COLOURING MATTERS IN MEDICINAL PRODUCTS FOR HUMAN USE REGULATIONS

COLOURING MATTERS

IN MEDICINAL PRODUCTS FOR HUMAN USE

SUBSIDIARY LEGISLATION 458.41

COLOURING MATTERS IN MEDICINAL

PRODUCTS FOR HUMAN USE REGULATIONS

19th November, 2004

LEGAL NOTICE 474 of 2004.

(1) The title of these regulations is the Colouring Matters

in Medicinal Products for Human Use Regulations.

(2) The objective of these regulations is to transpose Directive

78/25/EEC as amended by Directive 81/464/EEC.

(1) The only colouring matters that shall be permitted for

the colouring of medicinal products for human use shall be those

under Annex I, Sections I and II, to the Directive of the 23rd

October, 1962, as subsequently amended, as long as such colouring

matters satisfy the general and specific criteria of purity laid down

under Annex III to the Directive of the 23rd October, 1962.

(2) No distinction shall be made between colouring matter for

both mass and surface colouring, and colouring matter for surface

colouring only.

(3) The Licensing Authority shall adopt methods of analysis to

verify that the general and specific criteria of purity under Annex

III to Directive of the 23rd October, 1962 are satisfied.

Where a colouring matter is deleted from Annex I to the

Directive of the 23rd October, 1962 but the marketing of foodstuffs

containing this colouring matter is permitted to continue for a

limited period, this provision shall also apply to medicinal

products. This limited period of use may, however, be amended for

medicinal products according to the procedure laid down in Article

6 of Directive 78/25/EEC.