Herbal medicinal products in the European Union - AESGP

materials that have well recognised rehabilitating, preventive or curing properties. Herbal
remedies are defined as those products manufactured with a single part of a medicinal
plant, or a combination of its parts that have been used for the relief of certain symptoms
based on popular or traditional knowledge. Herbal products in either category should not be
combined with narcotics, psychotropics, chemical active ingredients, allopathic products,
human or animal hormones or products that have an anti-hormonal or hormonal activity.
Injectable presentations shall not be classified as herbal medicinal products.
Herbal tea products, such as camomile, are not classified as medicinal products. In
addition, there are vegetal extracts such as Cnidoscolos chayamansa, Sabila, Cuachalalate,
etc., which are presented in a pharmaceutical form and are not registered as herbal
medicinal products but are still considered as food supplements. This situation is mainly
explained by the fact that it was not until 1995 that the Ministry of Health strengthened its
classification criteria and started requesting herbal medicinal product manufacturers to
register their products as medicinal products. Before 1995, all of these products could be
registered as food supplements.
In accordance with the General Health Law, medicinal products are firstly defined by
function and secondly by presentation. That means that a medicinal product should have
rehabilitating, preventive or curing properties and be presented in a pharmaceutical form.
b ) Is there a specific category for herbal medicinal products that have no
therapeutic claim?
All products legally registered as herbal medicinal products may make claims i n
accordance with the authorisation issued by the Ministry of Health. Herbal remedies may
make symptomatic claims noting that such effects are based on their traditional use. As
mentioned above, there are also some products containing herbal extracts that are still
making unauthorised claims.
c ) Is there a specific category for herbal medicinal products containing wellknown
plants?
Yes, the herbal medicinal category.
d) Is there a specific category for traditionally used herbal medicinal products
(e.g., in the treatment of certain indications)?
Yes, the herbal remedies category.
e ) Are there “combination products” on the market, including combinations with
homeopathics, food supplements, vitamins, amino acids, etc.? How do the
authorities assess these products?
Currently, there are products that combine herbals, vitamins and minerals only. These
products may be considered food supplements provided that none of their vitamin or mineral
concentrations exceed the lower limits established for non-prescription vitamins or
minerals. Ministry of Health assesses these products as any other medicinal combination
products, looking at each component’s therapeutic activity and the possibility for it to cause
synergistic, antagonistic or adding effects.
f ) Are there modern herbal medicinal products on the market that have been
further developed from their traditional use (e.g., highly processed, new indications,
new pharmaceutical form, etc.)? Are there herbal medicinal products approved
and sold as OTC drugs?
There is one product made out of camomile that is presented in ointment and solution. Its
name is Camilosan and it is manufactured by a national pharmaceutical company.
Another product is made out of Garcinia cambogia and classified as a prescription for weight
reduction.
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