Import Unlicensed Human Medicine – Medicines can be imported as either an ‘introduced product’ or a ‘special product’.
An Introduced Product is an unlicensed medicine which can be imported from a country other than an approved country for import to be exported to a country other than an approved country for import, or if imported from a non-EEA country into Northern Ireland for export back to a country outside the EEA.
In order to import an introduced product you must hold a WDA(H) with the correct scope of the licence to procure and supply an introduced product, which must be obtained from a person authorised in the country, other than an approved country for import, or if in Northern Ireland in the non-EEA country to supply medicinal products by wholesale distribution.
An introduced product can only be exported to a person authorised in the country other than an approved country for import, or if you are in Northern Ireland the non-EEA country to receive medicinal products for wholesale distribution or supply to the public. Introduced medicinal products will not have a Marketing Authorisation for the UK or a country on an approved country for import list.
A Special product is an unlicensed medicine which can be imported if licensed medicines do not work for the special clinical needs of a patient and/ or there are no licensed medicines available for the patient’s clinical needs.
To import a Special product from a country other than an approved country for import or to Northern Ireland from outside the EEA, supporting documents will need to be provided and are required to apply for a manufacturer ‘specials’ licence. If you wish to import a Special Product from a country on an approved country for import list you will be required to apply for a WDA(H).
On top of the application for the relevant licence, a notification of intent to import an unlicensed medicine must be submitted 28 days prior to the date of import.
To create a notification of intent to import an unlicensed medicine a completed notification of intent form must be sent to the MHRA. Each entry must have the unique reference number which has been assigned to it. Each unlicensed medicine will need to be allocated a product code, which is less than 16 characters long, including spaces, containing only letters and numbers and detail the following:
- drug substances generic name
- brand name
- strength
- pharmaceutical form
- pack size for a single pack indicating the quantity of items per pack
- name and address of the manufacturer
- country from which the drug is being exported
Completed notifications will need to be sent to [email protected].
The notification to import may be objected by the MHRA if concerns are raised in relation to product safety or quality, or an equivalent licensed product is available to meet the individuals special clinical needs, or there is no patient special clinical need for the product. There are also several unlicensed medicines which the MHRA would normally object to import and should be noted.
If the MHRA do not object the notification of intent to import within 28 days of the MHRA acknowledgement letter.
Compliance with the Transmissible Spongiform Encephalopathies (TSE) Regulations is the responsibility of the importers and guidance on TSE requirements when importing an unlicensed medicine must be reviewed and followed.
In cases of a clinical emergency which are usually result from either a life-threatening illnesses or impending serious injury and urgent import notification may be submitted. Usually the MHRA are able to waive the 28-day notice period requirement and process the notification within one working day. However non-clinical reasons are not acceptable for urgency.
Import Unlicensed Human MedicineImport Unlicensed Human Medicine may be supplied between Northern Ireland and Great Britain without additional notifications to MHRA being required once, imported into / manufactured in the United Kingdom. The supplier in either territory may supply unlicensed medicine to a person authorised to receive it, or to a wholesaler in the receiving territory. Confirmation that there is a special clinical need for use of the medicine which is unlicensed in the territory to which it is being supplied. will need to be provided by the supplier.
Apply for a Manufacturer ‘Specials’ Licence
www.gov.uk/government/publications/medicines-application-forms-for-a-manufacturer-licence
Apply for a wholesaler licence
www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences
Make a notification of intent to import an unlicensed medicine
www.gov.uk/government/publications/notification-of-intent-to-import-an-unlicensed-medicinal-product
TSE compliance requirements for exempt imported productswww.gov.uk/government/publications/tse-requirements-for-imported-unlicensed-human-medicines