Packaging and Labelling Most medicines require packaging and labels in a prescribed format. There are detailed rules, setting out EU-wide standards on packaging and labelling. Very specific information is required on the label dealing with matters such as the name, pharmaceutical strength, qualitative and quantitative details of active ingredients, form and content by weight, list of recipients with the recognised effects, method of administration, warnings, […]
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 the regulations. The Animal Remedies Act is domestic legislation. The […]
Medical Product Authorisation A medicinal product is any substance or combination of substances presented as having properties for treating or preventing disease in human beings or any substance or combination which may be administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action or making a medical diagnosis. The placing of medicinal […]
Manufacture Authorisation The regulations on the manufacture of medicinal products are based on EU Directives. The competent authority is the Health Products Regulatory Authority. A manufacturer’s authorisation allows the 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 require a licence but is required to […]
Advertising 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 covers; visits by sales representatives, provision of samples, sponsorships or promotional meetings attended by persons entitled to prescribe, sponsorship […]
Overview For reasons that are readily apparent, many medicines may be supplied only on prescription. Medicines must be authorised under the appropriate authorisation regulations or under very limited exceptions to time. The supply of medicinal products by way of prescriptions is regulated under regulations made under the Health Products Regulatory Authority Acts and successor legislation. Prescriptions may be made by doctors, dentists, and registered nurses […]