S.L. 458.44 Art. 3Simplified registration procedure.

(1) Herbal medicinal products shall be subject to a simplified registration procedure, hereinafter referred to as traditional use registration, provided they fulfil all of the following criteria:

(a) they have indications exclusively appropriate to traditional herbal medicinal products which, by virtue of their composition and purpose, are intended and designed for use without the supervision of a medical practitioner for diagnostic purposes or for prescription or monitoring of treatment;

(b) they are exclusively for administration in accordance with a specified strength and posology;

(c) they are an oral, external and, or inhalation preparation;

(d) the period of traditional use as laid down in regulation 5(1)(c) has elapsed;

(e) the data on the traditional use of the medicinal product are sufficient; in particular the product proves not to be harmful in the specified conditions of use and the pharmacological effects or efficacy of the medicinal product are plausible on the basis of long-standing use and experience.

(2) Notwithstanding the definition of herbal medicinal product, the presence in the herbal medicinal product of vitamins or minerals, for the safety of which there is well-documented evidence, shall not prevent the product from being eligible for registration in accordance with subregulation (1), provided that the action of the vitamins or minerals is ancillary to that of the herbal active ingredients regarding the specified claimed indication or indications.

(3) However, in cases where the Licensing Authority, hereinafter referred to as "the Authority", judges that a traditional herbal medicinal product fulfils the criteria for a marketing authorisation in accordance with regulation 4(1) of the Medicines Regulations, or registration pursuant to regulation 10(3) of the Medicines Regulations, the provisions of this regulation shall not apply.