Importing unlicensed medicines

An unlicensed relevant medicinal product may only be imported in accordance with The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 (SI 2005/2789). An importer must hold the appropriate wholesale dealer's or wholesale dealer's import licence (for details please see the MHRA Guidance Note 6, 'Notes for applicants and holders of a wholesale dealer's licence' (279Kb) for further information) issued by the MHRA and must comply with their licence conditions. Importers` licence conditions include the requirement that they must notify the MHRA on each occasion that they intend to import such a product. Importation may proceed unless the importer has been informed by the MHRA within 28 days that it objects to importation. The MHRA may object and prevent importation, because it has concerns about the safety or quality of the product, or because there is an equivalent licensed medicinal product available and it is not satisfied that there is a 'special need' for the supply to an individual patient.

An imported unlicensed relevant medicinal product may only be supplied in accordance with Schedule 1 to The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994/SI 3144. Schedule 1 exempts, under defined conditions (discussed in the previous section on 'specials') such a product when it is supplied to meet the 'special need' of an individual patient.

The MHRA 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.
›  Notification of intention to import application form (321Kb)

MHRA statement on talc preparations for pleurodesis - 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.

Report on the importation of unlicensed medicines, Quarter 2, 2008
Following the publication of the Quarter 4 2007 Summary Report for Importation of Unlicensed Medicines the MHRA has received largely positive feedback, although it was suggested that publishing these reports quarterly may be too frequent. It is hoped that the current report will prove to be of interest to importers, manufacturers and users of unlicensed medicines and will also be of assistance in supporting the current Review of Unlicensed medicines legislation.
› Informal consultation paper on the review of the regulation of unlicensed medicines

The report is available below:
› Summary Report for Importation of Unlicensed Medicines - 1 Apr 2008 - 30 Jun 2008 (435Kb)

Comments or queries are welcome and should be addressed to imports@mhra.gsi.gov.uk

Report on the importation of unlicensed medicines, Quarter 4, 2007
Currently, the MHRA is conducting a Review of Unlicensed Medicines legislation:
› Informal consultation paper on the review of the regulation of unlicensed medicines

It was felt that it might be helpful to publish recent statistics on importation of unlicensed medicines, and to this end a report for Quarter 4 2007 which also includes some historical data is now available. If this report is found to be useful, consideration will be given to publishing further quarterly reports. Comments or queries are welcome and should be addressed to imports@mhra.gsi.gov.uk.
› 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 and Standards Division, 17th floor, MHRA, Market Towers, 1 Nine Elms Lane, London SW8 5NQ, telephone 020 7084 2844, fax 020 7084 2595, e-mail info@mhra.gsi.gov.uk.

For further information about notification of intention to import, please contact the Unlicensed Imports Section, 17th floor, MHRA, Market Towers, 1 Nine Elms Lane,  London SW8 5NQ, telephone 020 7084 2625, fax 020 7084 2676, e-mail info@mhra.gsi.gov.uk.