Medical license in Estonia

In Estonia, the procedure for issuing a license to trade in medicines (hereinafter referred to as the License) is established by the Law on Medicinal Products (hereinafter referred to as the Medicines Act). The authority in the field of issuing such a License, in accordance with the Law on Medicine, is exercised by the State Agency for Medicines (hereinafter referred to as the Agency). Also, the Law on Drugs extends its effect to medical preparations containing narcotic or psychotropic substances, unless otherwise provided by the special Law “On Narcotic Substances, Psychotropic Substances and Precursors”.

To obtain a License, the following documents must be submitted to the Agency:

1. Application of the established form (published on the official website of the Agency).

   To obtain a License, the following documents must be submitted to the Agency:

   • name and registration number of the company;
   • contact details of the company (postal address, email address, phone numbers);
   • the scope of the company and the code of the type of such activity;
   • position and contact details of the person who signed the application;
2. Documents confirming the right to use storage facilities.
3. Documents describing the technical equipment located in the warehouse.
4. Description of the storage conditions for medical preparations.
5. Description of the organization of quality control of medical preparations.
6. Documents containing information about the organizational structure of the enterprise.
7. Description of the groups of medicines and pharmaceuticals planned for storage.
8. List of active substances that affect humans, which are contained in preparations planned for export or import.
9. Planned number of employees, broken down by the number of professionals (pharmacists, pharmacy assistants, etc.) and non-specialists in the medical field.
10. Description of the processes of transportation of drugs with documents confirming the availability of transport and equipment for the transportation of certain drugs.

Regarding the conditions of storage and transportation, it should be noted that the general legislation of Estonia provides only conditions that ensure the safety of the quality of medicines (in accordance with the standards provided for each specific medical product), as well as exclude the possibility of falling into the hands of unauthorized persons (in accordance with the standards prescribed for different groups of medicines). In addition, the Licensee is obliged to ensure that storage and transport conditions are such that there is no danger to people, animals and the environment.