Russian Draft Serialisation Requirements – the AIPM’s response

Russian Draft Serialisation Requirements – the AIPM’s response


As I discussed in my last blog on the topic, the Ministry of Health in Russia has published a  draft federal drug traceability law.

As you would hope, the likes of the Association of International Pharmaceutical Manufacturers (AIPM) have responded to the Russian Ministry of Health (MoH) with the following points, which seem to cover most of the key concerns that manufacturers have.

  • The law is not detailed enough to enable implementation, particularly concerning given the very tight deadlines
  • Primary serialisation is not logical, given the requirement for secondary packaging in Russia, or technically feasible/economic
  • Product for export should only be labelled as required by the destination country(s)
  • Elsewhere, it has taken 10 years to develop effective regulations which all parties can achieve, so the timelines are unachievably short
  • Detailed pack printing requirements are key, including the use of international standards like GS1
  • Data security is key, and the commercial sensitivity of certain data needs to be recognised and catered for
  • Given the Eurasia Economic Union, it is recommended that any requirements are harmonised and agreed with all regulators across the union before being enforced

The AIPM have issued a questionnaire, urging companies to let them know their timeline to readiness and the significant investment that will be required. They intend to use this to further influence the MoH.

Do you think the AIPM missed any key points?

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