Pharmaceutical wholesalers will be required to verify
medicines that pass through their warehouses in specific circumstances as set out
in the Delegated Regulation. They may also have to decommission medicines
supplied to certain customers as per Article 23 of the Delegated Regulation*.
Wholesalers in Ireland will have to adapt their software systems to create a
connection to the Irish Medicines Verification System (IMVS).
IMVO will have an
onboarding process for wholesalers that connect to the IMVO repository but they
will not be required to pay any fees to IMVO. For now, IMVO is only
onboarding wholesalers who are taking part in the pilot as we want to fine-tune
the process and automate as much of it as possible before starting to register all
wholesalers who need to connect to the IMVS. We will open up onboarding for all
end-users in early Autumn when the pilot is completed and will communicate
widely to the relevant groups, including wholesalers, details of what is
In the meantime, wholesalers are encouraged to continue their preparations
to ensure that all steps are in place by 9th February 2019, when the new requirements become legally
SKUs are in-scope and all locations where scanning will need to take place;
pharma companies to establish when serialised packs will start to arrive in
Put in place
procedures to flag when stock must be verified and/or decommissioned & to
deal with any alerts from the IMVS;
customers you will have to decommission products for*;
software system(s) you will use to interact with IMVS;
changes are needed to work practices, SOPs, facilities and personnel to support
scanning operations and management of alerts.
* IMVO is in
ongoing contact with the Department of Health about areas in the legislation
where further clarification is required at national level, particularly Article
23 of the Commission Delegated Regulation which provides for wholesaler
decommissioning of medicines supplied to certain individuals and organisations.
We will communicate details of the scope of Article 23 to wholesalers once this
has been finalised by the Department