What APAC Producers Get Wrong About EU-GMP

Written by Dr Nickel Dittrich, Managing Director, GMPion

When Asia-Pacific producers talk about Europe, the conversation usually starts in the grow room. Licences, GACP certificates, genetics, yield per square metre. They look at German pharmacy demand, count their certified capacity, and treat the rest as paperwork.

That is the mistake. Whether a batch ever reaches a European patient gets decided in Europe, and in the end by one person: the Qualified Person at the importing manufacturer, who releases each batch and carries the legal responsibility for it. Plan around the certificate on your wall instead of around what that person needs before they sign, and you are planning for the wrong audience.

Since June, what that person needs has changed.

Thailand: Capacity is not the problem

Thailand has built real capacity. The register kept by the Department of Thai Traditional and Alternative Medicine (DTAM) listed 217 certified GACP growing sources in February 2026. Those are entries, not companies – one operator can show up once for each growing system.

In July, Dr Peeracha Kuekasemkit, who heads DTAM’s medical cannabis division, put exports of cannabis and hemp at 2.5 billion baht across 31 countries. Australia is the biggest market, and European buyers include Germany, the Czech Republic, Switzerland and Portugal.

Yet you won’t find a single Thai cannabis site in EudraGMDP, the EU’s database of GMP certificates. Thailand has no mutual recognition agreement with the EU, so that gap actually tells you something.

So how does Thai cannabis get to German patients? Germany has two import routes:

1. Finished cannabis flower, made under GMP. Here the importer needs a certificate under section 72a of the German Medicines Act for every supplier outside the EU. Without a mutual recognition agreement, state authorities only issue it after they have inspected the site.
2. GACP raw material. In legal terms this is an active substance of plant origin, and it is exempt from that certificate. No authority inspects the farm abroad. The importer qualifies the supplier instead, often in writing rather than through a site visit. GMP begins in Germany, where the Qualified Person releases the batch.

Thai cannabis comes in through the second route.

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Germany: The raw-material route is getting narrower

Annex 7 of the EU-GMP guidelines allows initial cutting and drying in the field under GACP, where the marketing authorisation justifies it. Any further cutting and drying falls under GMP. A lot of supply chains have read that generously: dry and trim under GACP at origin, ship, and finish the job under GMP in Europe.

On 8 June 2026, the Hessian State Office for Health and Care (HLfGP) rejected that reading, as Business of Cannabis reported in July. Its inspectors had found GMP steps being carried out outside GMP-certified sites. The guidance comes down to four points:

• Controlled drying is a critical manufacturing step, and its parameters are critical process parameters.
• The office knows of no process that has shown genuine GACP-stage flower can be transported over long distances, stored, imported and processed further without losing quality.
• Unless a company can prove otherwise, it expects GMP processing, drying and trimming included, at the site of harvest.
• Local regulations in the producing country still have to be followed, but they don’t replace EU-GMP. Where they differ, the EU guidelines apply on top. And the Qualified Person remains responsible for every step, wherever it happens.

Two of its requirements mean work right away. Every import application needs a scheme showing, supplier by supplier and site by site, which steps run under GACP and which under GMP. Importers with existing authorisations are expected to review those processes and hand in a gap analysis.

Hesse isn’t on its own here. When Krautinvest.de asked the other German state regulators in July, most said they share the view or reach the same conclusion. Saxony and Saxony-Anhalt would rather decide case by case, and Bavaria didn’t reply.

Put the two together and the consequence is clear. The guidance doesn’t abolish the raw-material route, but it narrows what still counts as raw material. If drying and trimming are GMP steps, flower that has been dried and trimmed abroad is already a GMP product. It then has to enter Germany as cannabis flower, with a section 72a certificate – which in practice means a German inspection of your site.

Anyone who wants to keep shipping flower to Germany should plan for GMP-grade drying and trimming at the farm, and expect an inspector to come and look at it.

Australia: Recognition Removes One Hurdle, Not All of Them

Australia has what Thailand lacks, a mutual recognition agreement with the EU. According to the European Medicines Agency, it covers herbal medicines made in Australia if they are classified as medicinal products. Under agreements like this, EU authorities rely on the partner’s GMP inspections and can waive batch testing on import.

That takes care of the inspection question. The rest is still on the table:

• The flower has to meet the European Pharmacopoeia monograph on cannabis flower (3028), which has been in force since July 2024. Hesse also expects microbiological quality category B under Ph. Eur. 5.1.8, unless inhalation is explicitly excluded.
• The TGA licence has to cover the actual activity and product.
• Stability data has to support a European shelf life and supply chain.
• And the Qualified Person still has to sign.

Whether guidance like the one from Hesse applies in full to product certified under the agreement is an open legal question.

Plan backwards from the release

If you are on your way to Bangkok, it is worth turning the usual order around: start with the European release decision and work back to the farm.

1. Agree on the regulatory category with your buyer. Under Annex 7, it is the manufacturer’s intended use that decides whether herbal material counts as an active substance, an intermediate or a finished product. Flower dispensed as it is and flower meant for extraction go down different paths.
2. Find out what your importer’s Qualified Person needs. Does their authorisation cover your product? What will they want to see on drying, trimming, storage and transport? A description of your process won’t be enough; they will want data.
3. Draw up your own site-by-site GACP/GMP scheme. German regulators now ask importers for one. It helps to have yours ready before your customer asks for it.

Asia-Pacific isn’t short of cultivation capacity. What decides market access is whether a European Qualified Person can stand behind the release. Producers who make that decision easy for them will find buyers.