The Danish Medicines Agency (DKMA) is temporarily allowing companies to sell face masks that have English, Norwegian or Swedish instructions and labelling in an effort to boost the supply of CE-marked surgical face masks for consumer use.
Last weekend, Denmark mandated the use of face masks on public transport, significantly expanding the contexts in which Danes are expected to wear face masks. DKMA changed its position on the instructions and labelling of masks shortly before the transport change came into effect.
Most people in Denmark should be able to comprehend the instructions and labels. A European Commission survey found 53% of Danes speak English and 7% speak Swedish; the Norwegian language shares many words with Danish, suggesting people could understand written instructions and labels.
Other aspects of the regulations are unchanged: Manufacturers must clearly list their name on the packaging and a CE mark is required. The revised policy is effective until 1 December.
Separately, DKMA is set to free applicants and marketing authorization holders from the need to file a Danish translation of the product information for medicines that come to market via the mutual recognition or decentralized procedures, provided the drug is not sold in Denmark. The change is set to take effect at the start of September.
Applicants that want to sell drugs in Denmark need to submit a Danish translation of the product information within seven days of the completion of the authorization procedures. DKMA will assume companies that miss that deadline do not want to market their products in Denmark. If a company later wants to enter the Danish market, it will need to submit translated materials to DKMA’s licensing division and wait up to three months.
DKMA Notice, More
Remdesivir shortage prompts Spain’s AEMPS to reroute supplies
The Spanish Agency of Medicines and Medical Devices (AEMPS) is rerouting supplies of remdesivir left over from clinical trials to prevent a shortage of the COVID-19 antiviral.
Late last month, AEMPS asked physicians to limit use of Gilead’s remdesivir, which is sold as Veklury, to certain patients to ensure its continued availability. AEMPS said that if physicians only used five-day courses of remdesivir in the subset of hospitalized COVID-19 patients in which it has been shown to work, Spain would have enough of the drug to meet its needs.
Now, with COVID-19 cases rising in Spain, AEMPS issued a statement about its efforts to ensure the availability of remdesivir. Spain has exhausted its supply, leading AEMPS to seek to reroute leftover clinical trial stocks while waiting on a shipment of new doses under a contract with the European Commission.
AEMPS Notice (Spanish)
Stephen Lightfoot named next MHRA chair
The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has appointed Stephen Lightfoot as its next chair. Lightfoot is set to take over from Sir Michael Rawlins at the start of September.
Lightfoot will arrive at MHRA with limited regulatory experience. Lightfoot spent 30 years working for life sciences companies including Daiichi Sankyo, GE Healthcare and Schering Healthcare. Lightfoot became a non-executive director of MHRA in 2015 and is deputy chair of Sussex Community NHS Foundation Trust.
Rawlins, in contrast, spent decades as an academic researcher, in which time he also held positions at UK bodies the Committee on Safety of Medicines, the Advisory Council on the Misuse of Drugs and the National Institute for Health and Care Excellence, where he spent 14 years as chair.
Lightfoot arrives at MHRA in the wake of an independent, government-commissioned review that called for the “substantial revision” of the agency to address perceived failings related to activities including the reporting of adverse events and the regulation of medical devices. MHRA will need to try to make the required changes while contending with the impact of Brexit and COVID-19.
MHRA Notice
France’s ANSM lifts COVID-19 restrictions on stool collection
The French National Agency for Medicines and Health Products Safety (ANSM) has lifted restrictions on the collection and processing of stools for fecal microbiota transplants (FMT) imposed at the start of the COVID-19 pandemic.
ANSM imposed the restrictions in March in response to the discovery of SARS-CoV-2 in the stools of infected individuals. Based on the risk that FMT could potentially transmit the coronavirus to recipients, ANSM advised healthcare professionals to suspend stool collection, quarantine stools collected after 30 January and only proceed with urgent transplants.
Healthcare professionals can now resume the collection of stools with added precautions. Specifically, collected stools, as well as medicines made from them, must be quarantined until validated additional protection methods. Stools and stool-based medicines may need to undergo retrospective testing before being released.
MaaT Pharma, a French developer of stool-derived biotherapeutics, responded to the change in the ANSM’s position by starting a new collection and manufacturing campaign. The campaign will gather materials for clinical trials of MaaT’s experimental medicines.
ANSM Notice (French), MaaT Statement
Ireland’s HPRA creates Patient Forum to exchange information
Ireland’s Health Products Regulatory Authority (HPRA) is creating a Patient Forum designed to improve engagement with patients and better understand their views.
HPRA hopes to create a platform to facilitate the exchange of information between it and patients. HPRA envisages the forum giving patients a greater role in the development of its policies and regulatory activities, while also enabling them to share their perspectives on the current use of medicines and medical devices.
Starting next month, HPRA will pilot the forum with patients and patient organizations to help establish the forum with a mandate, procedures and work program. The forum then will be rolled out to other patients and patient groups.
HPRA Notice
Other News:
The Finnish Medicines Agency (Fimea) has scheduled a horizon scanning event for companies that expect to win approval for a new product or significant label expansion in the year starting October 2020. Fimea is running the virtual event to support the health technology assessment process. Fimea Notice (Finnish)
August 27, 2020 at 10:40PM
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Euro Roundup: Denmark relaxes face mask label rules - Regulatory Focus
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