Falsified medicines - Major developments

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 herepdf.

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

19/02/2013
Responses to the concept paper submitted for public consultation 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.

28/01/2013
Importation of active substances for mediidicinal 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 Councilpdf(722 KB) Choose translations of the previous link български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) italiano (it) latviešu valoda (lv) lietuvių kalba (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv)

Eudralex Volume 1 >>>

22/01/2013
Responses to the concept paper submitted for public consultation 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 responses are available  here.

17/10/2012
Concept paperpdf(52 KB) for public consultation on 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

29/08/2012
Concept paper pdf(39 KB)for public consultation on 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.

More information >>>

29/08/2012
Responses to the concept paper submitted for public consultation concerning the Delegated act on the principles and guidelines of good manufacturing practice for active substances in medicinal products for human use
The responses 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 herepdf(702 KB).

10/07/2012
Template for the 'written confirmation' for active substances exported to the European Union for medicinal products for human usepdf

Importation of active substances for medicinal products for human use - Questions and Answers (version 1.0)pdf(32 KB)

More information >>>

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

Directive 2011/62/EU to fight against falsified medicines introduces obligatory 'safety features' to allow, inter alia, verification of the authenticity of medicinal products for human use ('unique identifier'). The Directive places the Commission under an obligation to adopt delegated acts setting out the details relating to inter alia the unique identifier. The enclosed concept paperpdf(93 KB) has been launched for public consultation until 27 April 2012 with a view to preparing both the impact assessment and the delegated act

Reponses to the public consultation >>>


16/04/2012
Draft template for the written confirmation for active substances imported into the European Union for medicinal products for human use
pdf(47 KB)
Public consultation

20/01/2012
Delegated act on the principles and guidelines of good manufacturing practice for active substances in medicinal products for human use - concept paper submitted for public consultation
pdf(35 KB)

Directive 2011/62/EU places an obligation on Member States to take appropriate measures to ensure that manufacturers of active substances on their territory comply with good manufacturing practice ('GMP') for active substances. It also places an obligation on the Commission to adopt, by means of delegated acts, the principles and guidelines of good manufacturing practice for active substances. This concept paperpdf(35 KB) is being released for public consultation with a view to preparing the delegated act on principles and guidelines of good manufacturing practice for active substances in medicinal products for human use.

The responses to the public consultation can be found here

7/12/2011

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 - Concept paper submitted for public consultationpdf(52 KB)

Directive 2011/62/EU introduces EU-wide rules for the importation of active substances: According to Article 46b(2) of Directive 2001/83/EC, active substances shall only be imported if, inter alia, the active substances are accompanied by a written confirmation from the competent authority of the exporting third country which, as regards the plant manufacturing the exported active substance, confirms that the standards of good manufacturing practice and control of the plant are equivalent to those in the Union. The requirement of a written confirmation is waived for third countries listed by the Commission in accordance with Article 111b of Directive 2001/83/EC. Article 111b(2) of Directive 2001/83/EC provides that the Commission adopts an implementing measure to apply these requirements. This concept paper is being rolled out for public consultation with a view to preparing this implementing act.

18/11/2011

Delegated act on the detailed rules for a unique identifier for medicinal products for human use, and its verification - Concept paper submitted for public consultationpdf(93 KB)

Directive 2011/62/EU introduces obligatory 'safety features' to allow, inter alia, verification of the authenticity of medicinal products for human use ('unique identifier'). The Directive places the Commission under an obligation to adopt delegated acts setting out the details relating to inter alia the unique identifier.  This concept paper is being rolled out for public consultation with a view to preparing both the impact assessment and the delegated act.

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.

For more information, please see .

16/02/2011

The European Parliament adoted the new legisaltion 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 reportpdf(395 KB) of the contractor, Europe Economics, and its annexes documents : annex Ipdf(340 KB) , annex IIpdf(2 MB) , annex IIIpdf(438 KB) are now made publicly available.

20/6/2008

Summary of responses to the public consultation document on a legislative proposal to combat counterfeit medicines for human usepdf(67 KB)

04/06/2008

Responses to the public consultation have been made public here.

04/2008

Background information on the legal proposal to combat counterfeit medicines for human usepdf(97 KB)

11/03/2008

DG ENTR launches a public consultation in preparation of a legal proposal to combat counterfeit medicines for human use "Key ideas for better protection of patients against the risk of counterfeit medicinespdf(62 KB) "

These measures relate to:

  1. Manufacture, placing on the market of medicinal products and related inspections
  1. Import, export, transit (transhipment) of medicinal products
  1. Manufacture, placing on the market of active substances and related inspections

For the purpose of this public consultation, which concentrates on sectoral pharmaceutical EU-legislation, the Commission has identified three areas of regulation of medicinal products where improvements to the regulatory framework could make a real contribution to protecting against counterfeit medicinal products.Counterfeiting of medicinal products has become an increasing threat for patients, healthcare professionals and industry and a concern for EU and national policy-makers. The Directorate-General Enterprise and Industry is consulting all stakeholders and interested parties on key ideas for amending the regulatory framework for medicinal products in an effort to combat the counterfeiting of medicinal products.

12/12/2007

WHO International Medical Products Anti Counterfeiting Task Force (IMPACT) endorses the recommendation "Principles and Elements for National Legislation against Counterfeit Medicinespdf " 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 Productpdf(85 KB)", 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 Counterfeitingpdf(395 KB)" held in Brussels on 14 May 2007

29/11/2006

DG Entreprise study on Distribution Chanels : Part I Combating Counterfeit Medicinespdf(216 KB)

6/09/2006

Resolution of the European Parliament on Counterfeit medicines

27/03/2006

Press Release IP/06/375
Commission warns about fake drugs on the internet

Delegated act on the detailed rules for a unique identifier for medicinal products for human use, and its verification - Concept paper submitted for public consultation
pdf(93 KB)
new legislation on falsified medicines pdf(823 KB) Choose translations of the previous link български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) italiano (it) latviešu valoda (lv) lietuvių kalba (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv) hereQuestions & Answers pdf(22 KB) Choose translations of the previous link Deutsch (de) français (fr)

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