On June 25, 2014 the State Service of Ukraine for Medicinal Products has promulgated the draft order of the Ministry of the Health of Ukraine "On Amendments to the Regulations for quality control of medicinal products during wholesale and retail trade” (hereinafter – Draft and Instruction respectively).
It is proposed by the document to complement the existing regulations by the following provisions:
- To prohibit trade in medicinal products which have not passed the state control at the import into Ukraine (for foreign-made medicinal products); and in immunological medicinal products which have not passed the state control in accordance with the procedure approved by the Ministry of Health of Ukraine.Herewith a business entity shall store and, if needed, provide territorial authorities of the State Service of Ukraine for Medicinal Products documents confirming the purchase, storage, transportation, trade, destruction or disposal of medicinal products for inspections for 3 years.
- To oblige business entities to have a plan for urgent actions which shall ensure the fulfillment of orders and the Ministry of Health of Ukraine and the State Service of Ukraine for Medicinal Products to suspend production, trade, withdraw medicinal products and make appropriate arrangements for the return to the seller (manufacturer) of the medicinal products or their destruction and disposal.If a business entity has more than one pharmacy, the quality system must ensure the interoperability between the authorized persons of the enterprise with regard to obtaining information about the substandard, suspected of fraud / counterfeit and unregistered medicinal products, division of responsibilities and order of the collaboration of authorized persons in the part of the interaction of the enterprise with the territorial authority of the State Service of Ukraine for Medicinal Products.
- Establish new requirements for authorized persons who perform outbound quality control of medicinal products of business entities. In case of approval of amendments to the Regulations, functions of an authorized person may be executed by a specialist with the full higher pharmaceutical education and work experience in the specialty for at least 2 years. Herewith the fulfillment of the duties of the authorized person, responsible for the operation of the system of insuring the quality of the medicinal products in the pharmacy, located in the countryside, can be entrusted to a person with a pharmaceutical educational who has received an educational qualification of the associate's degree, bachelor's degree, without any professional experience.
The draft provides for other significant changes in the procedure of the quality control of the medicinal products during wholesale and retail sale (trade), as well as changes into the terminology of Regulations.
