The publication of the Delegated Regulation (EU) 2016/161I supplementing the Falsified Medicines Directive (FMD) 2001/83/EC and its amendment 2011/62/EU was finally published in the Official Journal of the European Union on February 9, 2016. This date marks the three-year window in which manufacturers of pharmaceutical products in the European Union will need to comply with the requirements of the FMD, namely “…the placing of safety features consisting of a unique identifier and an anti-tampering device on the packaging […] for the purposes of allowing their identification and authentication.”II
The Regulation prescribes an “end-to-end”III verification system of medicine, from the point of manufacture through to its distribution to patients. The unique identifier takes the form of a two-dimensional barcode or matrix code that is machine-readable and consists of the product identity (name, dosage form, pack size and type, etc.), serial number, national reimbursement number, batch number, and expiry date.IV In addition, the Regulation mandates item-level serialization, meaning that the unique identifier “…should be unique to a given pack of medicinal product”.V The result is a randomly generated printed code that is less than 50 characters long and unique in the world.
Wholesalers throughout the supply chain will be able to verify the authenticity of a medicinal product by connecting to a “repositories system”VI. This system will contain the data elements of the safety features necessary for its identification or decommissioning. An individual Member State will connect to its own “national repositories”VII, whereas a group of Member States will connect to a “supranational repositories”VIII. In either case, a central ‘hub’ run by the European Medicines Verification Organisation or EMVO, a nonprofit organization located in Luxemburg, will eventually manage all data processing. Finally, brand owners will have to carry the costs of the verification system. (See Blog Article “New Developments in the Fight Against Falsified Medicines” for more information on the EMVO.)
The verification of the safety features boils down to a two-step verification process: one, the authenticity of the unique identifier and two, the integrity of the anti-tampering device.IX If either verification fails, regulatory authorities responsible for human medicine in the E.U. must notify the Commission and “…on the basis of casualties or hospitalizations of citizens of the Union due to exposure to falsified medicinal products, […] rapid action is required to protect public health […] at the latest within 45 days”X.
While the Regulation is the culmination of over 15 years of work, the many stakeholders involved in the legitimate supply chain, starting with the manufacturer all the way down to the patient, will undoubtedly feel the ramifications, both technological and financial of these measures. However, this work is also a remarked effort by the Union and the industry alike to harmonize product safety and in turn protect public health. The verdict on the success of this herculean effort is still out and won’t be known until February 9, 2019.
I Commission Delegated Regulation (EU) 2016/161, Official Journal of the European Union, 2 February 2016, retrieved on 29 February 2016 from europa.eu
IIISee Reference 1, L 32/1, (4)
IVSee Reference 1,L 32/7,Chapter II,Article4
VISee Reference 1,L 32/15,Chapter VII, Article 31
VIISee Reference 1,L 32/15,Chapter VII, Article 1 (b)
VIIISee Reference 1,L 32/15,Chapter VII, Article 1 (b)
IXSee Reference 1,L 32/10,Chapter III, Article 10