What are EudraLex volumes?
EudraLex consists of 10 volumes, of which only Volume 1 (concerning medicinal products for human use) and Volume 5 (concerning medicinal products for veterinary use) present official legislation. The basic legislation is supported by a series of guidelines that are published within the other eight volumes.
What are GVP guidelines?
Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP apply to marketing-authorisation holders, the European Medicines Agency (EMA) and medicines regulatory authorities in EU Member States.
What is GVP in pharma?
Good Pharmacovigilance Practices (GVP): A Quick-Guide. Advances in pharmaceutical research continue to save lives, alleviate pain, and prevent disease. One result of such progress is a continuous evolution in how the safety and efficacy of these incredible medicines are monitored.
What is pharmacovigilance commonly called?
Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.
What is Mah in pharmacovigilance?
Any company, firm or non-profit organization, which holds a marketing authorization granted by the European Medicines Agency (EMA), is called a Marketing Authorization Holder (MAH). An MAH is allowed to distribute and sell its medicinal products in one or more European Union (EU) member states.
What is the EU GMP guideline called?
Good manufacturing practice (GMP) describes the minimum standard that a medicines manufacturer must meet in their production processes. The European Medicines Agency (EMA) coordinates inspections to verify compliance with these standards and plays a key role in harmonising GMP activities at European Union (EU) level.
How many volumes are there in EudraLex?
10 volumes
EudraLex consists of 10 volumes: Concerning Medicinal Products for Human use: Volume 1 – Pharmaceutical Legislation.
What are the four main components of pharmacovigilance?
Core Capabilities: Pharmacovigilance delivers four primary capabilities to pharmaceutical companies: • Adverse Event Case Management including expedited reporting; • Aggregate Reporting; • Signal Intelligence; and • Risk Management.