Medicinal products for human use
Pharmacovigilance - Major developments
Pharmacovigilance related activities of Member States and the European Medicines Agency concerning medicinal products for human use (2012 – 2014)
On 8 August 2016 the Commission adopted a report on the pharmacovigilance related activities of Member States and the European Medicines Agency (EMA). The report and the accompanying staff working document which describe the main activities of the collaborative EU system for monitoring and managing the safety of human medicines since the new legislation came into effect in 2012 until 2014 are available here:
As of 1 February 2016 marketing authorisation holders will no longer be required to submit type IA variations in relation to administrative changes to the Qualified Person Responsible for Pharmacovigilance and the Pharmacovigilance System Master File. For further details see here.
The report on the pharmacovigilance tasks of the European Medicines Agency that were completed the during the first year of application of the EU’s new pharmacovigilance legislation is available here.
The report, prepared by the Agency, covers the period 2 July 2012 to 1 July 2013 and provides an overview of pharmacovigilance related activities such as assessment of new potential safety issues associated with medicines, regular periodic safety update reports and risk management plans.
Delegated Regulation on post-authorisation efficacy studies
Delegated Regulation (EU) No 357/2014 that concerns the efficacy of medicines, has been published in the Official Journal of the EU. The regulation complements new EU pharmacovigilance legislation adopted in 2010 and 2012, by specifying the situations in which post-authorisation efficacy studies are required.
The text of the Delegated Regulation is here
Medicines undergoing additional monitoring: Video and leaflet to explain new symbol
Since 1 September, a black inverted triangle has started to appear in the product information of medicines that are being monitored particularly closely by regulatory authorities. With this measure, the European Commission aims to improve the safety of medicines and also to highlight to patients, the importance of reporting suspected side effects to the medicines they are taking.
For more information on this new symbol, see:
Adoption of a legal proposal for fees for pharmacovigilance payable to the European Medicines Agency
The Commission has adopted on 26 June 2013 a Proposal for a Regulation of the European Parliament and of the Council on Fees payable to the European Medicines Agency for the Conduct of Pharmacovigilance Activities in Respect of Medicinal Products for Human use (COM(2013) 472 final).
The text of the proposal can be consulted here
The text of the accompanying Impact Assessment Report can be consulted here
The text of the Executive Summary of the Impact Assessment Report can be consulted here
Responses to the public consultation on the delegated act on post-authorisation efficacy studies
A public consultation took place from 28 November 2012 to 18 February 2013 on post-authorisation efficacy studies.
Overall, the Commission received 33 responses. A summary of the comments as well as the replies are here.
Adoption and Publication of Commission implementing regulation introducing a Black Symbol to identify medicinal products that are subject to additional monitoring.
On 7 March 2013, the Commission adopted an Implementing Regulation introducing a Black Symbol to identify medicinal products that are subject to additional monitoring.
The black symbol will allow patients and healthcare professionals to identify these products, and the accompanying text will encourage them to report unexpected adverse reactions through national reporting systems.
Responses to the public consultation on phasing-in requirements on a black symbol identifying medicinal products subject to additional monitoring
A public consultation took place from 21 November 2012 to 10 January 2013 on phasing-in requirements on a black symbol identifying medicinal products subject to additional monitoring.
Responses to the public consultation on the concept paper on the Introduction of Fees for Pharmacovigilance to be charged by the European Medicines Agency
The new pharmacovigilance legislation: Regulation (EU) No 1235/2010 of 15.12.2010 and Directive 2010/84/EU of 15.12.2010 (OJ 31.12.2010, L348) enables the European Medicines Agency to charge fees for its new pharmacovigilance activities.
The public consultation took place from 18 June 2012 to 15 September 2012. The summary of the comments and the comments received by the European Commission are here.
Public consultation on post-authorisation efficacy studies
Post-authorisation efficacy studies are studies which are undertaken after a medicine has been authorised with the purpose of providing more information on the efficacy of the product within the authorised indications.
Those studies are not an entirely new feature, already now post-authorisation efficacy studies may be conducted. However, with the new pharmacovigilance legislation those studies are formally recognised. It is clarified that marketing authorisation holders can be obliged to conduct such studies by imposing that obligation as a condition to the marketing authorisation. Moreover, competent authorities may require the performance of such studies even post-authorisation, if new scientific evidence indicate that previous efficacy evaluations might have to be revised significantly.
In this context the Commission is empowered to adopt a delegated act laying down the situations in which post-authorisation efficacy studies may be required.
In order to further explore the added-value and the content of such an act the Commission has prepared a reflection paper which is now being rolled out for public consultation with a view of receiving feedback from stakeholders on this issue.
The period of consultation ends on 18 February 2013. All citizens and organisations (public and private) are invited to contribute. For more information on how to contribute, please read the reflection paper.
Received contributions will be published on the internet. For more information on the processing of personal data in the context of this consultation, read the specific Privacy Statement.
Public consultation on phasing-in requirements on a black symbol identifying medicinal products subject to additional monitoring
Under the new pharmacovigilance provisions some medicinal products for human use are authorised subject to additional monitoring for reasons of their specific safety profile. Those products have to bear a black symbol which shall be selected by the Commission by July 2013 at the latest. In the context of selecting the symbol the Commission is currently considering the need for phasing-in arrangements for the inclusion of the symbol in the summary of product characteristics and the package leaflet of all products concerned.
Thisconcept paper is being rolled out for public consultation with a view of receiving feedback from stakeholders on this issue.
The period of consultation ends on 10 January 2013. All citizens and organisations (public and private) are welcome to contribute to this consultation. For more information on how to contribute, please read the concept paper. Received contributions will be published on the internet. For more information on the processing of personal data in the context of this consultation,read the specific Privacy Statement.
18 July 2012
Updated: Questions and answers on transitional arrangements concerning the entering into force of the new pharmacovigilance provisions in July 2012
The Commission updated its Q&A document as regards the correct phasing-in of the new pharmacovigilance requirements and the specific dates from which the new rules apply. This new version replaces the Q&A document published in February 2012.
20 June 2012
Adoption and Publication of Commission Implementing Regulation on pharmacovigilance activities
Following its adoption on 19 June the Commission Implementing Regulation (EU) 520/2012 on the performance of pharmacovigilance activities has been published in the Official Journal of the European Union. This Implementing Regulation complements the 2010 pharmacovigilance legislation, which starts to apply in July 2012, by providing the more technical details that have to be observed by marketing authorisation holders, national competent authorities and EMA in the daily practice of applying the new legislation. It is therefore an important piece in the new framework, which will promote and protect public health by strengthening the European system for monitoring the safety and use of medicines.
The text of the Implementing Regulation is here
The new pharmacovigilance legislation Regulation (EU) No 1235/2010 of 15.12.2010 and Directive 2010/84/EU of 15.12.2010 (OJ 31.12.2010, L348) enables the European Medicines Agency to charge fees for its new pharmacovigilance activities.
With this public consultation, Directorate General for Health and Consumers intends to consult all stakeholders on the proposed structure and levels of fees for pharmacovigilance.
- The public consultation paper can be found here. (Deadline for comments: 15 September 2012).
- Questions and Answers (last update : 11/09/2012).
20 February 2012
Questions and answers on transitional arrangements concerning the entering into force of the new pharmacovigilance provisions in July 2012
With the entering into force of the new pharmacovigilance provisions (Regulation (EU) No 1235/2010 and Directive 2010/84/EU) only a few months away, this Q&A documents addresses questions that have been raised to the Commission as regards the correct phasing-in of the new requirements and the specific dates from which the new rules apply. It is intended to facilitate the preparatory work of all stakeholders involved.
10 February 2012
Information to patients and Pharmacovigilance - New developments
On 10 February 2012, the Commission adopted:
- An amended Commission proposal for a Directive as regards information to the general public on medicinal products subject to medical prescription
- An amended Commission proposal for a Regulation as regards information to the general public on medicinal products subject to medical prescription
- A Commission proposal for a Directive as regards Pharmacovigilance
- A Commission proposal for a Regulation as regards Pharmacovigilance
The adoption of these proposals follows Commissioner Dalli' s announcement on 2 December 2011 at the Council on Employment, Social Policy, Health and Consumer Affairs (EPSCO) of the split of the amended proposals on information to patients, which were adopted on 11 October 2011, into two parts relating to "Information to Patients" and "Pharmacovigilance" respectively. The split of the proposals aims to facilitate the discussion of the proposals by the co-legislators. The proposals on Pharmacovigilance seek to to address some weaknesses identified in the EU pharmacovigilance system.
The four proposals will be now discussed by the European Parliament and the Council of Ministers.
9 February 2012
Responses to the Public consultation on the concept paper on implementing measures for the performance of pharmacovigilance activities
A summary of the responses is here
8 September 2011
Public consultation on a concept paper on implementing measures for the performance of pharmacovigilance activities
In order to harmonise the performance of the new pharmacovigilance activities introduced by the amended pharmacovigilance legislation (cf. Regulation (EU) No 1235/2010 and Directive 2010/84/EU) the Commission shall adopt several implementing measures. Those measures supplement essential details of the new pharmacovigilance system with the more technical details that have to be observed by marketing authorisation holders, national competent authorities and the European Medicines Agency in the daily practice of applying the new provisions.
With the public consultation the European Commission intends to describe the scope and content of the implementing measure which it is currently considering and seeks views and feedback from stakeholders on those issues. A more detailed description can be found in the concept paper.
The period of consultation ends on 7 November 2011. All citizens and organisations (public and private) are welcome to contribute to this consultation. For more information on how to contribute, please read the concept paper.
Received contributions will be published on the internet. For more information on the processing of personal data in the context of this consultation, read the specific Privacy Statement.
22 September 2010
Statement by John Dalli, European Commissioner for Health and Consumer Policy, on EU legislation on Pharmacovigilance
The European Parliament today voted in favour of the EU legislation on pharmacovigilance
Reacting to the vote, Commissioner John Dalli said: "I welcome today's vote by the European Parliament which formalises the agreement reached during the Spanish Presidency and I thank the Rapporteur, Mrs McAvan, for her excellent work. Today's vote is good news for Europeans as the legislation will ensure greater patient safety and improved public health. In addition, by better focussing the work of public administration and industry, red tape shall be cut. Once implemented, the new legislation will strengthen and modernize the current system for monitoring medicinal products for human use in the EU, making it more robust and transparent".
Once medicines are authorised and enter the market, they continue to be monitored through the EU system of pharmacovigilance. This is to prevent, detect and assess possible adverse effects. The reporting of adverse drug reactions is essential for effective pharmacovigilance and under the new legislation patients can report adverse drug reactions directly to the competent authorities.
For more information please visit:
5 February 2009
The Commission services wish to consult stakeholders on the Recommendation on "Pharmacovigilance Urgent Measures" procedure under Article 107 of Directive 2001/83/EC, with a view to the incorporation of the guidance in Volume 9A in Eudralex.
The public consultation document is here .
Contributions should be sent by e-mail to email@example.com 3 April 2009.
10 December 2008
In 2006 the European Commission consulted the public and its stakeholders on the current pharmacovigilance system. Based on the results of the public consultation, on 26 February 2007 Commission Vice-President Günter Verheugen announced a strengthening of the EU's pharmacovigilance system.
On 10 December 2008 the Commission adopted two legislative proposals, as part of the pharmaceutical packageaimed at amending the current legal framework.
The proposals focus on but are not be limited to:
- Maintaining the current split of competences between the Member States and the EMA, while making clear the respective roles and responsibilities and minimising the duplication of effort.
- Strengthening the rules on transparency relating to pharmacovigilance data, assessment and decision-making and involving stakeholders (e.g. patient and health care professional groups) in the processes, including reporting (including patient reporting).
- Establishing clear standards ('Good Vigilance Practices - GVP') for the conduct of pharmacovigilance by both the industry and the regulators.
Freeing up resources by rationalising and simplifying the reporting of suspected adverse drug reactions (ADRs), both expedited and periodic reporting, making the best use of current information technology (including Eudravigilance) and matching the reporting requirements with the level of knowledge about the safety of a specific product. The focus will also be on stimulating innovation, by establishing a clear legal requirement to conduct post-authorisation safety studies, including those in risk management systems.
The current EU System
The current EU pharmacovigilance system is organised with functions, responsibilities and accountability shared between the Member States' competent authorities, the European Medicines Agency (EMA) and the European Commission. The EMEA has responsibility for co-ordinating the pharmacovigilance activities of the Member States.
The exact division of responsibilities among the parties involved changes depending on how a particular medicine is authorised. If a medicine has been authorised through the national authorisation mechanisms, most (but not all) of the functions, responsibilities and accountability for pharmacovigilance rest with the Member States. In contrast, for centrally authorised medicines, that is, those authorised through the central Community authorisation procedure, more of the functions, responsibilities and accountability for pharmacovigilance fall to the EMEA and the European Commission.
Why we need to improve the EU's pharmacovigilance system
Pharmacovigilance is a key public health function and there is a need to strive to ensure it is optimally effective. The current system of pharmacovigilance in the EU is complex and there is potential for duplication of effort, as well as the potential for confusion of responsibilities. This is particularly true now with the introduction of innovative products, some utilising innovative technologies. Furthermore, with globalisation of the pharmaceutical market, products often enter different global markets simultaneously, with the exposure of large numbers of patients occurring in a short period of time.
Our society is changing and the expectations of EU citizens are also changing. There is a need to ensure that our pharmacovigilance systems are robust but also transparent, and we need to consider the appropriate level of involvement in the system of different stakeholders, including health care professionals and patients.
Although evolving over time, the current system of pharmacovigilance in the EU has been established for a number of years and it is an appropriate time to improve it.
The European Commission adopts two legal proposals aimed at amending the EU pharmacovigilance system.
Commission Pharmacovigilance Strategy: results of public consultation on draft legislative proposals
Between 5 December 2007 and 1 February 2008 the European Commission services consulted stakeholders on legislative proposals to strengthen and rationalise the EU system of pharmacovigilance.
- An analysis of the consultation results can be found here
- The individual consultation responses can be found here
Commission Pharmacovigilance Strategy: Public consultation on draft legislative proposals (5 December 2007 - 1 February 2008)
DG Enterprise and Industry of the European Commission wishes to consult stakeholders on legislative proposals to strengthen and rationalise the EU system of pharmacovigilance. All comments should be sent electronically to Dr Peter Arlett (firstname.lastname@example.org ) by 1 February 2008. The consultation document can be found here.
Announcement of February 2007
Based on the results of the public consultation of 2006 (see below), on 26 February 2007 Commission Vice-President Günter Verheugen announced a strengthening of the EU pharmacovigilance system. The announcement is based on the results of the 2006 public consultation and includes both better implementation of the current system and proposals to change the legal framework for pharmacovigilance in the EU. The change to the legal framework will involve an impact assessment during the course of 2007 with a view to a legal proposal in 2008.
- Press release from the Vice-President
- Details of the strategy
- Detailed analysis of the public consultation
- Individual consultation responses
Current rules on pharmacovigilance:
Commission Public Consultation 2006:
An Assessment of the Community System of Pharmacovigilance
The Commission today launches a public consultation on the Community system of pharmacovigilance. The objective of the consultation is to collect the views of stakeholders on the community system, including comments on the current functioning of the system and how it might be further strengthened.
A document to explain the consultation and its background is available here.
A template for your consultation responses is available here.
Electronic consultation responses are preferred and should be sent to email@example.com . Please note that your consultation response will be made public.
The Commission will be holding two workshops in April or May 2006 as part of the public consultation. One will be for patient groups and healthcare professionals, the other for the pharmaceutical industry. Places will be limited and we cannot guarantee to accommodate everyone that would like to attend but if you would like an invitation please email your name, the organisation you represent and all relevant contact details to firstname.lastname@example.org . As places are limited priority will be given to European organisations. All requests for the workshops should be sent by 31 March 2006.
This consultation is one key way that we can ensure that we strengthen pharmacovigilance, making it fit for the enlarged Community for decades to come and hence effectively protecting the health of citizens in the EU and beyond.