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Select Committee on Social Affairs debate -
Wednesday, 4 Oct 1995

SECTION 9.

Amendment No. 4 not moved.
Question proposed: "That section 9 stand part of the Bill."

Before we move from section 9, a question was asked earlier regarding veterinary vaccines and I now have the information. Veterinary vaccines are currently licensed by the Minister for Health under the Therapeutic Substances Act, 1932. Assessment of vaccines is carried out by officers of the Minister for Agriculture, Food and Forestry. There are also restrictions on certain vaccines under the Disease of Animals Act, 1966. Regulations are being finalised to transpose an EU directive on veterinary vaccines. These regulations will transfer full licensing responsibilities to the Minister for Agriculture, Food and Forestry. The Minister may involve the new Medicines Board to assist in assessing veterinary vaccines but will retain overall control. The reason for the Minister retaining control of veterinary vaccines is related to animal health policy considerations. The use of veterinary vaccines may be restricted or prohibited to take account of a country's animal health status or an eradication policy for a particular disease. The EU directive permits restrictions on the authorisation and use of veterinary vaccines on bona fide animal health policy considerations.

Question put and agreed to.
Sections 10 to 12, inclusive, agreed to.
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