Medicines that do not need a licence (Exemptions from licensing)

The manufacture and supply of unlicensed relevant medicinal products for individual patients ('specials')
Medicines legislation (specifically The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994/SI 3144) requires that medicinal products are licensed before they are marketed in the UK. However, some patients may have special clinical needs that cannot be met by licensed medicinal products. So that these special needs may be met, the law allows manufacture and supply of unlicensed medicinal products (commonly known 'specials') subject to certain conditions.

The conditions are that there is a bona fide unsolicited order, the product is formulated in accordance with the requirement of a doctor or dentist registered in the UK, and the product is for use by their individual patients on their direct personal responsibility. If a 'special' is manufactured in the UK, the manufacturer must hold a manufacturer's (specials) licence issued by the MHRA. A 'special' may not be advertised and may not be supplied if an equivalent licensed product is available which could meet the patient's needs. Essential records must be kept and serious adverse drug reactions reported to the MHRA.

The MHRA Guidance Note 14, 'The supply of unlicensed relevant medicinal products for individual patients', provides guidance to manufacturers about the conditions under which they may manufacture and supply 'specials' and their legal obligations.

Contact for further information
For further information about the manufacture and supply of 'specials' for individual patients and the importation/export of unlicensed medicines, please contact the Policy Unit, Inspection and Standards Division, 17th floor, MHRA, Market Towers, 1 Nine Elms Lane, London SW8 5NQ, telephone 020 7084 2131/2573/2442, fax 020 7084 2595, e-mail info@mhra.gsi.gov.uk.

The importation and supply of unlicensed relevant medicinal products for individual patients
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' 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 document, Guidance Note 14, 'The supply of unlicensed relevant medicinal products for individual patients', 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)

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 2605, 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 2574, fax 020 7084 2676, e-mail info@mhra.gsi.gov.uk.

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.

Manufacturers, importers and exporters of unlicensed medicinal products - TSE Regulations
We have introduced legislation to apply the European Commission's guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via medicinal products administered to humans to unlicensed medicines. The Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations 2003 (SI 2003/1680) came into force on the 30 July 2003. From this date all manufacturers, importers and exporters of unlicensed medicinal products for human use are required to comply with the provisions of the Regulations. To help with this requirement we have produced interim guidance on the TSE Regulations. We have also issued a policy document outlining acceptable practices for importers in assessing compliance of prospective imports of exempt imported products as defined in Statutory Instrument 1999/4, The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1999 (SI 1999/4) with UK TSE Regulations.

Herbal remedies exemptions
Products exempt from licensing include herbal medicines which satisfy the conditions laid down in Section 12 of the Medicines Act 1968.

Section 13(2) of the Act defines a herbal remedy as:

'... a medicinal product consisting of a substance produced by subjecting a plant or plants to drying, crushing or any other process, or of a mixture whose sole ingredients are two or more substances so produced, or of a mixture whose sole ingredients are one or more substances so produced and water or some other inert substance.'

Section 12(1) allows a person to make, sell and supply a herbal remedy during the course of their business provided the remedy is manufactured or assembled on the premises and that it is supplied as a consequence of a consultation between the person and their patient. Section 12 (2) allows the manufacture, sale or supply of herbal remedies where:

• the process to which the plant or plants are subjected consists only of drying, crushing or comminuting;
• the remedy is sold without any written recommendation as to its use; and
• the remedy is sold under a designation which only specifies the plant(s) and the process, and does not apply any other name to the remedy.

Contact for further information
For further information about herbal remedies exemptions, please contact the Herbal Medicines Policy Section, 16-1, MHRA, Market Towers, 1 Nine Elms Lane, London SW8 5NQ, telephone 020 7084 2404, fax 020 7084 2387 or e-mail info@mhra.gsi.gov.uk.