Our lawyers helped a Client to fulfill his business project in Ukraine
- Author: Volodymyr Misyurak
- Practice areas: Medical law
- Standardized procedures: License for medical practice in Ukraine
License for sale of medicines (drugstore license)
Hygiene certificate from the State Sanitary and Epidemiologic Service
Accreditation of a medical institution in Ukraine
Registration of medical equipment or medical products in Ukraine
- Дата публикации: 31/10/12
Activities that aren't subject to medical practice licensingIn March of 2012 a Client requested our legal support and advising of him emerging on the services market of teeth whitening using the latest LED technology in large shopping centers throughout Ukraine.
All the legal advices that were provided to the Client before came to the conclusion that according to stipulations of regulations in the field of healthcare, including the Order of the Ministry of Healthcare of Ukraine number 67 dated 14.02.2007 “On approval of temporary classifier of medical procedures (services) and surgical procedures” teeth whitening belongs to dental therapy group (group AED5 # 11 of the Order) which is indivisible and includes any kind of teeth whitening with usage of any technology.
Based on this a conclusion was made that teeth whitening is a medical procedure and provision of services by the Client was possible only after he would obtain a medical practice license.
In Client’s situation regulatory requirements set to obtain a medical practice license were impossible to comply with what disabled start and implementation of his business-project in general.
The Client could not agree with such conclusions since there is a practice of such service provision in the U.S., Europe and a number of other countries.
Law firm “Pravova Dopomoga” legal experts of “Medical and Pharmaceutical law” practice examined the documents for teeth whitening equipment and materials on qualification requirements for future staff, structure and technology of teeth whitening service, international experience.
Attention to details and significant experience allowed us to find legal grounds for our Client not to obtain medical practice license in Ukraine.
To confirm the conclusion that legal experts of law firm “Pravova Dopomoga” came to, we advised our Client to request clarifications from the Ministry of Healthcare of Ukraine and prepared text of the request with all the required evidence.
As the result of Client representation in relations with the Ministry of Healthcare of Ukraine, after the review of his request the Client received positive answer from the Ministry in which in particular was stated: “Therefore the mentioned activity cannot be defined as medical practice so it does not require medical practice license”.