December 2018: Promotion of unlicensed medicines “Specials”
Published 30 January 2019
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Quantum Pharma complained about the advertising of unlicensed medicines in Nova Laboratories’ Easter Newsletter. The complainant was concerned that the newsletter was freely available on the company website and listed unlicensed products that Nova can manufacture and was therefore advertising specific unlicensed products.
The MHRA upheld the complaint since the material included product claims about the unlicensed products supplied by Nova Laboratories. Nova Laboratories confirmed that future newsletters will be restricted to subscribers and no product claims will be included in any future listings of newly available unlicensed medicines.
0.1 MHRA Guidance
Regulation 279 of the Human Medicines Regulations 2012 (“the Regulations”) prohibits the advertising of medicines that do not have a valid UK marketing authorisation or registration.
Licensed manufacturers and suppliers of unlicensed medicinal products (“specials”) can promote the service they provide. They can make healthcare professionals aware of the unlicensed medicines they have available by sending out simple price lists to interested healthcare professionals for whom the price of specials may be relevant. These may be sent at reasonable intervals or in response to an enquiry. A price list would typically include the following basic factual information in a standardised format: the active ingredient, strength, dosage form, pack size and price for each product listed. No product claims highlighting the properties of specific products may be included and it should also be clear that the products are not licensed.
A factual informative announcement may be made listing the availability of new products in a catalogue or newsletter aimed at relevant healthcare professionals. Favourable statements that describe the qualities of the products, for example references to potential shelf life or formulation advantages would be considered to be product claims in this context. The material would then fall for consideration as an “advertisement” under the Regulations.
Companies can also provide factual responses to unsolicited enquiries about unlicensed products. Further guidance on this is available in section 4.2 of the MHRA Blue Guide.