Draft regulations on medicines

DRAFT regulations which provide for significant changes in the existing arrangements governing the supply and use of veterinary medicines have been issued by the Department of Agriculture.
Draft regulations on medicines

But there has been a critical response from the Animal and Plant Health Association (APHA), the representative body for manufacturers and sole distributors of animal and plant health products in Ireland. It warned that the proposals have the potential to seriously undermine competition and product availability in the animal health sector.

A provision that all medicines for food producing animals should be made subject to prescriptions is one of the proposals in the draft.

But it also contains an exemption clause that provides a mechanism for categories of medicines to be excluded from that requirement. The department intends to avail of the exemption mechanism to the optimum extent possible. Interested parties can submit their views to the department before September 12.

Meanwhile, the ICSA president Malcolm Thompson said he has grave reservations regarding the draft regulations on prescription only medicines.

“The entire approach hinges on the success of the department in obtaining exemptions from Europe on medicines which, at present, are freely available.”

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