INDIVIDUAL DEVIATION FROM THE TERMS OF MARKETING AUTHORISATION (OOS)

Marketing authorisation holder (MAH) must inform the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP) on unsuitable medicinal product quality detailing any deviations from the conditions of the marketing authorisation which are not related to different labelling of the medicinal product on the Form of suspicion of unsuitable quality (Slovenian version only) to the following email address: quality-defects@jazmp.si.

If a decision on the possibility of approving individual deviation from the detail described in the marketing authorisation has been made at JAZMP when discussing the possibility of deviations from the conditions of marketing authorisation or in cases related to different labelling of individual medicinal product batch, in extraordinary cases which are in the interest of public health protection, in accordance with provisions of indent three of Article 21 of the Medicinal Products Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 17/2014; hereinafter: ZZdr-2), based on paragraph one of Article 22 of the ZZdr-2, the MAH may submit an application for approval of individual deviation from terms and conditions of marketing authorisation which is related to an individual batch or a smaller number of individual batches.

In its application MAH shall provide information on the proposed scope of the approval measure of individual deviation, evidence that the deviation does not affect the quality, safety and efficiency of the medicinal product, and a proposal of preventive and correctional measures implemented to establish the supply of the medicinal product within the conditions of the marketing authorisation.