The Human Medicines Regulations 2012 (SI 2012/1916) contains certain important exemptions from licensing and makes provision for further exemptions to be included in statutory orders. This section outlines three of the more important exemptions: the manufacture and supply of unlicensed relevant medicinal products for individual patients ('specials'); the importation and supply of unlicensed relevant medicinal products for individual patients; and herbal remedies exemptions.
The manufacture and supply of unlicensed relevant medicinal products for individual patients ('specials')
Medicines legislation (specifically The Human Medicines Regulations 2012 (SI 2012/1916)) 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, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber 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.
MHRA Guidance note 14: The supply of unlicensed medicinal products ('specials') (364Kb), 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, Enforcement and Standards Division, 151 Buckingham Palace Road, Victoria, London, SW1W 9SZ, telephone 020 3080 6131/6573/6595, email firstname.lastname@example.org.
The importation and supply of unlicensed relevant medicinal products for individual patients
An unlicensed relevant medicinal product may only be imported into the UK in accordance with the provisions of The Human Medicines Regulations 2012 (SI 2012/1916). An importer must hold the appropriate wholesale dealer's or manufacturer’s licence that authorisers import (for details please see the MHRA Guidance note 5 'Notes for applicants and holders of a manufacturer's licence' and 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 the Regulation 167 of The Human Medicines Regulations 2012 (SI 2012/1916). This 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.
Contacts for further information
For further information on Wholesale distributors licences, please contact the Licence Office, Inspection, Enforcement and Standards Division, 151 Buckingham Palace Road, Victoria, London, SW1W 9SZ, telephone 020 3080 6844 email email@example.com
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 7200, email firstname.lastname@example.org.
Herbal remedies exemptions
Products exempt from licensing include herbal medicines which satisfy the conditions laid down in Regulation 241 12(1) only, 12(2) was revoked in 2011 of The Human Medicines Regulations 2012 (S1 2012/1916).
Regulation 8(1) of the Act defines a herbal medicinal product 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.'
Regulation 3(6) and (9) and Regulation 241 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) was revoked in 2011.
Contact for further information
For further information about herbal medicinal products exemptions, please contact the Herbal Medicines Policy Section, 5 Magenta, 151 Buckingham Palace Road, Victoria, London, SW1W 9SZ, telephone 020 3080 6404 or email email@example.com
* Guidance Notes currently under review