HMPC starts Revision of GACP Guideline
Recommendation
5/6 June 2024
All relevant GMP/GDP/GACP aspects for Medical Cannabis
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As previously announced, EMA´s HMPC is currently working on the revision of the Guideline on Good Agricultural and Collection Practice (GACP).
The goal is to draft a concept paper for revision to address stakeholder requests on required clarifications, e.g.
- overlap GMP vs. GACP,
- uncertainty about requirements,
- GACP certification and dossier,
- comparison to other GACP standards such as WHO.
The committee now adopted a concept paper for the revision of the Guideline on Good Agricultural and Collection Practice (GACP) of starting materials of herbal origin. The concept paper on the revision of guideline EMA/HMPC/246816/2005 will be published at EMA´s Herbal medicinal products: scientific guidelines website. Interested parties are invited to provide comments by 15 March 2022.
Please find more information in the HMPC meeting report of the 102nd HMPC meeting.
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