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 involved.  

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 binding.
  • Identify what SKUs are in-scope and all locations where scanning will need to take place;
  • Liaising with pharma companies to establish when serialised packs will start to arrive in your warehouse;
  • Put in place procedures to flag when stock must be verified and/or decommissioned & to deal with any alerts from the IMVS;
  • Identify what customers you will have to decommission products for*;
  • Identify what software system(s) you will use to interact with IMVS;
  • Consider what 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

Introductory webinars for wholesalers

IMVO is running a series of webinars to introduce wholesalers to the Irish Medicines Verification System and to describe what steps you to take to be ready to start verifying and decommissioning serialised packs by  9th February 2019 – see our Events page for details. Information is also available by contacting info@imvo.ie.