Wednesday, August 26, 2015

European Commission publishes draft text for the Falsified Medicines Directive Delegated Act

The European Commission has published the long-awaited draft text of the 'Delegated Act', setting out the requirements for the future system of medicines verification that must operate in all EU countries by a 2018 deadline.

EAHP EU Monitor - 25 August 2015 indicates 5 key points to note from the text:
1) The Unique Identifier and its components
The system of medicines verification will be underpinned by the placing of a 'unique identifier' on every package of medicine produced in the EU.
The Delegated Act mandates that the unique identifier take the form of a 2D barcode containing:
  • the product code;
  • a serial number;
  • the batch number;
  • the expiry date; and,
  • the national reimbursement number (if requested by the EU Member State)
2) An end-to-end verification system, not full track-and-trace
The Delegated Act describes the requirement for the future medicines verification systems in Europe to be "an end-to-end verification system supplemented by risk-based verifications by wholesalers".
This means the critical points in the verification system are at the production stage (when the unique identifier is placed on the outer packaging) and at the point that the medicine is "being supplied to the public" (which the Commission describes as meaning "at pharmacy level") when the unique identifier will be scanned to ensure authenticity, and thereafter the unique identifier will be marked in the data repository as "checked out". This is aimed to prevent any further unscrupulous use of the packaging by counterfeiters.
In very practical terms, it means that the system requires pharmacists in both community and hospital settings to ensure medicines are verified for their authenticity and 'checked out' of the repository system before the medicine is provided to patients. The check out will be conducted via a scan of the 2D barcode on the outer packaging containing the unique identifier.
3) A verification system operated by 'stakeholders'
As set out in the explanatory memorandum of the Delegated Act, the Commission expects that "The repositories system containing the unique identifiers should be set up and managed by stakeholders. National competent authorities should however be able to access and supervise the repositories system".
More specifically, the Delegated Act goes on to state: "The repositories system should be established and managed by the marketing authorisation holders, since they are responsible for placing the product on the market, and by the manufacturers of medicinal products bearing the safety features, since they bear the costs of the repositories system".
In practical terms, this means that the verification system will almost certainly be operated by the European Medicines Verification Organisation (EMVO), a collaboration of the European pharmaceutical industry (represented by the European Federation of Pharmaceutical Industry and Associations as well as the European Generic and Biosimilar Medicines Association), wholesalers (represented by the European Association of Pharmaceutical Full-line Wholesalers, and the European Association of Euro-Pharmaceutical Companies), and pharmacists (represented by the Pharmaceutical Group of the European Union).
4) Flexibility provided to healthcare institutions in respect of when to perform verification
The text of the draft Delegated Act states:
"In order to avoid an excessive impact on the daily operations of healthcare institutions, it should be possible for Member States to allow persons authorized or entitled to supply medicinal products to the public operating within healthcare institutions to perform the verification of the authenticity and the decommissioning of a unique identifier earlier than the time the medicinal products is supplied to the public, or exempt them from this obligation, subject to certain conditions."
This is an important flexibility for hospital pharmacists to have awareness of. In practical terms, it should enable each hospital to determine at what stage they wish to conduct their verification responsibilities, including the choice between verification on arrival to the hospital, or at a later stage, such as departure from the dispensary.
A 'healthcare institution' is defined in the Delegated Act as meaning "a hospital, in- or out-patient clinic or health centre.
5) A 10 day limit between a medicine being checked out, and still being able to return the medicine
Article 13 1 (b) of the draft Delegated Act means that after a period of ten days has passed since a pharmacy checked out a medicine, the status of the unique identifier on the outer packaging can no longer be reverted to active.
In the following months this issue will be a key area of EAHP investigation with the Commission, system operators and others. EAHP has consistently expressed its view that the 10 day limit could have damaging unintended impacts for medicines waste and potentially medicines shortage.

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Full text of the announced text or any other relevant text

New   Draft Text 1 is available for download in the following languages:

New   Draft Text 2 is available for download in the following languages:


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