Herbal medicinal products in the European Union - AESGP

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Medicinal products
(“Medicamentos”)
Plant-based medicinal products
(“Fitofarmacos”)
↓ ↓
Pharmaceutical specialties
Medicinal products which are not
(“Especialidades farmacéuticas”)
pharmaceutical specialties
Herbal medicinal products
(“Especialidades farmacéuticas a base de
plantas”)
Phytotraditional medicinal products
(“Productos fitotradicionales”)
Indication No indication
Authorisation Notification (except combinations)
Table 3: Categories of plant-based medicinal products in Spain
According to Article 8.6 of the draft Royal Decree, a pharmaceutical specialty (“especialidad
farmacéutica”) is a “medicinal product with defined composition and information, of
determined pharmaceutical form and dosage, prepared for immediate medicinal use, ready
and packaged for dispatching to the public, with uniform name, packing, packaging and
labelling, which has been granted a health authorisation by the State’s Administration and
registered in the Pharmaceutical Specialties Register.”
Note:
Medicinal products which are not pharmaceutical specialties can be prefabricated medicinal
products (Article 8.7), magisterial formulas (Article 8.9) or officinal preparations or
formulas (Article 8.10).
d) Summary: Definition of Herbal Medicinal Products
In almost all Member States, herbal medicinal products are considered as medicinal
products. As such, they are in principle subject to the general regulations for medicinal
products as laid down in national Medicines Law. A specific definition of herbal medicinal
products which is in line with the EC Guideline “Quality of Herbal Remedies” (“Quality of
Herbal Medicinal Products”) and which includes plants, parts of plants and their
preparations, mostly presented with therapeutic or prophylactic claims is available in many
cases. Different categories of products containing plant preparations are described e.g. i n
Spain according to a legislative draft as “herbal medicinal products” and “phytotraditional
products”. The latter are however not regarded as pharmaceutical specialties and are
therefore not herbal medicinal products.
VII.1.3 Classification of Herbal Preparations
As indicated above, Council Directive 65/65/EEC defines the basic criteria for a medicinal
product. Herbal preparations are not considered medicinal products if they are intended to be
used as food, cosmetics, etc. and are not intended or presented for treating, preventing or
diagnosing diseases or restoring, correcting or modifying physiological functions.
However, the line distinguishing medicinal from non-medicinal products, in many cases
such as in the case of herbal products, is not easy to draw. For this reason, in this study
national authorities were asked: (a) which criteria for classification as a medicinal product
(e.g., by function or presentation or both) are used; and (b) which products containing plants
are not classified as medicinal products. Herbal preparations that are not medicinal
products do not require a marketing authorisation from the competent authority. In some
cases, however, a notification has to be performed. Several examples of products are given
that might fit into both these areas (c). Furthermore, in several Member States medicinal
products exist which are exempted from licensing (d).