Strengthening administrative sanctions against violation of license conditions

The draft law on strengthening administrative sanctions against violation of license conditions for medicinal products quality proposed by the State Service of Ukraine on Medicines and Drugs Control and the Ministry of Health of Ukraine has been registered by the Parliament of Ukraine.

What does the draft provide?

• improvement of the control over medicinal products quality;
• prevention of manufacture and distribution of substandard medicinal products;
• creation of conditions that ensure qualitative, efficient and safe medicinal products to appear in the market of Ukraine and produced in accrodance with the standards.

Licensees which are subject to sunctions:

• licensees selling medicinal products prohibited by legislation (fine of 100 to 700 non-taxable minimum income of citizens);
• licensees distributing products that do not correspond starndard requirements (fine of 300 to 800 non-taxable minimum income of citizens);
• licensees providing services to the citizens-consumers that do not correspond starndard requirements (fine of 100 to 500 non-taxable minimum income of citizens);
• licensees which do not abide legal requirements of officials of the central executive authority that implements the state policy in the field of quality and safety of medicinal products (fine of 200 to 500 non-taxable minimum income of citizens);

* The Ministry of Health of Ukraine and the Cabinet of Ministers of Ukraine supports implementaion of the above mentioned draft law which will have a positive impact on the healthcare system for citizens.

** The fines and sanctions have not been updated during the last 10 years and do not correspond the amount of distributed substandard medicinal products, thus are not relevant nowadays.

The draft law on strengthening administrative sanctions against violation of license conditions for medicinal products quality proposed by the State Service of Ukraine on Medicines and Drugs Control and the Ministry of Health of Ukraine has been registered by the Parliament of Ukraine.

What does the draft provide?

• improvement of the control over medicinal products quality;
• prevention of manufacture and distribution of substandard medicinal products;
• creation of conditions that ensure qualitative, efficient and safe medicinal products to appear in the market of Ukraine and produced in accrodance with the standards.

Licensees which are subject to sunctions:

• licensees selling medicinal products prohibited by legislation (fine of 100 to 700 non-taxable minimum income of citizens);
• licensees distributing products that do not correspond starndard requirements (fine of 300 to 800 non-taxable minimum income of citizens);
• licensees providing services to the citizens-consumers that do not correspond starndard requirements (fine of 100 to 500 non-taxable minimum income of citizens);
• licensees which do not abide legal requirements of officials of the central executive authority that implements the state policy in the field of quality and safety of medicinal products (fine of 200 to 500 non-taxable minimum income of citizens);

* The Ministry of Health of Ukraine and the Cabinet of Ministers of Ukraine supports implementaion of the above mentioned draft law which will have a positive impact on the healthcare system for citizens.

** The fines and sanctions have not been updated during the last 10 years and do not correspond the amount of distributed substandard medicinal products, thus are not relevant nowadays.