Euro Roundup: New agreement places Northern Ireland regulation back in the UK

Regulation of human medicines in Northern Ireland now are the responsibility of the UK Medicines and Healthcare products Regulatory Agency (MRHA) under an changes to the Brexit agreement finalized by the UK and the EU.
 
Northern Ireland occupied a unique position under original Brexit agreement. While the region remained part of the UK, the European Medicines Agency (EMA) became responsible for human medicines, creating a situation in which a medicine was available in England, Scotland and Wales but not in Northern Ireland. The end of the grace period in 2024 threatened to disrupt the supply of medicines to Northern Ireland, which sources 80% of its drugs from the rest of the UK.
 
Last year, an EU legislative amendment addressed some problems, notably relating to generic medicines, but stakeholders continued to push the European Commission and the UK for a better system.
 
“The UK’s regulator will approve all drugs for the whole UK market, including Northern Ireland, with no role for the European Medicines Agency,” UK Prime Minister Rishi Sunak said in a statement. “That fully protects the supply of medicines from Great Britain into Northern Ireland, and once again asserts the primacy of UK regulation. The same medicines, in the same packs, with the same labels, will be available in every pharmacy and hospital in the United Kingdom.”
 
Now, application of the entire Falsified Medicines Directive will stop in Northern Ireland. The UK framed the change as “ending the unnecessary situation in which ... wholesalers and pharmacies” needed “to keep barcode scanners to check individual labels.” The Commission framed the change differently, noting that the lack of EU safety features on products sold in Northern Ireland will stop the illegal circulation of medicines because they will be easily distinguishable from EU products.
 
Manufacturers in Northern Ireland will retain frictionless access to the EU market, according to the UK government, but steps are in place to stop human medicines intended for sale in the UK from crossing the border. Individual packs of medicines sold in Northern Ireland will carry a UK-only label and the UK “should continuously monitor their placing on the Northern Ireland market,” the Commission said. If the UK fails to meet its obligations, the Commission can unilaterally suspend the new rules.
 
Richard Torbett, chief executive at UK pharma trade group the ABPI, offered a cautious welcome to the deal, saying that “while we wait to see all the details, today’s agreement appears to bring a return to a single UK market for medicines, providing the permanent solution that our members have been calling for.” Torbett added that the industry will need “the right amount of time” to transition to the new rules.
 
Press Release, Government Report, EU Q&A, ABPI Statement
 
EMA starts scientific advice pilot for high-risk medical devices to increase efficiency
 
EMA has begun accepting applications to take part in a scientific advice pilot project for certain high-risk medical devices under which 10 participants will receive free advice on clinical development of class III devices and class IIb active medical devices intended to administer or remove medicinal products.
 
Manufacturers can apply now via EMA's ServiceNow portal. EMA will prioritize devices that target rare diseases, pediatric populations and unmet medical needs, as well as novel technologies that can have a major clinical or health impact. Applications from small and medium-sized enterprises will get “special attention” to ensure smaller organizations are part of the pilot project.
 
EMA published a question-and-answer document explaining that participants will interact with the experts twice, first in a pre-submission meeting to discuss the draft filing, and then before the advice is finalized to clarify the experts’ remaining doubts. The applicant will be told about the doubts in advance to give it time to prepare for the discussion.
 
The agency expects to select the first five applications next month. The pilot will last for around a year, after which EMA will assess the process and the experience. EMA plans to hold a meeting with stakeholders to discuss potential improvements as it works to make the scientific advice procedure more efficient.
 
Press Release, EMA Q&A
 
Swissmedic creates regulations on the use of QR codes, other mobile technologies
 
The Swiss Agency for Therapeutic Products (Swissmedic) has published regulations on the use of mobile technologies for human and veterinary medicinal products. Swissmedic uses packaging QR codes as an example that, given the rapid pace of progress, might apply to other mobile technologies.
 
In the document, Swissmedic explains that QR codes should link only to information that complies with therapeutic products legislation and is “useful, medically necessary, clear and not misleading.” Marketing authorization holders must establish mechanisms to prevent attempted manipulation and use appropriate tools to ensure the information is accessible.
 
QR codes can link to required information such as approved packaging materials or to additional information including instructional videos. Additional information must carry a description, such as the script of an instructional video, and “be justified on medical grounds and beneficial to users.”
 
Swissmedic also addressed adding QR codes to authorized products, explaining that a variation must be submitted, and the process for changing existing QR codes. If the changes were triggered by updates to the required information, the authorization holder must implement the revisions itself. A variation filing is only needed if the changes affect the additional information.
 
The guidance came into force on 1 March.
 
Swissmedic Notice
 
Notified bodies create best practice guide for submitting IVDR technical documents
 
The European Association for Medical devices of Notified Bodies (Team-NB) has published best practices for the submission of certain technical documents under the In Vitro Diagnostic Regulation (IVDR).
 
Annexes II and III of IVDR describe technical document requirements. Individual notified bodies drew up best practice guidance documents based on the annexes and submitted them to Team-NB. The trade group created its own guide “to develop a unified approach on the expectations of technical documentation submissions from manufacturers.”
 
The Team-NB guide sets out why technical document reviews are delayed, stating that submissions that lack information needed for conformity assessments and poorly organized applications that make it hard to find information are the main problems. To avoid delays, the guide recommends manufacturers talk to their notified bodies to clarify the requirements related to language and documentation labeling.
 
Other recommendations address the submission itself. Team-NB is advising applicants to present their technical documents “in a clear, organised, readily searchable and unambiguous manner” and “include in particular regulatory references to the applicable regulatory requirements of the EU IVDR.” The guide also advises including complete verification reports and valid justifications for data deficiencies.
 
Team-NB plans to revise the document in two years.
 
Team-NB Notice