BoMRA BOMRABOMRA/IL/IL/P08/G02
BOMRA/IL/IL/P08/G02 is the official BoMRA identifier for “GMP Recognition and Reliance Guideline”. BOMRA/IL/IL/P08/G02 is the official identifier BoMRA uses for this instrument.
- Instrument
- BOMRA
- Full name
- BOMRA/IL/IL/P08/G02
- Category
- Registration
- Authority source
- English
- Readable HTML
- 0 articles · 1 language version
- Published
- —
- Effective
- 2026-04-23
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Each version has stable article anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.
GMP Recognition and Reliance Guideline
BoMRA's recognition and reliance guideline, Issue 2.0, effective 23 April 2026. It states when BoMRA will accept a foreign authority's inspection or decision instead of repeating the work, which authorities it recognises and on what basis, and how a reliance application is made. Two things about the copy are worth stating, because they are visible in the document itself and a reader should not be surprised by them. First, the document is internally inconsistent about its own title: page 1 of the PDF reads "GMP Recognition and Reliance Guideline", pages 2 to 10 read "Guideline for Good Recognition and Reliance Practices", and its own revision-status sheet records the change ("Changed the document title from 'GMP Inspections and reliance policy' to 'Guideline for Good Recognition and Reliance Practices.'"). Both titles are the source's; neither has been repaired here. Second, the instrument is about inspections of manufacturing sites and mentions devices only in passing — its substance is GMP recognition, not device registration — although its stated legal basis is section 7(a)(i) of the Medicines and Related Substances Act, 2025, an Act whose commencement is ON NOTICE. It is ingested at the title the batch declaration and the PDF's own first page carry.
BOMRA/IL/IL/P08/G02 is the official identifier BoMRA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.