Agency of the Republic of Slovenia for Medicinal Products and Medical Devices (hereinafter: Agency) has prepared the new Rules on fees in the field of medicines, blood, tissues and cells and as well fees for the implementation of professional tasks and services of the Agency (hereinafter: Rules).
To cover the costs of the implementation of the tasks the Agency currently charges fees that are established by the Rules on Fees in the Field of Medicinal Products (Official Journal of the RS, No. 65/11) and the Rules on Fees in the Field of Medical Devices (Official Journal of the RS, No. 37/10). These two regulations do not cover all of the tasks or processes carried out by the Agency as they were adopted prior to the adoption of a novel of the Law on Medicinal Products (Official Journal of the RS, No. 17/14; hereinafter: ZZdr-2) and prior to the most recent amendment of the Law on Medical Devices (Official Journal of the RS, No. 98/09; hereinafter: ZMedPri). To carry out the tasks, in particular in the fields of blood supply, quality and safety of human tissues and cells, intended for the treatment, and production of and marketing of narcotic drugs, the Agency charges administrative fees in accordance with the Law on Administrative Fees (Official Journal of the RS, No. 106/10 – official consolidated text; hereinafter: ZUT).
The Agency has prepared the Rules based on articles 189 and 190 of the ZZdr-e, articles 39 and 40 of the ZMedPri and article 11 of the Decision on the establishment of Public Agency of the Republic of Slovenia for Medicinal Products and Medical Devices (Official Journal of the RS, No. 115/06). The Council of the Agency confirmed the Rules on 27th January 2016 at its 24th regular meeting.
The Rules pursue the goals that the Agency shall cover the costs of all of its tasks (where allowed) with the fees, that the fees are determined for some administrative procedures, for which the Agency currently charges administrative fees in accordance with the ZUT, and that the fees are determined for other professional tasks and services provided of the Agency. The fees (the number of points) in the Rules for some administrative procedures are determined with the amount of the administrative fees in accordance with the ZUT and on comparable procedures, for which the Agency currently charges the fees. The purpose of the Rules is to ensure more stable and transparent sources of funding to cover the costs of the tasks or procedures carried out by the Agency and to reduce the risk of charging the State budget. The Rules governs also the method of the charging and the payment of the fees.
The Rules does not change the existing value of the fees (or the number of points). By the end of this year, it should be comprehensively redesigned with all the necessary bases, the norms and calculations for individual tasks and procedures.
The Rules does not cover the fees in the field of medical devices, as it is in the third paragraph of article 62 of the ZMedPri required that the amount of the fees shall be determined by the minister. This field will be addressed specifically.
We ask the legal persons as users of the services of the Agency to provide in accordance with the second paragraph of article 41 of the Law on Public Agencies (Official Journal of the RS, No. 52/02) their opinions, comments and suggestions at the latest by 21st March 2016. The Rules are accessible at the following LINK
Please send your opinions, comments and suggestions on the e-mail address: email@example.com. After receiving and considering of your responses, we will send the Rules to the Ministry of Health and the Government of the Republic of Slovenia in endorsement. The Rules will enter into force after the publication in the Official Journal of the Republic of Slovenia.