Market requirements · BA
Bosnia and Herzegovina
Bosnia and Herzegovina applies a single state-level act, the Law on Medicinal Products and Medical Devices published in the state gazette in 2008, but splits its administration across the state agency, the two entity health ministries and the Brcko District health department. Marketing authorisation is exclusively a state competence; a wholesale licence is a two-step chain that starts at entity or district level and finishes at the state agency, and consent to import an unauthorised medicine sits back at entity or district level again. Classification follows the authorisation itself, because the dispensing regime is fixed when the authorisation is granted.
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The regime
How compounds are classified in Bosnia and Herzegovina
| Governing law | The state act is the Law on Medicinal Products and Medical Devices, state gazette 58/08. Marketing authorisation procedure sits in that Law together with the regulation on the procedure and manner of granting authorisation, state gazette 75/11. Wholesale sits in the regulation on conditions for wholesale trade in medicines, state gazette 49/14, made on 10 June 2014 by the Minister of Civil Affairs on the proposal of the agency's expert council. Advertising sits in the regulation on advertising, state gazette 40/10. The 2014 wholesale regulation expressly repealed the surviving entity-level wholesale rules, which is what makes wholesale a state matter today. |
|---|---|
| What determines classification | A product's status is settled by whether the state agency has granted it a marketing authorisation, and its prescription regime is determined at the moment that authorisation is granted, on the basis of therapeutic width and safety of use. The agency's own guidance states that it does not control cosmetics, food or dietary supplements, so the boundary matters commercially: a product outside the medicine definition falls outside the agency entirely and, in the agency's own words, into an area where there is no regulation governing it. Article 5 of the 2014 wholesale regulation closes the loop on the trade side, because a wholesaler may trade only in medicines holding a state authorisation, plus those for which the competent authority has approved import despite the absence of one. |
| One state agency, two entities and a district | This is the operative fact for a buyer and it does not run the way the country's reputation suggests. Marketing authorisation is state-only: the agency decides within 210 days of a complete file, or 90 days for a renewal, and one authorisation covers the whole country. Wholesale is a two-step, two-level chain under Article 30 of the 2014 regulation: the competent entity ministry or the Brcko District health department first issues a decision, with no time limit, confirming staff, premises and equipment; only on the basis of that decision is application made to the state agency for the final licence, which it issues within 60 days for a term of five years. Any later change to staff or premises must be notified to the same entity body within 15 days. Retail is wholly entity or district competence, and so is consent to import a finished medicine holding no national authorisation. Practical count for a buyer: one state licence, plus one entity or district premises decision for each establishment. |
| Prescription and controlled substances | Not established for peptides specifically. No national schedule entry for any research peptide was verified. What is verified is that a controlled-substances regime exists and bites on storage: the 2014 regulation requires a separate mandatory room for narcotic drugs, psychotropic substances and precursors held in original packaging, and additional secure conditions for narcotics, poisons, flammable and explosive materials and thermolabile preparations. Prescription status is not set by a standing list at all but product by product in the authorisation, so an unauthorised product has no dispensing regime and no lawful supply route. |
| Enforcement posture | Active on paper with an inspectorate that publishes, but no dated enforcement action against peptides was found. The agency's published questions and answers of 22 May 2025 state that only licensed operators may trade, that wholesale requires a state licence and retail an entity licence, that online sale of medicines is not permitted under either entity's pharmacy legislation, and that illegal importation falls to the interior ministries and prosecutors. The same document records established cooperation between the agency, customs, the state prosecutor's office and the investigation agency for inspection and quality control of seized medicines, and names anabolics and weight-loss medicines among the products most commonly falsified, which is directly adjacent to this category. The inspectorate publishes its register of measures taken since 1 January 2021. |
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Your obligations
What a buyer in Bosnia and Herzegovina needs settled
- Obtain the entity or district decision on premises, staff and equipment first, then apply to the state agency for the wholesale licence, and budget for two permissions rather than one.
- Plan for the state agency deciding within 60 days of a complete application and a licence term of five years, and notify the entity body of any change to staff or premises within 15 days.
- Trade only in medicines holding a state marketing authorisation, and where a product has none obtain the import consent from the competent entity health ministry or the district department rather than from the state agency.
- Appoint both pharmacists the regulation requires, a full-time responsible person for receipt, release and documentation review and a half-time qualified person for quality control of every imported batch, and hold a contract with a control laboratory before importing.
- Keep purchase and sale records showing batch number, date, brand name, form, quantities and counterparty for at least five years, permanently available to inspectors, together with a written recall plan.
- Declare the goods to the indirect taxation authority and budget 17 per cent import VAT, since there is a single rate and no reduced rate, and advertise nothing to the public, because an unauthorised product cannot be advertised at all.
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 |
|---|---|---|
| Agency for Medicinal Products and Medical Devices Questions and answers on approval of medicines and information about medicines and devices, version 2 | 2025 | almbih.gov.ba/wp-content/uploads/2025/05/Najcesca_pitanja-... |
| Minister of Civil Affairs, on the proposal of the agency Regulation on conditions for wholesale trade in medicines, state gazette 49/14, Articles 5, 14, 16, 30 and 31 | 2014 | www.sluzbenilist.ba/page/akt/FXekVc4waYA= |
| Agency for Medicinal Products and Medical Devices Inspectorate: register of inspection measures since 1 January 2021, and the list of wholesalers holding a distribution certificate | 2026 | almbih.gov.ba/sr/inspektorat/ |
| Agency for Medicinal Products and Medical Devices Documents: regulations and implementing rules index | 2026 | almbih.gov.ba/en/documents/ |
| Indirect Taxation Authority General information on the VAT system: single 17 per cent rate, no reduced rate | 2026 | www.uino.gov.ba/portal/en/vat/general-information-on-vat-s... |
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 Bosnia and Herzegovina 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 | |
|---|---|---|---|
| RS | Serbia | 5 sources | Serbia applies the Law on Medicines and Medical Devices, published in the offi... |
| 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 Bosnia and Herzegovina 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 Bosnia and Herzegovina
Do you supply into Bosnia and Herzegovina?
We supply businesses that hold the authorisations their activity requires. Whether a specific compound can be supplied into Bosnia and Herzegovina 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 Bosnia and Herzegovina. 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 Bosnia and Herzegovina
Tell us the compounds and your authorisations. We confirm per compound before anything ships.