SERBIA Law and Practice Contributed by: Bisera Andrijašević and Anja Gligorević, BDK Advokati
Revoking of a Marketing Authorisation The ALIMS will revoke a marketing authorisation if it determines that the product is not safe for the life and health of humans and animals. The ALIMS will revoke the marketing authorisation if: • the medicinal product is harmful under normal conditions of use; • the medicinal product has no therapeutic efficacy; • the risk-benefit ratio is not favourable under typical application conditions; • the qualitative and quantitative medicinal product composition does not match the declared compo- sition of the medicinal product; • the marketing authorisation was issued on the basis of incomplete or false information, or if data is not amended in accordance with the law; • the marketing authorisation-holder no longer meets the prescribed requirements; and/or • the medicinal product was not marketed in Serbia for three years from the date of marketing authori- sation issuance or was withdrawn from the market in Serbia for three consecutive years. The ALIMS may vary, suspend, or revoke a marketing authorisation on the basis of data on adverse drug reactions collected within the scope of its pharma- covigilance activities. Medical Devices If the Ministry of Health determines that a medical device constitutes an unacceptable risk to public health and/or safety, or does not meet the statutory requirements, the Ministry may order the manufacturer or its authorised representative to take all appropriate and justified preventive or corrective measures. The Ministry may also prohibit or restrict the placing of a medical device on the market, set specific require- ments for the placement of a medical device on the market, or order the withdrawal of a medical device from the market. 3.4 Procedure for Obtaining a Marketing Authorisation Pharmaceuticals The Medicines Act and a series of implementing by- laws govern the granting of a marketing authorisa- tion. The ALIMS is the competent authority for issuing
marketing authorisation for a pharmaceutical product or registration of a medical device. The Medicines Act and the Medical Devices Act contain the criteria for classification. The main criterion for differentiating between pharma- ceuticals and medical devices is the following: phar- maceuticals are applied to humans or animals with the intention to restore, improve or modify physiological function by pharmacological, immunological or met- abolic action, or by setting up a medical diagnosis; however, medical devices do not fulfil their principal intended purpose in or on the human body by phar- macological, immunological or metabolic means, but the medical device may be assisted in its function by such means. 3.2 Marketing Authorisation for Biologic Medicinal Products Biological medicinal products must meet the same quality, safety and efficacy criteria as other medicinal products to receive marketing authorisation. Biosimi- lars, however, may benefit from the short-form pro- cedure for the granting of marketing authorisation, equivalent to the one available to generic medicinal products. 3.3 Period of Validity of Marketing Authorisations Validity and Renewal of Marketing Authorisation Marketing authorisation is valid for five years. It may be renewed based on the reassessment of the risk/ benefit ratio of the medicine. If, on the basis of the available pharmacovigilance data, the ALIMS deter- mines that a pharmaceutical is safe, it grants a per- manent marketing authorisation. In the event that the ALIMS determines that the pharmaceutical product is not safe, it will refuse to grant a permanent authori- sation. Instead, the ALIMS will decide on whether to renew an authorisation for an additional period of five years. A marketing authorisation may be renewed for an additional period of five years only once. If the ALIMS still has justified doubts with respect to prod- uct safety, it will terminate the already issued market- ing authorisation.
277 CHAMBERS.COM
Powered by FlippingBook