Schreiner, Edelman develop FMD-ready drug label

Schreiner-Medipharm and Edelman have unveiled a new booklet-label that makes product information available without opening the pack.

The design meets the requirements of the EU Falsified Medicines Directive (FMD), which requires packs to have a tamper-evident seal and means pharmacists cannot remove and read the patient package insert (PPI) before the pack is dispensed.

The full text of the press release can be seen below:

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The future of the package insert: booklet-label on the medicine pack

Schreiner MediPharm has developed in a joint project with the packaging manufacturer Edelmann an innovative solution which makes important product information accessible without opening the pharmaceutical pack. The packaging solution is based on the requirements of the EU Falsified Medicines Directive 2011/62/EU.

Among other things, the said EU directive requires a security seal for the outer packaging of medicines, in order to prevent manipulations. Pharmacists can then only read the package insert after destroying the seal which is meant to form a barrier and to serve as a first-opening indication. In order to avoid this, Schreiner MediPharm as a leading manufacturer of specialty labels for the pharmaceutical industry has jointly developed with Edelmann, a leading supplier of folding boxes, a novel solution combining a folding box with a Booklet-Label applied to the outside.

Applied to the outer packaging, the multi-page Booklet-Label from Schreiner MediPharm makes even multi-lingual product information easily accessible and readily visible without damaging the original pack. It reliably adheres to the medicine pack and is easy to open and close again with the top layer of the film. The Booklet-Label is additionally equipped with a security color-shifting ink for integrated protection against counterfeiting.

“The solution that has been jointly developed with Edelmann maintains the integrity of the pack, while allowing easy access to the package insert,” says Robert Unglert, Senior Sales Director at Schreiner MediPharm. The patient benefits from the booklet applied to the pack as well, because it is easy to open and close again. Since the booklet is firmly attached to the pack, it is also less likely to be misplaced.