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| NAVIGATOR: Home: Treatment FAQs: Non Surgical: Lipotherapy | 03 September 2010 | ||
Lipotherapyor simply scroll down.
Press Release: Lipostabil® not licensed for cosmetic use
Lipostabil®, also marketed as Flabjab™, Lipomelt, Liposdissolve and Fat-Away, is being unlawfully advertised in the UK as a cosmetic product for the reduction of fat. Lipostabil® is licensed as an intravenous medicine in Germany, its country of origin, for the prevention and treatment of blood vessel blockages by fat particles (fat embolism). It is not approved or licensed for cosmetic use. Product safety has not been established for subcutaneous use for cosmetic purposes. Consumers should be aware of this should they be offered the product. The Medicines and Healthcare products Regulatory Agency (MHRA) has received three reports of potential adverse reactions to cosmetic treatment with Lipostabil®. Some patients may experience allergic reactions or sensitivity issues to the product. The usual route of administration for cosmetic surgery is subcutaneous (injection under the skin) and this is warned against in the manufacturer’s information sheet which specifically states that Lipostabil® should not be given subcutaneously. Lipostabil® is not licensed in the UK. However, it may be imported into the country by doctors for clinical use for the prevention and treatment of fat embolism subject to compliance with the Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations (SI 1999/4). This allows for importation from elsewhere in the EU by holders of Wholesale Dealers Licences, or from outside of the EU by holders of Wholesale Dealers Import Licences. When ordering, proof must be available from the doctor to demonstrate the existence of a special clinical need for the patient. The MHRA must be consulted about the import by the wholesaler using the notification procedure set out in SI 1999/4. The use of Lipostabil® for cosmetic purposes does not constitute a special clinical need. Unlicensed medicines may not be advertised in the UK and Lipostabil® should not be imported for cosmetic purposes. The MHRA has concerns about the safety of this product for cosmetic use and continues to investigate a number of cases where medicines legislation may have been breached. 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 as follows: Guidance Note 14 The supply of unlicensed relevant medicinal products for individual patients may be found at: http://medicines.mhra.gov.uk/inforesources/publications/gn14.pdf Interim guidelines may be found at: http://medicines.mhra.gov.uk/ourwork/licensingmeds/exemptions/interimguide.pdf SI 1999/4 may be found at: http://www.hmso.gov.uk/si/si1999/19990004.htm A submission form for unlicensed import notifications may be found at: http://medicines.mhra.gov.uk/inforesources/infolicapps/licappforms/notimportfeb2004.doc To view the full PDF version of the warning letter (Size 47kb) from the Medicines and Healthcare products Regulatory Agency (MHRA), please see below.
Questions and answers about Lipostabil®, also marketed as Flabjab™, Lipomelt, Lipodissolve and Fat-Away, which is being illegally promoted as a cosmetic in the UK and is available for the reduction of fat.
Synonyms: Lipodissolve, Flabjab™, Fat-Away, Lipo-melt
Active Ingredient: Phosphatidylcholine Q Has the MHRA determined Lipostabil® to be a relevant medicinal product? A Yes, the MHRA considers that Lipostabil is a relevant medicinal product within the meaning of the Medicines for Human Use (Marketing Authorisations Etc) Regulations 1994, as amended (S.I. 1994/3144). Q Does the product have a Marketing Authorisation (sometimes referred to as a product licence)in the UK?
A No. Q Can a medicinal product be imported, supplied or used in the UK without a marketing authorisation?
A. Yes, if it is either imported for personal use (discussed below) or if it is exempt from the requirement to have a marketing authorisation by regulation 3(2) and paragraph 1 of Schedule 1 to SI 1994/3144. The exemption is limited to products which fulfil a clinical need. Where such a product is supplied by wholesale dealing, further conditions may apply under regulation 11 of and Schedule 4 to the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 (SI 2005/2789). In particular, importers of such products must provide MHRA with prior notification of import. Importation will only be permitted where the relevant conditions in Schedule 1 to SI 1994/3144 and Schedule 4 to SI 2005/2798 are met. Importers from elsewhere in the European Economic Area (EEA) must be holders of Wholesale Dealers Licences (WL), those from outside the EEA must be holders of Manufacturer's Licences, (ML) (previously Wholesale Dealers Import Licences WI, now being updated to Manufacturer's Licences.
Q Does the product have a marketing authorisation elsewhere?
A Yes, in Germany. Q What is Lipostabil®? A Lipostabil® is a preparation of phosphatidycholine for intravenous use. Q What use is Lipostabil® authorised for in its country of origin?
A For prevention (prophylaxis) and treatment (therapy) of blood vessel blockages by fat particles (fat embolism). Q What about cosmetic use for fat reduction?
A It is not authorised for this use. Q Is this product authorised anywhere for cosmetic use?
A No. Q Has the product been assessed for safety for cosmetic use?
A The product’s safety for cosmetic use would not have been assessed as part of the application for a marketing authorisation for treatment of fat embolism. The usual route of administration for cosmetic use is subcutaneous. This is contraindicated (specifically warned against) in the manufacturer’s information sheet. Q Are there any known adverse reactions to cosmetic treatment with Lipostabil®?
A The MHRA is aware of at least three potential adverse reactions to cosmetic treatment with Lipostabil® in the UK. Q Surely, subcutaneous use for cosmetic treatments is safer than IV use for the licensed indication?
A The product information sheet from the manufacturer specifically contra-indicates subcutaneous injection of the product (injection under the skin). Therefore, MHRA has particular concerns about its safety in cosmetic use. Q Are there any other safety concerns with Lipostabil®?
A The product is based upon soya bean extracts and also contains benzyl alcohol. There may therefore be allergy or sensitivity issues in some patients. Q What should I do if I suspect this treatment has affected meadversely?
A You should speak to your GP and ask them to complete a yellow card which will report the adverse reaction to the MHRA, or alternatively you can submit a report directly to the MHRA using the Yellow Card Scheme website address www.yellowcard.gov.uk. Q Why is this product banned by the MHRA? A The MHRA has not banned the product. The manufacturer has not applied for a marketing authorisation in the UK. Q Can I bring this product in for my own personal use?
A The regulations do not prohibit individuals from importing Lipostabil® for their own personal use. However, you should be aware that control of the distribution network from manufacturer to end user, including storage by the end user, is of major importance in ensuring the quality of medicines. Recommendations concerning storage temperatures given on product labels and in product literature are made to ensure optimum stability of products to which they relate in order to help to ensure that they remain safe and effective. For example, storage and transportation of medicines at temperatures above those recommended, can increase their rate of degradation. Failure to adhere to such requirements may result not only in reduced effectiveness, but also in increased toxicity. MHRA considers that if a doctor is involved in, for example, recommending a supplier, assisting in ordering or storing the medicinal product, the product cannot be regarded as imported for personal use.
Q If I import this product for personal use into the UK, can I lawfully give it to anyone else?
A Someone who personally imports Lipostabil® for his own use may give it to someone else in certain limited circumstances, e.g. a family member. Determination of whether importation is for personal use will depend on the particular factual circumstances and is ultimately a matter for the courts. Q I have seen Lipostabil® advertised in the UK - what is the situation with this?
A Unlicensed medicines may not be advertised or marketed in the UK. In addition, it is not lawful to advertise a prescription only medicine to the public. Lipostabil is a prescription only medicine. The MHRA will investigate cases where either activity appears to have taken place, and may take regulatory action. Advertising includes every form of advertising, whether in a publication, or by the display of any notice, or by means of any catalogue, price list, letter (whether circular or addressed to a particular person) or other document, or by words inscribed on any article, or by the exhibition of a photograph or a cinematograph film, or by way of sound recording, sound broadcasting or television, or in any other way, and any reference to the issue of an advertisement shall be construed accordingly
Further information: The MHRA website at www.mhra.gov.uk
To view the full PDF version of this question and answer sheet (Size 32kb) from the Medicines and Healthcare products Regulatory Agency (MHRA), please see below.
See Treatment section.
Not available.
See Treatment section.
See Treatment section.
See Treatment section.
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