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.
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
- mutual recognition procedure if you already have a national licence in 1 or more EU countries but want to market it in others
- 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)
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 you apply to are called the ‘concerned member states’ (CMSs).
To start your application with MHRA as the reference member state (RMS), book a DCP submission date.
We will normally reply within 24 hours to confirm your booking and issue your product licence (PL) number and DCP number.
As the RMS, MHRA 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 MHRA 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)
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.
To start your application with MHRA as the RMS, email MR-DCprocedures@mhra.gsi.gov.uk with the name of your product and the PL number.
We will confirm if the product can be accepted for a mutual recognition procedure and issue a mutual recognition procedure number to use on your application.
As the RMS, MHRA will lead the assessment of your application. The other member states you apply for are the ‘concerned member states’ (CMSs).
The application process takes up to 90 days, excluding time taken to provide further information or data required.
If the application is approved, MHRA 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.
An expedited process may be available if you only want to add Iceland, Malta or Cyprus and your product has already been licensed through mutual recognition with UK as RMS. Email MR-DCprocedures@mhra.gsi.gov.uk giving your PL number and mutual recognition procedure number(s) for more information.
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.gsi.gov.uk and we’ll issue a 5-digit company number.
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.
National informed consent ‘piggy-back’ applications
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 theto the covering letter of your MA application.
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.gsi.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.gsi.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 (DH). If you want to fast track your application because of a shortage of supply we recommend you discuss this with DH by emailing firstname.lastname@example.org or calling 0207 972 2913.
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 - 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.
Guidance can be found in The Rules Governing Medicinal Products – Notice to Applicants Volume 2A (chapter 1).
Complete this form if you need help identifying a suitable reference product for an application under Article 10 (1) or 10 (3).
If you have any questions about the legal basis for your submission you should email RIS.NA@mhra.gsi.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.
You must pay your fee before you apply and include proof of payment in your application.
Fees vary depending on the type and route of application. For full details see MHRA fees 2014/15.
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
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.
Application process (all procedures)
Submit your application using the electronic Common Technical Document (eCTD). If you can’t use eCTD you can use the Non-eCTD electronic Submissions (NeeS) process.
Use theto 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 Area1-INITIALSemail@example.com.
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 producedto 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. 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
It will become mandatory from the beginning of 2016 for new marketing authorisation, renewal and variation applications to make your submission 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.
MHRA will no longer accept physical media submissions (CD/DVD) for medicines licences and clinical trial applications.
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 Area1-INITIALSfirstname.lastname@example.org