CHAPTER X

LABELLING

Authorised investigational and authorised auxiliary medicinal products
Article 67
1
Authorised investigational medicinal products and authorised auxiliary medicinal products shall be labelled:
a
in accordance with Article 66(1); or
b
in accordance with Title V of Directive 2001/83/EC.
2
Notwithstanding point (b) of paragraph 1, where the specific circumstances, provided for in the protocol, of a clinical trial so require in order to ensure the safety of the subject or the reliability and robustness of data generated in a clinical trial, additional particulars relating to the identification of the clinical trial and of the contact person shall appear on the outer packaging and the immediate packaging of authorised investigational medicinal products. A list of these additional particulars appearing on the outer packaging and immediate packaging is set out in section C of Annex VI.