The Medicines Act contains certain important exemptions from licensing. One of these exemptions is for the importation and supply of unlicensed relevant medicinal products for individual patients and herbal remedies exemptions.
Under the Marketing Regulations (SI1994/3144) all medicines must have a marketing authorisation ('Product Licence') unless exempt. One of these exemptions, in Schedule 1 to these regulations, is for the importation and supply of unlicensed relevant medicinal products for the special needs of individual patients, commonly, but incorrectly called 'named patients'.
Prospective importers must hold a relevant licence and must notify the MHRA of their intention to import in accordance with The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 (SI 2005/2789).
The relevant licences are:
- for import from within the European Economic Area (EEA), a Wholesale Dealer's Licence valid for import and handling unlicensed relevant medicinal products
- for import from outside of the EEA, a Manufacturer's 'Specials' Licence valid for import
Importation may proceed unless the importer has been informed by the MHRA within 28 days of the date of the MHRA acknowledgement letter that it objects to importation.
Objections may be raised to import where:
- the MHRA has concerns about the safety or quality of the product
- there is an equivalent licensed medicinal product available that will meet the needs of the individual patient
- the MHRA is not satisfied that there is a 'special need' for the supply to an individual patient.
It is MHRA policy that 'special need' must be clinical in nature. Reasons of cost, convenience or institutional need are not acceptable.
Importers should note that they are responsible for ensuring that products imported comply with Transmissible Spongiform Encephalopathies (TSE) Regulations. Importers should also refer to the Import Notification Section Policy on TSE
(80Kb).
Submitting notifications for import of unlicensed medicines under SI2005/2789
Notifications may be submitted using the following form:
Notification of intent to import application form 
(16Kb) Spreadsheet which may be used for single or multiple notifications
Please note that the above form is preferred but not mandatory and it is recommended that this form should also be used for single notifications in place of the older "Single notification of intention to import application form"
This notification form is a spreadsheet where each line is a separate notification. Each notification must be individually identifiable by a unique reference. This is especially important for tracking of multiple repeat notifications.
It is also helpful if products are identified by a short product code. This assists us in entering repeat notifications consistently. The spreadsheet should be formatted so that the lines do not run over page boundaries when printed, ie a line should only occupy one page width.
Objections may be raised to import if the information provided does not comply with the requirements of the regulations.
Notifications should be submitted via email imports@mhra.gsi.gov.uk
Notifications may also be submitted by post to:
MHRA
Import Notifications Section
Floor 5
151 Buckingham Palace Road
London
SW1W 9SZ
Please do not submit notifications to individual members of the Import Notifications Section Team.
Submitting urgent notifications
In cases of clinical urgency ('Clinical Emergencies'), the MHRA is able to waive the 28 day requirement. This is only normally considered where medicines are required to treat life-threatening illnesses or those likely to cause significant injury to patients.
Commercial or other non-clinical reasons are not accepted reasons for urgency. Clinical Emergency notifications are normally turned around within one working day of receipt.
To ensure that Clinical Emergency notifications are handled in a timely fashion, they should be clearly marked as URGENT and the clinical reasons for urgency should also be given. This minimises the need for the MHRA to request further information.
For exceptionally urgent cases only, the Imports Notification Section may be contacted out of hours via the MHRA Duty Officer on 020 3080 6574. Please note, this number is also the number for reporting medicines defects. Email and incoming faxes are not routinely monitored out of office hours.
Queries concerning Clinical Emergency notifications during office hours may be made to the Import Notifications Supervisor on 020 3080 6625.
Obtaining licences
See Manufacturer’s and Wholesale Dealer’s licences
Also Guidance Note 6, 'Notes for applicants and holders of a wholesale dealer's licence' (279Kb)
Additionally, Guidance Note 14, 'The supply of unlicensed relevant medicinal products for individual patients' (154Kb), provides guidance to importers about the conditions under which they may import and supply unlicensed relevant medicinal products and their legal obligations.
(Please note: Changes have been made to the way in which appropriately authorised wholesale dealers and manufacturers can make healthcare professionals aware of the unlicensed medicines they have available - Advertising of unlicensed medicines.)
Periodic summary reports on the import of unlicensed medicines
These reports are listed in the right hand side of this page. They are issued on a quarterly basis, approximately one calendar quarter in arrears. They contain statistical data on the volume of import notifications under SI 2005/2789, the most frequently notified products (by generic name), performance statistics for the notification system and updates on important topics.
Price lists
On 19 August 2010 a change was made to the way in which appropriately authorised wholesale dealers and manufacturers can make healthcare professionals aware of the unlicensed medicines they have available. Holders of a licence permitting the manufacture, importation and/or distribution of unlicensed medicines can now issue a price list to healthcare professionals without first having received a bona fide unsolicited order.
MHRA advice is that any price list supplied should only consist of a basic line listing providing the following information:
- reference number
- drug name (British Approved Name or equivalent)
- dosage form
- strength
- pack size
- price
No product claims may be included.
The remaining restrictions on unlicensed medicines are unchanged in Schedule 1 of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (SI1994/3144) and Schedules 2 and 4 of the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 (SI2005/2789).
This means that catalogues and circular letters may only be sent to healthcare professionals on receipt of a bona fide unsolicited order, and that unlicensed medicines cannot be advertised to the public.
This change was made by Regulations 8 and 10 of the Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010 (SI 2010/1882) (see MHRA website).
Advertising and information
Enquiries have been received about the provision of updated information for existing customers and display of unlicensed product samples at conferences by exhibitors.
In the first case, some suppliers of unlicensed medicines have issued updated availability or pricing information to existing customers who have previously been supplied with the products in question, following unsolicited requests. The provision of information under these circumstances is arguably acceptable, however licence holders should take care to ensure that only existing customers are contacted and that the information provided is the minimum necessary in line with that for price lists given above and is not promotional in nature.
In the second case, whilst advertising services provided for the supply of unlicensed medicines is generally acceptable, the display of packages of unlicensed medicines at a conference (professional or otherwise) may breach the conditions of the exemption in Schedule 1 to the Marketing Authorisation Regulations, SI1994/3144 and should be avoided.
Important information relating to specific products
| Product | Comments |
|---|---|
| Cisapride | The Committee on Safety of Medicines (CSM) advised that the balance of risks and benefits for cisapride was negative in all indications and populations and in respect of importation of cisapride products not licensed in the UK. The CSM has additionally advised that the MHRA should object to importation of cisapride products on grounds of safety, both for adult and paediatric use. |
| Melatonin | There is a licensed controlled release melatonin tablet available in the UK, however it is recognised that unlicensed immediate release products, liquids and capsule preparations may be needed for the special needs of individual patients for whom the UK licensed product is unsuitable. There is at least one pharmaceutical immediate release product available within Europe, however, unlicensed melatonin products from the USA are frequently notified for import. These products are classified as supplements, not pharmaceuticals in the USA and are not made under pharmaceutical Good Manufacturing Practices. They should therefore only be used as a last resort. Importers must ensure customers are advised accordingly. |
| Mumps vaccines |
Currently (Dec 2009), Merck Mumpsvax is not being manufactured and is unavailable. This vaccine contains the Jeryl Lynn strain used in UK MMR vaccines and is the only strain to which the MHRA does not object to import. Historically, the following strains and products have attracted objections to import: Rubini strain, Urabe strain, L-Zagreb strain, Pavivac. In October 2009, the Commission on Human Medicines (CHM), following submission of evidence from prospective importers, advised that the MHRA should object to importation of L-Zagreb mumps vaccines on grounds of safety (possible association with incidence of aseptic meningitis). Clinics, doctors and parents should be aware that courses of measles, mumps and rubella single component vaccines may not be able to be completed due to unavailability of imported mumps vaccine. |
| Single component measles, mumps and rubella vaccines |
Currently (Dec 2009), Merck Mumpsvax is not being manufactured and is unavailable. This vaccine contains the Jeryl Lynn strain used in UK MMR vaccines and is the only strain to which the MHRA does not object to import. Clinics, doctors and parents should be aware that courses of measles, mumps and rubella single component vaccines may not be able to be completed due to unavailability of imported mumps vaccine. |
| Subcutaneous immunotherapy (allergy desensitising) products | Based upon CSM advice, the MHRA normally objects to importation of unlicensed subcutaneous desensitisation products, other than those for bee and wasp stings for use in specialist clinics with resuscitation facilities. |
| Sublingual Immunotherapy (SLIT) Products | In 2005, the Committee on Safety of Medicines (CSM, now Commission on Human Medicines) advised the MHRA that objection was not required to importation of unlicensed pollen-based SLIT products for use in non-asthmatic adults under the supervision of NHS specialists with access to resuscitation equipment. On this basis, the MHRA will normally object to importation all non-pollen-based SLIT products. |
| Supplements from the USA | Products classified medicines in the UK but as supplements in the USA are not made under pharmaceutical Good Manufacturing Practices. They should therefore only be used as a last resort. Importers must ensure customers are advised accordingly. |
| Talc preparations for pleurodesis |
On 10 October 2007, the MHRA issued the following statement announcing that we intend to treat talc preparations as medicinal products with effect from 1 January 2008: MHRA statement on talc preparations for pleurodesis Consequently, talc preparations for pleurodesis should be licensed as medicinal products for use in the UK and manufacturers of these preparations are invited to submit appropriate manufacturing authorisation applications. Given the current absence of licensed talc preparations for pleurodesis these products will be required to be prescribed by healthcare professionals as unlicensed medicines for the special clinical needs of individual patients on the direct personal responsibility of the prescriber. Importers of any medicine that is unlicensed in the UK must notify the MHRA in accordance with The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005/2789. |
| Thalidomide | Until June 2008, no licensed thalidomide product was available in the UK and unlicensed product had to be manufactured or imported. In June 2008, a licensed product became available in the UK (Thalidomide Pharmion 50 mg Capsules). In view of the serious safety concerns with thalidomide, the MHRA will object to notifications for importation of Thalidomide products unless there are very strong clinical reasons for the use of an unlicensed product. UK manufacturers of unlicensed thalidomide products are expected by the MHRA to adopt a similar position. |
Fees
Fees for safety and quality vetting of unlicensed imported medicines.
This is a banding system based upon the volume of notifications submitted by the importer.
Summary Report for Importation of Unlicensed Medicines
Summary Report for Importation of Unlicensed Medicines 1 April 2011 – 30 June 2011 (145Kb)
Summary Report for Importation of Unlicensed Medicines 1 January 2011 – 31 March 2011 (136Kb)
Summary Report for Importation of Unlicensed Medicines 1 October 2010 – 31 December 2010 (110Kb)
Summary Report for Importation of Unlicensed Medicines 1 July 2010 – 30 September 2010 (386Kb)
Summary Report for Importation of Unlicensed Medicines 1 April 2010 – 30 June 2010 (130Kb)
Summary Report for Importation of Unlicensed Medicines 1 January 2010 – 31 March 2010 (155Kb)
Summary Report for Importation of Unlicensed Medicines 1 October 2009 – 31 December 2009 (397Kb)
Summary Report for Importation of Unlicensed Medicines 1 July 2009 to 30 September 2009 (305Kb)
Summary Report for Importation of Unlicensed Medicines 1 April 2009 to 30 June 2009 (574Kb)
Summary Report for Importation of Unlicensed Medicines - 1 January 2009 to 31 March 2009 (279Kb)
Summary report for importation of unlicensed medicines - 1 October 2008 to 30 December 2008 (284Kb)
Summary Report for Importation of Unlicensed Medicines - 1 Apr 2008 - 30 Jun 2008 (435Kb)
Summary Report for Importation of Unlicensed Medicines Notified Under SI 2005/2789 (276Kb)
Contacts for further information
For further information on wholesale dealer's and wholesaler dealer's import licences, please contact the Licence Office, Inspection, Enforcement and Standards Division, 151 Buckingham Palace Road, Victoria, London SW1W 9SZ telephone 020 3080 6844, email info@mhra.gsi.gov.uk
For further information about notification of intention to import, please contact the Unlicensed Imports Section, 151 Buckingham Palace Road, Victoria, London SW1W 9SZ , telephone 020 3080 6625, email imports@mhra.gsi.gov.uk
