SixstepscarryaharvestintoGermany.Oneofthemdecidestherest.

A medical-cannabis harvest becomes a German medicine at one step in the middle of the route: processing at a plant certified to EU-GMP, Europe’s pharmaceutical manufacturing standard. Cannventure sequences all six licensed steps and runs the first batch through that turn, holding no title, no inventory, and no licence of its own.

From a GACP farm to a German pharmacy, in six licensed steps.

A GACP certificate says the farm grows to the recognised agricultural standard for medicinal plants. It is the start of the path; five steps follow it. The batch changes owner, jurisdiction, and legal standing as it moves, and the licence at every step stays with the party that holds it.

Cultivation

Held by · The farm

The farm grows the crop under GACP, the agricultural standard for medicinal plants. For a later German import, the paperwork must prove the cultivation ran under government control for medical use.

GACP · § 2 MedCanG state-control proof

Post-harvest

Held by · The farm

Drying, packing, and sampling, with batch records and retained samples. German practice holds the drying step to pharmaceutical manufacturing standards.

Batch records · GMP drying practice

The turn

EU-GMP processing

Held by · The EU-GMP processor

A licensed manufacturer turns the crop into a medicine, and a Qualified Person certifies each batch for release. This step changes what the product legally is.

§ 13 AMG · EudraLex Vol. 4 Ch. 4 · Annex 16

Licensed import

Held by · The German importer

Three permits stack here: the importer’s activity permit, a per-shipment authorisation, and, for goods from outside the EU, an import licence from the competent state authority.

§ 72 AMG · § 4 MedCanG · §§ 12, 14 MedCanG

GDP wholesale

Held by · The wholesaler

Distribution to pharmacies runs on a wholesale licence and the EU’s good-distribution-practice (GDP) rules. The wholesale act stays with the licence holder.

§ 52a AMG · EU GDP guidelines

Pharmacy

Held by · The pharmacy

Dispensed on a normal prescription; no narcotics paperwork since April 2024.

Ordinary e-prescription

What Cannventure holds on this route

Title
None
Inventory
None
Licences
None

The processor, importer, wholesaler, and pharmacy remain the legal holders at each step. Cannventure prepares the file, qualifies the counterparty, and coordinates the handover.

Editorial route model. Principal instruments: § 13, § 72, § 52a AMG (the German medicines act); § 2, § 4, §§ 12, 14 MedCanG (the German medical-cannabis act); EudraLex Volume 4, Chapter 4 and Annex 16.

The route turns at the processor.

Under German law, a crop becomes a medicine at manufacture: a licensed plant makes the product under § 13 of the AMG, Germany’s medicines act, and a Qualified Person certifies each batch before release under Annex 16. A farm can rent that step. The industry calls it toll processing: the farm supplies the crop, and a certified processor makes and releases the medicine from it.

For a farm without its own EU-GMP plant, toll processing is the near-term way into Germany. It also means the processor’s intake review is the first serious outside reading of the farm’s work, and it reads the batch before it reads the cultivation story.

GACP clears the farm’s export file. Processor intake asks a narrower question: can this batch enter a European manufacturing run without being rebuilt at the door? The gap between those two tests becomes visible on the first sample and the first batch file, when both sides read the same material at the same time.

What the intake review reads, in order

  1. Admissibility

    Whether the batch may enter the route from farm to German pharmacy at all, starting with proof the cultivation ran under state control for medical use.

  2. Batch identity

    Whether the records describe one batch and reconcile, with one identifier through the tolling step and no unexplained change.

  3. Analytical methods

    Which methods produced the numbers, and whether their validation status is stated.

  4. Format

    Whether the certificate of analysis (COA) matches the structure and reference points the receiving site works to, with records current and controlled per EudraLex Volume 4, Chapter 4.

The release

Certification of the batch

Held by · the Qualified Person, under Annex 16

Only a file that holds at every read reaches this step. The order is the point.

Three pieces of work, in order.

This is the Market Entry line. Upstream, Readiness builds the farm’s file to a processor’s standard. Downstream, Supply Management keeps every later shipment to the standard the first one set. In between, Cannventure takes a prepared farm and puts its first batch through the gate.

Request a route review
  1. Sequence the route

    Cannventure maps the six licensed steps for the specific origin and the specific processor: the counterparty at each step, the operating dependency, and the next decision at each gate. The output is a sequence a farm owner can put in front of a board.

  2. Qualify the processor

    Cannventure identifies the receiving intake standard and matches the batch package to it before the first shipment is at risk. Intake standards differ by processor and by batch; the match is specific work, done early.

  3. Run the first batch

    Cannventure manages first-batch qualification into the gate and plans release timing backward from the importer’s booking window, so the second shipment starts from a proven file.

The first shipment sets the terms of the next. The aim is a batch package that reads the same way every time it leaves the farm.