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The agency prepares a plan to implement new packaging safety features.
On Feb. 9, 2016, the European Medicines Agency (EMA) and the European Commission (EC) announced a plan to implement packaging safety features as part of the Falsified Medicines Directive (Directive 2011/62/EU) (FMD), adopted in July 2011. The implementation plan for centrally authorized medicines was created as a guide for applicants and marketing-authorization holders so they can meet the FMD requirements. These safety measures are part of Europe’s fight against falsified medicines. EMA defines falsified medicines as “fake medicines that pass themselves off as real, authorized medicines.”
The new FMD regulations, published in the Official Journal of the European Union, include two safety features: a unique identifier (a 2-dimension barcode) and an anti-tampering device (ATD). These safety features are required on the packaging of most drug products in Europe by Feb. 9, 2019.
To help enable implementation, EMA and the Quality Review of Documents (QRD) Group have revised the Human Product Information templates. The revised QRD template should be used for new marketing applications submitted from April 2016.
In the case of new marketing authorization applications that require the safety features, for drug products with no outer packaging that must have an ATD placed on the immediate packaging and the ATD affects the container and closure systems, information on the ATD and how it affects the container and closure systems must be included.
For ongoing marketing authorization applications that require the safety features, applicants with a Committee for Medicinal Products for Human Use (CHMP) opinion in March 2016 are advised to use the revised QRD form, but applicants with a CHMP opinion from April 2016 onwards are required to use the revised template. Applicants whose products require the ATD to be placed on the immediate packaging and the ADT affects the container and closure system are required to submit information on the ATD and how it affects the container closure system.
The implementation guide includes additional guidelines for existing marketing authorizations granted via the centralized procedure before the publication of the Delegated Regulation, for drug products that no longer need safety features, and for change of legal status.