MHRA Guidance: Applying for a Licence to Market a Medicine in the UK and Electronic Application Forms (eAF)
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has provided guidance on applying for a licence to market a medicine in the UK and on using electronic Application Forms (eAFs) for medicines licensing applications.
The first guidance explains the marketing authorisation application process, including electronic submissions, supporting documentation, product naming, fast-tracking, rejection, and fees. The second explains how applicants can download, complete, validate, and submit the applicable electronic forms.
Together, these guidances provide practical information for preparing and submitting marketing authorisation applications in the UK.
The MHRA guidance outlines the general process for obtaining a marketing authorisation (MA) for a medicine in the UK. Applicants should follow the requirements applicable to their chosen regulatory pathway, as additional steps may apply depending on the type of application.
Application Process and Electronic Submissions
All UK marketing authorisation applications should be submitted through the MHRA Submissions Portal using the electronic Common Technical Document (eCTD) format.
Applicants should use the pre-submission checklist and the eAF and cover letter tool to identify the documents and information required. The MHRA checks technical validity using the Lorenz Docubridge validation tool, which aligns with ICH standards and eCTD 3.2 regional requirements.
Incomplete applications or submissions that do not meet the applicable technical requirements may be rejected. Applicants are therefore encouraged to validate their submissions before filing.
Product Licence Numbers and Supporting Documentation
Applicants seeking a UK or Northern Ireland marketing authorisation must obtain a Product Licence (PL) number before submission through the MHRA Portal or by contacting the designated MHRA email address.
A PL number identifies an authorisation covering the whole UK, while a PLNI number identifies an authorisation covering Northern Ireland only. PLGB-prefixed numbers have not been issued since 1 January 2025, although previously issued numbers may continue to be used under the applicable arrangements.
Where an application relies on an Active Substance Master File (ASMF), the ASMF holder must submit the master file to the MHRA before or at the same time as the marketing authorisation application. Applications will not be validated without the required ASMF.
Certificates of Suitability (CEPs) remain acceptable in support of UK national authorisations.
Summary of Product Characteristics and Established Medicines
The Summary of Product Characteristics (SmPC) must be submitted using the MHRA's specified template. The template must not be altered other than to insert the relevant information; failure to use the required format may result in rejection.
For established active substance marketing authorisation applications within scope, the MHRA encourages applicants to include relevant checklists for bioequivalence studies or biowaivers and product information. These documents support more complete submissions at the initial assessment stage.
Product Naming and Fast-Tracking Applications
The MHRA assesses proposed medicine names to help ensure that medicines can be taken safely and correctly.
Applications may be considered for fast-tracking where there is compelling evidence of benefit in a public health emergency or a shortage of an essential medicine verified by the Department of Health and Social Care (DHSC).
Applicants should submit a justification letter of no more than three pages, including the rationale for fast-tracking, a brief description of the product's major clinical properties, and supporting evidence for the claimed benefits. For medicine shortages, discussion with the DHSC is recommended before submitting the request.
There is no additional fee for fast-tracking an application.
Application Rejection and Fees
Applications that fail to meet the applicable legal or technical requirements may be rejected. The MHRA explains the reasons for rejection, and applicants must correct the errors and resubmit the complete application rather than sending corrected deficiencies by email.
Applicants are not charged when a submission fails technical validation. However, fees for marketing authorisation applications vary according to the application type and regulatory route.
Once an application has been validated, the applicant receives an invoice. Outstanding fees must be paid upon receipt, and non-payment may result in penalties or other regulatory and legal consequences.
The second guidance explains how applicants can use electronic Application Forms for UK medicines licensing applications. The MHRA makes the current forms available for download as an interim business continuity measure.
The existing submission routes, validation requirements, and assessment processes remain unchanged.
Available Electronic Application Forms
The guidance provides the following forms for applicants:
Applicants should select the appropriate form for the type of application being submitted.
Downloading and Completing the Forms
Applicants should download and save the relevant form on their local computer and open it using Adobe Acrobat Reader.
If a security warning indicates that some features have been disabled, applicants should select the options provided and choose to trust the document. This unlocks the embedded features required to support form validation.
Where the form requests a country selection and the United Kingdom is unavailable, applicants should use their Organisation ID (OrgID) or Location ID (LocID) from the EMA Organisation Management Service (OMS) portal to find the appropriate organisation and address record.
Validating and Submitting the eAF
After completing the form, applicants should right-click the document, select “Save-link as,” and download a local copy to validate and save the completed form.
The completed eAF must be included in the eCTD submission package. Other submission requirements remain unchanged.
The guidance specifically advises applicants to use Adobe Reader or Adobe Reader DC for filling and locking the forms. Adobe Acrobat or Acrobat Pro DC should not be used for these tasks because this may cause issues when the locked forms are opened by recipients using Adobe Reader.
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