Are your operations compliant Russia regulations?
PharmaSecure can help you by extending support and services to make your organization compliant with Russia regulations. Need more information? Get in touch with us today and request a quote for our Russia compliance solutions.
What is Russia Mandate?
From November 1, 2018, Russia’s serialisation was moved under the new leadership of a new operator CRPT. All functionalities of the systems built will remain the same so that the transition can be smooth.
This move was to take place after Government Decree No. 791-r and No. 792-r were published. The main highlight of this decree was the introduction of crypto-codes for each pair of product code and serial number. Even though in the above-mentioned decree Medical products were not included, in August, all these doubts were put to rest with the release of the Government Decree no. 1018, which confirmed the role of CRPT as the operator of Russia Serialisation (Markirovka) from November 1, 2018
In the Russian pharmaceutical serialization regulation, unlike EU or USA , drugs are not divided to prescription and OTC. They are divided into 3 groups:
- 7VZN : The seven high-spending disease classes such as treatment of haemophilia or multiple sclerosis and patients after organ transplantation.
- ZhNVLP : Vital and essential medicines. Subject to upper price limit set by the authorities.
- All other medicines for human use.
Implementation Date for 7VZN – 01/07/2019 (*estimated)
Implementation Date for rest – 01/01/2020
Unique Identifier requirements: GS1 Unique Product code, Serial Number, 4 Digit Key (Commodity code), 88 Character signature, Batch/Expiry optional)
How PharmaSecure can help
PharmaSecure is one of the leading providers of regulatory serialization solutions to pharmaceutical companies operating around the world. Our solutions are backed by an experienced team that understands the criticality of plant operations and the complexities of Printers and Vision systems. Our teams support your during the entire lifecycle of your Russia Serialisation journey and ensure you maintain compliance with regulations moving forward.
- Serving pharmaceutical clients for around a decade
- Solutions based on non-proprietary and latest technology to deliver maximum value
- Seamless integration using industry standards
- Modular and easily customisable applications to fit your business process
- Require minimal training/education to end users
- Secure Application access can be enabled to 3PL or Distribution warehouse.
For more details, please contact us or mail to: firstname.lastname@example.org or call us on 022-67556011