Medicinal products for human use

Falsified medicines - Major developments

 
 

Falsified medicines

Major developments

09/02/2016
New safety features to protect EU consumers from falsified medicines.

The delegated Regulation 2016/161 , published today in the Official Journal, sets out the details of obligatory "safety features" for medicines which will guarantee medicine authenticity and secure the medicine supply chain.

For more information click here.

25/11/2014
Delegated Regulation on GMP for API.

COMMISSION DELEGATED REGULATION (EU) No 1252/2014 of 28 May 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use .

25/04/2013
Australia has been added to the "list of third countries" as regards standards of manufacture and supervision of active pharmaceutical ingredients equivalent to those of the EU.

The Commission Decision is available here.

12/04/2013
Importation of active substances for medicinal products for human use.

19/02/2013
Responses to the public consultation on the concept paper concerning the implementing act on a common logo for legally-operating online pharmacies/retailers offering medicinal products for human use for sale at a distance to the public.

A public consultation took place from 17 October 2012 to 17 January 2013 on the concept paper concerning the implementing act on a common logo for legally-operating online pharmacies/retailers offering medicinal products for human use for sale at a distance to the public.

The replies are available here.

28/01/2013
Importation of active substances for medicinal products for human use.

24/01/2013
Commission Implementing Decision of 23 January 2013 on the assessment of a third country's regulatory framework applicable to active substances of medicinal products for human use and of the respective control and enforcement activities pursuant to Article 111b of Directive 2001/83/EC of the European Parliament and of the Council .

For more information, see Eudralex - Volume 1.

24/01/2013
Responses to public consultation on the concept paper concerning the Implementing act on the requirements for the assessment of the regulatory framework applicable to the manufacturing of active substances of medicinal products for human use.

A public consultation took place from 7 December 2011 to 23 March 2012 on the concept paper concerning the Implementing act on the requirements for the assessment of the regulatory framework applicable to the manufacturing of active substances of medicinal products for human use.

The replies are available here.

22/01/2013
Responses to the public consultation on the concept paper concerning the delegated act on the criteria to be considered and the verifications to be made when assessing the potential falsified character of medicinal products.

A public consultation took place from 6 September 2012 to 10 December 2012 on the concept paper concerning the delegated act on the criteria to be considered and the verifications to be made when assessing the potential falsified character of medicinal products introduced in the Union but not intended to be placed on the market.

The replies are available here.

29/08/2012
Responses to the public consultation on the concept paper concerning the Delegated act on the principles and guidelines of good manufacturing practice for active substances in medicinal products for human use.

A public consultation took place from 20 January 2012 to 20 April 2012 on the concept paper concerning the Delegated act on the principles and guidelines of good manufacturing practice for active substances in medicinal products for human use.

The replies are available here.

25/07/2012
New rules on importing active pharmaceutical ingredients into the EU – information leaflet.

An information leaflet on the new rules on importing active pharmaceutical ingredients into the EU is available here.

10/07/2012
Template for the "written confirmation" for active substances exported to the European Union for medicinal products for human use.

For more information, see Quality of medicines and EudraLex - Volume 4.

14/06/2012
Responses to the public consultation on the concept paper on the detailed rules for a unique identifier for medicinal product for human use.

A public consultation took place from 18 November 2011 to 27 April 2012 on the concept paper on the detailed rules for a unique identifier for medicinal product for human use.

The replies are available here.

01/06/2012
Responses to the public consultation on draft template for the written confirmation for active substances imported into the European Union for medicinal products for human use.

A public consultation took place from 16 April 2012 to 1 June 2012 on draft template for the written confirmation for active substances imported into the European Union for medicinal products for human use.

The replies are available here.

01/07/2011
Publication of the new legislation to fight against falsified medicines.

Following adoption by the Council and the European Parliament, the was published on 1 July in the Official Journal of the European Union. The new legislation will be applicable on 2 January 2013. This legislation is the outcome of the legal proposal that the Commission put forward in December 2008. The new legislation introduces tougher rules to improve the protection of public health with new harmonised, pan-European measures to ensure that medicines are safe and that the trade in medicines is rigorously controlled.

16/02/2011
The European Parliament adoted the new legislation aimed at better protecting EU citizens from the dangers of falsified medicines.

Statement by European Comissioner or Health and Consumer Policy, John Dalli:

"I welcome today's vote on a Directive that will increase the protection our citizens from the dangers of falsified medicines and I congratulate and thank the Rapporteur, Ms. Marisa Matias, for all her work.
Since they may contain ingredients in the wrong dosage or no active ingredients at all, falsified medicines are a serious public health risk in the EU. They have not been subject to an authorisation procedure where aspects of quality, safety, and efficacy of the medicine are verified.
The law passed today introduces harmonized, pan-European safety measures that provide the highest possible level of assurance that only high-quality medicines are sold within the legal supply chain in the EU. It also addresses sales of falsified medicines over the internet by providing for an obligatory trust mark on websites of legally operating online pharmacies.
I look forward to a swift implementation of this Directive by the Member States".

10/12/2008
Adoption of a proposal of the Commission for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source.

11/11/2008
Report of Study on Distribution Channels, Part "Policies to Combat Counterfeit Medicines".

In 2006, DG Enterprise and Industry launched a study to assess policies to combat counterfeit medicines. An external contractor, Europe Economics, has now presented results of the study to the European Commission after Member States and stakeholders had the opportunity to provide data and views. The report includes a contribution to an assessment of social, economic and environmental impacts on various policy options to address any possible shortcomings. The report of the contractor, Europe Economics, and its annexes documents: annex I , annex II , annex III are now made publicly available.

20/06/2008
Responses to the public consultation in preparation of a legal proposal to combat counterfeit medicines for human use
.

A public consultation took place from 11 March 2008 to 9 May 2008 in preparation of a legal proposal to combat counterfeit medicines for human use.

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

04/2008
Background information on the legal proposal to combat counterfeit medicines for human use.

12/12/2007
WHO International Medical Products Anti Counterfeiting Task Force (IMPACT) endorses the recommendation "Principles and Elements for National Legislation against Counterfeit Medicines" which has been co-funded and supported by the European Commission.

10/12/2007
Speech by Director Georgette Lalis given at the WHO IMPACT International Conference "Developing Effective Legislation to Combat Counterfeit Madicinal Product", held in Lisbon on 10 December 2007.

14/05/2007
Speech by Director General Heinz Zourek given at the 1st European Parliamentary Symposium "Putting an end to Drug Counterfeiting" held in Brussels on 14 May 2007.

29/11/2006
DG Entreprise study on Distribution Chanels - Part I Combating Counterfeit Medicines.

06/09/2006
Resolution of the European Parliament on Counterfeit medicines.

27/03/2006
Press Release IP/06/375.

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