Telegram 
Viber 
Whatsapp 
Messenger Pharmacy License Kyiv
| Service | Timeframes |
|---|---|
| License for the right to trade (wholesale, retail) and manufacture medicinal products | from 15 business days |
| License for the production of medicinal products | from 15 business days |
Pharmacy Licensing
The pharmacy business in Ukraine is strictly regulated by state authorities.
Licensing of a pharmacy (its structural subdivisions), a pharmaceutical warehouse, as well as activities for the production of medicinal products is mandatory.
Pharmaceutical License
Pharmaceutical license for retail trade
Retail sale of medicines is carried out through pharmacies, as well as their structural subdivisions: pharmacy outlets and kiosks. A pharmaceutical license for retail trade is issued on the basis of submitting an application in the approved form and the necessary information about the availability of the applicant’s material and technical base and personnel with the appropriate qualifications. The licensing authority to which the documents are submitted is the State Service of Ukraine for Medicines.
| Service name | Timeframes |
| 1 working day |
| from 5 working days |
| 10 working days |
The fee for a pharmaceutical license is set at the level of one minimum wage established on the date of the licensing authority’s decision. Until 01.12.2015 this amount was set at 1218 UAH.
Pharmaceutical license for wholesale trade
Medicines can be sold wholesale only through a pharmaceutical warehouse (base) – a healthcare institution that supplies medicines to other healthcare entities, trade (retail, wholesale), as well as drug manufacturers. The pharmaceutical license for wholesale trade is issued in the same procedure and has the same cost as the license for retail trade.
License for the production of medicines
Medicines can be manufactured by both legal entities and individuals.
The main requirement is that their activity must take place according to technological regulations and the requirements of pharmacopoeial monographs. These are normative-technical documents that establish the most important requirements for the medicinal product itself, as well as its packaging, quality control methods, storage conditions and periods. Compliance with other international technical specifications and national state standards is also mandatory.
In addition to the general documents submitted to the licensing authority, namely the application, information about the applicant’s material and technical base and staff qualifications (or an individual in the case of individual production), for the industrial-scale production of medicinal products a copy of the manufacturing site’s dossier (approved by the enterprise) is also required.
The license for the production of medicines has an annex. It specifies the specific list of dosage forms that the licensee is permitted to manufacture, as well as other special conditions.
It should be noted that a license may be granted for all types of activities of pharmacy establishments (wholesale, retail trade, production) or separately for each.
Pharmaceutical licenses are issued for an unlimited period.
Contact the specialists of our company, and we guarantee you:
- qualified and full support throughout the procedure of obtaining a pharmaceutical license;
- representation of your interests in the state authorities of Kyiv;
- preparation of the necessary documents with minimal involvement from you;
- achieving a positive result in the shortest possible time.
LEGISLATION:
Law of Ukraine “On Licensing of Types of Economic Activity” dated 02.03.2015 No. 222-VIII;
Law of Ukraine “On Medicinal Products” dated 04.04.1996 No. 123/96-VR;
Order of the Ministry of Health “On Approval of the Licensing Conditions for the Conduct of Economic Activity for the Production of Medicinal Products, Wholesale and Retail Trade in Medicinal Products” dated 31.10.2011 No. 723.