Submission and assessment timetables for innovative medicines applications

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.

• If

  *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.

4. Contact

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