In addition, a license for medications is required in the context of each drug sold.
Legal aspects of this sphere regulation are set out in the laws on medicinal products, narcotic drugs and psychotropic substances, the Code on economic activities, and the decrees of the Minister of Social Affairs.
Restrictions on Licensing
The license for medications in Estonia is a prerequisite for companies involved in import and repackaging. If an entrepreneur plans to perform a production in parallel with a clinical research, it will be necessary to establish a second company and, accordingly, to receive permissions for it. Managers and shareholders must be different in each of the companies. It is not allowed to combine production and clinical trials with trade and repackaging within the same structure.
Documents for the License Registration
Regardless of the activity, whether it is a production or a trade of medications, the company must have the license. An appropriate application is submitted to the Department of medicinal products (Ravimiamet). The period of its consideration is 2 months. With a positive outcome after this time, the company-applicant receives a license. It is for an unlimited period of time.
A number of documents are submitted together with the application to the Department, the list of which depends on the type of a license. It is necessary to comply with the requirements established by the Department of Estonia and the EU regarding working premises, personnel, equipment. The following shall be transferred for consideration of the authorized authority:
- documents describing the structure of the company;
- confirmation of the right to use the premises;
- description of medications storage conditions;
- plan of premises;
- a set of rules for internal control;
- a list of medications;
- a description of the production cycle, technical means;
- a set of provisions for quality control;
- information on medications transportation;
- description of the processes of sterilization, calibration of preparations;
- information about the equipment, the schedule of its maintenance;
- a scheme of the ventilation and water supply system.
This is a common package of documents. Depending on the activity’s direction, it can be adjusted.
The recipient of the license shall be obligated to provide such conditions for the production, storage, transportation of medicinal products in which:
- their properties are preserved;
- the temperature/humidity regime is observed;
- the package integrity is ensured;
- harmful effects on humans, animals, environment are excluded.
Benefits from Cooperation with Aotopay
The work with medical products is regulated by a number of legal acts. It is difficult to take into account all the nuances and requirements without proper theoretical and practical training. Better to trust professionals who will undertake not only complex legal issues but also a routine bureaucracy. The Aotopay’ experts accompany customers from the moment of the jurisdiction selection and activity directions to the immediate receipt of permissions, reducing the risk of errors and legal violations to zero.
