On 29 November 2010 the Council of the European Union adopted new pharmacovigilance legislation. The decision follows a first reading agreement by the European Parliament on 22 September 2010 and was taken without discussion.

The new legislation forms part of a three-piece "pharmaceutical package" and amends pharmacovigilance legislation contained in Directive 2001/83/EC and Regulation (EC) No. 726/2004. The parts concerning counterfeit medicines and information to patients have not yet been adopted. The amendments entail new requirements as well as codification of various existing requirements laid down in Volume 9A containing the European Commission's Guidelines on Pharmacovigilance. Key changes include the possibility to impose obligations to conduct post-authorisation safety and efficacy studies and the fact that requirements concerning e.g. risk management systems, post-authorisation safety studies ("PASS") and Periodic Safety Update Reports ("PSUR") are tailored for individual medicinal products and are made proportionate to the specific risks of the medicinal product.

Monitoring of safety data

As part of the obligation to continuously monitor the safety of medicinal products, marketing authorisation ("MA") holders will be required to maintain a Pharmacovigilance System Master File ("PSMF") permanently available for inspection. The PSMF shall be kept up to date and replaces the current detailed description of the pharmacovigilance system ("DDPS"). The reporting responsibilities include providing all information available, including the results of clinical trials or other studies, as well as reporting of off-label use. MA holders and Member States will have to submit data into the central Eudravigilance database.  

Periodic Safety Update Reports (PSURs)

Routine reporting is no longer necessary for products with low risk or where reporting would be duplicative. PSURs will contain a scientific evaluation of the risk-benefit balance of the product rather than a detailed presentation of individual case reports. PSURs will have to be submitted to the European Medicines Agency who will further distribute to the Member States. The frequency for submitting PSURs for medicinal products that contain the same active substance or same combination of active substances may be harmonised to enable a single assessment.

Risk management systems

A risk management system is required for each new medicinal product or for existing products on the basis of safety concerns. The risk management system should be proportionate to the identified risks, potential risks, and the need for additional information on the medicinal product. For some products, a risk management system may consist solely of routine pharmacovigilance activities. In other cases, for example if there are concerns about the risks affecting the risk-benefit balance, an applicant shall be required to submit a detailed description of the risk management system which it intends to introduce.

Additional monitoring: post-authorisation safety and/or efficacy studies

Competent authorities may either at the time of granting of the MA or at a later moment require MA holders to conduct post-authorisation studies on safety and/or efficacy. For certain medicinal products, applicants may receive an MA under the condition that they perform additional monitoring. This includes all medicinal products with a new active substance and biological medicinal products including biosimilars. In those cases the SmPC and the patient information leaflet shall include the statement: 'This medicinal product is subject to additional monitoring'. That statement shall be preceded by a black symbol, and followed by an appropriate standardised explanatory sentence, still to be selected by the Commission.


Member States remain responsible for performing pharmacovigilance inspections. They will however strengthen their cooperation by sharing more information on the planning of inspections and on inspection findings.

Entry into force

Once signed by the President of the European Parliament and the President of the Council the legislative act will be published in the Official Journal of the EU after which it will enter into force after 20 days. The Member States will have to implement the legislation and within 18 months of entry into force and apply the legislation from that date onwards, which is expected for mid-2012.