Preparing for the Russian Track & Trace Compliance

//Preparing for the Russian Track & Trace Compliance

237 days before the launch of mandatory marking on 1 January 2020.

Pharmaceutical manufacturers that export and distributes medicines to Russia may also be prepared for the new regulation and must pay attention to these deadlines:

Since February 1, 2017, a track & trace experiment for pharmaceutical products has been being held in the Russian Federation.

On July 1, 2019, registration will begin of pharmacies and medical institutions in the Chestny ZNAK track & trace digital system handling medications listed as high-cost nosologies.

On October 1, 2019, marking will become mandatory for medications from the list of high-cost nosologies.

Starting January 2020, it will be mandatory for manufacturers to migrate to mandatory marking, while distributors and pharmacies will be obligated to ensure the movement and sales of marked pharmaceuticals.

The most complex require of the regulation is to add cryptographic code to the standard bidimensional data matrix.

Verifarma prepared a summary of the most relevant questions answered by the Chestny ZNAK track & trace digital about digital code:

  • What information does the Data Matrix code contain?

The marking code contains the following mandatory fields: serial number, global trade item number (GTIN). The code may also contain the following (optional) fields: expiration date, batch number, FEACN as per agreed format.

The marking code must contain the key ID and verification code that provide cryptographic information protection based on an open key encryption algorithm (GOST 34.10–2012)

  • How many requests to issue crypto tails may an operator receive from a single manufacturer daily?

Unlimited.

  • What protocol is used for data exchange with the equipment? Will any tools for exchanging data with the most popular systems in Russia be immediately available?

Currently, an all-purpose API protocol is available which you may request from CRPT, try to connect through it and test it for your system (it is compatible with all systems). If you have a self-writing system, you may configure it using a detailed instruction or contact our specialists.

  • Do I need to modify the size of pharmaceutical product packaging due to applying additional crypto protection marks in the digital marking code?

These extra 92 symbols only increase the density of the Data Matrix code, which means that they don’t need to be additionally printed somewhere else on the package, but are embedded into the code itself. The recommended code size by the GS1 documentation for Data Matrix code of this density is 16×16 mm. CRPT successfully conducted tests on 10×10 and 12×12 mm code size applications. This size is generally applicable and does not imply any increase in the PP packaging size.

  • Will I have to arrange for a designated communication channel between the factory and Russia in order to acquire generated codes?

Foreign companies only need to have web access and request the code from the service located in one of the European countries.

  • If crypto-protection is implemented, will it impact the process of delivery and acceptance of pharmaceutical products at the warehouses?

Crypto-protection is not applied for the warehouses. Warehouses use aggregation codes without any crypto-protection, which are further distributed across the system.

Verifarma is ready to comply with Russia compliance and make the process easier for pharmaceutical companies.  Verifarma is an international provider with 11 years of experience in the development of serialization solutions. We help pharmaceutical companies to generate its Russian compliance strategy by allowing them to communicate to CRPT web service to request and receive the crypto code and key and to send reports to the Russian Government.

Source: https://chestnyznak.ru

2019-05-08T16:19:15+00:00 May 8th, 2019|Categories: Uncategorized|