Packaging and labelling
Packaging and labelling of homeopathic medicinal products are regulated by Articles 68 and 69 of Directive 2001/83/EC. Article 68 lays down the legal basis for packaging and labelling of these products and Article 69 the specific requirements.
There are also special requirements on Braille for homeopathic medicinal products.
These articles apply to Article 14 products only. For Article 16.2 products and those with Marketing Authorisations, normal guidelines apply.