An unlicensed medicinal product which is supplied to fill “special requirements” and in response to a bona fide unsolicited order, formulated in accordance with the specification of a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber and for use by his or her individual patients on his/her direct responsibility. Examples of special requirements include, but are not limited to, an intolerance or allergy to a particular ingredient, or an inability to ingest a solid oral dosage form. Unlicensed medicinal products are exempt from the requirement of a marketing authorisation before being placed on the market and as such may not have been assessed by the Licensing Authority against the criteria of safety, quality and efficacy.
The prescriber, doctor, dentist or supplementary prescriber who places the bona fide, unsolicited order.
The manufacturer or assembler.
We minimise the risk as follows:
- All our products contain active ingredients which have been used for many years.
- With our experience we are able to guide prescribers to literature evidence to help them decide on the most appropriate dose.
- All products have stability data and a long shelf-life.
- Where applicable they are palatable to children.
- All are manufactured in compliance with the European Commission’s “Notes for guidance on minimizing the risk of transmitting animal spongiform encephalopathy agents via medicinal products” and any subsequent updates.
- All are manufactured by contractors with a manufacturing licence to manufacture “specials” to GMP standards (Manufacturer’s “specials” Licence).
- All have a Certificate of Analysis signed by a MHRA-approved Qualified Person.
Our “unlicensed medicines” are only sold to:
- Community Pharmacies.
- Pharmaceutical Wholesale Distributors.
- Medical, Dental and Veterinary Practices.
- Overseas versions of the above.
- MHRA Review of Unlicensed Medicines
- BNF for Children
- Our products comprise of tablets, capsules, injections, oral liquids, powders, suspensions and oromucosal solutions.
- Our products can only be prescribed by a doctor, dentist nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber under a bona fide, unsolicited order. For UK patients, the doctor, dentist or supplementary prescriber must be registered in the UK.
Our products can only be supplied by your doctor, dentist, nurse or consultant on a prescription-only basis, so you should discuss your ailment with a healthcare professional who can assess the technical data on our website after registration.