On 20 October 2014, the Parliament of Ukraine adopted the Law of Ukraine "On amendments to the Law of Ukraine On Medicines" related to dealing in products, and state control over quality of products imported into Ukraine (the "Amendment"). This Amendment improves the medicine registration rules, and streamlines state control over the quality of products imported into Ukraine.
Implications for importers and customers
The Law of Ukraine On Medicines, which was in effect prior to amendment, provided that any medicine can be marketed in Ukraine for a period of five years after its state registration. After the end of each such period registration of such medicine needed to be renewed.
The Amendment provides that after the first renewal of registration, marketing of such medicine will not be limited by time in the future. In other words, the Amendment has abolished the requirement to have the registration renewed every five years after its first renewal, helping importers to reduce the cost of bringing a product to market, and to ensure continuous supply of any product according to market demand, without the need to take into account the duration of registration once renewed.
Further, the Amendment provides that any product supplied to the market during the period when the respective medicine is allowed to be marketed in Ukraine may continue being offered until the expiration date indicated on its packaging. This novelty allows the medicine to be offered after registration is terminated, even if not renewed.
In addition to the above, the Amendment provides for a separate procedure for state control over the quality of products imported into Ukraine to be determined by the Cabinet of Ministers of Ukraine. The Law of Ukraine On Medicines, which was in effect prior to the Amendment, provided for state control over the quality of products imported into Ukraine prior to, and after, making them available on the Ukrainian market. Such Amendment helps to avoid duplication of oversight by the Health Ministry and the Cabinet of Ministers.
The Amendment became effective on 5 November 2014.
The Amendment simplifies the medicines marketing rules in Ukraine and is expected to have a positive effect on the ability of foreign pharmaceutical companies to bring their products to the Ukrainian market, and to help reduce their marketing costs thus enhancing patient access to medicines.