GxPlex

Annex 11 concept paper

EMA concept paper on the revision of Annex 11

not yet verified

Last verified: not yet verified Last observed: SHA-256: 17bed942038fa6e7a23e370ca1a5d341de9b9201504983145452b46b1c03b204

Not yet verified. The status of this instrument has not been confirmed against its primary source. It is recorded as unknown rather than estimated. Consult the primary source (opens in new tab) directly.

Resolution: direct document · nothing is hashed for this entry

Nothing is hashed for this entry. The concept paper's own PDF was located on 2026-07-31 and now carries the hash. The EudraLex consultation-documents listing this entry previously tracked has since gone dead, so the earlier statement that no stable public URL existed no longer holds. The document states the dates on which EMA's GMP/GDP IWG and PIC/S agreed it and the consultation window, but does not state a status in words; no status is read from it until a person confirms one.

Authority
European Medicines Agency
Jurisdiction
EU
Status
not yet verified
Effective date
—
Last changed
—
Last verified
: not yet verified
Watch cadence
weekly
Crawlable
yes · renders server-side
Text licence
freely reproducible
Primary source
Primary source (opens in new tab) ema.europa.eu
Listed at
discovery route (opens in new tab) health.ec.europa.eu
Topics
computerised systems · GMP · consultation

Current status#

No status has been confirmed against the primary source. Recorded as unknown rather than estimated.

Observation history#

First observed 31 July 2026. Last observed 3 August 2026. 14 observation(s) recorded.

10 of those returned a document to a standard HTTP client and produced a content hash.

No change to the retrieved text has been detected since observation began.

What is not known#

The source was retrieved, but no phrase stating a regulatory status was found near a mention of this instrument.

Sources#

Cite this instrument

Each format carries the permalink and the date this instrument was observed. The observation date is part of the citation: the underlying source may have changed since.

Plain text

GxPlex. EMA concept paper on the revision of Annex 11 [instrument record]. Observed 3 August 2026. https://gxplex.com/instrument/ema-annex11-concept-paper Primary source: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/concept-paper-revision-annex-11-guidelines-good-manufacturing-practice-medicinal-products-computerised-systems_en.pdf

BibTeX

@misc{gxplexinstrumentemaannex11conceptp,
  author       = {{GxPlex}},
  title        = {{EMA concept paper on the revision of Annex 11}},
  year         = {2026},
  note         = {instrument record, observed 3 August 2026},
  howpublished = {\url{https://gxplex.com/instrument/ema-annex11-concept-paper}},
  urldate      = {2026-08-03},
  url          = {https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/concept-paper-revision-annex-11-guidelines-good-manufacturing-practice-medicinal-products-computerised-systems_en.pdf}
}

APA

GxPlex. (2026). EMA concept paper on the revision of Annex 11 [instrument record]. Retrieved 3 August 2026, from https://gxplex.com/instrument/ema-annex11-concept-paper

Observation history

Observed on 14 occasion(s) since 2026-07-31. 10 produced a content hash.

××××··········

One mark per observation, oldest first. · unchanged · ! content changed · ~ fetched but rendered client-side, no hash · × could not be fetched, no hash.

First observed
2026-07-31
Last observed
2026-08-03 (HTTP 200)
Fetch method
direct
Current hash
17bed942038fa6e7a23e370ca1a5d341de9b9201504983145452b46b1c03b204

Subject and class (as stated)

The words this document uses about itself, matched verbatim against its own title. Not a statement of scope, and not a judgment about which organisations or products fall under it: each value quotes the span it was read from and links to where that span was read.

This document's title states no subject term this archive matches. That is a fact about the reading, not a subject it lacks — it is filed under no self-stated subject.

Sources