According to the Article 19 of the Law of Ukraine №123/96-ВР from 04.04.1996 “On Medicines” wholesale and retail trade of medical products is subject to mandatory licensing.
The wholesale of medicines means the acquisition of medicines from manufacturers or intermediary institutions, storage, sale of medicines to medical institutions, wholesale or retail entities. Each participant in the scheme of buying and selling of medical products must have a corresponding license.
The procedure for licensing is approved by the Ministry of Healthcare of Ukraine. Economic entities, claiming to obtain a license to wholesale medicines, must comply with the mandatory license terms:
The documentation confirming the fact of purchase and sale of medicinal products should contain: name, quantity, serial number and expiration date of the goods received and sold. Primary documents are kept at least three years from the date of the last inspection.
Wholesale supply of medicines is implemented via pharmacy warehouses. The total area of the base should be at least 250 m2. On the territory of the base there should be industrial premises for the acceptance, storage and release of medicines. In front of a separate exit from the warehouse, it is necessary to equip the loading and unloading platform.
Pharmacy warehouses are located in separated one-store buildings. The minimum distance to dwellings should be not less than 60 m, from public buildings – 80 m, from the industrial area – 30 m. It is forbidden to place a pharmacy warehouse in cellars, basements, second and higher floors, non-insulated premises, with constant presence of people.
Separate zones for the storage of flammable, poisonous and psychotropic drugs are obligatory placed in the pharmacy warehouse.
In the state of the organization engaged in medicines wholesaling, the head of the pharmacy warehouse and pharmacists should be listed.
Employees of the establishment should have appropriate diplomas confirming the presence of pharmaceutical education, certificates of qualification of the pharmacist. Only licensed pharmacists have the right to sell medicines.
Workers engaged in the selection and packaging of products do not fall under the compulsory requirements for the availability of education. All employees have to undergo periodic medical examination.
The functions of the State Service of Ukraine on Medicines include review of documents necessary for obtaining a permit to wholesale medicines, issuance, reissue and cancellation of licenses.
In order to obtain a license to wholesale medicines, the applicant should submit the following documents to the State Service of Ukraine on Medicines:
If documents are submitted not by official, but by a designated official, a power of attorney for representation of interests should be provided.
The period for consideration of the submitted package of documents should be not more than 10 working days from the date of application. Compliance of the information submitted by the applicant to the established requirements is subject to mandatory verification by a representative of the territorial unit of the State Service of Ukraine on Medicines. The decision on licensing will be based on the results of the actual inspection and verification.
Reasons for rejection the licensing:
In case of rejection, the organization can eliminate the remarks and re-send the license request, but not earlier than three months from the date of receipt of rejection.