Market requirements · RS
Serbia
Serbia applies the Law on Medicines and Medical Devices, published in the official gazette in 2010 and amended to 2017, administered by the medicines agency, alongside Article 39 of the law on preventing doping in sport, which makes unlawful placing of doping substances on the market a criminal offence carrying three to twelve years. Classification under Article 14 turns on a two-limb test: presentation as something shown to have properties for treating or preventing disease, or function through pharmacological, immunological or metabolic action. Serbia is an EU candidate, but the agency states plainly that no centralised or mutual recognition authorisation can be issued, so a European authorisation is a procedural shortcut and never a passport.
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The regime
How compounds are classified in Serbia
| Governing law | The primary act is the Law on Medicines and Medical Devices, gazette 30/2010 with amendments at 107/2012, 105/2017 and 113/2017. Wholesale conditions sit in the regulation on conditions for wholesale trade in medicines and medical devices, gazette 10/2012 of 10 February 2012, made by the health minister under the licensing articles of the Law. Doping substances are dealt with separately by the law on preventing doping in sport, gazette 111/2014 and 87/2018. The provisions of the 2010 Law governing medical devices ceased to apply from 1 December 2018 and devices now sit in a separate act. |
|---|---|
| What determines classification | Article 14 defines a medicine as a product placed on the market in a given strength, form and packaging which either contains a substance shown to have the property of treating or preventing disease, or which may be used with the intention of restoring, improving or altering a physiological function through pharmacological, immunological or metabolic action, or of making a diagnosis. Both limbs stand independently, so a product description that avoids the word medicine does not settle the question. The agency issues expert opinions on status, and a product's dispensing regime is fixed inside the marketing authorisation, which means a product with no authorisation has no lawful supply route at all. |
| EU candidate, but no recognition of European authorisations | The agency states on its own marketing authorisation page that because Serbia is not a member at this stage of its regulatory development, issuing a centralised authorisation, or one based on the mutual recognition procedure, is still not possible. Only a national authorisation is granted, on review of a full dossier. A European centralised authorisation has three narrow procedural effects in the Law, none of which is recognition: authorisation under special conditions where the product holds a centralised authorisation, access to the accelerated procedure, and eligibility for a conditional authorisation. A Serbian authorisation runs five years, is renewable, and may be converted to indefinite validity after five years of pharmacovigilance data. Membership of the central European free trade agreement and the stabilisation and association agreement are trade instruments and create no pharmaceutical recognition. |
| Prescription and controlled substances | Not established for peptides specifically. No entry for any research peptide was verified on the list of psychoactive controlled substances, which the health minister sets under the law on psychoactive controlled substances. The verified constraint runs through the doping route instead: Article 39 of the law on preventing doping in sport criminalises producing, processing, selling, offering for sale, purchasing for sale, holding, transferring or brokering doping substances for the purpose of doping in sport, at three to twelve years, with a lesser offence for equipment and materials, and mandatory confiscation. Peptide hormones sit inside the doping-substance definition by reference to the prohibited list, so the practical exposure is real even where scheduling is not. |
| Enforcement posture | Active, and prosecuted as organised crime rather than as a licensing lapse. In December 2024, on dated public reporting, the interior minister announced the seizure of three tonnes of anabolic steroids valued at three million euro, with eight arrests and ten people charged with unauthorised production and placing on the market of doping substances plus criminal association, and a parallel money-laundering investigation. The group falsified customs declarations and imported through a company registered for construction installation work, sourcing from India and selling in Serbia and European states, and the case had been worked for two years. No published enforcement action against research peptides as a distinct category was found. |
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Your obligations
What a buyer in Serbia needs settled
- Obtain a wholesale licence for medicines from the health ministry before any goods move, because the regulation places import and export inside the wholesale licence rather than beside it.
- Do not rely on a European authorisation: secure a national marketing authorisation, or a national import approval, in the company's own name first.
- Where the product has no Serbian authorisation, apply for import approval and accept its stated scope, which is treatment of a named patient or defined group, or scientific and medical research.
- Publish no claim about treating or preventing disease, or about altering a physiological function, because the Article 14 test catches presentation as well as action.
- Declare the goods to customs and budget 20 per cent import VAT, with the 10 per cent reduced rate available only where the product qualifies as a medicine under the VAT law.
- Employ the responsible pharmacist and keep the distribution records the regulation requires, including calibrated temperature and humidity logs and quality-complaint reporting.
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 |
|---|---|---|
| Medicines and Medical Devices Agency of Serbia Marketing authorisation policy: centralised and mutual recognition procedures are not available | 2022 | www.alims.gov.rs/humani-lekovi/stavljanje-u-promet-lekova/ |
| Ministry of Health, hosted by the agency Regulation on conditions for wholesale trade in medicines and medical devices, gazette 10/2012 | 2012 | www.alims.gov.rs/wp-content/uploads/2022/02/p-promet-lekov... |
| Medicines and Medical Devices Agency of Serbia Import licence register | 2026 | www.alims.gov.rs/humani-lekovi/pretrazivanje-uvoznih-dozvo... |
| Medicines and Medical Devices Agency of Serbia Regulatory framework index | 2026 | www.alims.gov.rs/regulativa/ |
| Radio Television of Serbia Three tonnes of steroids seized, ten charged with placing doping substances on the market, dated enforcement reporting | 2024 | www.rts.rs/lat/vesti/hronika/5604941/doping-steroidi-zaple... |
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 Serbia brief as a PDF
The regime, the buyer obligations and all 5 sources, dated and linked, in one document you can forward.
Same region
Western Balkans
Buyers supplying one of these usually supply the others. The requirements are not the same.
| Code | Market | Sources | |
|---|---|---|---|
| BA | Bosnia and Herzegovina | 5 sources | Bosnia and Herzegovina applies a single state-level act, the Law on Medicinal ... |
| AL | Albania | 7 sources | Albania applies Law no. 105/2014 on medicinal products and the pharmaceutical ... |
| MK | North Macedonia | 7 sources | North Macedonia applies the Law on Medicines and Medical Devices, published in... |
Scope
How to use this page
A summary of the published regulatory position in Serbia 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 Serbia
Do you supply into Serbia?
We supply businesses that hold the authorisations their activity requires. Whether a specific compound can be supplied into Serbia 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 Serbia. 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 Serbia
Tell us the compounds and your authorisations. We confirm per compound before anything ships.