RAC Pharmaceuticals EU Regulations |
Latest Update | 2024/2025 | Rated A+
What are Good Manufacturing Practices (GMP)?
Guidelines that ensure that pharmaceutical products are consistently produced and controlled
according to quality standards.
What does the term "Pharmacovigilance" refer t...
RAC Pharmaceuticals EU Regulations |
Latest Update | 2024/2025 | Rated A+
What are Good Manufacturing Practices (GMP)?
✔✔Guidelines that ensure that pharmaceutical products are consistently produced and controlled
according to quality standards.
What does the term "Pharmacovigilance" refer to?
✔✔The science and activities related to the detection, assessment, understanding, and prevention
of adverse effects or any other drug-related problems.
What is a Summary of Product Characteristics (SmPC)?
✔✔A document that provides healthcare professionals with information on the medicinal
product's properties and the conditions for its safe and effective use.
What is the significance of the European Public Assessment Report (EPAR)?
✔✔It provides detailed information about the evaluation of a medicinal product and the reasons
for the EMA's recommendation.
1
,What does the term "Orphan Drug" mean in the EU context?
✔✔A drug intended for the treatment of a rare disease affecting fewer than 5 in 10,000 people in
the EU.
What is the central procedure for marketing authorization in the EU?
✔✔A regulatory pathway that allows a single application for a marketing authorization valid in
all EU member states.
What are the responsibilities of a Qualified Person (QP) in the EU?
✔✔To ensure that the production and release of pharmaceutical products comply with EU
legislation and GMP.
What is the main focus of the EU Clinical Trials Regulation?
✔✔To ensure that clinical trials are conducted in a transparent and ethical manner while
facilitating the approval process.
What is the role of the European Commission in the pharmaceutical regulatory framework?
✔✔To implement EU laws and regulations and to oversee the approval of marketing
authorizations.
2
, What does the term "Active Substance Master File" (ASMF) refer to?
✔✔A document that contains detailed information about the manufacturing process and control
of an active substance used in a medicinal product.
What is the purpose of post-marketing surveillance in the EU?
✔✔To monitor the safety and effectiveness of a pharmaceutical product after it has been
authorized for use.
What is the significance of a "Pharmaceutical Development Report"?
✔✔It provides information on the development process of a pharmaceutical product, including
formulation, stability, and manufacturing.
What are "variation applications" in the context of EU regulations?
✔✔Requests for changes to the terms of a marketing authorization, such as modifications to the
manufacturing process or labeling.
What is the purpose of the Risk Management Plan (RMP)?
3
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