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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.

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