1. Introduction

This guidance should be read alongside our guidance on the MHRA’s national assessment procedure for marketing authorisation (MA) applications.

We operate fixed submission and assessment timetables for innovative medicines MA applications to facilitate consultation with the Commission on Human Medicines (CHM). Innovative medicines applications 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)

You should notify us of your intended submission date at least 3 months in advance, by completing the pre-submission notification form. If you are planning to submit a national MA application for a NAS, or a biological product including a biosimilar, we strongly recommend that you request a pre-submission meeting using the notification form.

2. Deadlines for initial submissions

The MA application dossier should be submitted through the MHRA submissions portal on or before the deadline (DD/MM/YYYY) as detailed below.

Submission deadline	Procedure start date* (Day0)	CHM meeting (Day83)	First RFI (Day90)
14/11/2025	05/12/2025	26/02/2026	05/03/2026
12/12/2025	02/01/2026	26/03/2026	02/04/2026
09/01/2026	30/01/2026	23/04/2026	30/04/2026
06/02/2026	27/02/2026	21/05/2026	28/05/2026
13/03/2026	03/04/2026	25/06/2026	02/07/2026
17/04/2026	08/05/2026	30/07/2026	06/08/2026
15/05/2026	05/06/2026	27/08/2026	03/09/2026
12/06/2026	03/07/2026	24/09/2026	01/10/2026
17/07/2026	07/08/2026	29/10/2026	05/11/2026
14/08/2026	04/09/2026	26/11/2026	03/12/2026
04/09/2026	25/09/2026	17/12/2026	24/12/2026
09/10/2026	30/10/2026	21/01/2027	28/01/2027
06/11/2026	27/11/2026	18/02/2027	25/02/2027
04/12/2026	25/12/2026	18/03/2027	25/03/2027
08/01/2027	29/01/2027	22/04/2027	29/04/2027
05/02/2027	26/02/2027	20/05/2027	27/05/2027
05/03/2027	26/03/2027	17/06/2027	24/06/2027
09/04/2027	30/04/2027	22/07/2027	29/07/2027
07/05/2027	28/05/2027	19/08/2027	26/08/2027
04/06/2027	25/06/2027	16/09/2027	23/09/2027
09/07/2027	30/07/2027	21/10/2027	28/10/2027
06/08/2027	27/08/2027	18/11/2027	25/11/2027
03/09/2027	24/09/2027	16/12/2027	23/12/2027
15/10/2027	05/11/2027	27/01/2028	03/02/2028
12/11/2027	03/12/2027	24/02/2028	02/03/2028
17/12/2027	07/01/2028	30/03/2028	06/04/2028
14/01/2028	04/02/2028	27/04/2028	04/05/2028
11/02/2028	03/03/2028	25/05/2028	01/06/2028
17/03/2028	07/04/2028	29/06/2028	06/07/2028
14/04/2028	05/05/2028	27/07/2028	03/08/2028
12/05/2028	02/06/2028	24/08/2028	31/08/2028
16/06/2028	07/07/2028	28/09/2028	05/10/2028
14/07/2028	04/08/2028	26/10/2028	02/11/2028
11/08/2028	01/09/2028	23/11/2028	30/11/2028
08/09/2028	29/09/2028	21/12/2028	28/12/2028

*If the application is not validated by this date, the next procedure start date will apply

3. Deadlines for responses submissions

Our submission and assessment timetables include monthly submission deadlines for your response to the first request for information (RFI). This is to facilitate further consultation with the CHM if required. The responses dossier should be submitted through the MHRA submissions portal on or before the deadline (DD/MM/YYYY) as detailed below. There are no fixed submission dates for your responses to the second or third RFI.

Submission deadline	Procedure restart date (Day 91)	CHM meeting (Day 143)	Second RFI or CHM letter (Day 150)
02/01/2026	05/01/2026	26/02/2026	05/03/2026
30/01/2026	02/02/2026	26/03/2026	02/04/2026
27/02/2026	02/03/2026	23/04/2026	30/04/2026
27/03/2026	30/03/2026	21/05/2026	28/05/2026
01/05/2026	04/05/2026	25/06/2026	02/07/2026
05/06/2026	08/06/2026	30/07/2026	06/08/2026
03/07/2026	06/07/2026	27/08/2026	03/09/2026
31/07/2026	03/08/2026	24/09/2026	01/10/2026
04/09/2026	07/09/2026	29/10/2026	05/11/2026
02/10/2026	05/10/2026	26/11/2026	03/12/2026
23/10/2026	26/10/2026	17/12/2026	24/12/2026
27/11/2026	30/11/2026	21/01/2027	28/01/2027
25/12/2026	28/12/2026	18/02/2027	25/02/2027
22/01/2027	25/01/2027	18/03/2027	25/03/2027
26/02/2027	01/03/2027	22/04/2027	29/04/2027
26/03/2027	29/03/2027	20/05/2027	27/05/2027
23/04/2027	26/04/2027	17/06/2027	24/06/2027
28/05/2027	31/05/2027	22/07/2027	29/07/2027
25/06/2027	28/06/2027	19/08/2027	26/08/2027
23/07/2027	26/07/2027	16/09/2027	23/09/2027
27/08/2027	30/08/2027	21/10/2027	28/10/2027
24/09/2027	27/09/2027	18/11/2027	25/11/2027
22/10/2027	25/10/2027	16/12/2027	23/12/2027
03/12/2027	06/12/2027	27/01/2028	03/02/2028
31/12/2027	03/01/2028	24/02/2028	02/03/2028
04/02/2028	07/02/2028	30/03/2028	06/04/2028
03/03/2028	06/03/2028	27/04/2028	04/05/2028
31/03/2028	03/04/2028	25/05/2028	01/06/2028
05/05/2028	08/05/2028	29/06/2028	06/07/2028
02/06/2028	05/06/2028	27/07/2028	03/08/2028
30/06/2028	03/07/2028	24/08/2028	31/08/2028
04/08/2028	07/08/2028	28/09/2028	05/10/2028
01/09/2028	04/09/2028	26/10/2028	02/11/2028
29/09/2028	02/10/2028	23/11/2028	30/11/2028
27/10/2028	30/10/2028	21/12/2028	28/12/2028

4. Contact

For further information, email RIS.NA@mhra.gov.uk.

Submission and assessment timetables for innovative medicines applications