Brief: Q&A on Falsified Medicines Directive published

Representatives of national medicines regulators in Europe have published a document answering questions on the implementation of the Falsified Medicines Directive.

The Co-ordinated Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) said the document has been drawn up in response to "several queries on the implementation of the FMD over the last year."

Most of the questions focus on the Quality Review of Documents (QRD) product Information template (version 10), which was updated last year to reflect the FMD's provisions for adding a unique identifier and anti-tampering device onto the packaging of the majority of prescription medicines and some non-prescription medicines.

Other questions cover whether more than one code is permitted on packaging and whether tamper-evidence and unique ID can be implemented in two phases.

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