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Market requirements · RO

Romania

3 dated sources Reviewed 2026-08-20 Next review 2026-11-18

ANMDMR operates under the EU medicines framework and has publicly identified a fraudulent tirzepatide product. Romania sits inside the EU-wide GLP-1 enforcement wave.

Buyers in this market search for: peptide angro, furnizor peptide, peptide de cercetare, cumpara peptide.

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The regime

How compounds are classified in Romania

EU medicines frameworkRomania operates under the same Directive 2001/83/EC baseline as the other four markets, with ANMDMR (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale) as the implementing national regulator; parenteral/injectable products are presumptively prescription-only by default.
ANMDMR fraud warningIn May 2026 ANMDMR publicly confirmed and debunked a fraudulent 'Mounjaro' (tirzepatide) capsule product sold illegally online, stating plainly that such capsules do not exist because tirzepatide is not administrable in capsule form -- evidence ANMDMR actively monitors fraudulent GLP-1 products in-market.
Prescription-only GLP-1 stanceRomania sits inside the same EU-wide EMA/HMA enforcement wave against illegal GLP-1-analogue sales as France, Italy, Spain and Portugal. Semaglutide and tirzepatide are approved-but-prescription-only medicines, so supplying them as 'research chemicals' is an enforcement target regardless of the national channel used.
Enforcement postureNo ANMDMR statement, warning, or enforcement action naming CertaPeptides or any other Romania-domiciled research-peptide wholesaler was found; the Mounjaro-capsule case involved an unrelated impersonation site, not a wholesaler. Whether ANMDMR regards research-peptide wholesalers as an enforcement priority is not established by anything. Melanotan II, HGH and HCG likewise carry no Romania-specific regulatory statement, only the inferred EU baseline.
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Your obligations

What a buyer in Romania needs settled

  • Do not assume Romania as a softer jurisdiction: ANMDMR enforces the same EU GLP-1 prescription-only rules as every other market studied.
  • Verify any Romania-based counterparty's VAT/registration via VIES rather than inferring legitimacy from wholesale pricing or automated checkout terms alone.
  • Avoid supplying GLP-1-class compounds, HGH or HCG as research chemicals into Romania.

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 documentDateLink
EMA/HMA
Joint warning on sharp rise of illegal medicines sold as GLP-1 receptor agonists across the EU
3 September 2025www.ema.europa.eu/en/news/warning-about-sharp-rise-illegal...
CertaPeptides / CERTALAB S.R.L.
Company footer/about page confirming Bucharest-registered legal entity (CUI 54169956) and EU-wide shipping
fetched 2026-08-20certapeptides.com/
CertaPeptides / CERTALAB S.R.L.
Wholesale program page: automatic 40% discount at EUR 5,000+, VIES-validated reverse-charge invoicing
fetched 2026-08-20certapeptides.com/wholesale

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 Romania brief as a PDF

The regime, the buyer obligations and all 3 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.

CodeMarketSources
BGBulgaria5 sourcesThe BDA regulates under the national medicines law and participates in the EU ...
IEIreland2 sourcesThe HPRA detained 763,027 dosage units of falsified or unauthorised medicines ...
SKSlovakia3 sourcesSUKL named BPC-157, ipamorelin and melanotan directly in a July 2025 press rel...
HUHungary5 sourcesOGYEI regulates medicines under Act XCV of 2005. A case-by-case research permi...

Scope

How to use this page

A summary of the published regulatory position in Romania 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 Romania

Do you supply into Romania?

We supply businesses that hold the authorisations their activity requires. Whether a specific compound can be supplied into Romania 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 Romania. 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 Romania

Tell us the compounds and your authorisations. We confirm per compound before anything ships.

Anything else you already know. All optional.

We supply businesses across the EU, and we reply within one working day.