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. 2022 Mar 10;19(6):3276. doi: 10.3390/ijerph19063276

Table 1.

Summary of the impact of the FMD in the pharmaceutical supply chain.

Manufacturers Wholesalers Healthcare Institutions (Community and Hospital Pharmacies)
Introduction of the unique identifier and anti-tampering device on medicine packages. Understand the type of operations that the wholesaler has in place, what organisations are supplied, and from where they receive their products. Decommission the unique identifier of the medicinal product before supplying it to the public.
Transfer encrypted data of the unique identifier to the EU Hub to be available in the national repository systems of respective member states of the MAH. Verify medicinal products returned by other parties (community and hospital pharmacy, wholesalers, other organisations that supply medicinal products). Hospitals have the possibility to decommission medicinal products in their internal supply chain depending on their workflow and selection.
Verify medicinal products returned by other parties (community and hospital pharmacy, wholesalers, other organisations that supply medicinal products). Decommission medicinal products:

  • distributed outside the European Union;

  • for destruction (for example, recalled or expired products).

 Workflow assessment is important to reduce expenditure and identify the best authentication points.
Decommission medicinal products:

  • Distributed outside the European Union;

  • For destruction (for example, recalled or expired products);

  • Returned that cannot be re-sold (fridge products in some EU countries);

  • Requested as a sample by competent authorities;

  • Supplied to institutions listed in the article 23 of the Delegated Regulation (DR);

  • Returned that cannot be re-sold (fridge products in some EU countries);

  • Requested as a sample by competent authorities;

  • Supplied to institutions listed in the article 23 of the Delegated Regulation (DR).
Impact for all of the supply chain
Verification and decommission are different processes.
Some products are excluded to bear the safety features required under the FMD, for:

  • Manufacturers: there is no need to change labelling requirements or adapt the production lines, this is optional;

  • Wholesalers and healthcare institutions: there is no need to perform verification or decommission of these products

The impact of the 10-day rule:

  • on operations;

  • returns to the supplier;

  • budget impact.