 107i criteria may apply?

Routine annual review of the pharmacovigilance system master file Consideration of suspension or revocation of a marketing authorisation Preparation of a standard periodic safety report Routine translation of an unchanged package leaflet

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EU Referral Mechanisms: Articles 20, 31, 107i and 30

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