Market requirements · HU
Hungary
OGYEI regulates medicines under Act XCV of 2005. A case-by-case research permit exists for controlled substances, and it is a permit route rather than an exemption.
| Tell us the compounds you need for Hungary. | Ask about Hungary |
The regime
How compounds are classified in Hungary
| Governing law and regulator | Medicines in Hungary are regulated under Act XCV of 2005 on medicinal products and related government decrees, enforced by OGYEI (Orszagos Gyogyszereszeti es Elelmezes-egeszsegugyi Intezet), which licenses manufacturing, wholesale distribution and pharmacy activity and runs counterfeit-medicine reporting. |
|---|---|
| Research-use permits, not a carve-out | For controlled substances, OGYEI's eseti kutatasi engedely (case-by-case research permit), issued under Government Decree 66/2012, is required before any research, analysis or handling can occur without a general activity licence. A research-purposes label on a product does not itself substitute for this permit. |
| GLP-1 class | OGYEI, via the national public health and pharmacy centre, published a notice on 18 October 2023 that counterfeit Ozempic (semaglutide) injections had entered the legal supply chain in several European countries. It stated Hungary was not confirmed affected but urged pharmacists and the public to be alert to unusual-looking product and to buy only through legal channels. |
| Melanotan II and peptides generally | No OGYEI-specific alert or classification statement on Melanotan II or on research peptides such as BPC-157, TB-500 or GHK-Cu as a class was located on ogyei.gov.hu. Hungarian coverage of Melanotan II risk comes from health and lifestyle press, not from a located OGYEI document. |
| Enforcement posture | OGYEI runs a dedicated illegal-medicine reporting channel, reviews advertising and website operator permits, and has ordered takedowns of non-compliant sites. It has also published results of INTERPOL Pangea seizure operations, including one release reporting over HUF 90 million of medicines seized by police during a Pangea action. |
| Already supplying Hungary? Send the compounds and volumes you buy today and we will quote against them. | Send your list |
Your obligations
What a buyer in Hungary needs settled
- Hold a gyogyszer-nagykereskedelmi engedely (pharmaceutical wholesale licence) issued by OGYEI before wholesale activity with any human medicine, and employ a named Responsible Person (RP) as OGYEI requires.
- Apply for OGYEI's eseti kutatasi engedely if handling controlled research substances without a standing activity licence; do not rely on a research-use label as a substitute for this permit.
- Assume somatropin and gonadotropin products is prescription medicines subject to OGYEI's drug database listing and standard Rx dispensing controls.
- Avoid any online sales channel not on OGYEI's registered-pharmacy list and report suspect sellers to hamisgyogyszer@ogyei.gov.hu; OGYEI actively orders takedowns and tracks counterfeit GLP-1 circulation.
We will ask about this at enquiry. We check the authorisations your activity requires before quoting, and we confirm the position per compound rather than for the market as a whole.
Sources
Check this yourself
Every position above traces to a dated public document. The authority, the document, the date and the link are below.
| Authority and document | Date | Link |
|---|---|---|
| OGYEI (Orszagos Gyogyszereszeti es Elelmezes-egeszsegugyi Intezet) Eseti kutatasi engedely (case-by-case research permit for controlled substances, under Government Decree 66/2012) | 2019-12-18 | ogyei.gov.hu/eseti_kutatasi_engedely/ |
| OGYEI Gyogyszer nagykereskedelem (pharmaceutical wholesale licensing page) | 2019-04-30 | ogyei.gov.hu/gyogyszer_nagykereskedelem |
| OGYEI Hamisitott Ozempic injekciok kerultek forgalomba Europa tobb orszagaban | 2023-10-18 | ogyei.gov.hu/hamisitott_ozempic_injekciok_kerultek_forgalo... |
| OGYEI Internetes gyogyszer-kereskedelem (illegal online medicine reporting and takedown page, hamisgyogyszer@ogyei.gov.hu) | undated | ogyei.gov.hu/internetes_gyogyszer_kereskedelem/ |
| OGYEI Magyarorszagon tobb mint 90 millio forint erteku gyogyszert foglalt le a Rendorseg (IX. Pangea akcio, 103 orszag, 193 hatosaga) | undated | ogyei.gov.hu/magyarorszagon_tobb_mint_90_millio_forint_ert... |
Links go to the issuing body wherever one exists. Positions change. If you are relying on any of this, check the source rather than this page.
Market brief
Take the Hungary brief as a PDF
The regime, the buyer obligations and all 5 sources, dated and linked, in one document you can forward.
Nearby
Central and Eastern Europe and nearby markets
Buyers supplying one of these usually supply the others. The requirements are not the same.
| Code | Market | Sources | |
|---|---|---|---|
| PL | Poland | 2 sources | GIF and GIS have issued a joint public warning on synthetic peptides offered a... |
| CZ | Czechia | 2 sources | SUKL holds that most synthetic peptides meet the functional definition of a me... |
| SK | Slovakia | 3 sources | SUKL named BPC-157, ipamorelin and melanotan directly in a July 2025 press rel... |
| HR | Croatia | 1 sources | HALMED has published a general rule on online medicine sales. No notice naming... |
| SI | Slovenia | 2 sources | JAZMP published a dated warning on injectable peptides in April 2026 and names... |
| BG | Bulgaria | 5 sources | The BDA regulates under the national medicines law and participates in the EU ... |
Scope
How to use this page
A summary of the published regulatory position in Hungary as at 2026-08-20, written for procurement teams deciding how to source. Every source is dated and linked so it can be checked at origin.
It is not legal advice. Full terms of supply, including where responsibility sits, are set out in our terms of supply.
Questions
Supplying into Hungary
Do you supply into Hungary?
We supply businesses that hold the authorisations their activity requires. Whether a specific compound can be supplied into Hungary depends on that compound and on your authorisations, and we confirm it per compound at the enquiry stage.
Who carries the compliance obligation?
The importer of record and the party placing the product on the market, which is the buyer. We supply the batch documentation that supports your file. We cannot hold your authorisations for you.
How current is this page?
It was reviewed on 2026-08-20 and is scheduled for review again on 2026-11-18. Every source is dated and linked, so you can check the original.
We already supply into Hungary. What changes if we source from you?
The batch documentation. You receive a Certificate of Analysis per batch, which can be issued under your own brand. The import and market-placing responsibilities stay where they are.
Is this legal advice?
No. It is a summary of the regulatory positions those authorities have published, as at the review date above. Take advice in your own market before you rely on it.
Enquire about supply into Hungary
Tell us the compounds and your authorisations. We confirm per compound before anything ships.