Impact report gives insight into EU drug safety features

Hands and EU mapFully harmonised codes, pharmacy verification with risk-based checking at wholesalers, and an industry-managed database are almost certain to underpin the EU's forthcoming requirements for safety features on medicines.

The format for safety features will be decided via a delegated act - one of the main implementation elements of the EU Falsified Medicines Directive (FMD) - that is not due to be published until later this year. However, a recently-completed European Commission impact assessment is likely to play a major role in elucidating the requirements of the draft.

Patrizia Tosetti, policy officer at DG Health and Consumers presented the findings of the assessment at the 13th European Generic Medicines Association (EGA) Regulatory and Scientific Affairs Conference, which took place in London last month.

The assessment covered the benefits, costs and cost-effectiveness of the use of a unique identifier (UI) for medicines packs, the verification of the authenticity of the product bearing the UI, and the repository system for the codes.

Unique identifier

On the issue of the UI, Tosetti indicated that both the number and the data carrier should be fully harmonised across the EU, rather than allowing partial harmonisation of the number. There had been calls in some quarters for UI to be 'adaptable' to allow continuity with some national coding systems.

The UI should include the manufacturer's product code, serial number, a national reimbursement number (if present), the batch number and expiry date, and be carried by a 2D datamatrix barcode, said Tosetti.


On the verification of the UI, the impact assessment's findings diverge a little from the approach preferred by the European Stakeholder Model (ESM), which has been developed by groups representing the pharma industry, wholesalers, parallel importers and pharmacists.

The ESM would have a single authentication at the point of dispensing the medicine to the patient, but the impact assessment suggest wholesalers should also be required to verify certain packs in a risk basis.

Specifically, the wholesaler will have to verify the safety features when the product is not obtained from the manufacturing/marketing authorisation holder, or when the product is returned by another wholesale distributor or a pharmacy.

Wholesaler verification has also been a point of contention with the FMD, but it is worth noting that the securPharm pilot in Germany included a wholesaler and concluded that sample verification at normal line speeds was feasible, allaying fears that it could have a significant negative impact on productivity.


Finally, with regard to the data repository Tosetti told the meeting that this should be set up and managed by stakeholders with supervision by the relevant competent authorities, according to the impact assessment, which is broadly in alignment with the ESM.

The alternatives under evaluation included establishment and management of repositories at either the EU or national level.

Tosetti noted that adoption of the delegated act by the Commission should take place around the end of 2014 at the earliest, and publication in the Official Journal will follow in 2015 "after successful scrutiny by the European Parliament, European Council and World Trade Organisation (WTO)."

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