Herbal medicinal products in the European Union - AESGP

Country National legislation Remarks
Austria 2nd amendment to the Medicines Law 1994 *1)
Belgium Royal Decree of 31 December 1992 *2)
Denmark Ministry of Health Order No. 314 of 18 May 1993
Finland Administered Regulation 5/93
France Decree 94-19 of 5 January 1994
Germany 5th amendment to the Medicines Law
Greece Ministerial Decree Y6a/776 [GR 4]
Ireland Medical Preparations (Labelling and Package Leaflets)
Regulations 1993 (S.T. No. 71 of 1993)
Italy Decreto legislativo No. 540 [I 11]
Luxembourg *3)
The Netherlands Decree on labels/leaflet *4)
Portugal Decree No. 101/94 of 19 April 1994 *5)
Spain Royal Decree of 2236/1993 of 17 December 1993
[SP 9]
Sweden Medical Products Agency’s Provisions and Guidelines
on the Packaging and Labelling of Medicinal Products
(LVFS 1995:11) [S 3]
United Kingdom The Medicines Labelling (Amendment) Regulations
1992 (SI 1992/3273) [UK 6]; Medicines Leaflets
(Amendment) Regulations 1992 (SI 1992/3274) [UK 7]
88
Table 27: Implementation of Council Directive 92/27/EEC
Notes:
1) Austria:
Additional general statements concerning a product’s medical surroundings (“medizinisches
Umfeld”) do not require special permission (“nicht genehmigungspflichtig”).
2) Belgium:
The package leaflet must be written in the three national languages (Dutch, French and
German). It must also be consumer-friendly in accordance with the Royal Decree of 7 April
1995 on the information and advertising of medicinal products.
3) Luxembourg:
The Division of Pharmacy and Medicinal Products mutually recognises the label and the
leaflet of the original product. The language should be German or French. It is not
mandatory to use both languages, but if both language versions are included, they should be
strictly similar in content.
4) The Netherlands:
Before the decree took effect, package leaflets were only compulsory if the medicinal product
was marketed with an outer packaging. Otherwise, the compulsory details had to be included
on the container label. According to current Dutch labelling rules, manufacturers are
obliged to mention all approved indications in the leaflet. However, in advertising to the
general public only indications suitable for self-medication may be mentioned. In
accordance with the Directive, label and leaflet information must be drafted in consumerfriendly
language. Pictograms may be used on labels and leaflets. All information must be
in Dutch. Additional languages are allowed as long as the same information is given in all
languages.
5) Portugal:
The information required on the outer packaging, on the label of the primary packaging and
in the patient information leaflet should be written in Portuguese, using language that i s
clearly and easily understood. The information may also be provided, in parallel, in other
languages. The outer packaging may include symbols or pictures to help explain certain
parts of the required information. The information must be in accordance with the summary
of product characteristics and should contribute to health education. Labelling and package
leaflets should not include any information of a promotional nature.