On 26.07.2012 President has signed the law adopted by the Verkhovna Rada of Ukraine #5065- VI "On Amendments to certain legislative acts of Ukraine concerning the strengthening of responsibility for fraud or circulation of counterfeit medicines".

The Law establishes liability for violation of restrictions imposed on workers of health care, pharmaceutical (pharmacy) institutions and their directors, while exercising their professional activities in the form of a fine of up to 300 untaxed minimum incomes, or in the form of a fine of 1200 untaxed minimum incomes of citizens, in the case of repeated violation.

Also the law establishes criminal liability for falsification of medicines. According to the changes producing, buying, transporting, sending, storing possession with intent to sell of the counterfeit drugs or knowingly selling counterfeit medicines

is punishable by imprisonment for a term of three to five years, with confiscation of counterfeit medicines, raw materials and equipment for their manufacture.

The same actions committed repeatedly or by prior arrangement by a group of persons, or in large amounts, or resulted in prolonged injury to the health of a person, as well as the production of counterfeit medicines - is punishable by imprisonment for a term of five to eight years with confiscation of counterfeit medicines, raw materials and equipment for their manufacturing and property.

If these actions resulted in human death or other serious consequences, or committed on a large scale, they are punishable by imprisonment for a term of eight to ten years or life imprisonment, with confiscation of counterfeit medicines, raw materials and equipment for their production and property.

A person who voluntarily delivered counterfeit medicines and identified the source of their purchase, or has contributed to the disclosure of crimes related to trafficking, shall be exempt from criminal liability for the manufacture, purchase, transportation, transfer, or possession with intent to sell of counterfeit medicines in the territory of Ukraine, export from the territory of Ukraine, or transit through its territory (the first part of this article, if such actions did not create a threat to life or health).

In addition, the Law introduced criminal liability for violations of the order in conducting clinical trials and drug registration. In accordance with the law, intentional violation of the established order of pre-clinical researches, clinical trials and registration of medicines, as well as falsification of the results - is punishable by imprisonment for a term of three to five years, with disqualification to hold certain posts or perform certain activities for a period of one up to three years.

The same acts committed repeatedly or by prior agreement of persons - shall be punishable with imprisonment for a term of five to eight years, with disqualification to hold certain posts or perform certain activities for up to three years.

If the above actions caused the death of the injured person or other serious consequences, - they are punishable by imprisonment for a term of eight to ten years, with disqualification to hold certain posts or perform certain activities for three years.

More detailed information can be found here - http://www.legalalliance.com.ua/rus/press/1880

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