MLH annual fees 2026
The REKS Council approved the annual fees for marketing authorization holders for 2026:
Flat fee – €5,000 – with turnover over €100,000
Exception 1 – €2,000 – with turnover €50,000 – €99,999
Exception 2 – €500 – with turnover €8,000 – €49,999
Exception 3 – €150 – with turnover €3,000 – €7,999
Exception 4 – €50 – with turnover of €0 – €3,000
Procedure for granting an exemption from the annual fee
The annual fee and the amount of the applicable exemptions are determined by the REKS Council every year, no later than in the fourth quarter. The amount of the exemption depends on the turnover of the MLH. From 2023, the annual fee will apply upon receipt of an exemption, according to which an exemption will be applied to the annual fee for the MLH according to the turnover of serialized products collected by the Estonian Medicines Agency. Therefore, the MLH does not need to submit a separate additional application for an exemption. If necessary, the MLH can submit specified data on turnover no later than two weeks after receipt of the invoice.
Annual fees are paid on the public REKS website and sent by email to the MLH contractual contact. Invoices are sent to MLHs during the second quarter of each year.
A supportive system even for MLH with lower turnover
Setting an exception
The annual fee and the amount of the applicable exemptions are determined by the REKS Council every year, no later than in the fourth quarter. The amount of the exemption depends on the turnover of the MLH. From 2023, the annual fee will apply upon receipt of an exemption, according to which an exemption will be applied to the annual fee for the MLH according to the turnover of serialized products collected by the Estonian Medicines Agency. Therefore, the MLH does not need to submit a separate additional application for an exemption. If necessary, the MLH can submit specified data on turnover no later than two weeks after receipt of the invoice.
Annual fees are paid on the public REKS website and sent by email to the MLH contractual contact. Invoices are sent to MLHs during the second quarter of each year.
System usage fee for the current year in Estonian
Issuing invoices
Invoices are issued to MLHs in the second quarter. If the invoice recipient wishes to dispute the exemption level (turnover volume) assigned to them, this can be done within 2 weeks after receipt of the invoice. To do this, it is necessary to send a written request to info(at)reks.ee. REKS will handle each request separately.