Russian Draft Serialisation Requirements – how will this evolve?

Russian Draft Serialisation Requirements – how will this evolve?

 

The Ministry of Health in Russia has published a  draft federal drug traceability law, a Russian version of which is on the official website www.regulation.gov.ru.

The draft law proposes to introduce a national electronic system to track product from manufacturer to end user, identifying product down to the primary pack level with machine readable coding. Unfortunately, as usual, the types of details that allow companies to implement solutions are absent from the law and will follow in an implementation document. So the full complexity of what is being proposed is uncertain at the point.

I also understand that this system may be used to manage drug pricing across Russia.

If the likes of primary coding requirements are not enough cause for concern, the proposed timelines are enough to send serialization program owners straight to the whisky cabinet:

  • January 1, 2017 – products associated with patients of hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms lymphoid, hematopoietic and related tissues, multiple sclerosis, persons after transplantation of organs and (or) tissues
  • January 1, 2018 – all other medicinal products for medical use

The Association of International Pharmaceutical Manufacturers have sent a letter to the Russian Ministry of Health pointing out a number of significant concerns with the draft legislation and it’s timing. They also urge individual companies to complete a questionnaire explaining their timeline to readiness and the significant investment that will be required. But more on that next week.

Any thoughts on how you think this will pan out?

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Serialisation Lessons Cover     Serialisation Legislation Cover     Booklet image (2)

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