Stojkovic Attorneys advise and represent clients on the legal aspects of health care, as well as facilitate procedures to obtain licenses and authorisations to perform healthcare activities and distribute medicine and medical devices.
We advise among the largest healthcare companies in the country and the region with respect to donation agreements, engaging expert personnel, sponsorship, as well as bidding in the public procurement to distribute medical equipment for the largest health centres in the Serbia. We also participate in procedures to conclude distribution agreements with the largest medical equipment manufacturers.
Our legal experts are there to help you manage all the administrative and business challenges that can arise in the healthcare sector and the distribution of medicines and medical devices.
When It Comes To Drugs & Medical Device Registration And Vigilance, you may engage us for:
- Registration of medicines
- Registration of medical devices
- Renewal of drug license
- Renewal of medical device registration
- Making sure the maximum price of a drug and its place on the List of Medicines are correct
- Making and putting drug and medical device labels in place
Registration Of Drugs And Medical Products in Serbia
Entering the market requires registration with the Agency for Medicines and Medical Devices of Serbia. An effective and high-quality registration is essential for corporate growth and enables many other tasks. Our team of professionals effectively manages pharmaceuticals and medical device licenses. Our goal is to provide the client with quality service and comply with the continuously changing requirements.
You may also consider engaging us for:
- conversation with the producer on preparing the registration file in compliance with the Serbian Law on Medicines and Medical Devices (EU or CTD format)
- submission of a request for the registration of a drug and medical device to the Agency for Drugs and Medical Devices of Serbia ALIMS and follow-up until the issuance of a Drug Permit, i.e., a Decision on the entry of a medical device into the register
- maintaining the validity of drug license/medical device registration decisions through the submission of modifications and renewal petitions submitting ALIMS or other experts’ professional opinion
- pharmacovigilance medical device vigilance
- insurance coverage covering the usage of medical gadgets
- preparation and submission of documentation in order to obtain the maximum drug price (wholesale drug price) in the Republic of Serbia preparation and submission of an application with a pharmacoeconomic analysis in order to obtain inclusion on the List of drugs prescribed and dispensed at the expense of mandatory health insurance funds (List of RFZO drugs).