The whole world is waiting for the pandemic to ease off, so coronavirus vaccines are being rolled out in Europe at an exceptional speed, as soon as the marketing authorisations are granted. The tight schedule also means that exceptional measures have been needed to secure the flow of product information.
Pharmaceutical Information Centre manages Nordic Product Numbers, or Vnr numbers. The Vnr number is mandatory information in many Nordic information systems, such the reporting system for adverse reactions and the product information system. The Pharmaceutical Information Centre also maintains the National Pharmaceutical Database, which contains the basic information of medicines marketed in Finland and publishes the national catalogue of drug information for clinical use in the Pharmaca Fennica service. Thus, Pharmaceutical Information Centre plays a key role in sharing accurate information regarding coronavirus vaccines.
“We work closely with the National Institute for Health and Welfare (THL) and pharmaceutical companies to ensure swift and appropriate communications regarding the new vaccines. The Vnr numbers and availability of up-to-date product information are vital: they make management of stock inventories and vaccine registers much easier,” says Riikka Leppänen, Pharmacist, Information Services at Pharmaceutical Information Centre.
Basic information on the vaccines supports stock and vaccine register management
Pharmaceutical companies must report all new products to the National Pharmaceutical Database no later than eight working days prior to the 1st and 15th day of each month. Coronavirus vaccines will be rolled out in European as soon as marketing authorisation has been granted, so the timetable for updating the product information is tight.
“For example, the statutory cut off point for the pharmaceutical companies to provide notification of new products for the Pharmaceutical Database in force as of 1 January 2021 was at 4 pm on Monday 21 December. However, the European Medicines Agency (EMA) was only expected to grant the marketing authorisation for the first coronavirus vaccine on 23 December. Finland was scheduled to receive the first batches of the vaccine during the Christmas holidays, which is when the basic information on the product, such as the Vnr number, was needed by healthcare providers,” says Leppänen.
Pharmaceutical Information Centre communicated actively with contact persons at the pharmaceutical company and helped compile and share the necessary information.
“The product made it to the Pharmaceutical Database published on 1 January 2021 and by Christmas the necessary basic information had been already shared with healthcare providers in collaboration with THL. The contact person at the pharmaceutical company was very grateful that we had assisted them during this critical time and had taken an active role in compiling and sharing information with healthcare.”
Information made available very quickly
The information on the first coronavirus vaccine to receive marketing authorisation in Finland was quickly shared with professionals through the Pharmaca Fennica service and with the general public through the pharmaceutical product information website Lääkeinfo.fi and the vaccine information website Rokotustieto.fi.
“The summary of product characteristics (SPC) for healthcare professionals was published on Pharmaca Fennica pharmacafennica.fi and the package information leaflet (PIL) for the general public was published on lääkeinfo.fi within 36 hours of the granting of the marketing authorisation: market authorisation was granted on Monday evening on 21 December and the information went live on the morning of Wednesday 23 December. The SPC and PIL contain essential information: The SPC provides guidance on how to prepare a vaccine for administration while the PIL gives details on the intended use of the vaccine and adverse reactions.”
We will continue to secure the flow of information on coronavirus vaccines with the same, tried and tested methods for other coronavirus vaccines as they are rolled out.
“We recently spoke with the US-based Moderna, which has not operated in Europe before, and is not aware of the specifics of the Nordic market, such as the Vnr number. It has been crucial to inform Moderna of the special requirements of the Nordic markets and we have also ensured that all Nordic countries have timely access to information. We have also received excellent feedback from DLI, our partner in Denmark, and the Danish and Norwegian medicines agencies for our quick and proactive approach. I would like to thank everyone involved in this collaborative effort,” Leppänen says.
Pharmaceutical Information Centre will continue to actively update information on authorized coronavirus vaccines. An up-to-date list can be found: Corona virus vaccinations have marketing authorization Finland
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