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    Falsified Medicines Directive: MHRA Responds to Comments, Addresses Brexit Impact

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) last month responded to comments on its proposal to implement packaging safety features under the EU Falsified Medicines Directive (FMD) .   The safety features, which include requiring a unique identifier comprised of a 2D data matrix code and human readable information and an anti-tampering device on the packaging of certain medicines, are detailed under Commission Delegated Regulation (EU) 2016/16...
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    Millions of Drugs, Medical Devices Detained in 116-Country Operation

    A total of 465 websites are the target of a global operation led by Interpol to crack down on the illegal sale of drugs, including opioids and cancer medications, and has resulted in the detainment of more than 10.1 million illegal dose units of drugs and medical devices.   The US Food and Drug Administration (FDA) also posted seven warning letters on Tuesday as part of the international collaboration dubbed Operation Pangea X, FDA spokesperson Jeremy Kahn confirmed wi...
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    WHO: 1 in 10 Medicines in Developing Countries is Substandard or Fake

    The findings come from two new reports, one looking at data collected from WHO's Global Surveillance and Monitoring System over the last four years and another that pooled data from 100 literature reviews to examine the public health and socioeconomic impact of substandard and falsified medicines. Based on the reports, WHO says that as many as one in 10 medicines sold in low- and middle-income countries is either substandard or falsified, at a cost to the global health s...
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    EU Regulation Requires New Safety Features on Drug Packaging by 2019

    A new regulation will require prescription drugmakers in all but three EU countries to incorporate new safety features on their product packaging by 9 February 2019. The European Medicines Agency (EMA) says these measures will protect patients from falsified and low-quality medicines by guaranteeing authenticity and improving supply chain security. The requirements are described in Commission Delegated Regulation (EU) 2016/161 , published in the Official Journal of ...
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    Book Excerpt: Fundamentals of EU Regulatory Affairs, Seventh Edition, Chapter 8: European Union Falsified Medicines Directive: Requirements and Implications for Multi-Stakeholder Healthcare Delivery

    The following chapter is an excerpt taken from  Fundamentals of EU Regulatory Affairs, Seventh Edition . Objectives Introduce the problem of falsified medicines Define falsified and counterfeit medicines Define active substances and excipients Explain the aims and scope of the Falsified Medicines Directive ( FMD ) Directive 2011/62/EU ) Identify requirements for different stakeholders in the medicines supply chain arising from the FMD ...
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    MHRA Proposal Would Save Industry £5M Annually in Fees

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is proposing to reduce many of the industry fees it collects by 10-15%, and it will introduce a new fee for online pharmacies to cover the cost of implementing the EU Falsified Medicines Directive. Fee Reductions Earlier this year the UK's Department of Health conducted its triennial review of MHRA. As part of the review, the Department of Health recommended MHRA revise its fees to better "align incom...
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    EU Online Pharmacies Required to Display New Logo Next Month

    New rules to help consumers in the EU identify legitimate online pharmacies are set to take effect on 1 July 2015. The rules require online pharmacies operating in the EU to display a "common logo," and register with authorities in the member states they do business in. Background Recognizing the threat to public health and safety posed by falsified medicines sold online, in 2011 the European Parliament and Council adopted Directive 2011/62/EU , also known as the Fa...
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    Poor-Quality Medicines a 'Global Pandemic,' New Research Says

    Poor-quality and falsified medicines are "potentially devastating" to global health, researchers and regulators said on Monday in a collection of articles posted in the American Journal of Tropical Medicine and Hygiene . Background: Counterfeit Drugs Not all poor-quality medicines are created equal. The authors of one of the articles break poor-quality medicines into three categories: falsified (including counterfeit), substandard and degraded. While each of these ca...
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    New Logo to Help EU Regulators Crack Down on Online Peddlers of Fake Medicines

    EU regulators have unveiled a new scheme they say will help European consumers avoid counterfeit or falsified medicines. The scheme involves the use of a logo, which will appear on the websites of all authorized online pharmacies known to provide authentic medicines. But beyond just a logo—which authorities implied could be easily faked—the logos will then be linked to the website of each national regulator, which will maintain a list of all legally operating online ph...
  • EU Regulators Warn of Counterfeit Copies of Cancer Drug Herceptin

    EU regulators have issued a warning that several batches of the cancer medicine Herceptin (trastuzumab) have been "tampered with," falsified and reintroduced into the supply chain, potentially putting patients at risk. Background High-cost cancer medications like Herceptin have become an increasingly tempting target for thieves and counterfeiters in recent years. While they lack the ready market that some drugs like Viagra have, their extraordinary cost means extraordin...
  • Revised EU Distribution Rules Target Falsified Medicines

    The European Commission issued final revised Good Distribution Practices (GDP) guidelines  on 8 March 2013 that are designed to incorporate the requirements of a 2011 Directive that targets so-called "falsified medicines" from entering the legal supply chain of the EU.  A draft version of the revised GDPs was issued for public comment (consultation) in July 2011 by the Commission, which noted at the time that the 1994 version of the GDPs was "no longer adequa...
  • How a Private Anti-Counterfeiting Initiative Could Pressure Regulators to Improve Drug Quality

    What happens when your local regulatory agency isn't known as being reliable or capable at overseeing the safety and quality of products in your country? In at least one country, consumers could soon have a private-sector solution to improve their ability to ensure their medicines are of sufficient quality and identity. That initiative, run by the Partnership for Safe Medicines India Initiative (PSMII), is a side project of the Partnership for Safe Medicines-a coalition ...