Market requirements · BG
Bulgaria
The BDA regulates under the national medicines law and participates in the EU counterfeit-GLP-1 warning network. No peptide-specific position was located.
Buyers in this market search for: peptidi na edro izsledovatelski Balgaria.
| Tell us the compounds you need for Bulgaria. | Ask about Bulgaria |
The regime
How compounds are classified in Bulgaria
| Governing law and regulator | Medicines in Bulgaria are controlled under the Zakon za lekarstvenite produkti v humannata meditsina (Law on Medicinal Products in Human Medicine), enforced by the Izpalnitelna agentsia po lekarstvata (BDA), the Executive Agency on Medicines under the Ministry of Health. |
|---|---|
| Applicable position | The general medicines framework applies, administered by the BDA. Classification follows the compound and its presentation rather than a separate rule for research-labelled products. |
| GLP-1 class | BDA participates in the EU-wide warning network on counterfeit GLP-1 products (semaglutide, liraglutide, tirzepatide); Bulgarian press citing EMA reports a sharp rise in illegal GLP-1 sales online, but no BDA-authored GLP-1 bulletin was located directly on bda.bg. |
| Prescription-only compounds | Somatropin and gonadotropin (HCG/HMG-class) medicines are registered prescription products in Bulgaria's national medicines register; Melanotan II has no marketing authorisation in Bulgaria or the EU, so its sale as a medicinal product would fall outside the authorised regime, though BDA has issued no product-named statement on it. |
| Enforcement posture | BDA operates the EU common logo scheme to distinguish legal internet pharmacies and refers illegal online sellers to GDBOP (police); a May 2026 Interpol-linked raid dismantled a Sofia facility producing counterfeit anabolic/hormonal products, reported in Bulgarian press rather than in a BDA bulletin. |
| Already supplying Bulgaria? Send the compounds and volumes you buy today and we will quote against them. | Send your list |
Your obligations
What a buyer in Bulgaria needs settled
- Apply to BDA for a razreshenie za targoviya na edro s lekarstveni produkti (wholesale trade authorisation for medicinal products) under Art. 195 of the Law on Medicinal Products before importing or reselling any compound classified as a medicine.
- Do not rely on a research-use-only label to avoid Bulgarian medicines law; BDA has not endorsed any research-label exemption, and prescription hormones (somatropin, HCG, HMG) require full wholesale/pharmacy channels.
- Screen the catalogue for GLP-1 analogues and gonadotropins before listing to Bulgarian buyers, since these are established prescription medicines subject to active BDA/EMA counterfeiting enforcement.
- Keep the business out of the unlicensed online-pharmacy patterns BDA is known to report to GDBOP (no visible licence, prescription products sold without prescription).
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 |
|---|---|---|
| BDA (Izpalnitelna agentsia po lekarstvata) Obshto logo na internet apteki (EU common logo for legal internet pharmacies) | undated | www.bda.bg/bg/%D0%BE%D0%B1%D1%89%D0%BE-%D0%BB%D0%BE%D0%B3%... |
| BDA Saobshtenie do targovtsite na edro s lekarstveni produkti (message to wholesale medicine traders) | undated | www.bda.bg/bg/58-business-info/messages-biz/1461-%D1%81%D1... |
| BDA Razreshenie za targoviya na edro s lekarstveni produkti - form F_3007_8_EU | undated | www.bda.bg/images/stories/documents/klp/FORMS/F_3007_8_EU_... |
| Paragraph22.bg (secondary press, citing Interpol/BG police) Interpol razbi nelegalna fabrika za lekarstva u nas | 2026-05-07 | paragraph22.bg/2026/05/07/%D0%B8%D0%BD%D1%82%D0%B5%D1%80%D... |
| media.framar.bg (secondary press, citing BDA report to GDBOP) IAL podade signal za nezakonen sayt za prodazhba na lekarstva | undated | media.framar.bg/%D0%B7%D0%B4%D1%80%D0%B0%D0%B2%D0%BD%D0%B8... |
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 Bulgaria brief as a PDF
The regime, the buyer obligations and all 5 sources, dated and linked, in one document you can forward.
Nearby
Elsewhere in the EU and nearby markets
Buyers supplying one of these usually supply the others. The requirements are not the same.
| Code | Market | Sources | |
|---|---|---|---|
| RO | Romania | 3 sources | ANMDMR operates under the EU medicines framework and has publicly identified a... |
| IE | Ireland | 2 sources | The HPRA detained 763,027 dosage units of falsified or unauthorised medicines ... |
| 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... |
Scope
How to use this page
A summary of the published regulatory position in Bulgaria 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 Bulgaria
Do you supply into Bulgaria?
We supply businesses that hold the authorisations their activity requires. Whether a specific compound can be supplied into Bulgaria 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 Bulgaria. 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 Bulgaria
Tell us the compounds and your authorisations. We confirm per compound before anything ships.