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Regulatory Focus™ > News Articles > 2020 > 5 > EU Regulatory Roundup: Regulators warn on COVID products online

EU Regulatory Roundup: Regulators warn on COVID products online

Posted 07 May 2020 | By Nick Paul Taylor 

EU Regulatory Roundup: Regulators warn on COVID products online

Regulatory agencies in Finland, France and Switzerland have posted warnings about the online trade in products for diagnosing, preventing and treating infections with the SARS-CoV-2 virus.
The alert shared by the Swiss Agency for Therapeutic Products (Swissmedic) highlighted online sales of chloroquine, a malaria drug with a similar chemical structure to hydroxychloroquine, as an area of concern. Swissmedic sees medicines sold online for use against COVID-19 as a “major health risk.” To avoid that risk, Swissmedic is asking consumers to only buy online via Swiss mail-order pharmacies.
Swissmedic issued its warning on the same day as it raised concerns about the quality of face masks on sale in Switzerland. The agency raised the concerns about learning people with no experience of the medical products sector are importing and selling face masks. Swissmedic thinks those operators may sell nonconforming or counterfeit face masks that do not provide the expected level of protection.
Days after Swissmedic’s notices, the Finnish Medicines Agency (Fimea) said it had banned from selling a test for anti-SARS-CoV-2 antibodies and fined the company €200,000 ($217,000). Fimea accused the company of repackaging tests meant for professional use and selling them online. The product webpage lacked a clear statement that the tests are not suitable for home use, leading Fimea to become concerned that lay people may generate unreliable results using the kits.
In France, the National Agency for Medicines and Health Products Safety (ANSM) warned the public against buying COVID-19 products online. The warning highlighted Artemisia annua, a plant extract that is being assessed in early stage coronavirus tests, as a particular concern, reflecting the agency’s long-standing criticism of the promotion of the herbal product in the treatment of infections.
Swissmedic, Fimea, ANSM
EU committee calls for UK to take over EMA lease of former London headquarters
A European Parliament committee has called for the United Kingdom government to take over the lease of a building vacated in response to Brexit. The request would free the European Medicines Agency (EMA) from a significant, long-term risk, but adds a potential sticking point to ongoing Brexit negotiations.
EMA entered into a 25-year lease on the building before the UK voted to leave the EU. A subletting deal last year gave EMA a way to cover the €465 million ($503 million) lease; however, the agency remains liable. The liability still could significantly damage EMA’s financial position and, by extension, its ability to carry out its regulatory functions.
Members of the Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) think that is a problem, expressing concerns that EMA “will have to manage a commercial property in a third country and will remain liable for paying rent until June 2039.”
ENVI wants the EU to find a way to release EMA from its “contractual and financial liabilities” and zeroed in on the UK government as an authority capable of delivering a solution. As ENVI sees it, “a sensible long-term arrangement” would be for EMA to assign the contract for its former offices to the UK government.
If EU negotiators take ENVI’s recommendation, the status of the EMA lease could be a chip in discussions with the UK about the post-Brexit relationship. ENVI’s recommendations touch on other potential fault lines in the negotiations.
ENVI wants the UK “to remain dynamically aligned” with the EU on the regulation of pharmaceuticals and medical devices in order to retain access to the single market. While the UK government has at times acknowledged the benefits of ongoing alignment, it has also talked up the prospects of using Brexit to adopt its own policies and regulations. Earlier this year, Dominic Raab, the foreign secretary, said ongoing alignment with EU regulations would “defeat the point of Brexit.”
Raab’s position suggests the UK will struggle to get major free trade deal with the EU. In a statement published after establishing its recommendations, ENVI said the UK will need to commit to “respect EU norms” if it is to secure a “broad and ambitious free-trade agreement.” The deadline for reaching an agreement is 31 December. That deadline can be delayed by up to two years, but only if the UK and EU agree to the extension by 1 July.
ENVI Opinion, More
Finland exempts Bayer and Roche from certain marketing authorization conditions
Fimea has granted exemptions to allow Bayer and Roche to sell foreign language packs in Finland. The exemption reflects the potential for supplies of Betaseron and RoActemra to be disrupted in the absence of special measures.  
Under regulations adopted last year, Fimea can grant a batch-specific exemption from marketing authorization requirements to avert supply shortages. On 1 May, Fimea began publishing details of the exemptions it has granted online. The document currently details exemptions for three products.
Bayer received an exemption for multiple sclerosis drug Betaseron. Fimea granted Roche an exemption for its immunosuppressive drug RoActemra. In each case, the exemption covers the sale of products with foreign language packaging. Fimea granted the same exemption to specialty pharma company Serb for fomepizole, a treatment for oral ethylene glycol poisoning.
Fimea Notice  
MHRA creates side effect reporting site dedicated to coronavirus drugs and devices
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has created a dedicated website for reporting side effects related to COVID-19 interventions. MHRA thinks the site will make it quicker and easier to report adverse events.
With MHRA expecting widespread use of fast-tracked coronavirus drugs, devices and vaccines, it wants to ensure new and emerging risks are identified quickly to support timely regulatory responses. That thinking led MHRA to create a subsection of its existing Yellow Card reporting site dedicated to products used in relation to the coronavirus.
The site features links to the reporting pages and forms for products such as diagnostics, Gilead Sciences’ remdesivir, personal protective equipment and ventilators. In theory, the site could enable users to share details of adverse events faster than via the standard Yellow Card site. 
MHRA Notice, Reporting Site
Dutch MEB switches to digital veterinary medicine filings amid COVID-19 crisis
The Dutch Medicines Evaluation Board (MEB) has switched to digital submissions of veterinary medicine applications and reports in response to the coronavirus crisis.
MEB has in the past encouraged veterinary medicine companies seeking authorization via national procedures to use the Common European Submission Portal. However, MEB has also permitted applicants to send submissions by post to its offices in Utrecht.
Late last week, MEB revealed a change to its policy, telling the veterinary medicine industry to file “applications or reports” digitally. MEB directed organizations affected by the change to its website, noting that “procedures for digital submissions may vary.”
MEB has retained its existing process for the handling of submissions related to human medicines.
MEB Notice
Other News:
The Australia, Canada, Singapore, Switzerland Consortium (ACSS) has outlined plans to extend its work-sharing approaches to the review of COVID-19 vaccines and treatments. As with other ACSS initiatives, the goal is to reduce regulatory duplication and increase the capacity at each of the four agencies. Swissmedic thinks the consortium could expedite development of drugs and vaccines for use against COVID-19. Swissmedic Notice


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