LONDON, June 1 (APM) - UK companies with centrally authorised medicines in Europe will likely need to transfer marketing authorisations to a holder in the European Union after Brexit, the EMA said in regulatory guidance over Britain's exit from the EU.
The same will apply to drugs with orphan designation, the regulator said, adding that substances manufactured in the UK will be considered "imported active substances" for European member states.
Companies based in or with activities in the UK are affected.
The British Generic Manufacturers Association's director general Warwick Smith branded the guidance "concerning" on Thursday.
"We have consistently stated that the existence of a single European regulatory system for medicines has generated considerable benefits for patients, the NHS and the industry," he said.
"We have urged both sides in the Brexit negotiations to find a way of maintaining these benefits in the interests of their citizens. It is concerning that the European Commission appears to be unwilling even to try to find a positive way forward in everyone's interests rather than assuming the worst outcome before the negotiations even begin."
The European Medicines Agency's (EMA) Wednesday statement is its first formal guidance on the UK's exit from Europe. The guidance - in the form of a Q&A document - will be followed by a series of other directions on the matter, it said.
This follows an early May statement declaring that unless the UK's timeline for Brexit is changed, "all Union primary and secondary law ceases to apply to the United Kingdom from 30 March 2019, 00:00h (CET). The United Kingdom will then become a 'third country'."
It stressed that the legal consequences of this applies not just to European and national administrations, but also to private parties.
For central EU marketing authorisation and EMA orphan designation, it said the licence-holder concerned must be "established in the Union".
Centrally authorised marketing authorisation and orphan designation holders "will therefore normally need to transfer [their] marketing authorisation to a holder established in the Union (EEA)", it said.
For European market authorisation holders, "this means that the addressee of the marketing authorisation decision changes to the new addressee", the regulator said. The same applies for orphan designation, with the additional option of the company changing its place of establishment to a member state and submitting further orphan designation documentation.
Pharmacovigilance activities - including the qualified person and the pharmacovigilance system master file - must also reside within a member state, it said, noting that these too would have to move from the UK to Europe after Brexit.
Companies with manufacturing sites based in the UK are also affected, since the products produced there will become imported substances.
Manufacturing authorisation holders are allowed to use, as starting materials, "substances that have been manufactured in accordance with the detailed guidances on Good Manufacturing Practice (GMP) for starting materials". However, a written confirmation from UK authorities is required to assure European bodies the standards of GMP are equivalent to Europe's.
"For centrally authorised medicinal products the marketing authorisation holder will… need to specify an authorised importer established in the EEA and submit the corresponding variation," the guidelines add.
Companies will also need to specify a site of batch control within the EEA where each production batch can undergo upon importation a full analysis to ensure products match up with quality requirements. If the batch release site is currently in the UK, it will need to move to a European country, it added.
The guidance is also bad news for small to medium-sized companies currently benefiting from financial and administrative assistance under the EMA's SME programme, since this only applies to companies within the EEA.
After Brexit, these companies can only apply for SME status once they have established a legal entity in the Union.
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