00000nam 2200000zi 4500 9.860039 CaOODSP 20221107160408 m o d f cr cn||||||||| 180802t20192019onc o f000 0 eng d 9780660274706 CaOODSP eng rda CaOODSP n-cn--- H13-9/24-2019E-PDF Guidance document : questions and answers : plain language labelling regulations for prescription drugs. Questions and answers : plain language labelling regulations for prescription drugs Plain language labelling regulations for prescription drugs Ottawa, ON : Health Canada = Santé Canada, 2019. ©2019 1 online resource (34 pages) text txt rdacontent computer c rdamedia online ressource cr rdacarrier Issued also in French under title: Ligne directrice : questions‐réponses : le règlement sur l'étiquetage en langage clair pour les médicaments sur ordonnance. Cover title. "Date adopted: 2015/04/30. Effective date: 2019/08/08. Revised date: 2019/08/08." "Publication date: August 2019." "Pub.: 180206." Issued also in PDF format. "This document provides information for industry on how Health Canada’s Health Products and Food Branch interprets and applies the 2014 Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) for prescription products and those administered or obtained through a health professional. Please note that this includes prescription pharmaceutical drugs, biologic drugs (Schedule D), and radiopharmaceuticals (Schedule C). This document does not address implementation for non-prescription products, which are addressed under the Guidance Document: Questions and Answers: Plain Language Labelling Regulations for Non‐prescription Drugs"--Overview, page 8. gccst Prescription drugs gccst Drug labelling Canada. Health Canada. Ligne directrice : (CaOODSP)9.860040 PDF 690 KB https://publications.gc.ca/collections/collection_2019/sc-hc/H13-9-24-2019-eng.pdf HTML N/A https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/questions-answers-plain-language-labelling-2019/document.html