NMPB RChRCh/R/01/01
Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.
RCh/R/01/01 is the official NMPB identifier for “Requirements for Variations”. RCh/R/01/01 is the official identifier NMPB uses for this instrument.
- Instrument
- RCh
- Full name
- RCh/R/01/01
- Category
- Registration
- Source publication
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Each version has stable passage anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.
Requirements for Variations
Mixed medicine and nonmedicine variation requirements. Medical-device clauses 2.3/4.3 refer to EC or FDA documentation and 11.2/11.3 to ISO and EC/FDA evidence; agency changes appear in section 12. Dissolution, solid-dosage and excipient provisions are not generalized to all devices or IVDs. Controlled copy issue 3/change 1 prints issue date 01/08/2012 on page 1 and 01/08/2019 on pages 2–5, change date 28/07/2020 and expiry 01/08/2022. These differing source readings are preserved. Current website linkage and a later variation notice do not establish that this expired template is the latest edition; exact incorporation into the 2017 registration rules and later amendments remain open.
RCh/R/01/01 is the official identifier NMPB uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.