News & Update

  • FMD: a progress check

    Brexit and FMD If this isn’t enough to be getting on with, it seems as if the MHRA is suggesting that FMD could be revoked just weeks after implementation, in the event of a no-deal Brexit. At the Pharmacy Show, Claymore Richardson, a senior policy manager at the Department of Health and Social Care (DHSC), referred to a recent MHRA statement clarifying that in the “unlikely” event of no deal and with no agreement on the post-Brexit transition period, FMD would, by law, have to be revoked “because you can’t have something that’s legally impossible to comply with”. This is because continued access to the EU FMD hub will depend on the future relationship between the UK and the EU. “From a legal point of view, if we crash out of Europe with no withdrawal agreement and no transition period, we have no right to plug into the European FMD hub and they have the right to pull the plug on anyone not in the club,” says Mr Buisson. Malcolm Harrison, chief executive of the CCA, has said: “In the event of the UK Medicines Verification System being disconnected from the European hub after Brexit, we similarly agree with the FMD Working Group that the government should fully compensate the sector, where all or part of the system which has been invested in becomes redundant.” Drop-dead dates With the FMD deadline only a few months away, Mr Buisson says the time for action is now. “Serialisation is a global approach, so actually, the ‘drop-dead dates’ dropped dead months, if not years, ago,” he says. “Having said that, I expect a lot of tweaks to go on after 9 February, with software updates that build on real world experience.” There’s going to be a long transition and Ms Koshkouei advises that, while pharmacies must be FMD compliant by 9 February 2019, “there is also a wash-out period where not all medicinal items will bear the safety features and so there will exist a natural phasing in of the verification and decommissioning workload”. Non-compliance For those who don’t – or won’t – get on board, it’ll come as no surprise that a recent DHSC and MHRA consultation contains a section on sanctions for non-compliance. “One approach would be the sole use of criminal sanctions for failure to comply with the requirements of the Delegated Regulation, with a person liable on summary conviction to an unlimited fine or liable on conviction on indictment to a fine, or to imprisonment for a term not exceeding two years, or to both,” says Zeeshan Ahmed, global serialisation expert, director and co-founder at Sigma Advance Consulting. “However, government is minded to move to an approach that would use a mixture of criminal and civil sanctions. Such civil sanctions might include written warnings, stop notices and civil fines, before the application of criminal sanctions, which would only be used for the most serious, intentionally fraudulent, breaches.” Mr Richardson confirmed that the MHRA is the overall enforcement agency for the Directive, but it will work with the relevant regulatory bodies (GPhC, CQC and others) to put FMD into the inspections it already has. Mark Davison, senior operations director, Europe, at rfxcel Corporation, which provides SaaS-based track and trace solutions for the pharmaceutical supply chain, suggests that “in theory, MHRA could start inspection and sanctions on 9 February when the FMD goes live”. “Why would you not comply?” says Mr Buisson. “Why, in effect, would you say you are happy to supply falsified medicines? FMD is happening, so your best bet is to get informed, get on board and keep your eyes open for further information that’s coming, as well as guidance on what you do if things go wrong, which we’re working on right now.” Source - -

  • European Commission: Article 23 Implementation

    EMVO invites you to consult the latest Application of Article 23: Wholesalers to decommission on behalf of persons authorised or entitled to supply medicines to the public. Please see the document listed under More Details. For more information, please contact the European Commission directly here. Source -

  • Announcement – Downtime & Disruption Information System (DDIS)

    EMVO has announced a new feature on their website, the Downtime & Disruption Information System (DDIS). This feature will allow any interested stakeholder to view downtimes of and disruptions to the EMVS. Both planned and forced downtimes and disruptions will be made available. The DDIS has gone Live on the News & Events page of EMVO’s website on Friday the 21st December. It will be possible to subscribe to notifications from the DDIS, something that EMVO encourages all EMVS stakeholders to do. The DDIS allows downtime and disruption information to be presented in an easily accessible manner, and it is a feature we are confident will speed up the communication of technical information to those who need to receive it. Source -

  • Russia Track and Trace Requirements

    Regulation Dates:

    1. January 1, 2020 for all medicines covered as per the Law No. 425-FZ.
    2. As per the Decree No. 1577 the final 12 Nosologies be registered by July 1, 2019 and the regulation date for these 12 Nosologies will be October 1, 2019.
    Regulation Scope: In comparison to the EU and US regulation, the Russian Regulation has no plans of dividing drugs in 2 groups. It actually divided them into 3 groups as stated below and plans to serialize all of them:
    1. 7VZN: The seven high-spending disease classes such as treatment of haemophilia or multiple sclerosis and patients after organ transplantation.
    2. ZhNVLP: Vital and essential medicines. Subject to upper price limit set by the authorities.
    3. All other medicines for human use.
    Unique Identifier requirements: GS1 Unique Product code, Serial Number, 4 Digit Key (Commodity code), 88 Character signatures, Batch/Expiry optional) The serialization scope also covers Aggregation as one of the mandatory requirements along with the new addition of Cryptography to cypher the data during transmission and validation. Serialization Requirements:
    1. Aggregation at Multiple-levels (secondary/unit, tertiary/case)
      The process of aggregation of serialized products, which includes aggregation into cartons and further into pallets, will be the same as in other countries. For this purpose SSCC codes with GS1-128 data structure will be utilized. No changes from the Russian side are to be expected here so far.
    2. Identifier Data elements 4 to 7 encoded in 2D Data Matrix barcode
      Russian serialization code consists of two parts:
      1. The first part is used for unique identification, "identification part", and consists of a GTIN and a serial number.
      2. The second part is for control and verification, "verification part", and is a sequence of characters formed as a result of a cryptographic transformation of an identification code. These cryptographic characters are intended to expose counterfeit codes during their verification.
    Cryptographic protection applied to each unit-level product identifier Center for Advanced Technology Development (CRPT) provides for allocation of crypto characters and transfer of the required data, as well as installation of Issue Recorders at the respective production sites. These devices will be connected to the national cloud. The pharma producer transmits serial numbers together with the GTIN to the cloud and in return receives the corresponding cryptographic key for the code to be printed and verified. The model provides for a fee to be charged for each cryptographic key. Reporting Requirements:
    1. Reporting to Russia centralized reporting system will be performed via XML transactions with inclusion of digital signatures
      1. Reporting to the FSIS MDC needs to be carried out via XML uploads and must include electronic signatures—a potentially cumbersome process. In addition, the responsibility to report is time bound, so tasks must be completed quickly—indications are that the window will typically be 5 business days—and in the required sequence.
    2. Up to 50 compliance events/notifications for tracking and reporting. Requires bi-directional exchange of Data, message sequencing of events, operational integration, audit trails and archiving of serialized product data
    3. Products must be accounted for at every step of their journey, from manufacture to patient dispensation. An important difference between the Russian and the EU and U.S. regulations is the requirement to track a wide range of product movements and packaging changes between transfers of custody. In addition, these events must trigger both bi-directional notifications with trade partners and reports to the Russian central system, the Federal State Information System for Monitoring Drug Circulation (FSIS MDC).
    4. Foreign manufacturers exporting into Russian market will be responsible for reporting up to 36 events which include product transactions and movements along with the aggregation/disaggregation activities and managing upstream and downstream notifications between trade partners.
    Summed up, the law is about quite normal serialization, but with a boosted track & trace with extra functionality for the government. The government wants to use the system to watch at pricing and availability of drugs around Russia and provide the consumers a possibility to use a mobile app to search which pharmacists have the drug they are looking for and check the prices, too.