Ledger

Dates we will stand behind. Nothing else.

Confirmed primary-source facts. Unconfirmed dates stay off this list rather than guessed. Corrections to our own pages are recorded here with the date they were made.

1. 2009-09-01

   Annex 7 operative

   EU GMP Annex 7 (manufacture of herbal medicinal products) in force. CONFIRMED against the European Commission text.

2. 2011

   Annex 11 operative version

   Computerised systems. The 2011 text is the operative one. A proposed revision and a separate AI annex are draft — not binding.

3. 2015-10-01

   Annex 15 operative

   Qualification and validation. Equipment is qualified in context at a site. It is not certified as an intrinsic property of a skid.

4. 2022

   Annex 1 revision

   Sterile manufacture revision is the operative Annex 1. Grades A–D and a documented CCS apply to sterile products. Do not copy Grade C onto a non-sterile extract room.

5. 2025-07-09

   GACP Rev. 1 adopted

   EMA/HMPC/246816/2005 Rev. 1 adopted 9 July 2025.

6. 2025-08-12

   GACP Rev. 1 published

   Published 12 August 2025. Supersedes the 2006 guideline. Current EU agricultural-stage reference.

7. 2026-04-28

   US cannabis — partial Schedule III

   FDA-approved marijuana products and state-licensed medical marijuana only. All else remains Schedule I. No blanket “marijuana is Schedule III.” Re-check the primary record before you rely on it.