The FOI through its Pharmaceutical Manufacturing Sector Group, is currently drawing up its position on the draft regulations concerning Colouring Matters in Medicinal Products for Human Use.

Consultation is proceeding with the FOI by the Medicines Authority. The FOI will be forwarding its recommendations for amendments to these draft regulations and, in particular, will be drawing the Medicines Authority's attention to a number of specifications in Annex II B (Specific Criteria of Purity).

These refer to colouring matters originally present in Annex III of the Directive of October 23, 1962, but which have since been deleted by Directive 76/399/EEC; as well as an Opinion on Toxicological Data on Colouring Agents for Medicinal Products: E 174 Silver, adopted by the Scientific Committee on Medicinal Products and Medical Devices of the Health and Consumer Protection Directorate-General on June 27, 2000.

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