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#FalsifiedMedicines – New rules to enhance patients’ safety

#FalsifiedMedicines – New rules to enhance patients’ safety

| February 11, 2019

The falsification of medicines has remained a serious threat to public health in the EU for too long. As of 9 February, the new rules on safety features for prescription medicines sold in the EU will apply. From now on, the industry will have to affix a 2-D barcode and an anti-tampering device on the […]

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European Medicines Verification System #EMVS goes live across EU to better protect patients from falsified medicines

European Medicines Verification System #EMVS goes live across EU to better protect patients from falsified medicines

| February 8, 2019

As of 9 February 2019, the supply chain for dispensing medicines to patients in Europe will become even safer. Prescription medicines dispensed in Europe which bear safety features, will be verified for the authenticity by the European Medicines Verification System (EMVS). The system and its functionalities were mandated by European law under the Falsified Medicines […]

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#Coreper approves #EMA and #EBA relocations

#Coreper approves #EMA and #EBA relocations

| October 18, 2018

On 17 October, the Permanent Representatives Committee (Coreper) approved, on behalf of the Council, an agreement with the European Parliament on the text of the regulations for the relocation of the European Medicines Agency (EMA) to Amsterdam, and of the European Banking Authority (EBA) to Paris, writes Martin Banks.  The two agencies are currently based […]

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MEPs back plans to boost joint assessment of #Medicines

MEPs back plans to boost joint assessment of #Medicines

| October 8, 2018

The new law adopted last week aims to avoid duplicating national assessments to determine a medicine’s added value that help EU countries decide on pricing. MEPs highlight that there are many barriers to accessing medicine and innovative technologies in the EU, the main ones being the lack of new treatments for certain diseases and the […]

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Rare #diseases: When marketing approval simply isn’t enough

Rare #diseases: When marketing approval simply isn’t enough

| January 15, 2018 | 0 Comments

Rare disease patients in Europe got a boost in late December after a European Medicines Agency (EMA) experts’ panel recommended seven medicines for approval, including two orphan drugs, bringing patients closer to new options for alleviating a number of serious conditions. The panel recommended granting a marketing authorization for Alofisel, which treats a severe complication […]

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Medical devices: #Health Committee MEPs approve stricter EU safety requirements

Medical devices: #Health Committee MEPs approve stricter EU safety requirements

  A silicon breast implant – ©AP Images/European Union/EP Plans for stricter monitoring and certification procedures to ensure full compliance and traceability of medical devices, such as breast or hip implants, were backed by Health Committee MEPs on Wednesday. MEPs also approved legislation to tighten up information and ethical requirements for diagnostic medical devices used […]

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#Superbugs: MEPs want to curb use of antibiotics in farming

#Superbugs: MEPs want to curb use of antibiotics in farming

To fight the growing resistance of bacteria to today’s antibiotics, the use of existing antimicrobial drugs should be restricted, and new ones should be developed, said the European Parliament on Thursday (10 March). In a vote on draft plans to update an EU law on veterinary medicines, MEPs advocate banning collective and preventive antibiotic treatment […]

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