According to Estonian legislation, blood and blood components are defined as medicines; the production of medicines requires licensing (manufacturing approval) by the State Agency of Medicines.
In order to obtain an activity licence the applicant and the site of activity have to comply with the requirements set out in the Blood Act and the Medicinal Product Act, as well as the relevant Regulations of the Minister of Social Affairs.
The issue of an activity licence, the renewal of an activity licence or alteration of data contained in the activity licence are decided by the State Agency of Medicines.
Before issue or renewal of an activity licence the State Agency of Medicines inspect the conformity of the premises and practices in relation to the licensed activity. To ensure that compliance with these requirements is maintained, compliance is monitored by regular on-site inspections during the period of validity of an activity licence.
Upon application for an activity licence, an application and the documents and information related to the handling operations of blood, in accordance with Chapter 6 of the Medicinal Product Act, have to be submitted to the State Agency of Medicines.
Payment of the applicable state fee is also required.