global regulations 05-08

Russia: The Deadlines Are Almost Upon Us and The Clock Keeps Ticking











***For an UPDATE to the deadlines below please see this new post on Russian Deadlines***

The deadlines for the pharma labeling system (cryptographic serialization and tracing system) MDLP, in the Russian Federation are fast approaching. Companies marketing drugs in the Russia Federation targeting seven named nosologies must register with CRPT, the governments service provider, by July 8, 2019. Then on October 1, 2019, packages of drugs targeting those seven named nosologies must be serialized according to very Russia-specific technical guidelines, and production and shipments reported to CRPT. And finally by January 1, 2020, all non-exempt drugs must be serialized and reported. Let’s take a closer look at this unique regulation.

Early Deadline for the Seven Nosologies

First, companies marketing drugs targeting the seven named nosologies have just a few short months left to implement, but the deadline for all other drugs is not far behind. The seven nosologies are:

  • Formation of malignant lymphoid haematogenic and related tissues, including:
    • chronic myeloleukemia,
    • chronic lymphatic leukemia and
    • other oncohaematological illnesses
  • Cystic fibrosis
  • Hemophilia
  • Pituitary dwarfism
  • Gaucher’s Disease
  • Multiple Sclerosis
  • Organ and tissue transplants

Register with CRPT Now to Avoid Delays

The registration and technical onboarding processes for CRPT are fairly complex and may require the involvement of your company CEO. Fortunately, there are resources available online for companies needing help registering with CRPT. The deadline for registration and technical onboarding of companies who do not supply drugs on the seven nosologies list is not clear. Russian Federation Decree #1557 states that registration cannot occur before July 1, 2019 but CRPT’s website appears to encourage companies to register “as soon as possible” (after November 1, 2018). We recommend you start the process as soon as possible to ensure you are ready by January.

The Technical Requirements

Requirements of the Russian regulation are more complex than those of any other market. There are two reasons for that. One is that the Datamatrix barcode applied to product packaging must encode a “crypto-code,” and the other is that so many supply chain activities must be reported.

The Datamatrix barcode printed on each saleable package must encode:

  • a GS1 GTIN,
  • a 13 character serial number
  • a crypto-code supplied by CRPT

and optionally:

  • a batch number
  • expiration date
  • a commodity code

The crypto-code is composed of a “signature” field and a “key” field. The “key” field is four characters long. The “signature” field was originally mandated to be 88 characters long but there is an effort to get the government to accept 48, 32 or even just 20 characters. The reduction in length is intended to reduce the resulting size of the Datamatrix barcode to improve its readability. Companies participating in the government pilot reported serious problems in the readability of barcodes that encoded an 88-character signature field.

Drug market authorization holders (MAH) must obtain the crypto-codes for their drug packages through one of two ways. Companies located within the Russian Federation must use a hardware device supplied by CRPT to generate the codes by feeding it the list of GTIN and serial numbers. Companies outside of the Russian Federation may use a CRPT web service to request the codes by supplying the GTIN and serial numbers. Each crypto-code generated using either technique is specific to the GTIN and serial number provided in the request and must be treated as a set when commissioning a saleable package.

Complex Government Reporting

The Russian government expects members of the supply chain to report all product activities to CRPT within five business days of their occurrence. The list of manufacturer activities that must be reported include labeling (commissioning), aggregation and disaggregation, product movement, shipping and receiving (returns).

Systech Can Help

Systech offers help with complying with the Russian regulation, including interfacing with CRPT for acquiring crypto-codes and government reporting. Contact us today to find out how we can work together to keep you compliant with Russian regulations.