NMPB DocumentNMPB factory-listing regulations, 2017
لائحة إدراج مصانع الأدوية والمستحضرات الصيدلانية والمستلزمات الطبية ومستحضرات التجميل لسنة ٢٠١٧م is published by المجلس القومي للأدوية والسموم. This document is identified by its title; no separate official document code is recorded.
- Instrument
- Document
- Full name
- NMPB factory-listing regulations, 2017
- Category
- GMP/QMS
- Source publication
- Arabic
- Readable HTML
- 1 language version
- Published
- —
- Effective
- 2017-12-05
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لائحة إدراج مصانع الأدوية والمستحضرات الصيدلانية والمستلزمات الطبية ومستحضرات التجميل لسنة ٢٠١٧م
Complete four-page signed Arabic factory-listing regulation, issued under section 40 of the Medicines and Poisons Act 2009. Signed 5 December 2017 and effective on signature. Article 2 repeals the 2010 foreign-factory listing regulation while preserving actions until repealed or varied. Article 4(7) requires written notification of a major change to a listed production line; article 5(5) permits delisting for an unnotified major change. Article 6 permits an additional inspection for a new production line or major line change, five years since the previous inspection, or justified exceptional inspection. The entire original has been visually transcribed and all four page images are retained. It governs factory listing and does not itself supply a complete individual-device variation procedure. Current amendments, fee instruments, listing forms and implementation rules remain under review.
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