SERBIA Law and Practice Contributed by: Bisera Andrijašević and Anja Gligorević, BDK Advokati
matter of the import is a medical instrument for scientific research or for emergency situations. In order to be imported, these medical devices must have undergone a conformity assessment. 3.6 Marketing Authorisations for Pharmaceuticals and Medical Devices: Ongoing Obligations Pharmacovigilance of Medicinal Products In the post-marketing phase, marketing authori- sation-holders must ensure continuous monitor- ing of adverse drug reactions to a pharmaceuti- cal product (pharmacovigilance), namely: • the continued monitoring of adverse drug reactions (ADRs), and have a full-time employee with adequate qualifications responsible for pharmacovigilance; • keep records on all suspected ADRs notified in Serbia, EU countries or any third coun- try, and provide the ALIMS with electronic reports; • keep records of all suspected serious ADRs reported by health or veterinary professionals, or records of ADRs that MAHs can reason- ably be expected to be aware of, and to report this information promptly to the ALIMS, no later than 15 days following the receipt of information; • submit to the ALIMS periodic drug-safety reports at six-month intervals if the marketing authorisation was conditional or under special circumstances; and • submit periodic drug-safety reports every six months for a period of two years following the placing of the pharmaceutical on the market, then annual reports for another two years and finally submit reports at three-year intervals. Vigilance of Medical Devices
A manufacturer of medical devices or its authorised representative must employ a per- son responsible for vigilance and continuously monitor the medical device on the market, with the aim of identifying any need for corrective or preventive measures. 3.7 Third-Party Access to Pending Applications for Marketing Authorisations for Pharmaceuticals and Medical Devices The Agency and the competent Ministries must treat as confidential all the data in the docu- mentation enclosed within an application for the issuance of a marketing authorisation, variation or a renewal. This obligation applies in particular in relation to trade secrets – ie, when the follow- ing cumulative conditions are met: • the data is confidential – ie, not generally known or easily available to persons usually dealing with that kind of information; • the data has commercial value due to its confidentiality, during the period of confiden- tiality; and • an applicant for a marketing authorisation, variation, and/or renewal, under the circum- stances, takes reasonable measures to keep that data confidential. Information from the documentation submitted during the procedure of obtaining a marketing authorisation, as well as in other procedures handled by the Agency and/or relevant Minis- tries, may only be disclosed to third parties with the consent of the applicant, or if the data is already available to the general or professional public for the purpose of providing information necessary for use or handling of a pharmaceuti- cal or a medical device, or required for the pro- tection of health in humans and animals.
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