University:
University of Wolverhampton
Course:
4PY019 | Pharmacy
Academic year:

2024
Views:

363

Pages:

3
Author:

Sara

1. Which regulatory collaboration group focuses on en- Access Consorsuring timely access to medicines tium 2. Which regulatory network is responsible for regulat- HMA (Heads of ing medicinal products in the EU? Medicines Agencies network) 3. Which type of changes require approval before imple- Type IB mentation in the regulatory process? (these changes do not have a significant impact on the safety, efficacy /quality of the product) 4. Which regulatory agreement addresses the regulatory Northern Ireland framework for Northern Ireland post-Brexit? Protocol 5. What are the 3 main types of EU legislation? - regulations - directives - decisions 6. What is the procedure that allows obtaining MA in 2 or Decentralised Promore EU member states simultaneously? cedure 7. What is the purpose of Access Consortium reduce duplication + increase each agency's capacity to ensure patients have timely access to high quality, safe + effective medicines 8. What triggered the British Medical Association to set sudden deaths folup an independent body to assess drug safety? lowing the introduction of chloroform as an anaesthetic 9. What was the suggestion made by the BMA working suggested setting party in 1880 regarding drug safety assessment? up an independent body to as1/3 sess drug safety due to a number of sudden deaths reported following the introduction of chloroform as an anaesthetic 10. What are the 2 main types of variations regarding changes to a product license? Type IA and Type IB variations 11. What is the difference between Type IA and Type IB - Type IA variavariations in terms of when they can be submitted and tions can only be the nature of changes they cover? submitted after the change has been made, cover minor changes to the product license + must be submitted within 1 year from the implementation of the change - Type IB variations cover minor changes, must be submitted + approved before the change is implemented + typically require competent authority approval before implementation 12. What is the timeline for submitting Type IAIN (immedi- submitted within 2 ate notification) variations? weeks of the im- 2/3 plementation of a change 13. What are the key characteristics of the DCP for obtain- - include the need ing MA in the EU based? for the applicant to not hold a license for the product in any EU member state - principle route to market for generic products 14. Which type of EU legislation is directly applicable without the need for national legislation? Regulations 15. Which type of variation involves major changes that Type II may have a significant impact on the quality, safety, or efficacy of a medicinal product? 16. Which procedure allows for obtaining Marketing Au- Decentralised Prothorisations in two or more EU member states sicedure multaneously, characterized by close coordination between the Health Authorities of the participating Member States? 17. Which body was set up in 1963 to prevent another Committee on disaster like the Thalidomide tragedy and has no legal Safety of Drugs powers but effectively advises on clinical trials and (CSD) the marketing of new medicines? 3/3