The holders of a marketing authorization for a medicinal product for human use must follow certain guidelines for labeling and packaging. These guidelines have now been updated.
The guidelines “Labeling of medicinal products” to be applied in the context of a new marketing authorization (MA), a renewal or a variation of a medicinal product for human use have been updated. The guidelines are thus adapted to European directives and other national or international agreements.
The main changes concern:
- sections 16, 17, 18 and 19 of the packaging text according to the QRD template;
- definition of small packages;
- definition and submission of mock-ups;
- use of trademarks, symbols ® and TM or mention “brand of”;
- use of logos and use of QR codes;
- labeling of combination packages and labeling of homeopathic medicines.