The EU’s Pharmacovigilance Directive

The Pharmacovigilance Directive underwent a major revision in 2010, by which a new legislation came into effect.

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Pharmacovigilance is a major public health initiative of the EU. It is aimed at reducing the risk attendant in any part of the production, marketing and supply chain of medicinal products. Monitoring is done not only before the medicinal products enter the market; it is done at every stage after, too.

safetyandsurveillance
The aim of putting a strict vigilance regimen is to help detect any aspect of a medicinal product that could compromise on its safety. This whole system of monitoring is called pharmacovigilance.

The EU’s Pharmacovigilance Directive is the legal structure that spells out the objectives and implementation plans for the EU’s pharmacovigilance system. The Pharmacovigilance Directive is part of the EU’s efforts to enforce very stringent assessment of all medical products for their safety, quality and efficacy before they become authorized.

Regulation on all areas of medicineIn essence, the Pharmacovigilance Directive lays out the conditions and rules by which medicinal products have to be marketed within the EU and beyond. It prescribes the manner in which products have to be manufactured, labelled, marketed, recalled and destroyed. The Pharmacovigilance Directive, which applies to products for human use, bans any medicinal product that is not authorized by any member state of the EU from being marketed.

The review of 2010The Pharmacovigilance Directive underwent a major revision in 2010, by which a new legislation came into effect. The legislation passed that year further fortifies and streamlines the system relating to the safety of medicines that enter the European market.

The Pharmacovigilance Directive of 2010 strategizes areas relating to preventing, detecting and assessing of adverse reactions in patients to ensure improved patient safety and with it, public health. One of the major features of this amendment is that patients are empowered to directly report adverse drug reactions to the designated competent authorities. Another important aspect is that the definition of an adverse reaction has been widened to include issues like overdose and medication errors.

Important features of the Pharmacovigilance Directive of 2010The Pharmacovigilance Directive of 2010 seeks to take concrete steps to enhance its core objectives of patient safety and public health. It is built on these foundations:

  • It puts in place a robust, proportionate and proactive risk management regimen
  • It enhances safety data quality
  • It strengthens the link between safety evaluations and actions from regulatory authorities
  • The Pharmacovigilance Directive of 2010 has led to greater communication, transparency and patient involvement
  • It assigns clear-cut responsibilities and tasks for everyone concerned
  • It facilitates the decision-making apparatus within the EU
  • The Pharmacovigilance Directive of 2010 has established The Pharmacovigilance Risk Assessment Committee, a new scientific committee to be based at the European Medicines Agency (EMA).

Author: compliance4all

Compliance4All, the ultimate continuing professional education provider offers you regulatory and compliance trainings from the industry's leading experts, but with one crucial difference -the cost. Compliance4All's objective is to be a platform that provides regulatory and compliance trainings with all the class and features that come with these trainings, at a lower price. Compliance4All seeks to make regulatory and compliance trainings low-hanging fruits. Industries We Focus On: • Trade & Logistics • Aerospace Defense • Banking & Insurance • Food & Beverages • Auditing/Accounting & Tax • Energy • Environment • Education • Automotive Transport • Science and Technology • Government • Construction • Electronics & Semiconductor • Operation • Engineering/Science • Purchasing & Vendor Relation • General counsel/Accountant • Geology & Mining • Documentation/Records

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