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calendary June 15, 2016

Cosmetic services with the use of hyaluronic acid and botulinum toxin type A

Roszdravnadzor warns: cosmetic services with the use of hyaluronic acid and botulinum toxin type A (trade names Botox, Dysport, Relatoks) should be provided by specially trained medical personnel in organizations with a license for the appropriate type of such medical activity.

In connection with the detection of cases of substandard and counterfeit medicines and medical products used in cosmetology, Roszdravnadzor declares the following.

On the territory of the Russian Federation the handling of pharmaceutical products and medical devices registered in the prescribed manner are authorized. The registration certificate is the confirmation of the product quality and safety.

The usage of unregistered or smuggled into the country drugs and medical products endangers the patient’s health and life.

However, some people do not pay enough attention to the origin and quality of health care products offered them; casually refer to the choice of institutions and doctors, providing beauty services.

Taking into account the risk of serious adverse reactions to botulinum toxin, as well as medical devices, which include hyaluronic acid, Roszdravnadzor warns: this medical product can only be used by physicians who have received special training in organizations that have a license for medical assistance on a profile “cosmetology”.

Please note that all the experts, officials and organizations using botulinum toxin preparations and medical products containing hyaluronic acid, in violation of the requirements for the use of medical products and health care bear administrative and criminal liability in accordance with Russian law.

Reference of Roszdravnadzor: in 2015 the Federal Service for Supervision in the Sphere of Health Care  identified and stopped handling three types of counterfeit medical products in healthcare, containing hyaluronic acid (HA gel implanted for endermic injection used for the treatment of wrinkles and folds, lip augmentation, improving skin tone and elasticity ).

In May 2016 the Altai Territory Investigative Committee of the Russian Federation revealed 700 unregistered drugs 33 items containing botulinum toxin type A.

References:
  1. http://www.roszdravnadzor.ru/news/3394

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