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1. Overview听

An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees This information is common to all procedures.听 Read the guidance for a specific pathway for any extra information or steps that might be required. The pathway that is followed will depend on the type of application being made.听

Find out more about the different鈥�national and international procedures.听

2. Application process听

All UK marketing authorisation applications should be submitted through the鈥�MHRA鈥疭ubmissions Portal. Any questions about the Submissions Portal should be sent by email to[email protected].听

The application should be submitted using the鈥�.听听

罢丑别鈥�鈥�(PDF,鈥�129 KB,鈥�7 pages) and the eAF and cover letter tool should be used to determine what documents and information to include in the application. If the correct documents and information are not submitted the application will not be validated.听

The MHRA check that eCTD submissions are technically valid using the Lorenz Docubridge validation tool which strictly aligns validation against the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) international standards and eCTD 3.2 regional requirements. It is recommended that a validation tool is used to check the submission.鈥���

For more information on the standards visit:听听

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If there are any questions about submitting an application, please contact:听

[email protected].听

2.1 PL number听

If applying for a UK or Northern-Ireland, licence, then a PL number must be sought from the鈥�鈥� or by emailing鈥� [email protected] 鈥痓efore you submit the application.听

When requesting a PL number, please note the following prefixes and their definitions:听

• PL:鈥痑n MA number for an application for a product to be licensed by the鈥�MHRA鈥痶hat covers the whole of the UK
• PLNI: 鈥痑n MA number for an application for a product to be licensed by the鈥�MHRA鈥痶hat covers Northern Ireland (NI) only as the territorial application.
• PLGB: MA numbers with a PLGB prefix will not be issued from or after 1 January 2025.听 MA numbers already issued with a PLGB prefix can continue to be used but authorisation, if granted, will cover the whole of the UK from 1 January 2025.

2.2 Active substance master files (ASMFs)听

ASMFs holders must submit dossiers to the鈥�MHRA. It is the MA applicant鈥檚 responsibility to make sure that the鈥�ASMF鈥痠s submitted either before an application is submitted or at the same time.听 Applications will not be valid without it.听

Submission of a new鈥�ASMF鈥痑nd any update to an鈥�ASMF鈥痵hould be made by the鈥�ASMF鈥痟older using鈥�MHRA鈥疭ubmissions. Updated versions of ASMFs should be clearly distinguished from earlier versions with a version number or other code. Questions about the鈥�MHRA鈥疭ubmissions portal, should be addressed by email to鈥�[email protected].听

The MHRA guidance about the鈥�submission of ASMFs is available at: Handling of Active Substance Master Files and Certificates of Suitability - 188体育 (www.gov.uk)听

Certificates of Suitability (CEPs) continue to be acceptable in support of UK national authorisations.听

2.3 Summary of product characteristics (SmPC)听

The summary of product characteristics (SmPC) should be submitted to the鈥�MHRA鈥痠n the correct format using the鈥�鈥�(MS Word Document,鈥�36 KB). If this template is not used the submission will be rejected. The templates should not be altered in any way, other than inserting the relevant information.听

2.4 Established medicines听

For established active substance marketing authorisation applications (MAAs).听

2.4.1 Process for review听

To ensure applications are complete on initial assessment, or as soon after submission as possible, read the听 guidance on the .听

Watch the webinar videos:听

• 听

2.4.2 Checklists 鈥� established active substance MAA听

For established active substances within scope of the relevant checklist, the MHRA encourage applicants to submit the听 following documents with the initial submissions. The main purpose of these checklists is to promote 鈥榬ight first time鈥� submissions.听

• 听听
• 听

2.4.3 UK public assessment report (UKPAR) templates听

The lay summary of the UK PAR forms are completed by the applicant of a national abridged applications only听 following the request for further information (RFI) from the MHRA.听

• 鈥�(MS Word Document,鈥�123 KB)听
• 鈥�(MS Word Document,鈥�114 KB)听
• 鈥�(MS Word Document,鈥�110 KB)听
• 鈥�(MS Word Document,鈥�97.3 KB)听
• 鈥�(MS Word Document,鈥�94.8 KB)听
• 鈥�(MS Word Document,鈥�101 KB)听

3. Providing a name for a medicine听

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

Applicants can find out more in guidance: Naming human medicines - 188体育听

4. Fast tracking a marketing authorisation听

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).听

To make a request for fast tracking your marketing authorisation you should email a letter of no more than 3 pages to鈥�[email protected].听

The letter should include:听

• the justification for fast tracking听
• a brief description of the major clinical properties of the product听
• evidence supporting the claimed benefits of the product for the proposed indication(s)听

If an applicant wants the MHRA to fast track an application because of a shortage of supply of medicinal product, it is recommend this is discussed with鈥�DHSC鈥痓y emailing 鈥�[email protected] before submitting the request.听

There is no additional fee for fast-tracking applications.听

5. Rejection听

Any submission that is incomplete because it does not meet the requirements set out in Regulation 50 and Schedule 8 of the Human Medicines Regulations 2012 (as amended) or does not meet the necessary technical requirements will be rejected.听

If a submission is rejected, the MHRA will email the reasons for the rejection. The complete application must then be resubmitted with the errors corrected. Do not send the corrected deficiencies by email.听

Applicants will not be charged if a submission fails technical validation.听

If applicants think a submission has been wrongly rejected, email [email protected].

6. Fees听

Fees vary depending on the type and route of application. More information about the fees charged can be found in the guidance鈥� MHRA鈥痜别别蝉.听

You can find out more about how to pay your fees in our guidance on鈥�making a payment to鈥�MHRA.听

6.1 Purchase Orders (POs)听

It is the applicant鈥檚 responsibility to make sure the invoices for submissions are paid on time. If an organisation operates a PO system, please make sure that the relevant PO is provided to the鈥�MHRA鈥痓efore the invoice is issued.听

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.听

6.2 Payments听

Once an application has been validated, applicants will receive an invoice so that a payment for the outstanding amount can be made. All invoices must be settled upon receipt.听

Penalty fees may be incurred for non-payment. Details of the penalties are explained in our鈥疐ees Regulations.听

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.