Herbal medicinal products in the European Union - AESGP

products. So-called “old” medicinal products must include a package leaflet one year after
re-registration. However, in practice, nearly all “old” medicinal products are already
marketed with leaflets and conform to the labelling requirements. If a medicinal product is
marketed without outer packaging, the leaflet may be omitted provided the required
information is displayed on the label.
Greece
Ministerial Decree Y6a/776 [GR 4] is applicable to all medicinal products. Both inner and
outer packaging (where they exist) should bear all information required by the relevant EC
Directive. The information must be printed clearly and legibly in Greek, using language
that is easily understood. For non-prescription medicinal products, the instructions for use
must appear on the outer and inner packaging. Special rules are included for small
packages. The patient information may be printed in more than one language provided they
all convey the same information.
A patient leaflet is mandatory. The outer packaging and the leaflet may include symbols or
pictures to explain certain parts of the required information in accordance with the
Summary of Product Characteristics. This information should contribute to health education
and should not be of a promotional nature.
Ireland
As there are no specific guidelines on the labelling of herbal medicinal products, they would
have to be labelled in accordance with the regulations of the Medical Preparations
(Labelling and Package Leaflets) Regulations, 1993 (S.I. No. 71 of 1993), and contain the
appropriate patient information leaflet.
Italy
In case a herbal product is considered as a medicinal product according to Council Directive
65/65/EEC and is registered as such, a leaflet which provides information on the indication
claims, risks, dosage, etc. must be provided as laid down in Legislative Decree No. 540/92
[I 11].
The Ministry of Health stresses the importance of developing package leaflets that use
language that is easily understood by patients and avoids the use of scientific terms
(Circular of 8 April 1993). This requirement is valid for all medicinal products except those
dispensed by a hospital or directly by a specialist (Articles 9 and 10 of Legislative Decree of
30 December 1992, No. 539 [I 12], implementing Council Directive 92/26/EEC).
Herbal medicinal products are presented in the leaflet as products of herbal origin. There is
no specific recommendation for the labelling of herbal medicinal products.
Luxembourg
As the Division of Pharmacy and Medicinal Products recognises marketing authorisations
issued by other Member States, the presentations on the market are those marketed in the
country of origin. It is not compulsory to have specific labelling for herbal medicinal
products such as “herbal medicinal product”, “natural medicinal product” or “natural
remedy”.
The Netherlands
The requirements are only applicable to authorised herbal medicinal products.
Portugal
The requirements are only applicable to authorised herbal medicinal products.
Spain
According to Royal Decree 2236/1993 of 17 December [SP 9] , which regulates the labelling
and patient information for human medicinal products, it is not necessary for non-
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