After declaration of the state of emergency to prevent further spread of corona virus, health care sector in Serbia saw a number of corresponding measures that naturally affected regular state of affairs.
This article focuses on providing an overview of the general legal framework and principles of registration for medical products and medical devices, with reference to the special regime introduced during the state of emergency.
The Law on Medicinal Products and Medical Devices (the “Law”), inter alia, regulates the conditions for placing on the market of medicinal products and medical devices, the conditions for production, marketing and testing of medicinal products and medical devices used in human and veterinary medicine, and regulates supervision in these fields.
The registration procedure takes place before the Medicines and Medical Devices Agency of Serbia (ALIMS) (the "Agency"), which was established by the Law.
According to the Law, tests are considered as medical devices, while vaccines are considered as medicinal products.
The condition for placing medical devices on the market in Serbia is the registration of medical devices in the Register of Medical Devices (the "Register"), which is performed at the Agency.
The procedure for registration of medical devices in the Register may vary, and it depends in particular on the fact whether such products carry the CE mark (SE mark) or not.
For medical devices bearing the CE marking, which implies that the control of these medical devices has been carried out in one of the institutions accredited by the European Union and that these medical devices are in accordance with the EU directives on medical devices, the registration in the Register is done through the administrative procedure, on the basis of appropriate certificates and documents proving compliance with EU directives on medical devices.
For medical devices that do not have the CE marking, entry in the Register is performed on the basis of an assessment of the quality, safety and efficacy through tests carried out in Serbia, in accordance with internationally accepted standards.
The procedure for issuing a decision on the registration of a medical device in the Register is in line with the guidelines of the Good Regulatory Practice.
To place medical devices on the market, a national authorization must be issued in a form of a decision on the registration of a medical device in the Register, whereby the Agency should recognize the relevant foreign certificates and documents, proving compliance with EU directives on medical devices and guaranteeing quality, safety and efficiency of such a medical device.
The Agency, in accordance with the Law, may also authorize the market of unregistered medical devices only at the request of certain health care facilities for the treatment of life-threatening patients or groups of patients, as well as for certain scientific or medical research.
The Agency also issues approvals for clinical trials of medical devices and monitors their safety, i.e. vigilance.
The Agency publishes a database of medical devices and lists of medical devices, which are registered in the Registry, on the Agency website.
On the other hand, medical product is, inter alia, a blood product derived from human or animal blood, an immunological drug for human and veterinary medicine (sera, vaccines, specific and non-specific immunoglobulins, toxins and allergens) and a radiopharmaceutical, ready-made or ready-to-use medicinal product, containing one or more radionuclides intended for medical use.
Applicants that wish to place medical products on the market of medicinal products in Serbia, especially when it comes to innovative medical products or medical products that have not been on the aforementioned market before, should prepare for special expert discussions with representatives of the authorities about the quality of the drug, the ingredients of the drug, effectiveness, indication area, side effects, pharmacoeconomic parameters etc.
The procedures for obtaining a market authorization are in accordance with the guidelines of the Good Practice, prescribed by the Law.
As previously implied, a national market authorization for medicinal products is issued in Serbia. But, given that Serbia is not an EU member state, it is still not possible to issue a centralized authorization or market authorization based on a mutual recognition procedure.
The Agency publishes lists of medicinal products for which a market authorization has been issued and for which a decision on the termination of a market authorization has been issued in the Official Gazette of the Republic of Serbia.
One of the consequences of the recently introduced state of emergency in Serbia is the Decree on Specific Technical Requirements and Standards and Application of Medical Devices During the Emergency of COVID-19 caused by the SARS-CoV-2 virus (the "Regulation") issued by the Serbian Government on 24 March 2020.
The Regulation aims to allow the application of medical devices and medicines, which have proven effective in the treatment of COVID-19, but are not authorized by the Agency.
Namely, for the duration of the state of emergency, in order to effectively combat the epidemic and treatment of patients with COVID-19 disease, medical devices not manufactured according to the prescribed standards can be procured, put into use and applied in treatments, provided that the manufacturer or distributor with medical device:
- submits one copy of the description of the technical characteristics and the use of the medical device, with translation into Serbian language;
- encloses a statement that the use of a medical device ensures its effectiveness in the treatment, that is, that the device meets the conditions of effective treatment as well as the corresponding product manufactured to the prescribed standard;
- submits a statement that he / she will train health care professionals who will provide health care on that facility;
- issues a statement by which undertakes obligation to provide service and spare parts for the medical device and to specify the period of validity of such an obligation.
All foregoing also applies accordingly to medicine products.
Also, it is very important to mention the provision which stipulates that the procedure of procurement of medical devices and medicines in accordance with the Regulation shall be governed by the provisions of the law governing public procurement in the event of a natural disaster or epidemic of an infectious disease.
The regulation entered into force on 24 March 2020.
By Miomir Stojkovic, Principal, and Ela Trisic, Associate, Stojkovic Attorneys