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To Whom It May Concern,
It has come to the Agency’s attention that the product Lipostabil®, also marketed as Flabjab™, Lipomelt, Lipodissolve and Fat-Away, is being promoted as a cosmetic in the UK and is available for the reduction of fat.
Definition of a medicinal product 
A relevant "medicinal product" is defined in Article 1 of Directive 2001/83/EC as:
"Any substance or combination of substances presented for treating or preventing disease in human beings. Any substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings is likewise considered a medicinal product".
Lipostabil 
The product Lipostabil® is an intravenous preparation of phosphatidycholine and is for the prevention and treatment of blood vessel blockages caused by fat particles (fat embolism). It is indicated as a medication for reducing blood fat (liquid reducer). It is a licensed medicine in some European Member States but not the UK. 
The Medicines and Healthcare products Regulatory Agency (MHRA) has determined that Lipostabil® is a relevant medicinal product and subject to the provisions of The Medicines For Human use (Marketing Authorisations Etc) Regulations 1994 as amended (Statutory Instrument 1994/3144). In accordance with section 3(1) of S.I. 1994/3144, no relevant medicinal product shall be placed on the market unless a marketing authorisation (formerly Product Licence) has been granted for it. 
Circumstances in which an unlicensed medicinal product may be supplied. 
In the UK, an unlicensed relevant medicinal product (other than a herbal medicine in respect of which different rules apply) may only be supplied in accordance with the provisions of Schedule 1 to S.I. 1994/3144. This provides amongst other things, that subject to certain conditions, an unlicensed product may be supplied in response to the order of a doctor or dentist, and on his personal responsibility, to meet the clinical needs of an individual patient.
The conditions are set out in paragraph 2 of Schedule 1. In very general terms there must be a bona fide unsolicited order. The relevant medicinal product must be formulated in accordance with the requirements of a doctor or dentist registered in the UK for use by his individual patient on his /her responsibility. It must be supplied to a doctor or dentist, or for use in a registered pharmacy, hospital or health centre. The relevant medicinal product must also be manufactured, assembled, imported or distributed by the holder of an authorisation. We would draw attention, in particular, to the fact that the regulations expressly provide that such products cannot be advertised to the general public or included in any catalogue, circular or price list.
Importation 
Persons who source a relevant medicinal product from another Member State of the European Economic area (EEA- all EC countries, together with Norway, Iceland and Liechtenstein) other than for personal use must hold a Wholesale Dealer’s Licence (WL). Persons importing a product from outside the EEA must hold a Wholesale Dealer’s Import Licence (WI) (Section 3 of SI 1994/3144). 
A holder of a WL or WI license who imports an unlicensed relevant medicinal product must comply with the provisions of Paragraph 8B of Schedule 3 to the Medicines (Standard Provisions For Licences And Certificates) Regulations 1971 which provides that the holder of a WL or WI who imports an unlicensed relevant medicinal product for the purpose of sale and supply in accordance with schedule 1 of S.I. 1994/3144 must meet specified requirements. The requirements provide for notification to the Licensing Authority (LA) concerning the importation of the unlicensed relevant medicinal product, record keeping and set maximum quantities for import.
The quantities permitted per importation are: 25 individual doses, or sufficient material for 25 patients in a 3 month period. Following receipt, the LA has 28 days to assess notifications.
Regulation of cosmetic products is governed by the Cosmetic Directive 76/768/EC. Lipostabil is not a cosmetic product within the meaning given to that term by the Cosmetic Directive. The recitals to the Directive state expressly that:-
"….products containing substances or preparations intended to be ingested, inhaled, injected or implanted in the human body do not come under the field of cosmetics;"
The regulations described above relating to medicinal products not those relating to cosmetic products are therefore those which are applicable to Lipostabil
Further information concerning the supply of unlicensed relevant medicinal products for individual patients and The Medicines (Standard Provisions For Licences And Certificates) Amendment Regulations 1999 (SI 1999/4) is available on the MHRA web-site.

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