Guidance document : questions and answers : plain language labelling regulations for prescription drugs.: H13-9/24-2019E-PDF
"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.
Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.860039&sl=0
| Department/Agency | Canada. Health Canada. |
|---|---|
| Title | Guidance document : questions and answers : plain language labelling regulations for prescription drugs. |
| Variant title | Questions and answers : plain language labelling regulations for prescription drugs Plain language labelling regulations for prescription drugs |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Format | Electronic |
| Electronic document | |
| Note(s) | 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. |
| Publishing information | Ottawa, ON : Health Canada = Santé Canada, 2019. ©2019 |
| Description | 1 online resource (34 pages) |
| ISBN | 9780660274706 |
| Catalogue number |
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| Subject terms | Prescription drugs Drug labelling |
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