By: Laura Portillo
According to RTCA 11.03.64:11 on sanitary registration requirements for natural medicinal products, these products correspond to:
Processed, industrialized, and labeled products with medicinal properties that contain 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 the RTCA 11.03.64:11 of requirements for sanitary registration of natural medicinal products in its paragraph 7.1 mentions that for the importation, production, distribution, commercialization, prescription, promotion, and advertising, all-natural medicinal products require prior sanitary registration with the regulatory authority, which is regulated by the National Directorate of Medicines.
The sanitary registration of natural medicinal products will be valid for five years, which may be suspended or canceled when there are sanitary reasons of a scientific, technical or legal nature, duly justified. There are categories of acceptance of ingredients in a natural medicinal product that correspond to natural drugs, natural preparations, combinations of any of the above and pharmaceutically accepted excipients and the non-accepted ingredients correspond to isolated molecules of natural ingredients and compounds of chemical synthesis or semi-synthesis used as an active ingredient, which by definition are excluded from natural medicinal products, natural substances prohibited according to international recommendations or regulation issued in each State Party, species identified as protected or endangered unless they come from managed cultivation or breeding and homeopathic ingredients (strains, mother tinctures, and dilutions).
Medicinal natural products to which active substances of chemical synthesis or isolated from natural material are added as responsible for the pharmacological activity are not considered medicinal natural products.
Which products are not natural medicinal products?
o Natural cosmetics
o Fruit drinks
o natural ingredients in combination with ingredients of other nature
o isolated active ingredients alone or in combination
o hormones
o enzymes
or probiotics
or 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.