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EU: Falsified Medicines Directive ‘Delegated Act’ accepted by European Parliament
  1. Richard Price
  1. Correspondence to Richard Price, Department of Policy and Advocacy, European Association of Hospital Pharmacy, 3 Rue Abbe Cuypers, Brussels 1040, Belgium; richard.price{at}eahp.eu

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A ‘Delegated Act’ of the European Commission setting out requirements hospital pharmacies must fulfil in respect to ‘check out’ verification of all medicines they receive, has been accepted by the European Parliament. The Act is now formal European Union law and must be implemented by a deadline of 9 February 2019.

The main elements of the Delegated Act for hospital pharmacists to be aware of include:

  1. The unique identifier that will be contained on the outer packaging of all medicines, and its components;

  2. The end-to-end verification principle, requiring all hospital pharmacies to conduct ‘check out’ scans of the medicines packages they receive;

  3. The governance model of the system;

  4. The flexibility provided to hospitals in respect of ‘when’ they choose to conduct the scan;

  5. The 10 day limit on returns.

Hospital pharmacists should give particular attention to Articles 25 and 26 of the Delegated Act.

Following this, EAHP is now advising all its member associations to engage as fully as they are able in national discussions on implementation issues, taking place via the current construction of ‘national medicines verification organisations’ (NMVOs). These national organisations will, for example, be in charge of defining the national user requirements under which verification systems will operate in the country in question.

EAHP RESPONDS TO EUROPEAN COMMISSION ORPHAN DRUG CONSULTATION

The European Association of Hospital Pharmacists (EAHP) has responded to a European Commission consultation on the EU's orphan drug regulatory framework.

The response:

  • Supports the suggestion that hospital produced medicines be included in the comparisons made to establish whether a candidate for orphan designation offers the potential of ‘significant benefit’ over existing treatments;

  • Further suggests that the significant benefit comparison also includes off label use;

  • Suggests ‘clinically relevant advantage’ be also widely understood as meaning improvements in the ease of administration, safety of the patient, and/or quality of life/options of the patient. This would, …

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