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Arseniy Salalayko
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License to Wholesale Medicines

Licensing of Medicines and Medical Supplies Trade

 
Standard
(serve)
12 000 грн
Standard +
(accompanying)
42 450 грн
Premium
(without grounds)
5 000 usd
Terms
10 w.d.
1 month
2 month
Consultation
Order on the approval of the staff schedule
Staff Schedule
The order to accept the warehouse manager
Application for employment
Order on assigning duties to the warehouse manager
Order about the mode of operation of the warehouse
Application for a license
Information on the availability of mat-base and personnel
Certificate of non-control
Power of attorney
Submission of documents to the licensing authority
Maintenance of on-site inspection in the warehouse
Registration of LLC
Diploma in the specialty "Pharmacy"
Employment history
Specialty pharmacist certificate
Certificate of professional development
Warehouse search
 

Order

 

Order

 

Order

 
* Warning:

* The work experience of a pharmacy specialist should be at least 2 years
* Director and pharmacist must be officially employed
* For obtaining a license, it is necessary to pay a state fee in the amount of one living wage

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.

Who Can Obtain a License to Wholesale Medicines?

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:

  • Provide the availability of the necessary material and technical basis for the storage and sale of medical products.
  • Comply with the requirements concerning the transport and sale of medicines.
  • Monitor the input quality of the products sold.
  • Adhere to the limit trade margins established by the Cabinet of Ministers of Ukraine.
  • Follow MOH orders regarding exclusion measures and returning certain types of medicines to the manufacturer.

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.

Requirements for Pharmacy Warehouses

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.

Qualification Requirements for Staff

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.

Licensing for Medicines Wholesaling

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:

  • Application as a form for licensing.
  • Information on the location of the pharmacy warehouse and equipment for storing medicines.
  • Confirmation of staff qualification: the head of the pharmacy warehouse, the pharmacist (in the form approved by the MOH).
  • Receipt of payment of state duty for licensing.
  • Inventory of the provided package of documents.

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:

  • Unreliability of the information submitted by the applicant;
  • Non-compliance of the license terms.

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.

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