Articles 68 and 69
Packaging and labelling of homeopathic medicinal products is 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.
These articles apply to Article 14 products only, which are mostly put on the market as over-the-counter medicines. They are required to be sold with a disclaimer, without indications and with restricted information. ECHAMP believes this means that patients are not given adequate information on safe and correct use of these products.
Specifically, the requirement to include a disclaimer, ‘homeopathic medicinal product without approved indication,’ is misleading since these products do have indications but are simply registered without indication.
Furthermore, no information can be provided on contra-indications or side effects linked to specific ingredients, or on contra-indications linked to allergies or dosage instructions.
The legislation is not good for patients; the situation is further complicated by the fact that the translation and interpretation of Article 69 in the Members States has resulted in differences of implementation, with different Member States allowing more or less restricted patient information. This fosters a high degree of uncertainty for manufacturers, dependent on the individual interpretations of the licensing authorities. The non-harmonised implementation is also an obstacle for Mutual Recognition.
For Article 16.2 products and those with Marketing Authorisations, normal guidelines apply.
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