How to license a medicine for sale in the UK, including applications through national and international routes.
This guidance also covers licensing a medicine in Northern Ireland through the centralised, decentralised and mutual recognition European procedures.
Which procedure to follow
There are 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. The markets in which each route is applicable are indicated in the following guidance:
You need to follow a specific application procedure depending on the licence (marketing authorisation) you need. To obtain a marketing authorisation, you need to use one of the following procedures:
Innovative Licensing and Access Procedure (ILAP) - The Innovative Licensing and Access Pathway (ILAP) aims to accelerate the time to market and facilitate patient access for innovative medicines, including new chemical entities, and biological medicines, new indications and repurposed medicines.
National Procedure (a 150-day procedure) – this national 150-day accelerated procedure is available for high-quality applications to market a medicine in the United Kingdom, Great Britain or Northern Ireland
Rolling review – permits the submission of your application in module(s), to obtain a marketing authorisation in the United Kingdom, Great Britain and Northern Ireland
EC Decision Reliance Procedure (a 67-day procedure) – For products under evaluation or approved in the EU centralised procedure, Great Britain may rely on decisions taken by the European Commission (EC) when considering the approval of new marketing authorisations.
MR/DC Reliance Procedure (a 67-day procedure) – MHRA may have regard to marketing authorisations approved through European decentralised (DC) and mutual recognition (MR) procedures, with a view to granting a marketing authorisation in the United Kingdom or Great Britain
Unfettered Access from Northern Ireland (a 67-day procedure) - applicants may seek recognition in Great Britain of a marketing authorisation approved in Northern Ireland under certain qualifying conditions.
Note that national applications intended to cover marketing of a product in Northern Ireland must continue to comply with the requirements of Directive 2001/83/EC, the Community code relating to medicinal products for human use, and Regulation 726/2004 on Community Procedures and Supervision of medicinal products.
International routes (collaborative procedures):
Access consortium - if you want to market a medicine in the UK, Australia, Canada, Singapore and/or Switzerland.
Project Orbis – Project Orbis is a programme coordinated by the US Food and Drug Administration (FDA), involving the regulatory authorities of Australia (TGA), Canada (Health Canada), the United Kingdom (MHRA), Singapore (HSA) and Brazil (ANVISA) to review and approve promising cancer treatments.
You will usually need to submit a Great Britain-specific paediatric investigation plan (PIP) compliance check early in the development of your product, when applicable.
In addition to the above procedures, the following procedures can be used to obtain a marketing authorisation in Northern Ireland:
Northern Ireland may be included in decentralised or mutual recognition procedure as a Concerned Member State (CMS)
Marketing authorisations approved in the European Union centralised procedure will automatically have effect in Northern Ireland.
Innovative Licensing and Access Procedure (ILAP)
ILAP awards a new “innovative medicine” designation (Innovation Passport). The pathway will bring together innovative approaches to support the safe, timely and efficient development of innovative products.
ILAP provides opportunities for enhanced regulatory and other stakeholder input, including interactions with patients, the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC), and the National Health Service (NHS England and Improvements), and other organisations - such as the Health Research Authority (HRA) and the National Institute of Heath Research (NIHR).
ILAP is open to both commercial and non-commercial developers of medicines.
See guidance on the Innovative Licensing and Access Pathway (ILAP).
You can also use the national procedure if you want to market a medicine in the UK, Great Britain or in Northern Ireland.
If this is your first application, email Reference.Data@mhra.gov.uk and we’ll issue a 5-digit company number.
The national procedure takes up to 150 days, excluding time taken to provide further information or data required.
For applications for new active substances and biosimilar products, the MHRA will operate a ‘fixed submission date’ system to facilitate consultation with the Commission on Human Medicines (CHM) at its scheduled meetings. The MHRA will publish a programme of dates to facilitate planning for the submission date and coordinating with appropriate meeting dates of CHM.
A pre-submission meeting with the MHRA around 90 days in advance of the intended submission is recommended for all applications concerning a new active substance. Pre-submissions meetings can be arranged by contacting AcceleratedandRollingReview@mhra.gov.uk.
The rolling review
The rolling review is a new route for marketing authorisation applications (MAAs), where an applicant for a marketing authorisation for a new active substance (NAS) in the UK, Great Britain, or Northern Ireland submits increments of the eCTD dossier for pre-assessment by the MHRA, rather than as part of a consolidated full dossier submission.
A pre-submission meeting with MHRA around 90 days in advance of the intended submission for the final phase is recommended. Pre-submission meetings can be arranged by contacting AcceleratedandRollingReview@mhra.gov.uk.
See guidance on the rolling review route for marketing authorisation applications (MAAs).
EC Decision Reliance Procedure
For 2 years from 1 January 2021, Great Britain may adopt decisions taken by the European Commission (EC) on the approval of new marketing authorisations through the centralised procedure.
A letter of intent should be submitted to MHRA at least 4 weeks before the Committee for Medicinal Products (CHMP) opinion is expected. Marketing authorisation applications should be submitted to MHRA on receipt of a positive opinion from the CHMP and should contain the entire dossier as reviewed by CHMP, all iterations of the assessment reports and the positive CHMP opinion.
All UK national requirements will apply. Confirmation of the EC decision should be provided immediately on receipt to allow determination of a Great Britain marketing authorisation as close to the EC approval as practicable.
MR/DC Reliance Procedure
The MHRA will have regard to marketing authorisations approved in European Union member states (or Iceland, Liechtenstein, Norway) through decentralised or mutual recognition procedures, with a view to granting marketing authorisations in the UK or Great Britain.
Applications should include the dossier approved for marketing in the EU member states, accompanied by all iterations of the Reference Member State (RMS) assessment report and the RMS end of procedure notification.
Applications will be reviewed for compliance with UK-specific requirements.
Further information on the MR/DC Reliance Procedure can be found here.
Unfettered Access from Northern Ireland
Applicants may seek recognition in Great Britain of a marketing authorisation approved in Northern Ireland.
This route is available for marketing authorisations approved in Northern Ireland via European (centralised, mutual recognition or decentralised procedures) or through the national procedure, if the marketing authorisation holder is established in Northern Ireland and the product is distributed from Northern Ireland to Great Britain.
For authorisations approved in EU procedures, applications should include the dossier as approved for marketing in Northern Ireland, accompanied by all iterations of the relevant RMS and CHMP assessment reports.
Get a PL(GB) number from the MHRA Portal or by emailing PLNumberAllocation@mhra.gov.uk before you submit your application.
The Access Consortium consists of health regulatory agencies from the Therapeutic Goods Administration (TGA) of Australia, the Health Products and Food Branch (HPFB) of Health Canada of Canada, the Health Sciences Authority (HSA) of Singapore, Swissmedic, Swiss Agency for Therapeutic Products of Switzerland and the Medicines and Healthcare products Regulatory Authority (MHRA).
The Access procedures can be used to market a medicine in two or more of the countries listed. The Access consortium has developed two worksharing procedures for New Active Substances and for Generic Medicines.
Project Orbis is a programme coordinated by the US Food and Drug Administration (FDA) involving the regulatory authorities of Australia (TGA), Canada (Health Canada), the United Kingdom (MHRA), Singapore (HSA) and Brazil (ANVISA) to review and approve promising cancer treatments. It provides a framework for concurrent submission and review of oncology products among international partners and aims to deliver faster patient access to innovative cancer treatments with potential benefits over existing therapies, across the globe.
Project Orbis submissions should also meet the qualifying criteria for the Innovation Passport within the Innovative Licensing and Access Pathway (ILAP).
Northern Ireland as a Concerned Member State (CMS)
You can use the decentralised or mutual recognition procedure if you want to market a medicine in Northern Ireland and other named EU countries.
One member state will lead the assessment of the application as the reference member state (RMS). The other member states (including Northern Ireland) you apply to are called the ‘concerned member states’ (CMSs).
The procedure takes up to 210 days (decentralised procedure) or 90 days (mutual recognition procedure), excluding time taken to provide further information or data required.
If the application is approved, each CMS (including Northern Ireland as a CMS) will issue a national marketing authorisation for the product within 30 days of approval.
There is more information about the mutual recognition and decentralised procedures on the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) website.
If this is your first application, email Reference.Data@mhra.gov.uk and we’ll issue a 5-digit company number.
Northern Ireland in the Centralised Procedure
The EU centralised procedure, including its mandatory scope, continues to apply in Northern Ireland. A centralised marketing authorisation application is mandatory in the EU for certain types of medicines, some new active substances and biotechnology products, and optional for others. Details of medicines that must have a centralised marketing authorisation can be found in annex I of Regulation (EC) No 726/2004.
The centralised procedure results in a single marketing authorisation to market a product in all EU member states, as well as Iceland, Liechtenstein and Norway and Northern Ireland (NI).
Centralised marketing authorisations are granted by the European Commission (EC). Find more information on the EMA website.
Fast track your marketing authorisation
Applications can be fast tracked if there is compelling evidence of benefit in a public health emergency or if there is a shortage of supply of an essential medicine that has been verified by the Department of Health and Social Care (DHSC).
To make a request for fast tracking your marketing authorisation you should email a letter of no more than 3 pages to RIS.NA@mhra.gov.uk.
The letter should include:
- the justification for fast tracking
- a brief description of the major clinical properties of the product
- evidence supporting the claimed benefits of the product for the proposed indication(s)
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
There is no additional fee for fast-tracking applications.
Types of application (legal basis)
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation:
- full application - Regulation 50 (previously Article 8(3) of Directive 2001/83/EC)
- generic application – Regulation 51 (previously Article 10.1 of Directive 2001/83/EC)
- hybrid application – Regulation 52 (previously Article 10.3 of Directive 2001/83/EC)
- similar biological application – Regulation 53 (previously Article 10.4 of Directive 2001/83/EC)
- well-established use application – Regulation 54 (previously Article 10a of Directive 2001/83/EC)
- fixed-combination application – Regulation 55 (previously Article 10b of Directive 2001/83/EC)
- informed consent application - Regulation 56 (previously Article 10c of Directive 2001/83/EC)
- traditional herbal registrations – Regulation 125 & 126 (previously Article 16a of Directive 2001/83/EC)
- certificate of homeopathic medicinal products (called Simplified Registration scheme) - Regulation 102 (previously Article 14(1) of Directive 2001/83/EC)
- national homeopathic products (called the National Rules Scheme) - Regulation 50(6)(g) and Schedule 10 (previously Article 16(2) of Directive 2001/83/EC)
The legal basis for all types of application is set out in the Statutory Instrument 2020 No. 0000, which outlines the amendments to the Human Medicines and Medical Devices Regulations on exit from the European Union.
Guidance can be found in The Rules Governing Medicinal Products – Notice to Applicants Volume 2A (chapter 1).
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 vary depending on the type and route of application. For full details see MHRA fees.
Please see make a payment to MHRA section on how to pay your fees.
Purchase Orders (POs) and non-payments
It is the responsibility of the applicant to ensure timely payment of invoices for their submissions. If your organisation operates a PO system, please ensure the relevant PO is provided to MHRA before the invoice is issued. Refusal to pay outstanding fees on the grounds that the PO is not provided on the invoice will not be accepted; the use of POs is an internal control process and cannot be used as a reason to withhold payment of legitimate invoices.
Once your application has been validated you will receive an invoice to allow you to make payment for the outstanding amount. All invoices must be settled upon receipt of invoice. Penalty fees may be incurred for non-payment. Details of the penalties are set out in the Fees Regulations. Non-payment may also result in suspension of any licence or authorisation, followed by legal proceedings for any unpaid amounts, as a debt due to the Crown.
Application process (all procedures)
All applications should be submitted through the MHRA Submissions Portal. If you have any questions about the Submissions Portal, you should email email@example.com.
The current Marketing Authorisation Application Form and guidance on how to complete this is available here.
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.
The MHRA will only recognise the MHRA Portal as an acceptable form of submission. All other forms of submission will be rejected.
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.
Submission of a new ASMF and any update to an ASMF should be made by the ASMF holder using the MHRA Submissions Portal. If you have any questions about the Submissions Portal, you should email firstname.lastname@example.org.
Read guidance concerning the submission of ASMFs.
Procedures concerning the use of Certificates of Suitability (CEPs) will remain the same.
Summary of product characteristics (SmPC)
The summary of product characteristics (SmPC) should be submitted to MHRA in the correct format using the SmPC 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.
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
Notice concerning Regulation 251
The UK remains a member of Council of Europe and the European Pharmacopoeia.
The British Pharmacopoeia (BP) continues to reproduce European Pharmacopoeia (Ph. Eur.) text for the convenience of our customers.
The UK was a founding member of the ‘Convention on the Elaboration of a European Pharmacopoeia’ and continues to be a member of the Ph. Eur. as the UK continues to be a member of the Council of Europe in its own right. The UK remains an active member of the European Pharmacopoeia Commission through the BP.
Compliance with the BP
Compliance with the BP continues to be a mandatory requirement in the UK including Northern Ireland. Products in the UK are expected to meet the standards published by the BP. This requirement will remain the same after the transition period in accordance with the Human Medicines Regulations (Regulation 251).
In exceptional circumstances, a EU derived marketing authorisation for a product that enters Northern Ireland via the Northern Ireland Protocol, and the UK via unfettered access, may not comply with the standard specified in the relevant BP monograph. The HMR have been amended to include a temporary exception to ensure these products can remain on the market whilst the relevant monograph is revised, if appropriate. If a revised monograph is published the exception is no longer applicable.