Human Use Regulations, 2004

L.N. 474 of 2004

MEDICINES ACT

(ACT NO. III OF 2003)

Colouring Matters in Medicinal Products for

Human Use Regulations, 2004

IN exercise of the powers conferred by article 106 of the Medicines

Act, 2003, the Minister of Health, the Elderly and Community Care has

made the following regulations>–

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

Medicinal Products for Human Use Regulations, 2004.

(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.

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press