00000cam 2200000zi 4500 9.951364 CaOODSP 20260901132434 m o d f cr cn||||||||| 250526e20260204onc ob f000 0 eng d 9780660774138 CaOODSP eng rda CaOODSP n-cn--- H139-90/2025E-PDF GUI-0036 : annex 13 to the Good manufacturing practices guide - drugs used in clinical trials. GUI-0036 : annex 13 to the GMP guide : drugs used in clinical trials, v3 Ottawa, ON : Health Canada = Santé Canada, February 4, 2026. ©2024 1 online resource (31 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier Issued also in French under title: GUI-0036 : annex 13 aux Lignes directrices sur les bonnes pratiques de fabrication des médicaments utilisés dans les essais cliniques. Title from cover. " Pub.: 250069"--Page [2]. Includes bibliographical references (page 23). "This guide is an annex to the Canadian Good manufacturing practices guidelines (GUI-0001). It applies to manufacturing, handling and storing of clinical trial drugs intended for use in clinical trials. Good manufacturing practices (GMP) are internationally recognized standards that apply to drug manufacturing. They ensure drug quality and safety. Drugs intended for use in clinical trials in Canada are regulated under Part C, Division 5 of the Food and Drug Regulations (regulations). Under section C.05.010(j), sponsors must ensure that drugs for use in clinical trials are manufactured, handled and stored in accordance with the applicable good manufacturing practices requirements referred to in Divisions 2 to 4. Exceptions are those requirements referred to in sections C.02.019, C.02.025 and C.02.026. Sponsors of clinical trials must also ensure that imported drugs are fabricated and packaged/labelled in accordance with these requirements. The relevant sections of the regulations are noted throughout. …"--Purpose, page 4. Pharmaceutical industry Canada Quality control. Drugs Safety regulations Canada. Drugs Standards Canada. Drugs Testing. Canada. Health Canada, issuing body. GUI-0036 : (CaOODSP)9.951365 PDF 318 KB https://publications.gc.ca/collections/collection_2026/sc-hc/H139-90-2025-eng.pdf HTML N/A https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/annex-13-guide-drugs-clinical-trials-0036.html 250069