Posted 09 February 2016
By Michael Mezher
A new regulation will require prescription drugmakers in all but three EU countries to incorporate new safety features on their product packaging by 9 February 2019.
The European Medicines Agency (EMA) says these measures will protect patients from falsified and low-quality medicines by guaranteeing authenticity and improving supply chain security.
The requirements are described in Commission Delegated Regulation (EU) 2016/161, published in the Official Journal of the European Union on Tuesday.
The regulation, which is part of a broader effort to combat falsified medicines in the EU, will require drugmakers to add a unique identifier and an anti-tampering device to the packaging of most centrally authorized products. Drugmakers in Belgium, Italy and Greece, however, will have until 9 February 2025 to implement the serialization requirements because they are implementing similar requirements already.
The unique identifier includes a 20-character alphanumeric serial number, product code, batch number and expiry date, as well as national identifying or reimbursement numbers where required.
Manufacturers will be required to display this information in a human readable format and as a two-dimensional barcode on the outer packaging of their products. If a product does not have outer packaging, then the unique identifier is to be placed on the product's immediate packaging.
The regulation also lists certain categories of products that are exempt from the new security requirements, including homeopathic medicinal products, medical gasses and tissue- or cell-based advanced therapies. The regulation also specifies that some non-prescription drugs will be subject to the security requirements, though at this point only two over-the-counter strengths of omeprazole, the active ingredient in Prilosec, are listed.
To help sponsors comply with the new requirements, EMA and the European Commission (EC) have released an implementation plan detailing timelines and regulatory requirements.
EMA has also updated its product information templates to reflect changes to the product information brought about by the new requirements, adding new sections to Annex IIIA of the Quality Review of Documents (QRD) template for human product information to account for the unique identifier.
Sponsors are instructed to use the new template for ongoing marketing applications with a Committee for Medicinal Products for Human Use (CHMP) opinion scheduled for March 2016 or later, and applications submitted after April 2016.
For already approved products, EMA says sponsors should add the required statements regarding the unique identifier in compliance with the revised QRD template while completing another regulatory procedure such as a renewal, line extension, or type IA, IB, or II variations, before 9 February 2019.