We have been assisting in starting a pharmaceutical business every day for 15 years. Here you can get a free professional consultation and order a range of turnkey services.
The process of obtaining a licence is not easy and has many nuances. Legislation changes quite often, and the requirements that were in place yesterday may no longer be relevant today. Therefore, in order to do everything right and obtain a licence on the first try, we advise you to contact professional specialists who deal with this on a daily basis.
Find out more about how we can help:
Minimum floor space
For the city – 50 sq.m.
Pharmacy outlets are subdivisions of a pharmacy and may be opened only if it is available.
Pharmacy outlets may be located only in healthcare facilities.
Such a structural unit as a pharmacy kiosk no longer exists.
A legally required ramp is required if there are stairs.
The person who will hold the position of the head must have a diploma of higher pharmaceutical education and a certificate: “Organisation and management of pharmacy”.
Licence validity period
The licence for retail sale of medicinal products is issued in electronic form and is unlimited. No paper version is issued. You can find out whether you have a licence or not on the website of the State Service of Ukraine on Medicines and Drugs Control.
To the attention of those who have a licence! We would like to additionally inform you that the legislative requirements are established by the Resolution of the Cabinet of Ministers of Ukraine dated 30 November 2016 No. 929 «On Approval of the Licensing Conditions for Conducting Business Activities for the Production of Medicines, Wholesale and Retail Trade in Medicines and Import of Medicines» – hereinafter referred to as the Licence Terms, have undergone significant changes.
All licensees of Ukraine that hold unlimited licences for trade in medicinal products issued before 22.09.2021 are obliged to bring their business activities in line with the Licence Terms (as amended by the Resolution of the Cabinet of Ministers of Ukraine No. 1002 dated 22.09.2021) within the period of 1 year provided for by law.
Thus, all licensees need not only to bring their activities in line with the new Licensing Requirements, but also to submit to the State Administration of Ukraine on Medicines and Drugs Control a notification of changes in data and a completely new statement on the availability of material and technical facilities and qualified personnel.
List of required documents
Registration / re-registration of medicinal products
Certification, declaration of medical devices
Certification of Ukrainian medical devices in Europe
Registration/legalization of cosmetic products
Registration/legalization of Ukrainian cosmetics in Europe and the USA
License for a pharmacy warehouse (wholesale trade in medicines)
Import license (import of medicines)
Licences for a pharmacy/pharmacy outlet (retail sale of medicines)
Licenses for an online pharmacy (electronic commerce in medicines)
License for manufacturing of medicinal products (industrial and pharmacy)
License for narcotic drugs, psychotropic substances and precursors
Conducting clinical/preclinical trials
Obtaining a certificate / conclusion on GMP confirmation
Courses for medical directors and heads of pharmacies
Recruitment for pharmacies and medical institutions
Promotion of your products in Ukraine
ACcreditation of medical institutions “TURKEY”
Resolving issues with antitrust law