With a post-transition Brexit looming on the horizon, the Medicines and Healthcare products Regulatory Agency (MHRA) have recently published guidelines relating to new rules dealing with, amongst other things, medical devices and medicines, which need to be complied with from 1 January 2021. In this note, we unpack some of the main points included in the guidance relating to the regulation of existing centrally (EU) authorised medicines and the importing of medicines into the UK.
During early September 2020, the MHRA published a variety of guidelines on its website (accessible here), which shed some light on the post-transition regulation of a variety of topics in the UK, such as clinical trials, medical devices, licensing, importing and exporting of medical devices, active substances and medicines, IT systems and pharmacovigilance matters. These guidelines are subject to change while the underlying legislation is still subject to parliamentary approval.
From 1 January 2021, the MHRA shall, for purposes of the UK, take all decisions and carrying out any functions which were previously taken or carried out by the European Medicines Agency (EMA) at EU-level; except for decisions on Marketing Authorisation (MA) applications to be made via EU procedures for purposes of marketing medicines in Northern Ireland.
Existing centrally authorised medicines in Great Britain
On 1 January 2021, all existing centrally authorised EU MAs will, for purposes of the supply of medicines in Great Britain, be converted automatically into UK MAs. Such UK MAs will be valid in Great Britain and a UK MA number will be allocated. Existing centrally authorised EU MAs shall remain valid for marketing products in Northern Ireland. MA holders may elect to opt-out of such automatic conversion by latest 21 January 2021 and doing so would prevent such product from being marketed in Great Britain.
To handle the ongoing regulation of the converted MAs for purposes of Great Britain, the MHRA requires certain data pertaining to the product to be submitted by latest 31 December 2021 (see further here for guidance on what data is required and how to submit it to the MHRA). Until such data is submitted and processed by the MHRA, it will not generally be possible for MA holders to renew and/or submit variations in respect of such converted MAs.
With regard to renewals, converted MAs are treated as if they were granted on the date on which the corresponding EU MA was granted. The converted MA will accordingly have the same renewal date in the UK as in the EU. Generally, once the abovementioned data is submitted to the MHRA, the normal renewal application process for national MAs and fees will apply.
Although MA holders won’t incur any fees for the automatic conversion process, as with all national MAs, an annual service fee will be due for converted MAs from 1 April 2021, unless, of course, the MA holder opts out of the automatic conversion by 21 January 2021.
Once the EU MA has been converted, MA holders have until 1 January 2023 to establish and register a Great Britain presence for such converted MA. As regards packaging, amended artwork will need submitting for approval to accommodate the following new administrative information: name and address of MA holder or representative; Great Britain MA number; and the name and address of product manufacturer for batch release. MA holders further have until 1 January 2024 to ensure all products released to market are in compliant packaging. For additional information regarding packaging, please see here.
Importing medicines into Great Britain
The MHRA guidance also addresses the importing by wholesale dealers of various categories of medicines into Great Britain from certain approved, listed countries (see here for the ‘listed countries’, essentially the EEA Member States, at least currently).
From 1 January 2021, the guidance provides that a wholesale dealer in Great Britain may only import medicines from the EEA that have been batch certified by an EU Qualified Person (QP), and once certain verifications have been made by the so-called Responsible Person (import) (RPi). The RPi is a newly introduced role player (see further here for some guidance regarding the role of a RPi). This role is in addition to the existing ‘Responsible Person’ (RP) function.
Generally, the guidance further states that (existing) UK wholesaler dealer’s licences (WDL) will remain valid from 1 January 2021. A wholesaler dealer, who wishes to import into Great Britain a medicine from a listed country, for use in Great Britain, must:
- within 6 months from 1 January 2021, notify the MHRA in writing of the intention to continue to import medicinal products from a listed country; and
- within 2 years from 1 January 2021, nominate and have named on the WDL a RPi.
Although this is not made too clear in the guidance, based on the above, with regard to existing WDLs, it appears that there is a transition period of 2 years during which an existing WDL holder can nominate a RPi for purposes of such WDL. Presumably, for purposes of new WDLs issued on or after 1 January 2021, a RPi must be in place.
The below table summarises some of the more important points relating to the importing of medicines into Great Britain from a listed country (for further information, see here):
|Category of medicine imported from a listed country||WDL required?||RPi required?||Further comments|
|Medicine with UK or Great Britain MA, for use in Great Britain, imported without QP certification||Yes||No||If there is no QP certification from a listed country, then QP certification under a UK manufacturing and import authorisation is required before being placed on the Great Britain market|
|‘Specials’ medicine without a UK, Great Britain or listed country MA||Yes||No||Ordinary RP required. The current notification of intent to import an unlicensed medicine remains the same|
|Medicines with a listed country MA (but not a UK or Great Britain MA)||Yes||Yes||The current notification of intent to import an unlicensed medicine remains the same|
|Medicines without a listed country MA (also no UK or Great Britain MA)||Yes||No||Ordinary RP required. The current notification of intent to import an unlicensed medicine remains the same|
|Medicines with listed country MA, for export as an ‘introduced’ medicine||Yes||Yes||Need to hold a WDL that authorises both import and export|
|Medicines without a listed country MA, for export as an ‘introduced’ medicine||Yes||No||Ordinary RP required. Need to hold a WDL that authorises both import and export|
|Medicines with listed country MA, for supply to the Great Britain Parallel Import market||Yes||Yes||The imported medicine must have the appropriate MA in a listed country for the designed Great Britain parallel import (PLPI) licence|
|Medicine without a UK or Great Britain MA sourced from Northern Ireland, for use in Great Britain||Yes||No||Ordinary RP required. The current notification of intent to import an unlicensed medicine remains the same|
With regard to batch release certification of products imported into the EU from the UK, based on the guidance available at this stage, it appears that there are currently no envisaged concessions from an EU perspective towards a more simplified system of recognising UK batch release certification.
From a practical perspective, the above changes may present some challenges to MA holders and other entities wishing to supply medicines in Great Britain after 1 January 2021. They are encouraged to review the MHRA guidance and to ensure that their businesses are ready for a post-transition Brexit UK.
Please do not hesitate to contact us should you require any assistance with making sense of the MHRA guidance and how it applies to your business.
(Last updated 28 September 2020)