Medicinal products for human use

Pharmacovigilance - Major developments

24/04/2017
Pharmacovigilance related activities of Member States and the European Medicines Agency concerning medicinal products for human use (2012-2014) - Update.

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 in publication format here:

The original version in all the EU official languages remains available below:

08/08/2016
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:

22/01/2016
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.

More information is available here.

02/05/2014
One-year report on human medicines pharmacovigilance tasks of the European Medicines Agency.

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.

10/04/2014
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 available here.

01/10/2013
Medicines undergoing additional monitoring: Video and leaflet to explain new symbol.

Black 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:

27/06/2013
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).

For more information:

15/03/2013
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 the delegated act on post-authorisation efficacy studies.

A summary of the comments as well as the replies are available here.

07/03/2013
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.

24/01/2013
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.

A summary of the comments as well as the replies are available here.

30/11/2012
Responses to the public consultation on the concept paper on the Introduction of Fees for Pharmacovigilance to be charged by the European Medicines Agency.

A public consultation took place from 18 June 2012 to 15 September 2012 on the concept paper on the Introduction of Fees for Pharmacovigilance to be charged by the European Medicines Agency.

A summary of the comments as well as the replies are available here.

18/07/2012
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.

The updated Q&A document is available here.

20/07/2012
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 available here.

20/02/2012
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.

10/02/2012
Information to patients and Pharmacovigilance - New developments.

On 10 February 2012, the Commission adopted:

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.

09/02/2012
Responses to the public consultation on the concept paper on implementing measures for the performance of pharmacovigilance activities.

A public consultation took place from 8 September 2011 to 7 November 2011 on the concept paper on implementing measures for the performance of pharmacovigilance activities.

A summary of the comments as well as the replies are available here.

22/09/2010
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 the pharmacovigilance section of Public Health website.

05/02/2009
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 available here.

Contributions should be sent by e-mail to sanco-pharmaceuticals@ec.europa.eu by 3 April 2009.

10/12/2008
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 package aimed 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 EMA 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 EMA 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

10/04/2008
Responses to the public consultation on draft legislative proposals to strengthen and rationalise the EU system of pharmacovigilance.

A public consultation took place from 5 December 2007 to 1 February 2008 on draft legislative proposals to strengthen and rationalise the EU system of pharmacovigilance.

A summary of the comments as well as the replies are available here.

26/02/2007
Reponses to the public consultation on the Community system of pharmacovigilance.

A public consultation took place from 15 March 2006 to 12 May 2006 on the Community system of pharmacovigilance.

A summary of the comments as well as the replies are available here.

Additional information: