The Legislation The Legislation in respect of veterinary medicines is broadly similar to that for human medicines. It has now been consolidated at the EU level pursuant to the Directive. Principles of mutual recognition of animal remedies apply within the EU. The Irish regulation is the EU (Animal Remedies) Regulations. The Department of Agriculture administers […]
Category: Medicines
Regulation of Medicines
A medicinal product, is any substance or combination of substance presented as having properties for treating or preventing disease in human beings or any substance or combination which may be in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action […]
Wholesale Licensing
The regulations on wholesale manufacture of medicinal products is based on EU Directives. The competent authority is the Health Products Regulatory Authority. A manufacturer’s authorisation allows manufacture of medicinal products for supply in the European Economic Area (EU plus EFTA countries) or for export outside the EEA. The manufacture of ingredients per se may not […]
Advertising of Medicines
The advertising of medicines is regulated under EU derived legislation. It is also subject to general legislation and codes of practice on advertising. Advertising includes any form of promotion, canvassing or inducement. It includes advertising to the general public and to persons entitled to prescribe. It also cover; visits by sales representative, provision of samples, […]
Prescription Medicine
The supply of medicinal products by way prescriptions by way is regulated under regulations made under the Health Products Regulatory Authority Acts and successor legislation. Prescription may be made by doctors, dentists, and registered nurses in Ireland and equivalents in other EU States exercising EU community rights. The controls apply to supplies made in the […]