On November 30th, 2016, the Cabinet of Ministers of Ukraine by its Resolution No. 929 approved the License Terms for the Production of Medicinal Products, Wholesale and Retail Trade in Medicinal Products and Import of Medicinal Products (Except for Active Pharmaceutical Ingredients) (hereinafter – the “License Terms:). The License Terms are not officially published yet, however, the latest version thereof can be found on the government portal.
The License Terms have combined license terms for four types of economic activities regarding medicinal products that were previously approved by two separate regulatory acts. It will make it somehow difficult for the licensees engaged not in all, but only in a single type of economic activities, such as import of medicinal products, to “navigate” in them, however, it complies with the requirements of the current licensing legislation.
Almost every type of license has its transitional periods for bringing economic activities in line with the License Terms. In particular, a general 2-month term of Resolution No. 929 effective date was established for the licensees engaged in manufacture of, wholesale and retail trade in medicinal products and import of medicinal products (except for active pharmaceutical ingredients). However, the licensees engaged in retail trade in medicinal products should create the necessary conditions for people with disabilities and other people with limited mobility to have access to the premises in accordance with state building rules, regulations and standards within one year of Resolution No. 929 effective date, that is, of the date of its official publication. However, most of the changes for entities engaged in import of medicinal products (paras 194-200, 258, 259 and 265 of the License Terms) take effect from March 1, 2018.
Although the list of documents to be attached to the application for a license for the relevant types of activities has not changed significantly, rather than making a blanket reference to the article of the ineffective law, the entire exhaustive list of such documents in accordance with the Law “On Licensing of Economic Activities” is provided in the License Terms. The only essential change for the licensees was the requirement to provide plain-text information that the activities of the applicant for a license are not controlled by persons - residents of other states engaged in armed aggression against Ukraine and/or whose actions create conditions for the emergence of armed conflict and the use of military force against Ukraine. As the licensees already known provisions of the Law of Ukraine “On Licensing of Economic Activities”, establishment of such a decisive influence on economic activities of the licensee is one of the reasons for cancellation of the license.
Another change, which is bringing the License Terms in line with the Law “On Licensing of Economic Activities”, is to secure the place of activities for each type requiring licensing. Remember that information about such places of activities (their change, termination of activities and establishment of new places) is entered to the Unified State Register.
Each of such premises must be specified in the application for a license, since as opposed to the currently effective license terms, it is prohibited to carry out activities outside such places.
Also the License Terms stipulate new exhaustive cases where it is allowed to store medicinal products and related products not belonging to the licensee at the premises of pharmacies, and the new obligation for the licensee to notify the licensing authority of contracts (or amendments thereto) with another licensee on such storage.
Licensees engaged in industrial production of medicinal products first of all should learn new requirements for the pharmaceutical quality system, including for outsourcing business; assessment and control of risks, including cross-contamination; investigation and evaluation of quality defects, decision-making on the withdrawal of the product; selection, qualification and approval of suppliers of raw materials; self-inspection; requirements for record keeping; test methods.
Changes for the licensees engaged in wholesale trade in medicinal products to pay attention to are the following:
For the licensees engaged in retail trade in medicinal products and production (manufacture) of medicinal products in pharmacies there is a requirement to ensure the availability of logistics, technical facilities and their compliance with regulatory requirements for production, storage, quality control and sale of medicines trade in medicinal products. The requirements to premises were slightly changed. An obligation was set that a settlement document confirming the purchase should be issued to a person buying medicinal products.
As for import, as mentioned earlier, most of the changes take effect in 2018. Other changes are rather specific, however still require individual amendments, for example, to medicinal products supply agreements.
Thus, the License Terms introduced a number of general organizational requirements under the Law “On Licensing of Economic Activities”, and set some rules for each type of economic activities in the area of medicinal products circulation.
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