Launch of the verification system in Norway
9th of February we finally went live with the new verification system to ensure safe medicines to the Norwegian market. Years of planning and system development finally paid off, and pharmacies and wholesalers in Norway were able to verify the authenticity of medicines before dispense. This would not have been possible without the dedication of all stakeholders to make this system a success.
Preparations and planning
The Norwegian verification system went live in May, and has since been tested to ensure that the system operates correctly by February 9th. In parallell the pharmacies and wholesalers have developed their connecting IT-systems. Together we have tested and verified that the transactions between our systems work correctly.
Both private and hospital pharmacies are all connected to the system. Regular wholesalers and 3PL distributors are also connected, and the hospitals will soon be connected.
The Norwegian pharmacy association will issue guidance to all pharmacies on how to work with the system and how to handle exceptions.
Soft launch approach
Recognising the need for new processes to be tested and safely implemented the Norwegian Medicines Agency (NOMA) have decided to allow some time before all new regulations and principles will be enforced.
More information (in Norwegian) from NOMA can be found here.
Without going in to too much details the main components of the soft launch approach are:
- The pharmacies will only verify and dispense products with a confirmed batch uploaded. This is done through Farmalogg.
- End-users may ignore certain alerts until further notice
The time period for the soft launch is evaluated continuously, but the idea is to allow time for the new process to settle and not to create uneccessary disruptions in the supply chain.
Exception handling by MAH
The verification system will automatically generate alerts to On-boarding Partners (OBP) when an alert is raised on a known product. (Obviously, if no master data for a GTIN is loaded no OBP is associated). If you are an MAH please make sure you know how you receive information from your OBP, and how you should follow up locally.
Equally, it will be very useful for Nomvec to be able to quickly reach the correct contact person within the MAH if an issue is reported or an alert is raised. Please provide Nomvec with the correct contact information. Nomvec may also share this information with wholesalers or pharmacy chains to allow them to solve alarms efficiently.
Before the system went live in Norway a quick study revealed that master data was only loaded for roughly 25% of the GTINs and actual serialised pack data was only loaded for roughly 10% of the GTINs. Some of this situation can easily be explained since products could be released until February 9th without safety features, and some manufacturers can be planning to retrospectively upload the data after February 9th.
But even so, it is clear that many MAHs and their OBPs are late in uploading data. We therefore ask that you ensure that you have uploaded all data, and if not that you do this as quickly as possible.
Many MAHs and wholesalers have asked us how to interpret Article 20 and Article 33 of the Delegated Regulation 2016/161. We are aware that there are some differences in how to interpret the definition of what constitutes a designated wholesaler (Article 33.2.h). Guidance for this can be found in the master data guide. Nomvec can not advise as to whether a concrete business relationship confirms to the definition of a designated wholesaler or not.
Indian packs will currently not be registered at Farmalogg as FMD compliant and consequently not be checked against the verification system.