The European Medicines Agency has released recommendations on pack design and labelling for centrally authorised non-prescription human medicinal products for a three-month public consultation period. The draft document summarises recommendations for companies preparing mock-ups and specimens of the packaging of non-prescription medicines authorised through the centralised procedure. 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 (QRD). It is open for consultation until 30 June 2011.
Download: Draft QRD recommendations on pack design and labelling for centrally authorised non-prescription human medicinal products