New UK National Procedure – Expedited 150 day procedure
There are now several routes to obtain a marketing authorisation in the United Kingdom (UK), Great Britain (England, Scotland and Wales) or Northern Ireland. The options available will be determined by the intended market and the type of application. In this article we will discuss the purely National procedure.
To help you to decide what type of license you will require, here is a brief explanation of the new types of MA you can obtain:
|MA prefix for UK||Possible MA types||Territory||Leg & Guidance|
|PL||UK wide||Authorised for use in United Kingdom (Great Britain & Northern Ireland)||EU & MHRA rules apply|
|PLGB||GB||Authorised for use in Great Britain only (England, Scotland and Wales only)||MHRA rules apply|
|PLNI||NI||Authorised for use in Northern Ireland only||EU rules apply|
One option you can pursue is the National procedure (a 150-day procedure) to obtain a marketing authorisation (MA) in the UK, Great Britain or/in Northern Ireland. The MHRA has introduced this accelerated procedure aimed at expediting the availability of medicines for patients in the UK and proposes to reach its opinion on marketing authorisation applications (MAAs) within 150 days of filing an application (excluding the time taken to provide further information or data required).
Applications should be submitted via the MHRA Submission Portal, and the appropriate national fee will apply.
The accelerated assessment is available for all high-quality new MAAs for both new, and existing active substances, as well as orphan designations. Interested applicants should contact the MHRA in advance of submitting the application.
For medicines containing new active substances or biosimilar products, the MHRA encourages applicants to provide a summary of the dossier to share their intentions and to verify the new active substance status.
The pre-submission meeting offers the opportunity to discuss the arrangements for the UK Compliance Check (CC) on Paediatric Investigation Plans (PIPs). Additionally, it also offers the opportunity to enhance joint discussion with National Institute for Health and Care Excellence (NICE) Health Technology Assessment (HTA) evaluation process.
The MHRA will operate a ‘fixed submission date’ system to facilitate consultation with the Commission on Human Medicines (CHM) and will publish a set of dates to facilitate planning the submissions to coordinate with appropriate meeting dates of CHM. The submission slots will be linked to the dates of CHM meetings.
The assessment timetable will begin after the validation of the application. The assessment process will run in two phases totalling 150 days like so:
- Phase I: completed 80 days after the clock starts. Issues that arose or requiring clarification from the initial assessment will be raised with the applicant and should be addressed within the clock off period of 60 days.
- Phase II: commence on receipt of the applicant’s responses. The MHRA will provide a decision on the acceptability of the product by day 150.
If the MHRA refuses to grant the MA-based on advice from CHM, there is an opportunity for the applicant to request a review of the decision.
The conclusion of the assessment will lead to the publication of a UK Public Assessment Report for the product.
Here are some useful links to obtain further information:
If you need any clarification or support to help you to navigate the new post Brexit procedures, please contact us and Ivowen will gladly assist you in a timely manner.