Medicinal cannabis under EU GMP: GACP for growing, Annex 7 for herbal processing
Agree where GACP ends and GMP begins for each step, then build the Annex 7 specification and supplier audit file around it.
In Short
- Field steps: GACP; then GMP.
- Annex 7 para 8: a long spec list.
- Audit and document each supplier.
The Cannabis and Hemp Guide
Authorised inputs. Tested batches. Packs that meet your market's rules.
- Which rules reach your product
- Supplier to vault
- Extract, formulate, test, approve
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The Cannabis and Hemp Guide
Authorised inputs. Tested batches. Packs that meet your market's rules.
Cannabis grown for medicinal products in the EU sits where agricultural practice meets pharmaceutical GMP. Opened: EudraLex Volume 4 Annex 7, Manufacture of Herbal Medicinal Products (revision in operation since 1 Sept 2009), and the EMA guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin, Rev. 1, adopted by the HMPC on 9 July 2025. Neither names cannabis; this guide applies them to cannabis as an herbal starting material. Not opened: national cannabis laws, the full text of EU GMP Parts I and II, Annex 16, Directive 2001/83/EC and Ph. Eur. monographs. It is orientation, not legal advice. Sources checked 5 Oct 2026.
Which guideline applies at which step
Annex 7 includes a table that maps activities from cultivation and harvesting, through cutting and drying, extraction and further processing, to the finished dosage form, across GACP, GMP Part II and GMP Part I. Its footnotes say initial cutting and drying in the field may follow GACP where justified in the marketing authorisation, with GMP applying to further cutting and drying.
Which guideline for this step? (simplified Annex 7)
- Cultivation, collection and harvest.
More on which guideline applies at which step
The explanatory note says classification depends on the use the manufacturing authorisation holder makes of the material, and the manufacturer of the medicinal product must ensure the appropriate classification. Whether a cannabis product is a medicinal product at all is a question of national law, which this guide did not open.
What GACP Rev. 1 covers
The GACP guideline covers cultivation, collection, harvesting and primary processing of herbal starting materials, including cultivation indoors and in greenhouses. It is meant to be read alongside GMP Part II and Annex 7, which take over once material enters GMP steps.
More on what GACP Rev. 1 covers
It sets expectations for documentation by batch, staff training and hygiene, seeds and propagation material, soil and fertilisers, contamination control, and handling of harvested material. It also notes obligations on protected species, such as CITES, and access and benefit-sharing, which apply alongside quality rules.
The Herbal Starting Material Specification
Paragraph 8 of Annex 7 lists what the specification for an herbal starting material should include, as appropriate. Items include the binomial scientific name and, where relevant, the chemotype; details of the source, including country, region and cultivation details; the plant part used; the drying system, if dried plant is bought; identification tests, including known marker substances; water content; assay of constituents with therapeutic activity or markers; pesticide methods and limits; tests for microbial contamination, including aflatoxins and other mycotoxins; toxic metals; and foreign materials.
Herbal starting material specification (Annex 7, para 8)
More on the Herbal Starting Material Specification
Any treatment to reduce contamination must be documented.
Premises, Sampling and Quality Control
Annex 7 asks for herbal materials to be stored in separate areas, with quarantine and approved stock kept apart, protected from insects and other animals, and with temperature, humidity and light controlled and monitored where needed. It asks for dust control during sampling, weighing, mixing and processing.
Worked Example: Incoming Dried Flower Lot CF-2210
| Check | Result | Who |
|---|---|---|
| Container examined for foreign matter | Pass | Warehouse |
| Reference sample retained | Yes | QC |
| Supplier GACP audit on file | 2026 audit | QA |
| Release | Pending QC results | QC |
- Container examined for foreign matter
- Result
- Pass
- Who
- Warehouse
- Reference sample retained
- Result
- Yes
- Who
- QC
- Supplier GACP audit on file
- Result
- 2026 audit
- Who
- QA
- Release
- Result
- Pending QC results
- Who
- QC
More on premises, Sampling and Quality Control
Paragraph 10 asks for each incoming container to be examined for adulteration or foreign matter. Sampling should be done by people with suitable expertise, a reference sample retained, and quality control staff should have the expertise to perform identity testing and recognise adulteration.
Suppliers and Release
Paragraph 7 of Annex 7 says only herbal starting materials manufactured in line with GMP and the marketing authorisation dossier should be used, and that documentation on audits of herbal substance suppliers, including the grower, should be kept, because the quality of the starting material depends on it. Audits should confirm suppliers follow GACP.
More on suppliers and Release
Batch certification by a Qualified Person sits in Annex 16 and Directive 2001/83/EC, which this guide did not open. Keep supplier audits, specifications, test results and batch records linked, so the person certifying a batch can see the full chain.
Questions
Does EU GMP Annex 7 mention cannabis?
No. Annex 7 covers herbal medicinal products and herbal starting materials generally. Whether a cannabis product is a medicinal product depends on national law, which was not opened.
Is cultivation under GMP or GACP?
Annex 7's footnotes apply GACP to initial field steps where justified in the marketing authorisation and GMP to further cutting and drying. The manufacturer ensures the appropriate classification.
What must a herbal starting material specification include?
Annex 7 paragraph 8 lists items such as the binomial name and chemotype, source, plant part, drying, identity tests, water content, assay, pesticides, microbes, toxic metals and foreign matter.
Does V5 certify batches for release?
No. V5 records supplier audits, specifications, test results and batch records linked to each lot. A Qualified Person certifies batches under the applicable EU rules.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
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