Guidance

Apply for a licence to market a medicine in the UK

How to license a medicine for sale in the UK and Europe, including applications through national, centralised and decentralised procedures.

You can contact the Medicines and Health Products Regulatory Agency (MHRA) for advice before you make your application.

Email: RIS.NA@mhra.gov.uk
Telephone: 020 3080 7400

Which procedure to follow

You’ll need to follow a specific application procedure depending on the licence you need. You need to use the:

  • decentralised procedure (DCP) if you want to market the medicine in the UK and other named EU countries (The UK can only be a CMS during the transition period)
  • mutual recognition procedure if you already have a national licence in 1 or more EU countries but want to market it in others (The UK can only be a CMS during the transition period)
  • national procedure if you want to market a medicine only in the UK
  • centralised procedure to market certain types of medicines throughout the EU

You will usually need to submit a paediatric investigation plan (PIP) early in the development of your product. Proposals for PIPs must be submitted to the European Medicines Agency (EMA).

Decentralised procedure (DCP) during the transition period

The UK can only act as a CMS in a Mutual recognition procedure (including repeat use) during the transition period.

You should use the decentralised procedure if you want to market the medicine in the UK and other named EU countries.

One state will lead the assessment of the application as reference member state (RMS). The other member states and the UK you apply to are called the ‘concerned member states’ (CMSs).

The RMS will lead the assessment of your application. The other member states you apply to are called the ‘concerned member states’ (CMSs).

The procedure takes up to 210 days, excluding time taken to provide further information or data required.

If the application is approved, the UK as a CMS and each CMS will issue a national licence for the product within 30 days of the approval being granted.

Find more information about the DCP on the Co-ordiniation Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) website.

Mutual recognition procedure (including repeat use)

The UK can only act as a CMS in a Mutual recognition procedure (including repeat use) during the transition period

Use the mutual recognition procedure when your product already has a national licence in at least 1 EU country, and you want to market it in more EU countries. The principle is that the countries you wish to add recognise the national licence(s) already granted.

The application process takes up to 90 days, excluding time taken to provide further information or data required.

If the application is approved, the UK as a CMS and each CMS will issue a national licence for the product within 30 days of the approval being granted.

Find more information about the mutual recognition procedure on the Heads of Medicines Agencies website.

Repeat use procedures

You can use the mutual recognition procedure more than once to add more member states to a mutually-recognised licence – this is known as a repeat-use procedure. The process for repeat use is identical to the first mutual recognition procedure.

National procedure

You should use the national procedure if you want to market a medicine only in the UK.

If this is your first application, email Reference.Data@mhra.gov.uk and we’ll issue a 5-digit company number.

Get a PL number from the MHRA Portal or by emailing PLNumberAllocation@mhra.gov.uk before you submit your application.

The application process takes up to 210 days, excluding time taken to provide further information or data required.

We can accept applications at any time.

If you are making a national application for an informed consent marketing authorisation and the licence you are using as a reference complies with current regulatory requirements then attach the informed consent checklist (MS Word Document, 350KB) to the covering letter of your MA application.

Centralised procedure

A centralised licence is mandatory for certain types of medicines, some new active substances and biotechnology products, and optional for others. Details of medicines that must have a centralised licence can be found in annex I of Regulation (EC) No 726/2004.

Use the centralised procedure to get a single licence that can be used to market a product in all EU member states as well as Iceland, Liechtenstein and Norway.

Centralised licences are granted by the EMA. Find more information on the EMA website.

Fast track your marketing authorisation

Applications can be fast tracked if there is compelling evidence to show that the product would provide a major breakthrough in the treatment of certain conditions. There is no additional fee for fast-tracking applications.

The disease categories for which fast tracking of applications may be applicable are:

  • chronic, debilitating diseases for which available treatments are ineffective or otherwise inadequate
  • severe or life-threatening diseases for which available treatments are ineffective or otherwise inadequate
  • the emergence of a disease with wide-spread resistance to treatment with currently available treatments
  • the emergence of a new disease entity which has severe or life-threatening effects and for which currently available treatments are ineffective or inadequate

To get your application fast tracked you should email a letter of no more than 3 pages to RIS.NA@mhra.gov.uk. The letter should include:

  • the disease category
  • a brief description of the major clinical properties of the product
  • evidence supporting the claimed benefits of the product for the proposed indication(s)

MHRA Corporate Executive Team will consider your request for a fast-tracked application and their decision will be communicated to you in confidence.

For more information about fast tracking your marketing authorisation email RIS.NA@mhra.gov.uk or call 020 3080 7400.

Applications can also be fast tracked if there is shortage of supply of essential medicines that has been verified by the Department of Health and Social Care (DHSC). If you want to fast track your application because of a shortage of supply we recommend you discuss this with DHSC by emailing DHSCmedicinesupplyteam@dhsc.gov.uk.

You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation:

  • full application - Article 8(3)
  • generic, hybrid or similar biological applications - Article 10
  • well-established use application - Article 10a
  • fixed combination application - Article 10b
  • informed consent application- Article 10c

Certain types of application can use the abridged application procedure. This means the application does not need full pre-clinical or clinical studies. The types of application that may be able to use this route are generic/biosimilars (Article 10) , well-established use (Article 10(a)) and informed consent (Article 10(c)) applications.

The legal basis for all types of application is set out in Directive 2001/83/EC and in Regulation (EC) No 726/2004.

Guidance can be found in The Rules Governing Medicinal Products – Notice to Applicants Volume 2A (chapter 1).

If you need help identifying a suitable reference product for an application under Article 10 (1) or 10 (3) please complete this form.

If you have any questions about the legal basis for your submission you should email RIS.NA@mhra.gov.uk.

Name for your medicine

MHRA considers each application for a product name to ensure that the proposed name will allow the medicine to be taken safely and correctly.

Further information is available in the MHRA naming of medicines guidance (PDF, 235KB, 20 pages).

Fees

Fees vary depending on the type and route of application. For full details see MHRA fees.

Include your proof of payment as a labelled PDF in the workingdocuments folder of your electronic Common Technical Document (eCTD). It should be one of:

  • BACS or CHAPS electronic confirmation form
  • photocopy of the cheque for the required sum (dated and signed)
  • MHRA iRIS email account receipt (preferred for iRIS account holders)
  • email confirmation from MHRA finance department

Fees calculator

Use this form to work out what the fee for your submission will be. This form is a guide. You should pay the fee when you submit your application to MHRA.

Fees calculator (ZIP, 1010KB)

Application process (all procedures)

Submit your application using the electronic Common Technical Document (eCTD).

Use the pre-submission checklist (PDF, 129KB, 7 pages) to help you with your application.

We check that NeeS and eCTD submissions are technically valid using the Extedo Eurs is Yours (EiY) validation tool.

We recommend that you use a validation tool to check your submission.

If you have any questions about submitting your application you should email IPUenquiries@mhra.gov.uk.

Active substance master files (ASMFs)

ASMFs holders must submit their dossier to MHRA. It is your responsibility to make sure that the ASMF is submitted either before you submit your application or at the same time, as your application will not be valid without it.

The ASMF holder will need to register with the Common European Submission Platform (CESP) and then make their application through CESP.

We have produced guidance on submitting an ASMF (PDF, 69.1KB, 2 pages) to help the ASMF holder prepare their dossier.

Summary of product characteristics (SPC)

The summary of product characteristics (SPC) should be submitted to MHRA in the correct format using the SPC template (MS Word Document, 36KB). If you do not use this template your submission will be rejected. These templates should not be altered in any way, other than inserting the relevant information.

Ways to make your submission

You can now submit your application via the Central European System Platform (CESP).

Since January 2016 it has become mandatory for new marketing authorisation, renewal and variation application submissions to be made using electronic application forms (eAFs). This will apply to all procedure types, including national procedures. If you are making a submission using the portal, you will have to submit using the portal forms as well as submitting the eAF. If you are submitting your application through CESP you will only need to submit the eAF.

Read the latest User Guide for the electronic application form

Request for Information (RFI)

To ensure compliance with the May 2019 update on CMDh requirements for MRP/DCP/NP submissions for new MAAs (CMDh/085/2008, Rev.21), as well as Variations and Renewals (CMDh/006/2008, Rev.20), the UK will no longer accept responses submitted via email, Eudralinks, paper or CD/DVD.

The MHRA will only recognise CESP and the MHRA Portal as acceptable forms of submission.

All other forms of submission will be rejected.

Submissions through the Common European Submission Portal (CESP)

This system is available from the Heads of Medicines Agencies (HMA) and provides a simple and secure mechanism for exchange of information between applicants and regulatory agencies.

The purpose of the system is to:

  • provide a secure method of communicating with regulatory agencies via one platform
  • allow submission of an application once to reach all required agencies
  • reduce the burden for both industry and regulators of submitting/handling applications on CD-ROM and DVD

If you are a first time CESP user and wish to setup up an organisation/university or trust to manage multiple users on the system, register with CESP here.

If you are a standalone user and wish to upload for Non Commercial Use on your own behalf, register with CESP here.

Once registered you will receive credentials to access the portal to your registered email address.

Please view MHRA clinical trials guidelines here.

General CESP training is available to all registered users via CESP’s training menu once logged into the system. Training on demand videos are available and you can also sign up to our free online weekly live demonstrations. CESP encourage all users to attend training before using the system. View FAQs here.

Rejection of submissions

Any submission received that does not meet the requirements will be rejected.

If a submission is rejected we will email you the reasons for the rejection. You must then resend the entire submission with the errors corrected. Do not send the corrected deficiencies by email.

You will not be charged if your submission is rejected for technical reasons.

If you think your submission has been wrongly rejected you should email IPUenquiries@mhra.gov.uk

Applying for a licence during the transition period

UK’s regulatory role during the implementation period

UK will not act as ‘leading authority’ for medicines

Article 123 of the draft Withdrawal Agreement states that “During the transition period, the United Kingdom shall not act as leading authority for risk assessments, examinations, approvals and authorisations at the level of the Union or of Member States acting jointly referred to in the acts/provisions listed in Annex y+6”.

A “leading authority” conducts assessments on behalf of specific EU agencies. The UK and EU are still discussing the scope of activity that this article will cover with respect to medicines. It does not cover medical devices.

UK authorities will remain available to provide expert advice during this period, and UK businesses will have the same rights during the implementation period as EU-based businesses to have their cases accepted and processed by EU agencies and EU-based leading authorities.

Some elements of the MHRA’s role will change. For example, the UK will no longer have voting rights in EMA and EU committees but will continue to respect their decisions regarding regulation of medicines and medical devices.

Submitting an application using the UK as the Reference Member State (RMS)

Under the terms of the Withdrawal Agreement, the UK can continue to participate in the decentralised and mutual recognition licensing procedures, but is excluded from acting as RMS in these procedures for approval of marketing authorisations. In addition, the UK cannot act as a rapporteur or co-rapporteur.

During the implementation period:

  • pharmaceutical firms will be able to continue UK batch release testing and Qualified Person certification in the UK, with this being recognised by the EU and vice versa
  • marketing authorisation holders and qualified persons for pharmacovigilance will continue to be able to be based in the UK and access EU markets. There will be continued mutual recognition of manufacturing and distribution licences, as well as associated inspections such as good manufacturing practice (GMP)
  • firms based in the UK will be able to continue to apply for marketing authorisations via either the centralised or decentralised procedures
Published 18 December 2014
Last updated 18 February 2020 + show all updates
  1. Updated content to reflect that the UK cannot act as a Reference Members State (RMS) for approval of marketing authorisations in decentralised and mutual recognition licensing procedures during the transition period.

  2. The DHSC contact for fast-tracking a licence has changed.

  3. Inserted text - Request for Information (RFI)... Under 'Ways to make your submission'

  4. Updated email address and naming to Department of Health and Social Care

  5. Removed link to Excel spreadsheet list of products.

  6. Added spreadsheet under "types of application" heading

  7. Added a link to the User Guide for the electronic application form.

  8. Updated contact information for Department of Health for advice when seeking to fast-track an application due to a shortage of supply of essential medicines.

  9. New fees calculator.

  10. First published.