The European Union Delegated Regulation on ‘safety features’ under the Falsified Medicines Directive (FMD) comes into force in the United Kingdom on 9 February 2019 and will be directly applicable on all relevant actors in the medicines supply chain, including those dispensing medicines. Healthcare institutions (hospitals and general practitioner practices) and pharmacies will need to be able to decommission products from the national repository by this time. However, in the case of other places where medicines are supplied to patients the delegated regulation allows member states some flexibilities as to where products are decommissioned in the medicines supply chain.
A UK Government consultation on the implementation of the FMD will be released shortly. The consultation and accompanying impact assessment will focus on where the UK has the scope to legislate making use of the flexibilities. The number of dispensing points that will need to have FMD compliant IT systems in place by February 2019 is dependent on the outcome of the consultation.