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    UK, French Regulators Call Out Two Noncompliant Indian Pharma Sites

    UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) and France’s ANSM (National Agency for Medicines and Health Products Safety) have sent notices of noncompliance to two Indian pharmaceutical companies that restrict the dissemination of their products in Europe. In February, ANSM inspected Anuh Pharma’s Maharashtra-based site and uncovered 24 deficiencies, including one that was critical and two that were major. The critical deficiency was linked to the fact...
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    MHRA Halts Kickback Scheme for Independent Pharmacies

    The UK’s Medicines & Healthcare Products Regulatory Agency on Tuesday said that it shut down a scheme whereby independent pharmacists would accumulate personal spending money based on the sales of certain medicines. The regulator said the Bloc Group Limited’s proposed promotional scheme for healthcare professionals was brought to the attention of MHRA. “Independent pharmacies were offered points on the purchase of medicines. These points accumulated on a card and were ...
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    European Regulatory Roundup: EMA Looks to Cut PML Risk in Patients Taking MS Drug Tysabri (18 February 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. PRAC Aims to cut Risk of PML in Patients Taking Biogen’s Tysabri with Frequent MRI Scans The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed its review of Tysabri, the Biogen multiple sclerosis drug associated with increased risk of developing progressive multifocal leukoencephalopathy (PML). To mitigate this danger, PRAC is recom...
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    European Regulatory Roundup: EMA Revises Conflict of Interest Rules for Board Members (21 January 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. PRAC Adopts Strategy to Monitor Effects of Risk-Minimization Measures The Pharmacovigilance Risk Assessment Committee (PRAC) has implemented a strategy to enable it to measure the impact of its activities. Officials have designed the strategy to deliver feedback on the effectiveness of risk-minimization measures and other actions. PRAC, a part of the European Medicines Agen...
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    MHRA Calls for Continued Quarantine of Silimed Implants

    The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) on Friday reiterated its call to quarantine implants manufactured by Brazil’s Silimed, saying it’s still trying to determine if there are potential health risks associated with particles found on the surface of the devices. The caution from MHRA comes a day after Jeffrey Nugent, Sientra chairman and CEO, a US-based supplier of Silimed products, sent a letter to plastic surgeons informing them that an indep...
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    European Regulatory Roundup: EMA Offers New Pharmacovigilance Updates (17 December 2015)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Releases More Pharmacovigilance Documents The European Medicines Agency (EMA) has released a batch of draft pharmacovigilance documents. EMA covers multiple aspects of good pharmacovigilance practice (GVP) in the texts, from changes to a template for direct healthcare professional (HCP) communication, to tweaks to a biologics-focused document. In total, EMA pub...
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    European Regulatory Roundup: EMA Looks to Further Prevent Medication Errors (3 December 2015)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Adopts Batch of Documents Aimed at Preventing Medication Errors The European Medicines Agency (EMA) has adopted a handful of guidance documents designed to prevent the occurrence of medication errors. In the documents, EMA outlines the best practices for minimizing risk, how to code and assess errors and specific concerns relating to insulin and other diabetes medicin...
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    European Regulatory Roundup: MHRA Phasing Out Use of CDs, DVDs in Submissions (30 November 2015)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. MHRA to Stop Accepting Submissions on Physical Media in February The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) is to stop accepting submissions for medicines licenses on physical media on 1 February 2016. MHRA has decided to drop support for physical media after talking to trade groups about the use of the format. Having completed the...
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    PIC/S Elects New Chairman, Adds Croatia’s HALMED as Participating Authority

    The Pharmaceutical Inspection Cooperation Scheme (PIC/S) has elected Paul Hargreaves of the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) as its new chairman for 2016 and 2017. Hargreaves, elected at a meeting in Indonesia last month, will be the fourth PIC/S chairman from the UK and he will follow the departure of Joey Gouws, acting head of South Africa’s Medicines Control Council, who was the first PIC/S chairperson from Africa.   Following the succe...
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    European Regulatory Roundup: EMA Unveils Antimicrobial Strategy (19 November 2015)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Releases Five-Year Antimicrobial Strategy The European Medicines Agency (EMA) has released a document outlining how it plans to ensure the availability of effective antimicrobials for animals while minimizing the risks their use poses to humans. EMA is proposing to restrict the administration of certain antimicrobials to humans. Over the course of the 16-page doc...
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    European Regulatory Roundup: Sweden Limits Availability of Paracetamol (5 November 2015)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Swedish Regulators Limit Availability of Paracetamol Sweden has prohibited the sale of paracetamol tablets outside of pharmacies. The action follows a decision by the Swedish Medical Products Agency (MPA), which ruled in April to limit where the drug is sold in an attempt to curb the rise in paracetamol poisonings.  MPA’s ruling overturned a decision from 2009, at which ...
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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...