Euro Roundup: EMA explains how tweaked Brexit deal will affect medicinal products

The European Medicines Agency (EMA) has answered nine questions on how the revised Brexit rules apply to centrally authorized medicinal products for human use that are sold in Northern Ireland.

Under the original Brexit agreement, EU pharmaceutical law continued to apply in Northern Ireland after the UK left the union, creating challenges for trade and situations in which medicines were approved in one part of the UK but not another. Last year, the European Commission and the UK agreed on changes to fix these problems.

The Windsor Framework and follow-up EU regulations describe the rules relating to medicinal products for human use intended to be placed on the market in Northern Ireland. The regulations will apply from the start of 2025, provided the UK gives the Commission certain written guarantees by that date.

EMA has published a question-and-answer document to provide practical guidance on the revised Brexit agreement. In the document, the agency explains that the regulation passed last year applies to all human medicines in Northern Ireland; veterinary medicines are outside its scope.

Human medicines can only be put on the market in Northern Ireland if authorized by UK bodies, EMA wrote. UK rules also apply to the supervision of medicines. A temporary process that allowed the UK to authorize products that lack EU approval in Northern Ireland for up to six months will be deleted once the new regulations take effect.

Centrally authorized products that are lawfully put on the Northern Ireland market before the regulation takes effect can stay on the market until their expiry date without having to comply with the terms of the new agreement. The flexibility frees companies from removing safety features or adding “UK only” labels to products that are put on the market before the regulations are applied.

The flexibility also applies to multi-country packs, products that are labeled so they can be sold in several EU countries with the same packaging. Once the regulations take effect, multi-country packs between Northern Ireland and member states will no longer be possible. EMA advises companies that sell such packs to “consider taking the appropriate measure” before applying the regulations.

Other marketing authorization holders need to act before the deadline, too. The regulation will make references to the local representative for Northern Ireland in the product information obsolete. EMA asks companies to update the information during variation or renewal procedures “as of [the date of application] and at the earliest opportunity.”

Another response explains that “parallel distribution notices for centrally authorized human medicinal products with the UK as the only destination country with respect to the territory of Northern Ireland will no longer be valid.” The UK will be removed from notices when it is one of multiple destinations.

EMA Q&A

Generic drug trade group warns wastewater plan ‘massively underestimates’ costs

A generic drug trade group has urged the European Council and Parliament to push for changes to an EU wastewater directive that it believes is “profoundly unfair” and “massively underestimates” costs.

The Urban Wastewater Treatment Directive currently debated by EU bodies features the extended producer responsibility (EPR) system. The system is designed to make the pharmaceutical and cosmetic industries cover the cost of treating and monitoring micropollutants. The proposal is underpinned by a belief that the two industries are the primary sources of the pollutants in urban wastewater.

Medicines for Europe, which represents manufacturers of off-patent medicines, is “deeply concerned” about the EPR system. Some of the concerns apply to on- and off-patent medicines. The trade group said the system makes pharma and cosmetics manufacturers cover the cost of treating pollution other industries generate. Quoting estimates from the German Environmental Agency, the trade group calculates the annual cost could be around four times as much as the European Commission’s prediction.

Other grievances are specific to generic medicines, which the trade group said account for around 70% of EU prescriptions and 29% of pharmaceutical spending. Manufacturers of cheap, low-margin generics will be affected by the EPR systems while companies selling some expensive branded medicines will be exempt, Adrian van den Hoven, Director General at Medicines for Europe, said.

“The most expensive and profitable drugs will contribute almost nothing, and other industrial sectors responsible for micro-pollutants will pay nothing. This is really concerning also for patients, who rely on essential medicines to manage their conditions and already face challenges with shortages. This certainly will not improve that,” van den Hoven said.

Van den Hoven wants EU bodies to agree to certain safeguards introduced by the Parliament and adopt targeted measures to protect essential generic medicines, for example, by factoring sales, rather than just volumes, into fee calculations and allowing member states to opt out of EPR to ensure the availability of critical products.

Press Release

Swissmedic orders corrective measures against devices covered by old certificates

The Swiss Agency for Therapeutic Products (Swissmedic) has ordered corrective measures after authorized representatives continued to place devices issued by an obsolete notified body on the market.

In 2020, authorization to certify medical devices, including high-risk cardiovascular products and orthopedic implants, expired for German notified body ECM. Swissmedic noticed that medical devices from foreign manufacturers continued to be put on the Swiss market under ECM certificates, leading it to inform 980 authorized representatives last June of the expiry of ECM’s notified body status.

Months later, Swissmedic assessed a sample of 15 authorized representatives, seven of whom were found to have devices covered by ECM certificates in their portfolios. The finding triggered a response from Swissmedic.

“Despite prior communication, neither suitable measures had been taken nor had the matter been clarified with Swissmedic in another way. Swissmedic is ordering corrective measures for such authorized representatives to ensure that the devices placed on the market in Switzerland fulfill the requirements of the therapeutic products act,” the regulator wrote.

Swissmedic added that “some authorized representatives do not observe their responsibilities to a sufficient extent.” The agency reminded the representatives of their responsibilities and liabilities.

Swissmedic Notice

European Commission publishes dashboard of data on adoption of MDR, IVDR

The European Commission has published a dashboard of the data gathered through assessments of the availability of medical devices and in vitro diagnostics (IVDs) in the context of the new regulations.

The dashboard presents the results to date from a three-year study on the availability of medical devices, alongside data the Commission collected in previous studies of notified bodies.

One tab on the dashboard presents data on the Medical Device Regulation (MDR). The figures show how the number of MDR filings and certificates and the reasons for refusal of applications have changed over time. Another tab shows equivalent data for IVDs.

The dashboard currently focuses on notified body data but will be expanded over time to cover the results of prior and upcoming surveys of manufacturers and authorized representatives, health service providers, patient representatives and competent authorities.

Commission Notice

Euro Roundup: EMA explains how tweaked Brexit deal will affect medicinal products

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