Marketing Authorization procedures in EU: centralized, decentralized, mutual recognition, national MCQs With Answer

This quiz collection on Marketing Authorization procedures in the EU — centralized, decentralized, mutual recognition and national routes — is designed for M.Pharm students preparing for Regulatory Aspects of Drugs & Cosmetics (MRA201T). It summarizes the regulatory pathways, key authorities (EMA, CHMP, CMDh, PDCO), the scope of each procedure, common timelines, and essential requirements such as pediatric plans, orphan designation and data exclusivity. The questions emphasize real-world application: choosing the appropriate route, understanding roles of Reference and Concerned Member States, referrals and dispute resolution, and dossier/CTD expectations. Use these MCQs to test conceptual clarity and regulatory decision-making relevant to EU marketing authorizations.

Q1. Which EU procedure grants a single marketing authorisation valid across all EU Member States and EEA countries after an opinion by the CHMP?

• Centralised procedure
• Decentralised procedure
• Mutual recognition procedure
• National procedure

Correct Answer: Centralised procedure

Q2. Which body within the European Medicines Agency (EMA) is primarily responsible for issuing scientific opinions on centralized marketing authorisation applications?

• Committee for Medicinal Products for Human Use (CHMP)
• Pharmacovigilance Risk Assessment Committee (PRAC)
• Committee for Orphan Medicinal Products (COMP)
• Committee for Advanced Therapies (CAT)

Correct Answer: Committee for Medicinal Products for Human Use (CHMP)

Q3. For which of the following categories is the centralized procedure mandatory under EU law?

• Medicinal products derived from biotechnology (e.g., recombinant proteins)
• All generic small-molecule medicines
• Over-the-counter traditional herbal medicines
• All veterinary medicines

Correct Answer: Medicinal products derived from biotechnology (e.g., recombinant proteins)

Q4. Which procedure is appropriate when an applicant seeks simultaneous approval in several Member States for a product that has not previously been authorised in any EU Member State?

• Decentralised procedure (DCP)
• Mutual recognition procedure (MRP)
• National procedure
• Centralised procedure only

Correct Answer: Decentralised procedure (DCP)

Q5. What is the primary difference between the Mutual Recognition Procedure (MRP) and the Decentralised Procedure (DCP)?

• MRP relies on an existing national authorisation in one Member State; DCP is for products not yet authorised in any Member State
• MRP results in a single EU marketing authorisation; DCP gives separate national authorisations only
• MRP is administered by EMA’s CHMP; DCP is handled exclusively by the European Commission
• MRP is mandatory for biotech products while DCP is not

Correct Answer: MRP relies on an existing national authorisation in one Member State; DCP is for products not yet authorised in any Member State

Q6. Which EU committee is responsible for assessing paediatric investigation plans (PIPs)?

• Paediatric Committee (PDCO)
• Committee for Advanced Therapies (CAT)
• Pharmacovigilance Risk Assessment Committee (PRAC)
• Committee for Orphan Medicinal Products (COMP)

Correct Answer: Paediatric Committee (PDCO)

Q7. Which of the following is a correct statement about data exclusivity in the EU after a marketing authorisation is granted?

• There is typically 8 years of data exclusivity, 2 years of market exclusivity, plus 1 additional year for new indications
• There is 10 years of data exclusivity and no separate market exclusivity period
• There is no data or market exclusivity in the EU; only patents provide protection
• Data exclusivity always blocks any generic application for 15 years

Correct Answer: There is typically 8 years of data exclusivity, 2 years of market exclusivity, plus 1 additional year for new indications

Q8. Which coordination group represents Member States in mutual recognition and decentralised procedures and supports harmonised decisions (not the EMA scientific committees)?

• Coordination Group for Mutual Recognition and Decentralised Procedures — Human (CMDh)
• Committee for Human Medicinal Approvals (CHMA)
• European Commission Working Party (ECWP)
• Pharmaceutical Harmonisation Council (PHC)

Correct Answer: Coordination Group for Mutual Recognition and Decentralised Procedures — Human (CMDh)

Q9. Which route would a company use to extend the indication of a medicine already authorised nationally in one Member State to gain approval in several other Member States using that existing national authorisation?

• Mutual recognition procedure (MRP)
• Decentralised procedure (DCP)
• Centralised procedure
• National procedure in each country independently

Correct Answer: Mutual recognition procedure (MRP)

Q10. Which dossier format is required by the EMA for centralized marketing authorisation applications?

• Common Technical Document (CTD) in electronic format (eCTD)
• Non-structured paper dossier only
• US NDA format
• ISO 9001 quality manual only

Correct Answer: Common Technical Document (CTD) in electronic format (eCTD)

Q11. What is the role of a Reference Member State (RMS) in a decentralised or mutual recognition procedure?

• To perform the initial scientific assessment and prepare the assessment report used by Concerned Member States
• To issue the final EU-wide marketing authorisation
• To act as an appeals court for national regulatory decisions
• To manage pricing and reimbursement across Member States

Correct Answer: To perform the initial scientific assessment and prepare the assessment report used by Concerned Member States

Q12. Which of the following is TRUE regarding referral procedures when Member States disagree on the approval or use of a medicinal product?

• Disputes can be referred to the EMA and CHMP for arbitration and a binding EU-level opinion
• Disputes must be resolved only by the European Commission without EMA involvement
• All disagreements are resolved by national courts and cannot be escalated to EU bodies
• There is no formal mechanism to resolve disagreements between Member States

Correct Answer: Disputes can be referred to the EMA and CHMP for arbitration and a binding EU-level opinion

Q13. Which of the following products is most likely to require mandatory centralised authorisation rather than a national or decentralised route?

• An orphan medicinal product designated for a rare disease
• A traditional herbal remedy with long-standing use restricted to one Member State
• A simple generic tablet with an established reference in one country
• A medical device (not a medicinal product)

Correct Answer: An orphan medicinal product designated for a rare disease

Q14. Which advantage correctly describes the centralized procedure compared to national routes?

• One single marketing authorisation covers the entire EU and EEA, simplifying lifecycle management
• It completely bypasses scientific assessment by independent committees
• Approval is guaranteed faster than any national approval regardless of the product type
• It eliminates the need for GMP, GCP or pharmacovigilance compliance

Correct Answer: One single marketing authorisation covers the entire EU and EEA, simplifying lifecycle management

Q15. In the context of generic applications in the EU, which approach allows approval based on bioequivalence to a reference product without repeating full clinical trials?

• Abridged (generic) application using an abridged dossier relying on the reference product
• Full stand-alone application requiring all original clinical trials
• Orphan designation pathway
• Traditional use registration

Correct Answer: Abridged (generic) application using an abridged dossier relying on the reference product

Q16. Which committee within EMA assesses safety signals and makes recommendations on pharmacovigilance matters across the EU?

• Pharmacovigilance Risk Assessment Committee (PRAC)
• Committee for Orphan Medicinal Products (COMP)
• Paediatric Committee (PDCO)
• Committee on Herbal Medicinal Products (HMPC)

Correct Answer: Pharmacovigilance Risk Assessment Committee (PRAC)

Q17. Which of the following best describes the “national procedure” for marketing authorisation in the EU?

• A route to obtain an authorisation valid only within a single Member State
• A method to obtain a single EU-wide authorisation issued by the European Commission
• A mandatory pathway for all biotech-derived medicines
• A harmonised pricing negotiation mechanism across Member States

Correct Answer: A route to obtain an authorisation valid only within a single Member State

Q18. Which of the following is a common reason for issuing a “referral” on a medicinal product at the EU level?

• Significant disagreement between Member States on safety, efficacy or interpretation of data for a product
• A company’s desire to change its manufacturing site within the same Member State
• Routine annual pricing review requested by a national payer
• Trademark disputes unrelated to medicine quality or safety

Correct Answer: Significant disagreement between Member States on safety, efficacy or interpretation of data for a product

Q19. Which element must generally be submitted and approved (or a waiver granted) before marketing authorisation for paediatric use is granted in the EU?

• Paediatric Investigation Plan (PIP) agreed by PDCO
• Manufacturer’s global marketing strategy
• National pricing agreement in each Member State
• Proof of sales forecasts for three years

Correct Answer: Paediatric Investigation Plan (PIP) agreed by PDCO

Q20. Which statement about the European Commission’s role after CHMP issues a positive opinion in the centralized procedure is correct?

• The European Commission adopts the final legally binding marketing authorisation decision for the EU
• The Commission replaces the CHMP opinion with a national authority decision
• The Commission issues a COA (certificate of analysis) for the product batches
• The Commission negotiates price and reimbursement terms across Member States

Correct Answer: The European Commission adopts the final legally binding marketing authorisation decision for the EU

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