MADO SYSTEMY TOGETHER WITH WIPOTEC-OCS IS READY FOR SCENARIO WITH A LARGE SIGNATURE CONTAINING 88 CHARACTERS.

Federal Law No. 381-FZ is thereby supplemented with regard to the mandatory labelling of goods for unique identification. A labelling code in machine-readable form, presented as a data matrix code/barcode or recorded in an RFID tag, is stipulated as the identification means. It also lists the definitions for its essential components:

• Labelling code (a unique sequence of characters, consisting of an identification code and a verification code; AI01 GTIN, AI21 SN, crypto code AI91&92)

• Identification code (a sequence of characters representing a unique number of units of goods; AI01 GTIN, AI21 SN)

• Verification code (a sequence of characters generated by the cryptographic transformation of the identification code and enabling the identification of forged identification codes when it is verified using a control data module and/or with verification code verifiers; AI 91, AI 92)

• Verification code verifiers (checking of the authenticity or forgery of the identification code as a result of verifying it using the verification code and the key document for verification of the identification code)

• Technical means for generating a check code – hardware-software encryption (cryptographic) information security tools, which ensure the generation of a check code as the result of a cryptographic conversion of an identification code and for which a security agency has issued a document.

FACTS

Deadline 01.01.2020.

Products that are placed on the market up to the deadline have to be serialised and aggregated, so for imports the regulations must be implemented even before the deadline. As a result, registration, contracts and verification (test) with the system operator (CRPT) must take place in advance.

SPECIFICATIONS OF THE LABELLING REQUIREMENT

Furthermore, Executive Order No. 1556 – “Directive governing the system for monitoring the movement of pharmaceuticals for medical purposes” – of 14.12.18 defines further details concerning the specific appearance and operation of the Russian system for tracking medicines and labelling the packaging of pharmaceuticals. The Executive Order came into force on the day of its publication. Regulations are stipulated for primary (e.g. blister packs for tablets), secondary (e.g. boxes) and tertiary packaging (in the sense of aggregation in shipping cases). Identification means is to be represented as a 2D data matrix conforming to the standard ISO/IEC 16022-2008 with error correction ECC-200. Its grading according to ISO/IEC 15415-2012 should have at least classification C or higher.

The identification means may be applied by printing on the packaging or by means of a label. In conjunction with Federal Law No. 488-FZ, 6 data groups are specified for identification and verification parts which are listed in the following table (Serialisation). In line with international standards and in accordance with ISO/IEC 15417-2013, the aggregation code for consolidating serialised products in a third packaging level for transport and storage is generated in the form of a one-dimensional barcode as SSCC 128. Information contained in the aggregation code can be printed in readable form. The aggregation code can be printed on the tertiary packaging or can be applied using a label.

The process of assigning the electronic signatures and verification keys is carried out in four steps according to the (simplified) procedure shown:

1. The registered pharmacist/distributor sends its generated serial numbers, linked to the GTIN, to the system operator (CRPT)

2. The system operator (CRPT) uses the data received to create the cryptographically generated electronic signature. Furthermore sends it back to the pharmacist/distributor together with the verification key

3. Application of the data matrix code to the products

4. Sending of reports and the data of correctly applied data matrix codes

POTENTIAL FUTURE DEVELOPMENT

In December 2018, the system operator CRPT signalled its willingness to talk to market participants. It may be possible to shorten the cryptographic electronic signature of the Application Identifier (91) which currently has 88 characters (numbers, lower/upper case letters and special characters). At present there is no more detailed official information available about the final number of characters planned. For this purpose, CRPT is carrying out a series of tests with participants of the Russian pilot project. Should a reduction of the AI (91) be possible, it might be expected to take several months until any changes are made to the Russian legislation. This will not alter the deadline for the mandatory serialisation of pharmaceuticals on 01.01.2020.

Mado Systemy together with WIPOTEC-OCS has prepared itself for this scenario with a large signature containing 88 characters. We already have appropriate solutions ready for both existing and new machines.

We encourage you to contact us and to familiarize yourself with our Track & Trace devices. We’ll be happy to advise you on a specific project.

Source: WIPOTEC-OCS

How to get ready for European FMD

In less than a year, Europe’s Falsified Medicines Directive (FMD) will come into full effect, starting on 9th February 2019. This definitely implies a massive challenge for those entities in the small and medium side of the industry. But what does this really mean for the companies in pharma distribution?

Smaller and medium-sized companies in the Pharma Industry will have the choice to apply the needed serialization processes through an outsourced partner. This process, however, can take several months. Therefore taking action promptly is recommended to be able to market these products before the directive comes into place.

Small Pharma Companies

“Small and medium sized Pharma Companies needs agility and cost-effective solutions to remain competitive without compromises in their operation. That’s a big challenge when the countdown is running.” concludes Ariel Romero Diaz, Verifarma Head of Sales for EMEA.

The main issues for this part of the industry is the master data management and data exchange. Especially with contract manufacturing organizations (CMOs). For them, a solution familiar with a lower volume of production and specific target markets makes way for a quicker solution to sort through aspects such as traceability and FMD compliance.

Manufacturers should also be aware that delays in their serialization process without proper professional guidance could result in direct effect to the lines or production. From packaging lines to warehouses in pharma distribution. Many of them assume that the practice impacts only the first ones. However it demands many changes in automation and data handling. That cannot be changed in such short notice, affecting several aspects in departments such as IT, engineering and logistics, among others.

Acquiring a specialized and previously authorized partner for managing your products’ EMVO data is extremely recommended. As it will have enough time to process, therefore successfully avoiding any future issues in your production lines or track and trace solutions. To be sure to get enough time, the best choice is to go through a partner with working knowledge of both track and trace and FMD compliance. So, consequently will make the serialization of your products a quick and painless procedure to adjust your products to the new EU measures.

About Verifarma

Verifarma is a comprehensive and flexible Track & Trace solution for the pharmaceutical industry with more than 10 years of experience, optimized deployment processes and an unbeatable price. Our know-how on regulation is key to help you meet legal compliance on time. As a result achieving prompt adaptation to regulatory changes while applying best practices and industry standards. Verifarma is an active member of Open SCS Working Group.

With active deployments in 15 countries, over 2,000 companies in the pharmaceutical industry rely on Verifarma for Serialization Levels 3, 4 and 5. Among leading Pharmaceuticals, Distributors, 3PLs, Pharmacies and Health Care Centers.

Please take a look at our Track & Trace and software solutions.

Source: Verifarma