Marking of medicines: from experiment to reality

     Pharmaceutical manufacturers are concerned about the nuances of the implementation of the marking project, which became known the day before.


     In Kaliningrad, on 7th and 8th of June, the third conference of the series «PROjects of the Future» was held: «Marking of medicines: effective participation throughout the chain». About a hundred specialists, experts and managers of Russian and international pharmaceutical companies, as well as central and regional pharmacy chains, gathered together to discuss topical issues related to the marking of medicines.


     A number of issues related to the launch of the project, cause serious business concerns. The marking of drugs with the special barcodes, using which it will be possible to track each package of the medicine, from producer to consumer, will become mandatory since 2020. In 2017 the project started as an experiment. Federal Law-425 («On Amendments to the Federal Law «On the circulation of medicines»), which launched the marking system, imposed the main responsibility on the manufacturer. «More than 4000 subjects of the pharmaceutical market have become participants of the marking. Pharmaceutical manufacturers have begun to install expensive equipment, to implement informational and technological solutions based on the basic principles of the monitoring system, taking into account the experience of other countries. These principles were noted as the main methodological recommendations for running the experiment, Viktor Dmitriev said, the General Director of the Association of the Russian Pharmaceutical Manufacturers (ARPM) in his speech. — It’s been 1.5 years now — there are still no legislatively fixed requirements for the identification marks. In addition, now we can expect dramatic changes in the entire technology of marking: we are offered to implement an additional cryptographic protection. Firstly, it contradicts the requirements of methodological recommendations for the experiment. Secondly, we are offered to comply with the requirements of cryptographic protection, which are absent in most international systems of traceability of goods, which means we will face even greater problems with exports and rising prices. Innovations will require producers of significant unplanned timing and material resources, as a result, we will not be able to guarantee the readiness of the industry by 2020».


     Viktor Dmitriev has added that re-equipping of already equipped packaging lines within one site will require serious additional investments. In addition, the participants of the experiment are constantly faced with failures and technical errors. A number of legal, technical, financial and administrative aspects have not been solved yet. In addition, the perplexity of experts is caused by a slow discussion of issues in the conditions of a new geopolitical system within the EEU. Meanwhile, experts note that the problem of marking in the coming months will affect everyone, even those who do not know about it yet.

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