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EMA consults on non-prescription product pack design


The European Medicines Agency has released recommendations for pack design and labelling of centrally authorised non-prescription human medicinal products.

The draft document, which summarises recommendations for companies preparing mock-ups and specimen packaging, is open to a three-month public consultation period.

It was developed after consulting member states on national practices regarding pack design and labelling.

Pack design and labelling are key elements in ensuring the safe use of medicines, since they can be used to reduce the risk of confusion and error.

They are particularly important for medicines that are available without a prescription, especially when no intervention from a pharmacist is needed.

The document was prepared by the Working Group on Quality Review of Documents.

It is open for consultation until 30 June 2011.

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