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Home > Pharmacist > Counterfeit Medicines

Counterfeit Medicines

Counterfeit medicines and devices: MHRA

This section provides information on how we are tackling the problem of counterfeit medicines and medical devices.

Source: webarchive.nationalarchives.gov.uk
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Directive 2011/62/EU of the European Parliament and of the Council
of 8 June 2011

amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products

Source: ec.europa.eu
Pharmacy Resource: Directive
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Last Checked: 04/11/13 Link Error: Report It

 

Q&A: Directive on falsified medicines

Source: europa.eu
Pharmacy Resource: Questions and Answers
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Last Checked: 04/11/13 Link Error: Report It

 

The Falsified Medicines Directive : MHRA

  • Background
  • Brokers of finished medicinal products
  • Legislation
  • Importation of active substances
  • Importing medicinal products for export (introduced medicines)
  • Registration of manufacturers, importers and distributors of active substances
  • Safety features
  • Sales of medicines at a distance to the public
Source: webarchive.nationalarchives.gov.uk
Pharmacy Resource: Various
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Last Checked: 23/02/15 Link Error: Report It

 

FIP (International Pharmaceutical Federation) Statement of Policy on Counterfeit Medicines

Source: fip.org
Pharmacy Resource: Statement
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Last Checked: 04/11/13 Link Error: Report It

 

IFPMA Statement under WHA 66 agenda item 17.1 on Substandard / spurious / falsely-labelled / falsified / counterfeit medical products

Source: ifpma.org
Pharmacy Resource: Statement
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Last Checked: 04/11/13 Link Error: Report It

 

White Paper on “The Anti-Counterfeiting of Medicines”
European Federation of Pharmaceutical Industries and Associations Anti- Counterfeiting Group

EFPIA issued its original White Paper on “The Anti-Counterfeiting of Medicines” in November 2005. That paper focussed on the need to further develop European legislation against counterfeit medicines as well as on effective and affordable solutions for transparent supply chain control. This updated EFPIA White Paper is intended to express the views of the European-based innovative pharmaceutical industry associated within the EFPIA to combat counterfeiting effectively.

Source: efpia.eu
Pharmacy Resource: Position Paper
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Last Checked: 04/11/13 Link Error: Report It

 

Falsified Medicines and the Global Public’s Health

This report was researched and written by Dr Usman Kahn and Stephan Kreutzer of Matrix Insight and Dr Jennifer Gill and Professor David Taylor of the UCL School of Pharmacy.

Against this background this brief report examines issues relating to the control and prevention of falsified medicines supply, and the related public health protection and improvement roles of the World Health Organisation and other ‘UN system’ agencies.

Source: ifpma.org
Pharmacy Resource: Report
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Last Checked: 04/11/13 Link Error: Report It

 

Pharmaceutical crime

We are seeing a significant increase in the manufacture, trade and distribution of counterfeit, stolen and illicit medicines and medical devices. Patients across the world put their health, even life, at risk by unknowingly consuming fake drugs or genuine drugs that have been doctored, badly stored or that have expired.

Source: interpol.int
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Last Checked: 04/11/13 Link Error: Report It

 

ESM (European Stakeholder Model): ensuring patients have access to safe medicines

Guaranteeing the safety and security of the pharmaceutical supply chain has become a growing concern for all. The risk of counterfeit medicines entering the legitimate supply chain is now greater than ever before and has begun to raise concerns over the capabilities of the present supply chain system to deal with more sophisticated and structured criminal activities.

Source: esm-system.eu
Pharmacy Resource: Publication
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The role of hospital pharmacists in counterfeit medicines

Pharmacists are the key to patient safety with regard to medication. Hospital pharmacists can play a major role in the fight against counterfeit medicines not only by ensuring the safety of medicines but by reporting suspicious cases and raising the awareness of the general public.

Source: eahp.eu
Pharmacy Resource: Journal Article
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Last Checked: 04/11/13 Link Error: Report It

 

Counterfeit medicines – it will never happen to me

There are two kinds of medicine: quick acting and long lasting, and we have to decide whether we want to feel better now or later. But there is another, counterfeit medicine, and this one is not funny at all. The risk is that, at best, it will never make you feel better. At worst, it will kill you.

Source: eahp.eu
Pharmacy Resource: Journal Article
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Last Checked: 04/11/13 Link Error: Report It

 

IFPMA'S 10 Principles on Counterfeit Medicines

Source: ifpma.org
Pharmacy Resource: Infographic
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Last Checked: 04/11/14 Link Error: Report It

 

Council of Europe European Directorate for the Quality of Medicines and HealthCare (EDQM) and the Directorate General of Human Rights and Legal Affairs, Criminal Law Division UN Internet Governance Forum (IGF), Sharm El Sheik, 15-18 November 2009 Workshop “Medicines on the web – risks and benefits”

The workshop, co-organised by the Council of Europe EDQM and the Criminal Law Division, dealt with health protection of the internet user from counterfeit medicines and other illegal offers of pharmaceuticals and healthcare products via the internet through empowerment of the internet user, establishment of best practices and regulatory policies, and, where necessary, legal instruments for combating counterfeiting of medicinal products and similar crimes threatening public health, where necessary.

Source: edqm.eu
Pharmacy Resource: Workshop Report
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Last Checked: 19/10/15 Link Error: Report It

 

New mandatory logo for selling medicines online

From 1 July anybody in the UK selling medicines online to the general public needs to be registered with the MHRA and to be on the MHRA’s list of UK registered online retail sellers.

Source: gov.uk
Pharmacy Resource: Press Release
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Last Checked: 25/06/15 Link Error: Report It

 

Safe internet buying of medicines: why and how pharmacists should help

The impact of the Internet on the delivery of healthcare services is phenomenal. People’s ability to assess risk has not changed, so we become vulnerable to new ways of exploitation. An understanding of thought processes may enable us to change the “it will never happen to me” mentality!

Source: eahp.eu
Pharmacy Resource: Journal Article
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Last Checked: 04/11/13 Link Error: Report It

 

Internet Sales and Access to Safe Medicines

As more and more patients look to the Internet for the supply of medicines, IFPMA, PhRMA, EFPIA, and JPMA are united in the effort to protect their safety. We are committed to promoting access to safe and efficacious medicines, advocating for robust patient education and awareness, and combating unsafe medicines, including those sold by illegitimate online drug sellers that circumvent laws, regulations and pharmacy standards put in place to protect patients and their health.

Source: ifpma.org
Pharmacy Resource: Statement
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Last Checked: 04/11/13 Link Error: Report It

 

Model Approach "Counterfeit Medicines in Europe: Risk Communication Strategies for Drug Regulatory Authorities"

At its 2nd meeting on 28 and 29 October 2008, the Council of Europe EDQM Committee of Experts on minimising public health risks posed by counterfeiting of medicines and related crimes endorsed inviting the WHO IMPACT Working party “Communication” to submit the enclosed document comprising a model approach “Counterfeit medicines in Europe: risk communication strategies for Drug Regulatory Authorities” for a possible endorsement at the 3rd General Meeting of WHO IMPACT, Hammamet, Tunisia, on 3-5 December 2008.

Source: edqm.eu
Pharmacy Resource: Model Approach
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WHPA Counterfeit Medical Products Campaign

The World Health Professions Alliance WHPA is extremely concerned about the infiltration and sale of counterfeit medical products of the legitimate supply chain in causing life threatening, adverse effects in patients. With WHPA “Be Aware, Take Action” we provide dentists, nurses, pharmacists, physicians and physical therapists with tools and strategies to advocate for appropriate investments in the education and capacity building of health professionals to detect counterfeits and to safely inform colleagues and patients.

Source: whpa.org
Pharmacy Resource: Campaign Materials
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Last Checked: 04/11/13 Link Error: Report It

 

Partnership For Safe Medicines

Counterfeit drugs are a serious patient safety problem. The Partnership for Safe Medicines is working together to protect the safety of your prescription drugs.

The Partnership for Safe Medicines is a group of not-for-profit organizations and individuals that have policies, procedures, or programs to protect consumers from counterfeit or contraband medicines. Corporate entities play a role in the Partnership by supporting our programmatic work.

Source: safemedicines.org
Pharmacy Resource: Various
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Last Checked: 04/11/13 Link Error: Report It

 

European Alliance for Access to Safe Medicines

The European Alliance for Access to Safe Medicines (EAASM) is an independent, pan-European initiative dedicated to protecting patient safety by ensuring access to safe and legitimate medicines. The Alliance was formed by a cross-section of European stake-holders from a variety of backgrounds. Its key activities include campaigning for the safer use of unlicensed or off-label medicines and also the exclusion of counterfeit and substandard medicines from the supply chain, raising public awareness around such issues, and promoting effective legislation and enforcement in relation to falsified medicines.

On this website you will find a wealth of information about counterfeit and substandard medicines. Our top tips section will help you to reassure yourself that the prescription medicine you are buying is genuine. Our news section will provide you with the latest news on counterfeit medicines in Europe and around the world as well as updates about the EAASM activities. The EAASM constantly updates and adds useful resources to the website so you can get as much information as possible about obtaining safe medicines.

Source: eaasm.eu
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WHO | International Medical Products Anti-Counterfeiting Taskforce — IMPACT

Responding to the growing public health crisis of counterfeit drugs, in February 2006, the World Health Organization launched the International Medical Products Anti-Counterfeiting Taskforce (IMPACT). At its core, IMPACT aims to build coordinated networks across and between countries in 0rder to halt the production, trading and selling of fake medicines around the globe. IMPACT is a partnership comprised of all the major anti-counterfeiting players, including: international organizations, non-governmental organizations, enforcement agencies, pharmaceutical manufacturers associations and drug and regulatory authorities.

Source: who.int
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Pharmaceutical Security Institute

The Pharmaceutical Security Institute is a not-for-profit, membership organization dedicated to:

Protecting the Public Health
Sharing Information on the Counterfeiting of Pharmaceuticals
Initiating Enforcement Actions through the Appropriate Authorities

Source: psi-inc.org
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Fight The Fakes

Fight the Fakes is a campaign that aims to raise awareness about the dangers of fake medicines. The campaign gives a voice to those who have been personally impacted and shares the stories of those working to put a stop to this threat to public health. It seeks to build a global movement of organizations and individuals who will shine light on the negative impact that fake medicines have on people around the globe and to reduce the negative consequences on individuals worldwide.

Fight the Fakes partners endorse the campaign and share the belief that coordination among all actors involved in the manufacturing and distribution of medicines is vital to tackle this public health threat.

As part of this effort, Fight the Fakes www.fightthefakes.org is collecting and sharing the stories of those who are impacted by fake medicines and are speaking up. The website also serves as a resource for organizations and individuals who are looking to support this effort by outlining opportunities for action and sharing what others are doing to fight fake medicines.

Source: fightthefakes.org
Pharmacy Resource: Campaign
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Last Checked: 09/12/13 Link Error: Report It

 

Counterfeit medicines

The issue of counterfeit medicines was mainly associated with developing countries, however it has now become of significant concern world-wide. While the exact extent of the problem is still unknown, the prevalence of counterfeit medicines is increasing, with a shift in focus from life style medicines to life saving medicines. As compared to 2005 the EU registered an increase of 380% of counterfeit medicines seized at EU borders in 2007.

Source: mcppnet.org
Pharmacy Resource: Journal Article
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Last Checked: 04/11/13 Link Error: Report It

 

Counterfeit Medicines & Patients’ Safety - A global threat
Thalassaemia International Federation

The Thalassaemia International Federation (TIF) has focused attention for some time now and continues to do so, on the need for more strengthened and coordinated actions towards ensuring patients’ safety by protecting them against what WHO refers to as counterfeit/substandard/spurious/falsely labelled/falsified medicinal products .

Source: thalassaemia.org.cy
Pharmacy Resource: Position Paper
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Last Checked: 04/11/13 Link Error: Report It

 

Tool for Visual Inspection of Medicines

The tool is designed to help health professionals carry out a visual inspection of medicines for signs of counterfeiting such as improper packaging, labelling or description of dosage.

Source: usp.org
Pharmacy Resource: Checklist
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Framework for a Guide on counterfeit medicines for pharmacists

guide prepared by the EuroPharm Forum Working Group Quality of Medicines

Source: europharmforum.org
Pharmacy Resource: Guide
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The Genuine Danger of Counterfeit Medicines

How counterfeit medicines can affect patients' health in Europe.

Source: youtube.com
Pharmacy Resource: Video
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FIP-IFPMA Brochure: The threat of false friends

Falsified medicines have been found in 124 countries and everybody, whether rich or poor, is at risk of this criminal activity.

Source: ifpma.org
Pharmacy Resource: Brochure
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Watch Out for False Friends

Every day, fake medicines find their way into online and physical pharmacies, hospitals, and street markets. This plague knows no borders. In the best case scenario, fake medicines leave patients with no side-effects but also without a cure.

Source: ifpma.org
Pharmacy Resource: Video
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European Commission: European Union fights fake medicines

Source: ema.europa.eu
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European Commission: Buying medicines online: The wrong click could be fatal

Source: ema.europa.eu
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