Delegated Regulation to the Falsified Medicines Directive (FMD) 2011/62/EU, published on the 9 February 2016, will come in to force by February 2019.
The new regulation will require manufacturers to place safety features on all medicines and contribute financially to the establishment of an IT verification system that will allow the assessment of the authenticity of a medicine at the time of supply to the patient.
Falsified medicines include those medicines with little or no active ingredients, the wrong active ingredients, fake or tampered packaging, and those where products and/or packaging have been stolen for re-use or re-sale.
Although unlicensed internet sites have now become the main route for trading falsified medicines to the public, regulatory authorities continue to find and report falsified medicines in the supply chain. Such products pose an unacceptable risk to patients, as well as undermining confidence in the genuine products supplied by manufacturers, wholesalers and pharmacies.
Under the Directive, all new packs of prescription medicines placed on the market in Europe from February 2019 onwards will have to bear two safety features: a unique identifier (UI) in the form of a 2D data matrix (barcode) and an anti-tamper device (ATD).
Pharmacies, and those who are authorised to supply medicines to the public, will be required to authenticate products, which means visually checking the ATD and performing a verification and decommissioning scan, "at the time of supplying it to the public". There is still a debate about what this actually means in practice (e.g., what is the definition of supply? Can checking the ATD and scanning barcodes be done separately?).
It means that the FMD process must have been completed at the point the medicine is released to the patient or their representative. One way of achieving this efficiently, where more than one product is involved, is for pharmacy IT systems to aggregate the medicine pack barcodes onto the pharmacy bag label.
This idea is still under consideration in the UK. Wholesalers can decommission products for a range of healthcare professionals, public service bodies and other organisations that use or supply medicines as an occasional part of their work [Article 23], but community and hospital pharmacies are specifically excluded from this.
Article 23 institutions includes the following: Veterinarians and retailers of veterinary medicinal products (in relation to human medicines for veterinary use), Dental practitioners, Optometrists and opticians, Paramedics and emergency medical practitioners, Armed forces, police and other governmental organisations maintaining stocks of products for the purposes of civil protection and disaster control, Universities and other higher education establishments using medicinal products for research and education, Prisons, Schools, Hospices , Nursing homes.
Pharmaceutical manufactures across Europe must begin to enact requirements of the published Delegated Regulation to the FMD in advance of the regulation coming in to force in 2019.
Some packs are already appearing with 2D barcodes (as well as linear barcodes) as manufacturers and packagers change over in advance of the FMD requirements. However some of these 2D barcodes are not related to FMD and further discussions will be needed on how these packs will be handed by national medicines verification systems.
It is likely that there will still be packs without 2D barcodes in the supply chain when the requirements for authentication under the Falsified Medicines Directive come in to effect in February 2019. During this transition period these packs will still be able to be dispensed and supplied but in the absence of a 2D barcode they will not be require decommissioning.
Below provides further details on the 2011 Directive alongside an overview of what is required for the implementation of the Delegated Regulation (EU 2016/161) in the UK by 2019.
For more details, please contact Dr Rick Greville.
The original Falsified Medicines Directive (FMD) 2011/62/EU was published on 1st July 2011 by the Council and Parliament of the European Union and contained measures aimed at improving the safety and security of medicine supply in Europe.
List of resources for background information on the Falsified Medicines Directive and the Delegated Regulation.
The ABPI has worked with SecurMed and the MHRA, as the UK National Competent Authority, to provide useful guidance and perspective to Manufacturers and Marketing Authorisation Holders on commonly asked questions relating to the implementation the ‘safety features’ aspect of the Falsified Medicines Directive.