SERBIA Law and Practice Contributed by: Bisera Andrijašević and Anja Gligorević, BDK Advokati
and types of medicines on the market for which a marketing authorisation has been issued due to production or distribution problems, if in Serbia there are insufficient quantities of a medicine with the same INN, strength, pharmaceutical form, and packaging size as the medicine for which an import request has been submitted. Compassionate Use Programme In addition to the import of unregistered pharma- ceuticals under the general conditions previously described, import is also permitted on the basis of a compassionate use programme. The purpose of such a programme is to treat specific patients or a group of patients who are afflicted by life-threatening diseases such as AIDS, cancer and other malignant or auto-immune diseases. Import is organised as a donation or humanitarian aid to a health institution, provided that such pharmaceuticals are not subject to clinical trial in Serbia at the moment of the submission of request for import, and provided that they: • are undergoing an advanced stage (Phase III) of clinical trial procedure in an EU country or in a country with similar requirements to Serbia regard- ing issuance of a marketing authorisation; • have completed a clinical trial procedure in that country; • are currently subject to a centralised marketing authorisation procedure in the EU; or • have received a marketing authorisation in the EU centralised procedure. Exceptionally, a patient or a group of patients who are not eligible to participate in the ongoing clinical trial for that medicinal product in Serbia may receive a dona- tion or humanitarian aid in the form of unregistered pharmaceuticals or registered pharmaceuticals for an unregistered indication, which are at that time subject to clinical trial in Serbia. Import of Unregistered Medical Devices The ALIMS may also authorise the import of a medical device not registered in Serbia. This is permissible if that import is intended for a particular patient or group of patients, or comes as a donation or humanitarian aid, or the subject-matter of the import is a medical instrument for scientific research or for emergency sit-
uations. In order to be imported, these medical devic- es must have undergone a conformity assessment. 3.6 Ongoing Obligations Imposed by Marketing Authorisations Pharmacovigilance of Medicinal Products In the post-marketing phase, marketing authorisa- tion-holders must ensure continuous monitoring of adverse drug reactions to a pharmaceutical product (pharmacovigilance), namely: • the continued monitoring of adverse drug reac- tions (ADRs), and have a full-time employee with adequate qualifications responsible for pharma- covigilance; • keep records on all suspected ADRs notified in Serbia, EU countries or any third country, and pro- vide the ALIMS with electronic reports; • keep records of all suspected serious ADRs report- ed by health or veterinary professionals, or records of ADRs that MAHs can reasonably be expected to be aware of, and to report this information prompt- ly 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 person 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 The Agency and the competent Ministries must treat as confidential all the data in the documenta- tion enclosed within an application for the issuance of a marketing authorisation, variation or a renewal. This obligation applies in particular in relation to trade
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