On November 10, 2015, the State Service on Medicinal Products published at its official website the Cabinet of Ministers Draft Resolution«On Approval of Licensing Requirements to Manufacturing, Wholesale and Retail Trade, and Import of Medicinal Products (excluding active pharmaceutical ingredients)» (hereinafter — Licensing Requirements). This Draft Resolution presents the second attempt of the State Service on Medicinal Products to develop the licensing requirements to the abovementioned business activities.
One of the positive aspects of Licensing Requirements is the implementation of the comprehensive list of requirements compulsory for the licensee, and the complete list of documents attached to the license application for license acquisition for manufacturing, wholesale and retail trade, and import of medicinal products.
It is worth to mention that the actual list of documents attached to the license application has not been substantially adjusted. It mostly repeats the list of documents provided by the Cabinet of Ministers Resolution № 756 as of July 4, 2001. It is also noteworthy that Licensing Requirements, in comparison to current requirements approved by the Ministry of Health Orders № 723 as of 31.10.2011 and № 143 as of 20.02.2013, do not have any provisions neither for leaving the licensing application without consideration, nor for licensing rejection. Therefore, these issues shall be regulated by the Law of Ukraine «On Licensing of Business Activities» № 222 as of 02.03.2015 (hereinafter – Licensing Law).
Licensing Requirements approved the list of necessary documents or their copies, which the licensee should store during the whole term of license for the purpose of accuracy confirmation of the data provided by the licensee. This list of documents shall include:
Another adjustment is the provision, which allows the licensee to store his medicinal products and other supplies on the premises of the pharmacies. But this opportunity is stipulated only in certain cases: when medicinal products have been purchased with the use of state funds or received as a humanitarian aid and/or charity support; when medicinal products belong to another licensee, and the licensee that stores confirmed the compliance with good distribution practices.
In addition, some new licensing application forms have been approved, i.e., application for the inclusion into EDRPOU of the information on the business activity premises; application on the reduction of the business activity type, etc. Such changes have been introduced in order to enforce the requirements of the Licensing Law, which bind the licensee to report to the licensing authorities on all data changes in the documents submitted together with the licensing application.
Moreover, the licensee henceforth should notify the licensing authority on the conclusion of agreements (or changes to the agreements) with other licensee, which shall store the medicinal products under such agreement. This notification should also include the information on the business entity being a party to such agreement, other corresponding details and pharmacy depot address.
Certain changes have also been introduced to the terminology. Thus, in accordance with the Licensing Requirements the production (manufacturing) of the medicinal products on the pharmacy’s premises shall also mean the production of the concentrates, semi-products and medicinal products for storage; the terms «license», «licensee» have been excluded from the Licensing Requirements.
The Licensing Requirements also provide for the clarification of qualification requirements to the personnel of license holders. In particular, the entities engaged into the wholesale trade of medicinal products should have the following:
а) Diploma confirming the pharmaceutical education at the educational institutions of ІІІ-ІV levels of accreditation, and of І-ІІ levels;
b) With complete higher education — certificate of specialist degree acquisition (confirmation) of the pharmaceutical chemist, or certification on this specialty with the confirmation of qualification categories for the diplomas issued by educational institutions of І-ІІ levels.
The abovementioned requirement shall not apply to the pharmacy depots employees who pick and pack the orders. They should take continuing training in accordance with their responsibilities, as well as periodic medical examinations.
In general, the adoption of new Licensing Requirements has been driven by the need to bring such requirements into compliance with the Licensing Law. The introduced Licensing Requirements shall support the implementation of the unified state policy in the area of licensing.
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