On November 12, 2019 a draft law has been submitted to the State Duma which provides that pharmaceuticals introduced into civil circulation until July 1, 2020 can be sold in Russia within their shelf life without applying identification marks.
Such deferral also applies to pharmaceuticals for the treatment of “High-cost nosologies” only if they were brought into civil circulation before October 1, 2019. This category includes medicines for patients with haemophilia, cystic fibrosis, pituitary nanism, Gaucher’s disease, malignant neoplasms of lymphoid, hematopoietic, and related tissues, multiple sclerosis, as well as persons who have undergone organ and/or tissue transplants.
Under the current laws, mandatory labelling with identification marks for pharmaceuticals applies as of January 1, 2020. Subject of the obligation is apart from the putting of marks on the packaging the submission of information to a monitoring system about the movement of the pharmaceuticals at all stages on their way to the consumer. Aim of the introduction of the monitoring system is ensuring the traceability of goods, and thereby reducing the number of counterfeit products and improving the quality of the pharmaceuticals.
According to the legislators, the deadline for the introduction of mandatory labeling with identification marks for pharmaceuticals should be postponed in order to grant the relevant businesses more time to implement the required processes. The explanatory note to the draft law mentions that only a small number of manufacturers have managed to ensure the conditions for proper labelling, in particular, to add equipment for labelling to their production lines. Furthermore, a full scale testing should be conducted.
SCHNEIDER GROUP has extensive experience in advising pharmaceutical companies through its own Pharma Competence Centre. Our experts are happy to advise you on labelling issues and offer solutions.