The EU guideline on complying with the requirement to affix safety features on medicine packs has been updated to address specific aspects of parallel trade, such as re-sealing of medicine packs that are legally opened to replace patient information leaflets.
The European Commission has issued updated guidance on the safety features – a unique identifier and an anti-tampering device (ATD) - that are required on most medicinal packs from February 2019 under the EU Falsified Medicines Directive. The updated guidance offers advice on the practical implications of this requirement for parallel trade.
It clarifies, among other things, that if a medicinal pack is lawfully opened by a parallel trader/manufacturer under the supervision...
MSD is gearing up to demonstrate the value of its pulmonary arterial hypertension drug, after England’s health technology assessment institute provisionally said the product was not cost-effective. Meanwhile, the company told the Pink Sheet about Winrevair’s reimbursement status across Europe.
The European Medicines Agency’s ongoing pilot to streamline drug reviews by allowing companies to voluntarily pre-fill factual data in assessment report templates appears to add significant workload for industry, without delivering clear value to regulators.
Talks between the UK government and the pharmaceutical industry that were intended to resolve issues around high clawback rates under the voluntary pricing scheme for branded medicines have failed, meaning that the mechanism used to calculate rebates will remain in place.
Europe’s research-based pharma industry group, EFPIA, is pressing EU policymakers to protect innovative medicines after the EU-US trade deal confirmed a 15% tariff on pharmaceutical exports. Generic products, meanwhile, have secured an exemption.
The European Medicines Agency’s ongoing pilot to streamline drug reviews by allowing companies to voluntarily pre-fill factual data in assessment report templates appears to add significant workload for industry, without delivering clear value to regulators.
Talks between the UK government and the pharmaceutical industry that were intended to resolve issues around high clawback rates under the voluntary pricing scheme for branded medicines have failed, meaning that the mechanism used to calculate rebates will remain in place.
After an Aug. 6 safety labeling change, the FDA became aware of “more compelling evidence” that the risk for serious chikungunya-like illness is not limited to older adults, CBER Director Prasad said.
