This concerns cases of changes to the name of the medicinal product, the name of the applicant or the manufacturer.
Object of declaration
According to the Procedure for declaring prices for medicinal products in the National Catalogue of Prices, approved by the resolution of the Cabinet of Ministers of Ukraine of 4 April 2025 No. 439 "Some issues of state regulation of prices for medicinal products", the object of declaration is the maximum price for a medicinal product under a certain trade name, dosage and pharmaceutical form within one registration certificate.
Use and sale of remaining stock
In accordance with Article 9 of the Law of Ukraine "On Medicinal Products", medicinal products released into circulation during the period in which they were authorized for use in Ukraine may be used until the expiry date determined by the manufacturer and indicated on the packaging.
Remaining stock of medicinal products with the previous trade name, name of the manufacturer or holder of the registration certificate, manufactured and/or placed into circulation before the approval of the relevant changes, may continue to be sold, even if the updated data are already reflected in the National Catalogue of Prices.
When such remaining stock is sold, the maximum wholesale prices that were declared in the National Price Catalogue and were in effect at the time of acquisition of ownership of the relevant medicinal products shall apply.
Changes in registration dossiers = changes in the National Catalogue
Adding a manufacturer and/or marketing authorisation holder, changing its name or location, as well as changing the trade name belong to the procedure for amending the registration dossier materials and do not affect the price of the medicinal product.
If a declared price already exists for the relevant registration certificate, a change of the trade name, name of the manufacturer or marketing authorisation holder within that certificate is a technical update, rather than the creation of a new product item.
Important! Holders of registration certificates and/or manufacturers are advised to submit to the National Price Catalogue up-to-date technical changes regarding:
- the trade name of the medicinal product;
- the name of the manufacturer;
- the name of the marketing authorisation holder
immediately after approval of the relevant MoH order.
To make changes to the National Catalogue, send a letter to the email address: technk@dec.gov.ua
Legal status
The State Register of Medicinal Products (SRMP) and the corresponding order on state registration, re-registration or amendments to registration materials are the primary sources of information on the legal status of a medicinal product and its manufacturers in Ukraine. The National Catalogue of Prices is a derivative control tool.
A delay in transferring technical data from the State Register of Medicinal Products to the National Catalogue of Prices is not an obstacle to the circulation of a medicinal product, provided that its price is duly declared and does not exceed the established maximum level.
Important! To ensure uninterrupted supply of medicinal products and fulfilment of contracts, distributors are advised to accept medicinal products from a new manufacturer or marketing authorisation holder or with a new trade name, if such data are specified in the valid registration certificate and the State Register of Medicinal Products.
In this case, the declared price already entered in the National Catalogue of Prices should be applied for the relevant registration certificate.
Such a price applies to all manufacturing sites specified in the registration materials.
Until the next update of the National Catalogue of Prices, the current entry in the State Register of Medicinal Products is sufficient confirmation of the manufacturer's legitimacy.
