package leaflets, spc and labelling
The MEB has an explanatory document (only in Dutch) to the ‘Guideline on Summary of Product Characteristics, October 2005’ set by the European Commission. This explanatory document indicates on which points the new text deviates from the Guideline of December 1999.
The Guideline supersedes existing Notes for Guidance for the SPC of specific substances or pharmacotherapeutical groups.
The following documents are of importance for drawing up an SmPC:
The patient package leaflet is derived from the Summary of Product Characteristics (SPC). This package leaflet is intended for the patient or the consumer, so medical terms are translated in a patient-friendly manner in this document. The package leaflet is evaluated and approved by the MEB.
A new version of the QRD template, in which the package leaflet was amended, was published at the initiative of the MEB on 4 January 2010. The revision of the QRD-template was brought about because of research done at Utrecht University, which formed part of a larger study dealing with the creation of more patient-friendly and clearer package leaflets.
The new template for the package leaflet will first be used for new applications and for full revisions (for renewals, for example). Marketing authorisation holders will only be asked to amend the texts for full revisions.
The following documents are of importance when drafting of a good package leaflet:
The MEB evaluates the labelling text submitted by the company. There are fixed items that have to be printed on the label, such as the name of the medicinal product, the active ingredient, including its strength, and the expiry date.
Is the product available without prescription (e.g. paracetamol)? In this case, what the medicinal product is intended for and when not to use it must also be printed on the label.
The European legislation makes it mandatory to state the name of new medicinal products on labelling in braille as well.
The following documents are important when drafting a good label text and a mock-up:
The regulations related to the labelling and package leaflets of pharmaceutical products is set out in Directive 2001/83/EC of the European Commission and in the Medicines Act. The following documents are also relevant when drafting a good SmPC, package leaflet or labelling text:
Please contact the secretariat of the Pharmacotherapeutical Group (PT) under which your product falls for specific file-related questions and questions of a more technical nature.