Wholesale of Medicines
Cost of services
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What we offer
- Advise the Client on all matters related to the requirements for the pharmacy storage facilities, as well as for the qualification of personnel;
- Analyze available documents for the pharmacy storage facilities and personnel;
- Prepare an application, statements and other documents to be submitted to the State Service of Ukraine on Medicines and Drugs Control for obtaining a License to Wholesale Medicines;
- Submit the documents signed by the Client to the State Service of Ukraine on Medicines and Drugs Control;
- Monitor the process of the documents review by the State Service of Ukraine on Medicines and Drugs Control.
Documents required for starting a pharmacy storage facility
In addition, we will need information about:
- the characteristics of the building (premises) where the pharmacy storage facility will be located;
- engineering equipment used for medicines storage.
The period of obtaining a license for the pharmacy storage facilities (to wholesale medicines) is 20 - 30 business days from the date of receipt of all necessary documents signed by the Client.
We obtain a license for the pharmacy storage facilities for enterprises located at all regions of Ukraine. The price of obtaining a License to Wholesale Medicines will be the same for Clients from any region, because our specialists provide distance services.
The cost of our services does not cover a one-time state license fee, which amounts to one living wage as of the day the licensing authority takes a positive decision (to issue a license).
We are ready to help you!Contact us by mail [email protected] or by filling out the form:
A License to Wholesale Medicines is often called a pharmacy license or a license for the pharmacy storage facilities. But a Pharmacy License is a broader concept and covers both licenses for wholesale and retail trade in medicines.
One of the key documents in wholesale trade in medicines is a quality system, which is developed by the licensee and shall ensure good practice of distribution and storage of medicines, risk management.
The licensing regulations have a number of requirements to the quality system, including:
- staff responsibilities, processes and risk management, which enable the storage and delivery of medicinal products with appropriate quality indicators;
- description of the change management system, which operates in compliance with the principles of quality risk management.
In addition, wholesale pharmacies shall develop and use:
- cleaning programs;
- cleaning protocols;
- documents describing the process flow stages;
- inventory turnover system.
If necessary, we can help prepare all the necessary documents.
Terms of obtaining a License for the pharmacy storage facilities
Our employees develop documents for signing within one or two business days from the day they receive all the necessary information and scanned copies of documents for the premises and personnel. In practice, it often happens that the documents for signing are prepared as and when the Client provides us with the necessary information.
It takes 20-30 business days from the day we receive all the necessary documents signed by the Client and till the date the State Service of Ukraine on Medicines and Drugs Control publishes its decision on the license issuance on it official website.
Answers to frequently asked questions
No, unlike retail pharmacies, the requirements for pharmacy storage facilities do not depend on the place of their location.
No, because retail trade in medicines is subject to another kind of licensing.
Requirements to pharmacy storage facilities in UkraineThe pharmacy storage facilities shall be located in a separate stout building, have a loading and unloading area for cars located outside the front of the windows of the premises where there are always people on any floor.
The pharmacy storage facilities shall have production premises with a total area of at least 250 square meters: areas used for receiving and storing medicines and auxiliary materials, their release.
Location of premises of the pharmacy storage facilities shall ensure the sequence of technological process (receipt of medicines, quality control, storage, assembly and release).
The pharmacy storage facilities shall have separate areas or premises for storing medicines that require special storage conditions (strong, narcotic, psychotropic, flammable medicinal products, etc.).
If you want to get a license for the pharmacy storage facilities quickly and easily, don’t hesitate to call us!