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 training education and competency requirements under scientific animal protection legislationPDF: 243KB | Published 01/04/2025
Opens 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: 182KB | 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
Opens in new windowGuide to project applications under scientific animal protection legislationPDF: 1048KB | Published 14/03/2025Opens in new windowView tracked changesOpens in new window
Opens in new windowGuide to applications for a variation to a manufacturer's authorisationPDF: 394KB | Published 28/02/2025Opens in new windowView tracked changesOpens in new window
Opens in new windowGuide to applications for a new manufacturer's authorisationPDF: 345KB | Published 28/02/2025Opens in new windowView tracked changesOpens in new window