package leaflets, spc and labelling
SPC
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:
Package leaflet
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:
Labelling
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:
Directives
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.