TITLE IIIPLACING ON THE MARKET

CHAPTER 2Specific provisions applicable to homeopathic medicinal products

Article 16

1

Homeopathic medicinal products other than those referred to in Article 14(1) shall be authorized and labelled in accordance with F1Articles 8, 10, 10a, 10b, 10c and 11.

2

A Member State may introduce or retain in its territory specific rules for the F1preclinical tests and clinical trials of homeopathic medicinal products other than those referred to in Article 14(1) in accordance with the principles and characteristics of homeopathy as practised in that Member State.

In this case, the Member State concerned shall notify the Commission of the specific rules in force.

3

Title IX shall apply to homeopathic medicinal products, with the exception of those referred to in Article 14(1).