Brexit – Centralised Procedure

Today we’ll be looking at how licences authorised via the EU centralised procedure are going to be handled.

All existing Marketing Authorisations (MAs) authorised through the centrally authorised procedure (CAP) will automatically be converted into UK MAs. These MAs will be issued with a UK MA number before the end of the transition period.

Companies will receive a letter from the MHRA regarding:  Conversion of Community Marketing Authorisations (CAPs) to Great Britain Marketing Authorisations (MAs).

To facilitate the process, the MHRA will assign a Great Britain Product Licence (PLGB) number to CAPs based on the existing practice for national licences.

As a Marketing Authorisation Holder (MAH) there are several ACTIONS for you:

1. Review the list of your currently authorised CAPs and advise the MHRA as soon as possible of any errors or omissions in that list;
2. Advise the MHRA of any CAPs that you do not want to be converted into Great Britain MAs;
3. Advise the MHRA of the Great Britain marketing status of each of the products (i.e. marketed or not marketed);
4. Advise the MHRA of any product/presentations that have been withdrawn or cancelled;
5. Advise the MHRA of the MAH company number;
6. If possible, provide the MHRA with a single point of contact for all your products.  (In the case of a company group, the MHRA need a contact for each MAH affiliate within that group).

Reply with the number of PLGB numbers you require, if you are intending to do a Change of Ownership (COA) when you submit your baseline submission.  Inform the MHRA which company number prefix to use and the MHRA will allocate the PL number(s) and send an updated list for you to use when submitting the baseline submission.

The email address to use is capconversion@mhra.gov.uk

To help with planning, the MHRA ask that you advise them as soon as possible at capconversion@mhra.gov.uk if you are planning to opt out of having a GB licence for a product (i.e. point 2 in the above list), ideally as part of your full return, or if not via a separate communication to the MHRA.

MAHs can opt-out of the conversion process for all or some of their CAPs by notifying the MHRA in writing by 21 January 2021.  If a MAH chooses to opt-out, after 21 January 2021 their product(s) will no longer be licensed in Great Britain.  This will mean they can no longer be placed on the market in Great Britain.

MAs for CAPs that are not currently marketed in the EU or Great Britain can still be converted to UK MAs.  For the purposes of operating the Sunset Clause, the period of three years will be restarted from the date of conversion to a Great Britain MA.

There is no fee associated with the conversion from a CAP to a Great Britain MA.  In line with existing legislation, the annual periodic fee will be payable for converted CAPs from 1 April 2021.

Questions about this conversion process can be sent to capconversion@mhra.gov.uk

How will applications for Centrally Authorised Products (CAPs) be handled?

The MHRA has issued guidance on grandfathering of CAPs, which covers the issuing of Great Britain MAs for products subject to Community Marketing Authorisations (CMAs) already issued by the European Commission following an application through the European Medicines Authority’s (EMA) centralised procedure.

Currently pending and future applications for Community Marketing Authorisations will continue to include Northern Ireland and, when granted, the authorisation will cover marketing of the product in Northern Ireland.

I have included information below which sets out how the MHRA, acting for Great Britain, is handling centralised applications that were still pending on 1 January 2021.

The handling will be determined by the regulatory route chosen by the company and the stage of the procedure the application was at on that day, as detailed in the table on the MHRA website.

The company has two options:

1. To apply to MHRA for an in-flight assessment of a Great Britain MA in parallel with the application for an EU MA.  In that case the approach of the MHRA will be to take into account any assessment that has already been reported on before 1 January 2021 with a view to completing the application no later than the issue of the EU Commission Decision.
2. To wait for the Commission for Medicinal Products for Human Use (CHMP) positive opinion and to apply to Great Britain using the new Reliance Route as explained in published guidance on new application routes to market. The application will be determined when the EC decision has been confirmed.

In all cases, as the MHRA does not hold supporting data for applications made to the EMA, applicants will need to submit an application and supporting dossier to the MHRA accompanied by all iterations of the CHMP assessment report.  Further guidance is given on the MHRA website.

Northern Ireland in the Centralised Procedure

The EU centralised procedure continues to apply in Northern Ireland.  The centralised procedure results in a single MA to market a product in all EU member states, as well as Iceland, Liechtenstein and Norway and Northern Ireland (NI).

Community Marketing Authorisations – Variations:

Under the Northern Ireland Protocol, Medicinal Products authorised via the centralised route will be directly authorised for use in Northern Ireland.  Any variations to these MAs will be centrally managed by the EMA in accordance with relevant procedures.  A separate MA will not need to be issued by the MHRA for Northern Ireland.

If the same product is separately authorised in Great Britain a separate variation application will need to be submitted to vary that MA.  Type IA notifications can only be processed on the basis of what is actually submitted to the MHRA for Great Britain.  However, for Type IB and Type II variations, if such a variation is submitted for the corresponding Great Britain authorisation, after approval of the identical changes by the EMA, and evidence of this is included with the submission, this will be taken into consideration according to the reliance route for variations.  (A lower fee will be charged.)

Further guidance will be issued by the MHRA on this topic in due course.

A note on Renewals for converted Centrally Authorised Products (CAPS)

• CAPS converted from EU to UK MAs will be treated as if they were granted on the date the corresponding EU MA was granted.
• The renewal date will stay the same.
• Your MAs remain in force until a decision has been made on your renewal applications.

More information can be found here: Guidance on Converting Centrally Authorised Product (CAPS) to UK MAs.