Guidance documents – medicines for human use

Guide to Registration of Processes under Article 61(5) of the Clinical Trial Regulation

Guide to good distribution practice of medicinal products for human use

Guide to advertising compliance

Guide to batch-specific requests for human medicines

Guide to THMP Registration Scheme

Guide to applications for a variation to a manufacturer's authorisation

Guide to applications for a new manufacturer's authorisation

Guide to labels and leaflets of human medicines

Guide to Combining Multiple Presentations of a Parenteral Product in One Product Authorisation

Guide to attainment of Qualified Person status in Ireland

Guide to renewal of marketing authorisations - human medicines

Medicines shortages framework

Guide to clinical trials conducted under the CTR in Ireland

Guide to Interchangeable Medicines

Updated following clarification received from the Department of Health that the demonstration of bioequivalence is not required by the Health (Pricing and Supply of Medical Goods) Act 2013.

Guide to definition of a human medicine

Guide to reclassification (switching) of legal supply status for human medicinal products

Guide to managing changes to registration for active substance manufacturers importers and distributors