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

2024
Views:

285

Pages:

2
Author:

Sara

1. In what year did 2003 the MCA (Medicine Control Agency) merge with the Medical Device Agency to form the MHRA (Medicines + Healthcare Products Regulatory Agency? 2. Which one of these - assessing safety, efficacy , quality of medicine + issuing is a medicine regulatory function? - controlling promotion + advertising of medicine 3. PRAC is a function Pharmacovigilance Risk Assessement Role of EMA it stands for? 4. What is the role of - assess + monitor the safety of human medicines, proPRAC? viding recommendations to minimise risks + optimise the safe use of medications in the European Union - the data collected through yellow card is reviewed by the PRAC at the European Medicines Agency (EMA) - PRAC assesses these reports to identify + minimise risks associated with medicines, contributing to the overall safety monitoring + regulatory decisions 5. What is a regula- law that is addressed to all member state, they are directtion (in EU term)? ly applicable without the need for national legislation 6. Which must be in- a) the manufacturing method cluded in a product b) expected shelf life, precautionary measures + safety dossier? during storage c) summary detailing the applicant's pharmacovigilance 7. 1/2 What is a product - is a comprehensive doc that contains all the necessary dossier? info about a medicinal product - it includes data on the quality, safety + efficacy of the medicine, as well as details about its manufacturing process, formulation, packaging, labeling + pharmacovigilance system - the dossier is submitted to regulatory authorities for product registration + approval 8. A medicinal product in all EU member state, which type of these should try to use? - centralized procedure = is recommended for obtaining MA for a medicinal product in all EU member states 9. __________ 1 in 3 EU member + company already held a licence in 1 member state, which type of application procedure? - Mutual Recognition Procedure (MRP) = allows for recognition of an existing national MA in 1 member states by other member states, facilitating the approval process for the same product in multiple countries - this procedure provides a single MA that is valid across the EU( European Union), ensuring consistent standards of quality, safety + efficacy 2/2