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
- pack size
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 (external link) and Schedules 2 and 4 of the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 (external link).
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 No. 1882) (external link).