By; Laura Portillo and Olga Torres
According to RTCA 11.03.64:11 of sanitary registration requirements for natural medicinal products, these products correspond to:
Product processed, industrialized and labeled with medicinal properties that contains in its formulation ingredients obtained from plants, animals, minerals or mixtures of these. It may contain excipients in addition to the natural material.
According to RTCA 11.03.64:11 of sanitary registration requirements for natural medicinal products, in its literal 7.1 it mentions that, for the import, production, distribution, commercialization, prescription, promotion and advertising, all natural medicinal products previously require their sanitary registration before the regulatory authority which is regulated by the National Directorate of Medicines.
The health registration of natural medicinal products will be valid for five years, which may be suspended or canceled when there are health reasons of a scientific, technical or legal nature duly justified.
There are categories of acceptance of ingredients in a natural medicinal product which correspond to natural drugs, natural preparations, combinations of any of the above and pharmaceutically accepted excipients, and non-accepted ingredients correspond to isolated molecules of natural ingredients and chemical synthesis or semi-synthesis compounds used. as an active principle, which by definition are excluded from natural medicinal products, natural substances prohibited according to international recommendations or the regulation issued in each State Party, species identified as protected or endangered unless they come from managed crops or breeding and Homeopathic ingredients (strains, mother tinctures and dilutions).
Natural medicinal products to which active substances of chemical synthesis or isolated from natural material are added as responsible for the pharmacological activity, are not considered as natural medicinal products.
What products are not medicinal natural products?
- Cosmetics naturales
- fruit drinks
- natural ingredients in combination with ingredients of another nature
- Isolated active ingredients alone or in combination
- Hormones
- enzymes,
- Probiotics
- Batch flowers, homeopathic and others
If you need any advice, you can contact our team of professionals in the Life Sciences-Regulatory Affairs area through the communication channels indicated on our platforms.