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New QRD templates for human medicines

11/6/2010

The updated European QRD templates for human medicinal product information have been published, most recently the version for MRP/DCP procedures (Version 5, April 2010) which was formally made available at the beginning of this month. Generally, the changes are not substantial but there are important updates, for example the way the paediatric information should be expressed in the Summary of Product Characteristics (SmPC) has evolved, and there is a new sub-heading of ‘Environmental Risk Assessment’ in section 5.3 ‘Preclinical safety data’ of the SmPC. In the continuous strive to keep up to date, evaluating how updates to the template affect an authorisation holder’s product information can be a time-consuming task, especially if the aim is to review the impact across a whole portfolio with the aim of maintaining consistency. Wainwright Associates’ product information specialists have many years of experience at writing SmPCs, label and package leaflets texts, and testing package leaflets, and will be pleased to help. Please contact us for further information.