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    European Regulatory Roundup: UK Starts Risk-Based Inspections of Online Pharmacies (9 March 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. UK Starts Risk-Based Inspections of Online Pharmacies After Finding bad Actors The United Kingdom has initiated a risk-based inspection program targeting online pharmacies and healthcare service providers. Officials at the Care Quality Commission (CQC) began the operation after urgent inspections of two digital providers of primary care and a review of 43 other services rais...
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    New FDA Guidance for First Responders as Track-and-Trace Requirements Take Effect

    Beginning Tuesday, the delayed implementation of product tracing requirements for pharmacies will take effect, and the US Food and Drug Administration (FDA) on Monday issued final guidance saying it will not take action against first responders who fail to obtain tracing information. Background On 27 November 2013, the Drug Supply Chain Security Act (DSCSA) was signed into law, putting forth new definitions and requirements related to pharmaceutical product tracking and...
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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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    India’s CDSCO Looks to Crack Down on Online Drug Sales

    An Indian government committee is looking to stem the spread of illegal sales of prescription medicines online. The prevalence of such illegal online pharmacies is pushing India’s Drugs Consultative Committee (DCC) to consider amending the country’s prescription drug law – known as the Drugs and Cosmetics Rules, 1945 – to stop the spread of websites willing to sell medicines without a prescription in India and abroad. According to a summary of the committee’s meeting fr...
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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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    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...
  • New Bill Hopes to Curb Drug Shortages, Price Gouging

    • 23 May 2012
    A new bill proposed by Rep. Elijiah Cummings aims to curb drug shortages resulting from so-called "gray market" drug sales where companies purchase stock of medicines experiencing shortages and exorbitantly mark up prices to subsequent purchasers. "Nobody should be allowed to engage in profiteering at the expense of children and adults with cancer or other critical illnesses by jacking up the price of drugs that are in critically short supply," said Cummings.  ...
  • Brazil: Consultation Opened On OTC Drugs

    The public consultation on allowing the placement of over-the-counter (OTC) medicines for direct consumer purchase in pharmacies, rather than purchase from behind the counter was opened on 13 April 2012 ( Public Consultation 27/2012 ).  The proposal would implement the recommendations of an expert group that found that the restrictions imposed on access to OTC drugs in 2010 has led to "greater market concentration" for certain of the products. Read more: ANVIS...
  • Brazil: New Rules on Pharmacies and Wholesale Distributors

    The same company can now own pharmacies as well as drug distribution centers, as long as the activities are conducted in separate establishments, according to regulations issued by Brazil's national regulatory agency, ANVISA, on 26 March. Companies that apply for permission to distribute drugs must comply with the requirements of Good Distribution Practice and Storage established by ANVISA. Before engaging in an additional activity, a company must first obtain an ANVISA...