FSI «SID & GP»
The Ministry of industry and trade of the Russian Federation
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Representatives of the pharmaceutical industry discussed the issues of labeling and serialization at the opening of the demonstration and training center

On 28 January, in Moscow, the demonstration and training center ACG Experience Studio was opened for representatives of the pharmaceutical industry. It is an opportunity to test the equipment for labeling, aggregation and serialization and to try the software to better understand what and how many of it is necessary for the manufacture to comply with the requirements of Federal Law No. 425 as of 28 December, 2017 “On Amendments to Federal Law “On Drugs Circulation””.

The opening of the demonstration and training center was attended by representatives of the pharmaceutical industry, the General Director of the Association of Russian Pharmaceutical Manufacturers Mr. Viktor Dmitriev, the Head of Good Engineering Practices Department of the State Institute of Drugs and Good Practices of Minpromtorg of Russia Mr. Igor Falkovskiy and an expert of the department Mr. Sergey Orlov.

Starting from 01 January, 2020, labeling of drugs with control (identification) codes allowing for monitoring of the flow of drugs from the manufacturer to the ultimate user will become mandatory. As it is variously estimated, the total costs of implementation of the labeling system for the manufacturing sector will comprise from 8 to 15 billion rubles. Yet, this is not the key problem of pharmaceutical manufacturers.

In his speech towards representative of the pharmaceutical industry, the Head of Good Engineering Practices Department of FSI “SID & GP” Mr. Igor Falkovskiy outlined several challenges faced by the industry upon implementation of the labeling system. Currently, one of the key problems is absence of the regulatory document establishing the main requirements for the systems and identification codes applied onto the packaging of a drug. Due to this, many foreign companies operating on the Russian market do not initiate any actions towards implementation of the labeling system at their manufacturing sites.

The question is also the length of the cryptocode – additional symbols in the Data Matrix code to be applied onto the packaging of a drug. The cryptocode is centrally generated by an operator using local cryptography technologies and prevents any “twins” and possibilities to re-commercialize commodities on the market. Currently, the operator of the monitoring system is determining the optimal length of the cryptocode to guarantee the required level of security.

It’s worth mentioning the tight timelines of project implementation. The industry has less than a year to launch the labeling system at manufacturing sites. And for the products listed for the seven nosologies, labeling will become mandatory from 01 October, 2019.

“We hope that opening of the demonstration and training center giving a chance to test the equipment for serialization and aggregation and the software will allow pharmaceutical manufacturers to try such equipment in real time with their secondary packaging and estimate the resources needed for the company to implement the labeling system at its sites”, said the Head of Good Engineering Practices Department of FSI “SID & GP” Mr. Igor Falkovskiy. “Experts of the Institute, in their turn, are ready to help in defining the scope of validation and its execution.”