National assessment procedure for medicines

We offer a national assessment procedure for UK-wide marketing authorisation (MA) applications. This new guidance for applicants is effective for applications received after the publication date. We keep our processes and metrics under continual review, and we may update this guidance if needed.

Different requirements, procedures and timelines apply for MA applications via the International Recognition Procedure (IRP).

The national assessment procedure guidance applies to national MA applications for both innovative and established medicines, but the requirements, procedures and timetables differ. Timetables are measured in calendar days excluding regulatory clock-stops.

Innovative medicines applications are covered in section 2. These are defined as applications for:

* new active substances (NAS), defined as active substances that have not been authorised in a medicinal product in the UK before

* all biological products (derived or manufactured from a living biological system) including advanced therapy medicinal products (ATMPs), vaccines and biosimilars

* new combinations of existing active substances

* orphan medicinal products

* conditional MA or MA under exceptional circumstances

* line extensions of any of the above (for example, addition of strengths, pharmaceutical forms or routes of administration)

Section 2 also applies to MA applications via Project Orbis Type A, B or C. MA applications via the Access Consortium New Active Substance Work Sharing Initiative (NASWSI) are subject to a different timetable but we aim to make a national decision within 210 days of the start of the work-sharing procedure (see section 2.8 for more details).

The innovative medicines timetable allows for a positive decision within 150 clock-on days if all issues are resolved following one round of questions. Where there are outstanding issues at Day 150, we will come to a final decision as soon as possible and within 210 clock-on days.

Established medicines applications are covered in section 3. These are defined as applications that do not meet the innovative medicines application criteria outlined above. We will come to a final decision on established medicines applications within 210 days. If we have raised only minor issues, there is the opportunity for an earlier decision.

Variations to existing MAs, including type II variations to add a new therapeutic indication, are not covered by this guidance. You should refer to Medicines: apply for a variation to your marketing authorisation on applying for a variation to your marketing authorisation.

1.2 Before you apply

You can ask the MHRA for scientific advice at any stage of your medicine’s development. This is explained in Get scientific advice from MHRA.

UK paediatric requirements may apply. You should refer to Procedures for UK Paediatric Investigation Plans (PIPs). When a UK PIP compliance check is required, you should submit the request at least 60 days before the planned submission date for your MA application.