Market requirements · MK
North Macedonia
North Macedonia applies the Law on Medicines and Medical Devices, published in the official gazette in 2007 and amended twenty-one times, administered by the Agency for Medicines and Medical Devices. Classification turns on a two-limb definition whose second limb catches any substance administered to humans to restore, correct or modify physiological functions by pharmacological, immunological or metabolic action, irrespective of presentation, and the agency runs a published borderline-product procedure to decide contested cases. For a small market the practical route is reliance: an authorisation already granted in three or more EU member states converts the national procedure into a fifteen-day approval.
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The regime
How compounds are classified in North Macedonia
| Governing law | The Law on Medicines and Medical Devices, official gazette 106/2007, amended by twenty-one subsequent acts through to 2025. Implementing rules include the regulation on obtaining a marketing authorisation, gazette 203/2015, the regulation on the content of the application and the manner of obtaining an import authorisation, gazette 151/2008, and the wholesale authorisation regulation of the same gazette. Controlled substances sit under the law on control of narcotic drugs and psychotropic substances, gazette 103/2008 as amended. |
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| What determines classification | Article 2 states that a medicine is any substance or combination formulated for treating or preventing disease, and also any substance that may be used or administered to humans to restore, correct or modify physiological functions by inducing a pharmacological, immunological or metabolic action, or to make a diagnosis. The second limb has no presentation requirement, so a pharmacologically active peptide falls inside it however it is labelled, and the Law expressly includes substances obtained by biotechnological process or chemical synthesis. There is also a published borderline-product regime: the director of the agency prescribes the conditions, route, documentation and costs, and the agency publishes a product classification request form. That form is the one concrete pre-shipment step available to a supplier who wants a documented classification. |
| EU candidate, and recognition of reference-country authorisations | Yes, and this is the operative fact for a small market. Article 29 tiers the decision deadline by where the product is already authorised: 210 days for a standard application, 90 days where an authorisation exists in fewer than three EU member states, 60 days where it is authorised in the United States, Japan, Switzerland or Canada, and not more than 15 days where it is authorised in at least three EU member states, in that last case on the basis of the assessment obtained in the European procedure. Article 33 delegates to the director the manner of recognising an authorisation issued in European Union countries, and the delegated instrument is the 2015 regulation. Abridged dossiers are available on well-established use where the active substance has been used as a medicine for at least ten years, or as a generic of a reference product on the market for at least eight years. Note the limits: the recognition wording covers the European Union only, a United States approval buys a faster national procedure rather than recognition, and the applicant must be established locally or act through a local legal representative. |
| Prescription and controlled substances | Prescription status is set per product rather than by substance list, because the Law makes the dispensing route part of the approved product information, and classification runs through the regulations on over-the-counter categorisation and on prescribing and dispensing. Substance-level status is not established. The only controlled-substance schedule published by the agency, the classification lists in gazette 104 of 10 May 2021, is a scanned image with no usable text layer, so it cannot be searched, and no anabolic-agent or peptide-specific national list was found. One data point is confirmed: the agency issued a healthcare professional letter in November 2023 about counterfeit semaglutide appearing on the European and national market, which establishes that semaglutide products are treated as regulated medicines domestically. |
| Enforcement posture | No published enforcement was found against peptides, anabolic agents or illegal imports. The agency publishes safety notices rather than sanctions: the counterfeit semaglutide letter of November 2023, and a public notice of September 2017 stating that a named paracetamol product made by an Indian company is not registered and not in circulation. The announcements index, whose most recent item is dated May 2026, carries no seizure or prosecution item. Customs enforcement is unverified because the customs administration site could not be reached, though the Law names customs among the parties in the chain of custody obliged to comply, and gives the agency competence to approve each batch of an imported medicine. |
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Your obligations
What a buyer in North Macedonia needs settled
- Hold an agency wholesale authorisation, with premises, a permanently available pharmacy-graduate responsible person, traceability and recall documentation, and a quality system built on good distribution practice.
- Meet the additional importer condition by employing a permanently available pharmacy graduate who gives a written guarantee that each imported batch complies with the marketing or import authorisation.
- Obtain a per-consignment import authorisation from the agency, allowing 30 days for the decision, and do not assume an unregistered product can be imported for resale, because every statutory exception is a named end-use such as patient supply, clinical trials, research or further manufacturing.
- Never sell at retail as a wholesaler, and keep no capital, management or family link between your wholesale entity and any pharmacy you supply.
- Budget import VAT at the preferential 5 per cent rate only where the goods fall in the customs headings the tax authority lists as human medicines, and price anything outside those headings at the 18 per cent standard rate until its classification is confirmed.
- Where classification is contested, file the product classification request with the agency before shipping rather than after, and keep the batch-level records that batch approval and the written guarantee both presuppose.
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 Medicines and Medical Devices Laws index: Law on Medicines and Medical Devices, gazette 106/2007, with all amending acts and the unofficial consolidated text | 2007 to 2025 | malmed.gov.mk/%d0%b7%d0%b0%d0%ba%d0%be%d0%bd%d0%b8/ |
| Agency for Medicines and Medical Devices Placing medicines on the market: the statutory definition and the authorisation requirement | 2026 | malmed.gov.mk/%d1%81%d1%82%d0%b0%d0%b2%d0%b0%d1%9a%d0%b5-%... |
| Agency for Medicines and Medical Devices Borderline products: definition and the product classification request form | 2026 | malmed.gov.mk/%d0%b3%d1%80%d0%b0%d0%bd%d0%b8%d1%87%d0%bd%d... |
| Agency for Medicines and Medical Devices Regulation on the conditions for a borderline product, the approval route and the required documentation, gazette 203/2015 | 2015 | malmed.gov.mk/wp-content/uploads/Pravilnik_za_pobliskite_u... |
| Agency for Medicines and Medical Devices Classification lists for substances and plants under the international conventions, gazette 104 | 2021 | malmed.gov.mk/%d0%bb%d0%b8%d1%81%d1%82%d0%b8-%d0%be%d0%bf%... |
| Public Revenue Office Preferential tax rates: 5 per cent on the supply and import of medicines by customs heading | 2026 | www.ujp.gov.mk/s/plakjanje/povlasteni_danocni_stapki |
| Public Revenue Office General tax rates: 18 per cent standard VAT rate | 2026 | www.ujp.gov.mk/s/plakjanje/opsti_danocni_stapki |
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 North Macedonia brief as a PDF
The regime, the buyer obligations and all 7 sources, dated and linked, in one document you can forward.
Nearby
Western Balkans and nearby markets
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... |
| 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 ... |
| GB | United Kingdom | 7 sources | The United Kingdom prohibits the sale or supply of any unauthorised medicinal ... |
| DE | Germany | 2 sources | Germany applies the Arzneimittelgesetz alongside anti-doping legislation, and ... |
Scope
How to use this page
A summary of the published regulatory position in North Macedonia 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 North Macedonia
Do you supply into North Macedonia?
We supply businesses that hold the authorisations their activity requires. Whether a specific compound can be supplied into North Macedonia 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 North Macedonia. 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 North Macedonia
Tell us the compounds and your authorisations. We confirm per compound before anything ships.