package leaflets, spc and labelling
SPC
A
Summary of Product Characteristics (SPC) has to be drawn up for
all article 16 products. An SPC is a summary of the product
information and a precursor to the package leaflet. The difference
is that the SPC is written in technical language while in the
package leaflet the terminology is adapted to make it easier for
patients to understand. As homeopathic medicinal products are
assessed differently from conventional medicinal products, the
structure of the SPC is also slightly different. Section 5, which
normally contains information on pharmacological properties, is
changed to Properties. This section can contain a description of
the specific homeopathic properties of the product couched in very
general terms.
Sections 2, 3, 4.2 (relevant parts), and 6.1 to 6.6 are treated
in the same way as for conventional medicinal products.
Current package leaflets
The MEB adds new and
revised package leaflets to the
Database of Human Medicines.
Labelling
Click here for more information on package leaflets, SPC, packaging
and labelling.