Notification of intent to import an unlicensed medicinal product
Updated 29 January 2025
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This publication is available at https://www.gov.uk/government/publications/notification-of-intent-to-import-an-unlicensed-medicinal-product/notification-of-intent-to-import-an-unlicensed-medicinal-product
Notification process
After receiving a notification of intent to import an unlicensed medicine the MHRA will issue an acknowledgement letter to the importer.
The unlicensed medicine must not be imported if an objection to the importation is issued by the MHRA within 28 days of the acknowledgment of the notification.
Within this 28 day period, the MHRA will assess the notification and issue the importer with a relevant letter. This letter may:
- Confirm the no objection to the importation of the unlicensed medicine stating under which conditions the importation may take place;
- Request further information to be provided by the importer;
- Object to the importation of the unlicensed medicine into the UK.
Expedited and Urgent Notifications
When justifiable, the MHRA may expedite the assessment of notifications and waive the 28 day period from the date of acknowledgement, to enable faster access of critical medicines to patients.
For life threatening or immediately injurious clinical emergencies the MHRA may be able to process and assess notifications of intent to import unlicensed medicines into the UK in 2 working days.
Submitting a notification
Notifications of intent to import must be submitted to: imports@mhra.gov.uk
Importers are advised to use a dedicated corporate email address for unlicensed medicine imports, and should avoid individual accounts.
The email should have an appropriate subject header and should contain:
- A completed notification submission form
- Evidence of compliance with relevant medicine Good Manufacturing and Distribution Practices;
- Evidence of special clinical need(s);
- Where appropriate, evidence of TSE compliance requirements for exempt imported products.
Subject of the notification email
The subject line of the E-mail should reflect the notification type and should contain the form reference number which is assigned by the importer to the specific e-mail and notification form (the form reference number is different from the unique reference of individual notifications):
| Notification type | Email subject line template |
|---|---|
| Standard import | STANDARD - [form reference number] - [importer name] |
| Import to mitigate UK shortage of licensed medicines | UK SHORTAGE - [form reference number] - [importer name] |
| Import for urgent clinical need | URGENT - [form reference number] - [importer name] |
| Import of CBPM | CPBM - [form reference number] - [importer name] |
| Response to FIR | RESPONSE - [form reference number] - [importer name] |
| Example | URGENT - 27122024-1 ImporterXXX |
Notification form
All notifications should be submitted using this form. Please refer to our form completion guidance on how to complete the notification form.
Each line in the form is an individual notification.
Each line on the form must have a unique reference that cannot be repeated. This is specific for each individual notification.
Each line on the form must have a product code. These may be repeated in different notifications. The product code is generated by the importer and defines:
- Non-proprietary Name (INN, Generic Name, BAN)
- Proprietary Name (Brand name)
- Strength and pharmaceutical form
- Pack size
- Manufacturer of the finished medicinal product, its name and address
- Country where the finished medicinal product is imported from
- Country where the finished medicinal product is licensed
Providing Supportive information with your Notifications
In your email you need to attach evidence of compliance with relevant GMDP standards and evidence of a special clinical need.
Examples of supportive documentation may include:
- Patient information leaflets (PILs)
- Labels
- Evidence the product is licensed in the country of origin
- Certificates of Conformity
- Certificates of Analysis
- Declarations of Conformity from suppliers
- GMP certificates
- Letters of Clinical need
- Evidence of unavailability of UK licensed medicines
- Clinical justification of Urgency
Incomplete notifications lacking the necessary supportive information may be rejected.
Importers are responsible for ensuring that imported products comply with the Transmissible Spongiform Encephalopathies (TSE) Regulations.
Submitting a response to a request for further information
When further information is required for the MHRA to reach a decision a “Further Information Requested” letter is issued to the importer.
Upon receipt of this letter, the importer may not import the unlicensed medicine until stated otherwise by the MHRA.
Responses to requests for further information should be submitted using the following e-mail subject, where the form reference number remains the same.
| Notification type | Email subject line template |
|---|---|
| Response to FIR | RESPONSE - [form reference number] - [importer name] |
The following information should be clearly included in the e-mail:
- Letter of “Further Information Requested” sent by the MHRA;
- Original/amended notification form, as applicable (the form reference number remains the same);
- Product name and Product code for which the response is provided;
- Any requested information by the MHRA.