Euro Roundup: MHRA sets guidance on importing medicines into Northern Ireland
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance on the importation of medicines into Northern Ireland before 31 December, in response to a European Commission notice on “markets historically dependent on medicines supply from or through Great Britain.”As part of the Brexit process, European authorities recognized that the historical reliance of Cyprus, Ireland, Malta and Northern Ireland on medicinal products from Great Britain meant those markets may need additional time to adapt to the changes. In January, the Commission published guidance on how the regulatory flexibility will work in practice, in which it said the industry must notify MHRA about medicines imported into Northern Ireland.
MHRA has followed up with guidance stating that companies with products approved in the UK before 31 January 2021 have a justifiable reason for using the flexibilities ”where each batch is released by a [Qualified Person] on an EU site, or a UK site demonstrating equivalent standards.”
Companies with products that came to market before the end of the Brexit transition need to tell MHRA if they no longer plan to use the flexibilities made available to businesses trading with Northern Ireland. Companies that want to use the flexibilities should email MHRA their name, marketing authorization, and strength and pack size for each affected product. MHRA also expects companies to explain why the flexibilities are not required.
Similar rules apply to products approved for use in the UK between 31 January and the end of 2021. MHRA said companies in that situation may need the flexibilities “to enable industry to use existing manufacturing and supply chain logistics while the necessary changes are made to ensure continued supply” to Northern Ireland.
The policies set out in the guidance will apply until the end of the year. As it stands, the Commission is set to rescind flexibilities currently provided to markets historically reliant on Great Britain after 31 December.
MHRA published the advice days after updating its guidance on the implementation of the incoming medical device and in vitro diagnostic regulations in Northern Ireland. The updated guidance has a new section on importer requirements. Individuals and companies bringing products into Northern Ireland from Great Britain will be treated as importers under the regulations, exposing them to legal, labeling and registration requirements.
MHRA Guidance, More
Ireland updates guides to good distribution practices, wholesale authorizations
Ireland’s Health Products Regulatory Authority (HPRA) has updated its guides to good distribution practices (GDPs) and applications and variations to wholesale authorizations.
The updated guide to wholesale distribution features a new section on the general requirements needed for HPRA authorization. HPRA expects companies to have a permanent physical site where wholesaling activities take place in Ireland. The agency must be able to access wholesaling activity records onsite at all times. Sites must have “sufficient staff” with a thorough understanding of their roles who are continuously contactable and able to help HPRA with unannounced inspections.
HPRA updated its GDP guide with additional information on sourcing exempt medicinal products (EMP). The revised version states wholesalers can procure an EMP from a third country and supply it to a customer in Ireland without taking physical receipt of the product “in justified circumstances.”
That option is available to wholesalers trading products that are short dated or destined for use in response to “an exceptional urgent patient need.” Wholesalers retain regulatory responsibility for an EMP even if they never physically possess the item and must have “an alternate means of verifying the details of the physical product supplied, to ensure the necessary quality checks are complete and notification to the HPRA EMP database is accurate.”
Other changes to the GDP guide include the addition of text mandating the translation of documents originally not in English by independent and certified translators.
Wholesale Guide, GDP Guide
EMA supports emergency use of Eli Lilly’s anti-SARS-CoV-2 antibodies, starts rolling review
The Committee for Medicinal Products for Human Use (CHMP) ruled on 5 March that Eli Lilly’s anti-SARS-CoV-2 antibodies can be used to treat COVID-19 in certain patients. A rolling review of data on the antibodies was initiated less than a week later, on 11 March.
CHMP concluded the evidence supports the use of the antibodies in combination in patients with COVID-19 who do not need supplemental oxygen and are at high risk of progressing to severe disease. Bamlanivimab monotherapy also can be used.
CHMP’s recommendation provides an EU-level opinion to support national decisions about emergency use of the antibodies as well as support national advice on the use of the antibodies ahead of a marketing authorization.
The recommendations to have implications beyond the EU, according to Eli Lilly CEO David Ricks. “Other countries look to CHMP advice to support their own reviews,” he said. “We hope this opinion will accelerate those reviews and authorizations, particularly in low- and middle-income countries, where Lilly is prepared to provide doses at greatly reduced costs or free of charge.”
The CHMP recommendation comes shortly after the committee issued advice on similar antibodies developed by Regeneron.
Emer Cooke, executive director of the European Medicines Agency, asked CHMP to review the data on bamlanivimab and etesevimab under Article 5(3).
EMA Notice, Rolling Review, Press Release
EMA starts rolling review of Sputnik V COVID vaccine
EMA initiated a rolling review of Russian COVID-19 vaccine Sputnik V on 4 March following weeks of claims and counterclaims about the status of the regulatory submission.
Viral vector vaccine Sputnik V is authorized for use in scores of countries but already has a contentious history in the EU. Last month, EMA issued a statement to deny it had received a filing for rolling review. Now, the review has officially started but the volatile mix of geopolitics and public health continues to cause problems.
This week, the developers of Sputnik V demanded a public apology from EMA after the chief of the agency’s management board said she would advise against member states authorizing the vaccine before an EU-wide decision is reached. Meanwhile, European politicians have questioned the quality of the data on Sputnik V.
EMA Notice
SIngapore supplants India as main source of illegal imports into Switzerland
Singapore has replaced India as the leading country of origin for illegal imports of medicinal products into Switzerland. The change marks the first time a country other than India has topped the Swiss Agency for Therapeutic Products (Swissmedic) list.
The enlarged role of Singapore in the supply of illegal medicines into Switzerland was partly due to suppliers using the city-state as a delivery hub. In October, German authorities arrested two people suspected of procuring illegal pharmaceuticals from Asia and shipping them worldwide from a hub in Singapore. Swissmedic cited the case in its explanation of the rise of Singapore.
Other aspects of the data on seizures in 2020 are in line with earlier years. Amid the pandemic, the number of seized imports fell 13%. Erectile stimulants again accounted for around 90% of seized shipments. Swissmedic highlighted purported herbal products that contain active pharmaceutical ingredients as a particular concern.
Swissmedic Notice