25 March, 2020
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Coronavirus in Serbia: import of unregistered medicines and medical devices

Serbia is currently in the midst of a state of emergency due to the COVID-19 pandemic.  No area of healthcare has escaped the effects of the measures to combat the outbreak.  From the very outset, there was a rush on antiseptic, disinfectant, thermometers, protective masks and gloves in pharmacies and retail outlets, leading to shortages. It is only a matter of time before stocks of certain medicines being to run out.

In this article, we look at what challenges lie ahead for pharmaceutical companies and healthcare institutions.  The EU has also recognized the need for health care measures, with special regulations in place to govern imports of medical equipment during the coronavirus outbreak (click here for more details).

Serbian legislation stipulates that only medicines that have marketing authorization and medical devices listed in the Register of Medical Devices may be legally used and marketed. Let’s imagine that there is a medicine that has significant efficacy in treating coronavirus? What happens to medicines that do not have a market authorization in Serbia, but there is a need for them?

However, there is a mechanism to cover shortages of licensed medicines on the market.  Medicines not having market authorization or medical devices not listed in the Register of the Medical Devices may be imported to Serbia with permission from the Agency for Medicines and Medical Devices (“AMMD”).

 

What is the solution?

The Medicines and Medical Devices Act stipulates that in the event of an epidemic, natural disaster or emergency AMMD, at the request of the Ministry of Health, may issue a temporary market authorization for a certain type and quantity of medicine prior to it qualifying for market authorization.  The medicine can then be imported with the appropriate paperwork while it awaits the outcome of the marketing authorization application.

During an epidemic, besides medicines, medical devices such as instruments, devices, and products for diagnosing, preventing, monitoring, treating or alleviating the effects of a disease are vital.  They can also be imported following the procedure outlined below.

 

Import of unregistered medicines or medical devices

Applications to import unregistered medicine and medical devices should be filed with the AMMD in order to ensure sufficient quantities and types of medicines and medical devices in times of epidemics, natural disasters, and other emergencies. This procedure is detailed in the Rulebook on Documentation and Methods of Importation of Medicines that Do not Have a Market Authorization i.e. Medical Devices Not Listed in the Medical Devices Register (“Rulebook”).

The Rulebook stipulates that a healthcare institution (for example, the Infectious Diseases Clinic) may propose that certain unregistered medicines be imported (the “Applicant“). Subsequently, the procedure is transferred to a pharmaceutical company licensed by the Ministry of Health for the wholesale distribution of medicinal products (“Importer“). Finally, the Importer, on behalf of the Applicant, files an application with AMMD to import the medicine or medical device concerned.  The Importer of an unregistered medicine or medical device must submit all the statutory documentation with its application to the AMMD.

 

Pharmaceutical activity for general purpose

The foregoing demonstrates that pharmaceutical legislation does make provision for an effective mechanism for importing urgently needed medicines and medical devices in times of crisis, serving not only the pharmaceutical industry but also members of the public.

 

For more information, please contact us via covid19@geciclaw.com