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Press release
| Date: | 21 Apr 2005 |
|---|---|
| Time: | 13:32 |
| Subject: | Aimspro |
| Contact: | Press Office 020 3080 7651
or press.office@mhra.gsi.gov.uk Out-of-hours 07770 446 189 |
The MHRA is aware that certain allegations have been made that it has put the production of Aimspro on hold. This is not correct. Aimspro is not a licensed medicine and the Agency is concerned, therefore about the quality, efficacy and safety of this product. The MHRA’s role is to ensure that products are manufactured and supplied lawfully.
There are no UK clinical trials ongoing for this product. It could be supplied under a ‘specials’ licence but there is currently no such licence in place for Aimspro.
UK medicines legislation contains certain exemptions from licensing. Some patients may have special clinical needs that cannot be met by licensed medicinal products. In order to meet these special needs the law allows for the manufacture and supply of unlicensed medicines (commonly known as "specials") subject to certain conditions. These 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. Essential records must be kept and serious adverse drug reactions must be reported to the MHRA. 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.
To date, Aimspro has not been manufactured or supplied under the authority of a manufacturer’s (specials) licence.
Notes to Editor
