• New Regulation on register of wholesale prices for pharmaceuticals and medical-purpose products is approved
• Procedure for labeling medical-purpose products is clarified

New Regulation on register of wholesale prices for pharmaceuticals and medical-purpose products is approved

On 17 October 2011 Order of the Ministry of Health of Ukraine No.602 dated 21 September 2011 ”On approval of the Regulation on the register of wholesale prices for pharmaceuticals and medical-purpose products, the procedure for amending this register and application forms for registration of wholesale prices for pharmaceuticals and medical-purpose products” took effect.

The previous order that approved the Regulation on the register of wholesale prices for pharmaceuticals and the procedure for amending it (Order of the Ministry of Health of Ukraine No.1006 dated 18 November 2010) ceased to be in force.

Order No.602 introduces a new register of wholesale prices. Unlike the previous one, it consists of two registers:

• A register of wholesale prices for pharmaceuticals, and
•A register of wholesale prices for medical-purpose products.

The Order also establishes that the register of prices for pharmaceuticals should include information on all active materials in cases when a pharmaceutical contains several active materials.

The register of wholesale prices on medical-purpose products must include information on: the code, type, kind and brand of the product; the code under the Ukrainian Foreign Activity Commodities’ Nomenclature; the application of the product; the registered wholesale price for the foreign-origin product in UAH and in foreign currency; the registered wholesale price of the locally produced product in UAH; and the official currency exchange rate as of the date of the filing of the application.

The Ministry of Health of Ukraine must form the register and publish it on its official website.

Procedure for labeling medical-purpose products is clarified

Recently letter No.15363-16/11.1/17-11 dated 31 August 2011 was promulgated. In this document the State Inspection for Control of Pharmaceuticals’ Quality reiterates that the sale and use of medical products in Ukraine is allowed only after these products have been duly registered.

The order for labeling medical products is established in the relevant national standards or in those standards that cover certain groups of products.

The Law of Ukraine “On protection of consumers” requires the labeling of products. It says that a consumer has the right to receive information about products. This information must be sufficient for the customer to make a conscious and competent choice.

The State Inspection notes that labeling medical-purpose products should take place before these products go on sale in Ukraine.