The directive and delegated act set forth obligatory safety features for the outer packaging of drugs as part of efforts to avoid the distribution of counterfeit drugs, and different authentication mechanisms or different national or regional traceability requirements.
In terms of specifics, the commission calls on manufacturers to place a unique identifier on the packaging of a drug, which will be encoded in a 2D barcode, and is aligned with what has been outlined by the industry-led European Stakeholder Model.
The unique identifier will contain (i) a code allowing the identification of at least the name, the common name, the pharmaceutical form, the strength, the package size and the package type of the medicinal product bearing the unique identifier; (ii) a numeric or alphanumeric sequence of maximum 20 characters, generated by a deterministic or a non-deterministic randomisation algorithm; (iii) a national reimbursement number or other national number identifying the medicinal product, if required by the Member State where the product is intended to be placed on the market; (iv) the batch number; (v) the expiry date.
The 2D barcodes are expected to be a machine-readable Data Matrix and have error detection and correction equivalent to or higher than those of the Data Matrix ECC200.
Manufacturers are also expected to print the following data elements of the unique identifier on the packaging in “human-readable format,” including: (a) the product code; (b) the serial number; and (c) the national reimbursement number or other national number identifying the medicinal product.
In addition, the manufacturer placing the safety features on their drugs are required to keep records of every operation performed with or on the unique identifier on a pack of a drug for at least one year after the expiry date of the pack, or five years after the pack has been released for sale or distribution.
This setting up of this “end-to-end” system for the verification of the authenticity of the safety features of marketed drugs is complemented by risk-based checks at the wholesaler level.
The draft released by the commission also goes into detail about the establishment, management and accessibility of the repositories system where the information on the safety features shall be contained. All repositories will need to maintain a complete record, or audit trail, of all of the operations of a unique identifier, of the users performing those operations and the nature of the operations.
In the annexes of the delegated act, the commission also lists the prescription drugs or products not subject to the safety features, which includes homeopathic medicinal products, medicinal gases and radionuclide generators, among others. The commission also calls for comment on which non-prescription drugs may be at risk for falsification.