Paragraph 2

In the Medicines (Labelling) Regulations 1976^f1, for paragraph (2) of regulation 1 (citation and scope) substitute the following paragraph—

“(2)

Nothing in these Regulations applies to—

(a)

a medicinal product for human use to which—

(i)

the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994^f2,

(ii)

the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994, or

(iii)

the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005,^f3

apply; or

(b)

a medicinal product which is an investigational medicinal product within the meaning of the Medicines for Human Use (Clinical Trials) Regulations 2004^f4.”.