Regulatory Focus™ > News Articles > 2020 > 12 > Euro Roundup: EMA warns ‘large number’ of products still need Brexit-related changes

Euro Roundup: EMA warns ‘large number’ of products still need Brexit-related changes

Posted 17 December 2020 | By Nick Paul Taylor 

Euro Roundup: EMA warns ‘large number’ of products still need Brexit-related changes

A “large number” of centrally authorized products (CAPs) contain UK sites and activities that need to be removed by early next year due to Brexit. Companies have until the end of February to submit the required Type IA variation.
 
The European Medicines Agency (EMA) identified the continued presence of UK sites and activities on the marketing authorization dossiers of CAPs as an area in which the industry still needs to act on a recent webinar. EMA used the webinar to discuss preparations for the end of the transition period that has kept the UK subject to EMA rules in recent months. 
 
EMA also emphasized the need to replace UK representatives with people based in the European Economic Area or Northern Ireland. The agency wants companies to make the change during the first regulatory procedure affecting annexes of 2021. CAPs for human use should only use the Article 61(3) procedure if no amendments to the annexes are planned for 2021.
 
Other required changes will need to take place in narrower time windows. This week, EMA began allowing companies with UK nationally authorized medicinal products to change the country code in their marketing authorizations. Ideally, EMA wants companies to change to “United Kingdom (Northern Ireland)” by the end of the year. The final deadline is the end of January.
 
While there is still work to do, many preparations for the end of the transition period are already complete. EMA said marketing authorization holders for all human CAPs have indicated they will be compliant with EU law and able to place their products on the market by the end of the year. A “very small number” of veterinary medicine manufacturers are yet to confirm compliance.
 
As of the end of November, 23 human and veterinary CAPs still needed to transfer manufacturing activities or change the Qualified Person Responsible For Pharmacovigilance. Companies have until the end of the year to make the changes.
 
Webinar Summary 
 
EU details temporary flexibilities to ease impact of Brexit on medicine supply
 
The EU has shared details of how it will handle medicine regulation in Northern Ireland in 2021 to reduce the risk of disruption to product supply. EU law will apply in Northern Ireland after the rest of the UK completes its split from the union, but authorities want to soften the impact of the changes.
 
In a unilateral declaration, the EU set out three actions it will take to support the continued supply of medicines. The EU will remove the obligation for companies covered by EMA falsified medicine regulation to decommission safety features when they supply products to the UK, removing a barrier to the post-Brexit trade in medicines.
 
Secondly, the EU will allow quality control testing in Great Britain. The provision reflects a belief that small markets historically dependent on Great Britain for medicine supply are “justifiable cases” for the allowance of third-country testing. EMA detailed the “justifiable cases” provision last year.
 
Finally, the EU will hold off on punishing certain legal breaches “arising due to the absence of manufacturing authorization holders in Northern Ireland.” The three flexibilities will apply for up to 12 months. The UK has taken note of the EU declaration.
 
The UK Medicines and Healthcare products Regulatory Agency (MHRA) cited the declaration in new guidance on how Brexit will affect the supply of investigational medicinal products (IMPs) to Northern Ireland.
 
Authorities will take a pragmatic approach to importation throughout 2021. The situation will change at the start of 2022, when IMPs that enter Northern Ireland via Great Britain will be subject to importation controls. Companies can bypass the controls by supplying products from the EU or moving their Qualified Person certification activities.
 
Unilateral Declarations, MHRA Guidance
 
MHRA posts guidance on involvement in Project Orbis and Access Consortium
 
MHRA has shared guidance on the work sharing initiatives it is joining in association with its split from EMA. The UK regulator will join the schemes in January to compensate for the loss of opportunities to share regulatory work with EU countries.
 
Three of the guidance documents cover Access Consortium, the new name for the initiative set up by regulators in Australia, Canada, Singapore and Switzerland to compensate for the fact they represent small markets and lack the direct support of a body such as EMA. MHRA described the group in one of its guidance documents before delving into specifics in the two other texts.
 
One of the other texts addresses Access’ generic medicines work-sharing initiative. Manufacturers can submit identical dossiers for generic medicines to all Access members. A lead agency will prepare assessment reports for review by other Access members. Each agency then independently decides whether to approve the drug. MHRA will only accept applications in the eCTD format.  
 
The third Access text covers the consortium’s new active substance work-sharing initiative, which differs from the generic program somewhat. For example, MHRA explained product labelling is outside of the scope of the joint review process.
 
MHRA released guidance on its involvement in Access on the same day as a text covering its role in the US Food and Drug Administration’s (FDA) Project Orbis. FDA is the primary coordinator for the selection and review of oncology drugs covered by the program. As a partner, MHRA can propose products for inclusion.
 
The guidance details what will happen if the UK participates in a Project Orbis procedure and briefly touches on how the scheme will interact with health technology assessment (HTA) agencies. MHRA said it will collaborate with UK HTAs “within the Innovative Licensing and Access Pathway.”
 
Access Consortium, Project Orbis
 
Swissmedic describes legal barriers to emergency approvals of COVID vaccines
 
The Swiss Agency for Therapeutic Products (Swissmedic) has described how the lack of a legal basis for emergency approvals in Switzerland is shaping its approach to COVID-19 vaccines.
 
Regulatory agencies in countries including the UK, Canada and US have now permitted the use of the COVID-19 vaccine developed by BioNTech and Pfizer. Swissmedic, in contrast, has not yet made a decision, despite being among the agencies to perform a rolling review of the vaccine.
 
One issue is that Switzerland lacks a legal instrument to grant an emergency authorization to a vaccine. Swissmedic is fast-tracking vaccine applications and assigning extra staff to the work but has not yet made a preliminary risk-benefit assessment of the Pfizer vaccine.
 
As of late last week, Swissmedic had reviewed data submitted for rolling review by Pfizer and other vaccine developers and submitted questions for them to answer. Swissmedic is yet to commit to a target for authorizing any of the vaccines.
 
Swissmedic Notice
 
Other News:
 
The French National Agency for Medicines and Health Products Safety (ANSM) has named Christelle Ratignier-Carbonneil as its next director general. Ratignier-Carbonneil has worked as deputy director general since 2016. ANSM Notice (French)

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