Consultation relative aux recommandations de l’EMEA relatives au packaging et à l’étiquetage des médicaments non soumis à pre…

On 1 April 2011, the European Medecines Agency released recommendations (for a three-month public consultation period) on pack design and labelling for centrally authorised non-prescription human medicinal products. The aim of the recommendations is to improve the safety of medicinal products, where legible and clear labelling is a key factor in ensuring such safety of use.

A key factor in the safe use of medicinal products is clear and legible information. This is even more important for non-prescription medicines, especially when there is no pharmacist involved in the delivery of such products.

Based on that premise, the European Medicines Agency released recommendations aimed at ensuring a high level of information to both consumers and healthcare professionals for non-prescription medicines. Those recommendations are meant to apply to centrally authorised non-prescription human drugs.

For those products, the EMA aims to ensure a better use of this information, in order to ensure that such information can be read and understood by those who receive it. This should ensure a higher degree of safety of use of those medicines.

In that framework, the EMA aims to set up recommendations that are applicable to all non-prescription medicines authorised under the centralised procedure. Since those medicines are supplied in a number of different ways throughout Europe (pharmacists, general stores, etc.), those recommendations should be generic, so that they apply to all those situations.

The document, drafted by the EMA in cooperation with the different Member States authorities, is open for consultation until 30 June 2011.