Cap. 458 Art. 32Homeopathic medicinal products.

(1) Without prejudice to article 28, homeopathic medicinal products which satisfy the conditions in paragraphs (a)

to (c) shall be subject to special simplified procedures as provided in subarticle (2) to (4). The products to which this subarticle applies are products which -

(a) are administered orally and externally, subject to such regulations as may be made by the Minister in respect thereof;

(b) have no specific therapeutic indication appearing on the labelling of the medicinal product or in any information relating thereto; and

(c) have a sufficient degree of dilution to guarantee the safety of the medicinal product, in particular, the medicinal product may not contain either more than one part per 10,000 of the mother tincture or more than th 1/100 of the smallest dose used in allopathy with regard to active principles whose presence in an allopathic medicinal product results in the obligation to submit a medicinal prescription.

(2) The criteria and rules applicable to the granting of a marketing authorization shall also apply to the special simplified procedure with the exception of the proof of therapeutic efficacy.

(3) Any application for the registration of a homeopathic medicinal product shall contain such documents and information as may be prescribed by regulations made under this Act and such application may cover a series of medicinal products derived from the same homeopathic stock or stocks.

(4) Homeopathic medicinal products which do not satisfy the conditions prescribed in subarticle (1) shall be authorized and labelled in accordance with the provisions of this Act applicable to medicinal products, and shall also be subject to the requirements of pharmacovigilance as established by regulations under this Act.

(5) The Minister may by regulations under this Act prescribe rules for the toxicological and pharmacological tests and clinical trials of homeophathic medicinal products.