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 Which approach is most appropriate when determining whether an MAH's product falls within a referral initiated by another company's product?

Assume inclusion only if the MAH agrees Assume exclusion because the MAH did not generate the signal Review the formal referral scope and the defined safety or regulatory question Include every product in the same therapeutic area automatically

Question 2 of 10 An MAH identifies long-standing differences in warnings, posology and indications across national authorisations but no new pharmacovigilance signal. What should be the primary regulatory focus?

Urgent Article 107i action based solely on the existence of differences Article 20 because product information is safety-related Article 30 harmonisation analysis of the divergent national positions Routine signal validation without regulatory review

Question 3 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 4 of 10 Who can initiate an Article 107i urgent Union procedure according to the article?

A Member State competent authority or the European Commission Any MAH without involvement of an authority Only PRAC after completing a signal assessment Only CMDh following a national referral

Question 5 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 6 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

Question 7 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 8 of 10 Which committee is the principal scientific committee for an Article 30 referral?

PRAC CMDh CHMP The EMA Pharmacovigilance Risk Assessment Secretariat acting alone

Question 9 of 10 What is the key practical reason an MAH should determine product authorisation routes early in a referral?

Authorisation route determines whether the safety evidence can be submitted Authorisation route helps determine the available legal basis and whether CHMP or CMDh follows the PRAC assessment Authorisation route determines whether adverse reactions must be reported Authorisation route eliminates the need to read the formal referral notification

Question 10 of 10 If an Article 31 pharmacovigilance referral includes only nationally authorised products, which body generally receives the PRAC recommendation?

CHMP CMDh The European Commission directly, without a committee position The EMA Management Board

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

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