Regulatory guidance documents
Guidance documents provide information about complying with regulatory procedures. Select a product area from the dropdown list.
Opens in new windowGuide to NDSWeb extranetPDF: 827KB | Published 28/04/2025Opens in new windowView tracked changesOpens in new window
Opens in new windowGuide to new, amendment, renewal and reactivation applications for individuals under SAP legislationPDF: 225KB | Published 10/04/2025Opens in new windowGuide to good distribution practice of medicinal products for human usePDF: 378KB | Published 07/04/2025Opens in new windowView tracked changesOpens in new window
Opens in new windowGuide to training education and competency requirements under scientific animal protection legislationPDF: 243KB | Published 01/04/2025Opens in new windowGuide to advertising compliancePDF: 446KB | Published 28/03/2025Opens in new windowView tracked changesOpens in new window
Opens in new windowGuide to clinical investigations carried out in IrelandPDF: 183KB | Published 25/03/2025Opens in new windowView tracked changesOpens in new window
Opens in new windowGuide to batch-specific requests for human medicinesPDF: 107KB | Published 25/03/2025Opens in new windowView tracked changesOpens in new window
Opens in new windowGuide to THMP Registration SchemePDF: 203KB | Published 25/03/2025Opens in new windowView tracked changesOpens in new window