Licensing of drugstore with wheelchair ramp in 2017

At the end of December 2016, we were contacted by a Client who intended to set up a drugstore and needed to obtain a special license. The Client tried to set up a drugstore before the new license regulations came into force, but he was delayed due to the need to repair the premises of the future pharmacy. That’s why he inquired about whether something had changed drastically, whether he needed to obtain any additional certificates and whether he had to make any changes.

Since our company’s lawyers knew the legislation from A to Z and had practical experience in obtaining the licence under new License Terms, they thoroughly studied the Client’s case and didn’t found any circumstances preventing him from obtaining the licence. Despite the fact that the License Terms and the practice of the State Service of Ukraine on Medicines and Drugs Control have changed significantly, we had extensive experience in preparation of documents according to the new regulations.

At first glance, the news on the requirements to provide persons with disabilities and other people with limited mobility with easy access to the premises, in accordance with the state building rules, regulations and standards (para. 165 of the License Terms for the Production of Medicinal Products, Wholesale and Retail Trade in Medicinal Products and Import of Medicinal Products) seemed insignificant.

The previous License Terms required to ensure necessary conditions for persons with disabilities to access the pharmacy. Pursuant to the current regulations, both people with disabilities and other people with limited mobility shall be provided with easy access to the premises. The fact is that the law of Ukraine does not provide the definition of “a person with disabilities”. While in accordance with Article 2 of the Law of Ukraine “On the Fundamentals of the Social Protection of Disabled Persons in Ukraine”, a disabled person is a person with consistent disorder of the body functions, which, in the course of interaction with the environment, can lead to the restriction of his/her activities; therefore the state is obliged to create the conditions which would enable that person to exercise his/her rights in the same way as other citizens and to ensure his/her social protection. Previously, the key focus was given to the possibility of wheelchair users to access drugstores. But disability can be connected with loss of sight, hearing, etc. Thus, the new License Terms expand the requirements for accessibility.

In view of all this, the requirements of the State Service of Ukraine on Medicines and Drugs Control for the installation of the wheelchair ramp became stricter. While previously it was enough to set a wheelchair ramp in accordance with the established requirements, now it is required to obtain the conclusion of the construction expertise on the conformity with the State Building Standards of Ukraine (DBN) V.2.2-17: 2006 “Buildings and structures. Availability of buildings and facilities for limited mobility groups of population”. In particular, paragraph 6.2 of the State Building Standards specifies not only the norms of the wheelchair ramp width, height and angle of inclination, but also the materials it shall be made of.

Another significant difference between the old and new License Terms is the ability to practice medicine in a drugstore. But our Client wasn’t interested in this. To learn more about the peculiarities of medical practice in drugstores, click here.

Despite the significant changes in the License Terms and the need to obtain additional documents, our company’s specialists ensured that the Client obtained the license in the shortest possible time.

You can find more detailed information on the terms and conditions of cooperation in respect of obtaining a Drugstore License here.