Planning on how to import medicines to Serbia or ship in medical devices? Whether you are a multinational pharmaceutical company exploring a new market, a medical device manufacturer looking to expand into Southeast Europe, or a regional player scaling up operations, Serbia offers real opportunity. The market is growing, legislation is increasingly aligned with EU standards, and demand for innovative products is strong.
But before your product reaches a single patient, you need to navigate the regulatory process. This guide walks you through the three main pathways: importing and registering a medicine, registering a medical device, and manufacturing under licence. No legal jargon, just practical steps, timelines, and what you need to prepare.
The Big Picture: Who Regulates What
Two institutions sit at the centre of pharmaceutical regulation in Serbia. ALIMS (Agencija za lekove i medicinska sredstva Srbije), the Medicines and Medical Devices Agency, handles marketing authorisations for cases when someone wants to importa medicines to Serbia and registration of medical devices. The Ministry of Health issues manufacturing licences and wholesale licences. Understanding which institution you need to deal with, and when, is the first step to getting your product to market efficiently.
Pathway 1: Import Medicines to Serbia and Register It
This is the most common route for foreign pharmaceutical companies entering Serbia. You manufacture abroad and want to sell your product on the Serbian market. Here is how it works, step by step.
| 1 | Appoint a local representative Foreign companies cannot file directly with ALIMS. You need a legal entity registered in Serbia to act as your authorised representative. This can be your own subsidiary (d.o.o.), a local partner, or a specialised regulatory agency. The representative will handle all filings and communication with ALIMS on your behalf. |
| 2 | Prepare the registration dossier ALIMS requires a full documentation package in CTD (Common Technical Document) or EU dossier format. This includes Module 1 (administrative data, Serbian-language labelling, patient information leaflet), Module 2 (summaries), Module 3 (quality/pharmaceutical data), Module 4 (non-clinical data), and Module 5 (clinical data). If your product already has EU marketing authorisation, much of the dossier can be adapted, but automatic mutual recognition does not apply. Serbian-language translations of the patient leaflet and labelling are mandatory. |
| 3 | Submit the application to ALIMS The application is filed electronically. ALIMS reviews the dossier and may request additional data or clarifications. The standard review timeline is up to 240 days from submission of a complete dossier. For products already authorised in the EU or ICH founding member countries, an expedited procedure may be available. |
| 4 | Obtain the marketing authorisation Once approved, ALIMS issues a marketing authorisation (dozvola za stavljanje leka u promet). The authorisation is valid for five years and can be renewed. It specifies the product name, pharmaceutical form, strength, packaging, and the marketing authorisation holder. |
| 5 | Get a wholesale licence and start importing To physically import and distribute the product, you (or your distributor) need a wholesale licence from the Ministry of Health. The licence covers purchase, storage, distribution, import, and export. The application requires information about premises, personnel, equipment, and a product recall plan. The licence is issued for an indefinite period for medicines. |
| Key numbers for Pathway 1:Registration fee: from approx. RSD 900,000 (varies by product type and forms)Wholesale licence fee: RSD 40,020Standard review timeline: up to 240 daysMarketing authorisation validity: 5 years (renewable)Language requirement: patient leaflet and labelling must be in Serbian |
Pathway 2: Registering a Medical Device
Medical devices follow a different regulatory path than medicines. There is no marketing authorisation procedure. Instead, devices must be registered in the ALIMS Register of Medical Devices. The process depends on whether your device carries a CE mark.
If your device has a CE mark
Good news: the process is largely administrative. Serbia recognises EC certificates issued by EU notified bodies, subject to conditions aligned with EU Regulation 2017/745 (MDR). Since March 2023, ALIMS has been applying updated requirements for recognising these certificates, most recently revised in January 2025.
| 1 | Appoint an authorised representative in SerbiaThe foreign manufacturer must authorise a representative with a registered seat in Serbia to act on its behalf before ALIMS. This representative submits the registration application and handles all regulatory communication. |
| 2 | Prepare registration documentationYou will need: the registration application (Form 1), a valid EC certificate from a notified body, the declaration of conformity, technical product documentation, instructions for use in Serbian, written authorisation from the manufacturer for the Serbian representative, and proof of payment of registration fees. |
| 3 | Submit and obtain registrationALIMS processes the application and, if all requirements are met, issues a decision on registration (resenje o upisu u Registar medicinskih sredstava). The validity of the registration follows the validity of your EC certificate, plus 60 days. |
If your device does not have a CE mark
The process is more involved. ALIMS will require local testing and evaluation of quality, safety, and efficacy, conducted in accordance with internationally accepted standards. This adds significant time and cost. For most foreign manufacturers, obtaining CE marking before entering Serbia is the more practical route.
| Key numbers for Pathway 2 (CE-marked devices):Registration fee: varies by device class (from approx. RSD 25,000 to RSD 120,000)Registration validity: follows EC certificate validity + 60 daysFor non-sterile, non-measuring Class I devices: 5 yearsRenewal: apply no earlier than 180 days before, no later than 90 days after expiryLanguage: instructions for use must be in SerbianClassification: follows EU MDR rules (Class I, IIa, IIb, III) |
| Transitional deadlines to know (EU MDR alignment):EC certificates under old Directives 90/385/EEC and 93/42/EEC remain valid until:– 31 December 2027 for Class III and implantable Class IIb devices– 31 December 2028 for other Class IIb, IIa, and sterile/measuring Class I devicesManufacturers must have applied to a notified body for MDR conformity assessment by 26 September 2024 |
Pathway 3: Manufacturing Under Licence in Serbia
Some companies choose a deeper form of market entry: licensing a Serbian manufacturer to produce their product locally. This is common for generic medicines, established branded products, and certain medical devices. It takes longer to set up but creates a stronger, long-term market position.
| 1 | Find and qualify a local manufacturing partnerSerbia has several established pharmaceutical manufacturers (Galenika, Hemofarm/STADA, Zdravlje, Pharmanova, among others) as well as smaller specialised producers. Your partner needs to have (or be able to obtain) a GMP-compliant manufacturing facility for your product type. |
| 2 | Negotiate and sign the licence agreementThe agreement should cover the scope of the licence (which products, which territory), technology transfer obligations, quality oversight and audit rights, intellectual property protection, exclusivity terms (if any), royalty or fee structure, and termination provisions. This is where experienced legal counsel makes a significant difference. A well-drafted agreement protects both parties and avoids costly disputes later. |
| 3 | Obtain a manufacturing licence from the Ministry of HealthThe Serbian licensee applies to the Ministry of Health for a manufacturing licence. The application includes details on the production site, equipment, qualified personnel, products to be manufactured, and standard operating procedures. The Ministry inspects the site for GMP compliance. The licence is valid for an indefinite period for medicines and five years for medical devices. Fee: RSD 80,030. |
| 4 | Transfer the technologyThis is the most complex phase. It involves transferring formulations, manufacturing procedures, analytical methods, quality control specifications, and raw material sourcing guidance. The receiving site must validate the manufacturing process and demonstrate that locally produced batches meet the same quality standards as the originator product. |
| 5 | Register the locally manufactured product with ALIMSThe locally manufactured medicine needs its own marketing authorisation from ALIMS (or the existing one must be transferred/amended). The dossier must reflect the local manufacturing site and any process adaptations. This is a full regulatory procedure, similar to Pathway 1, but referencing the originator dossier where applicable. |
| Key numbers for Pathway 3:Manufacturing licence fee: RSD 80,030Manufacturing licence validity: indefinite (medicines) / 5 years (medical devices)Marketing authorisation: separate application to ALIMS requiredGMP inspection: mandatory before licence is issuedTypical setup timeline: 12-24 months from agreement signing to first commercial batchKey regulation: Law on Medicinal Products and Medical Devices (2010, as amended) |
Practical Tips for All Three Pathways
Start the Serbian-language translations early. Patient leaflets, labels, and instructions for use must be in Serbian. Translation and regulatory review take time, so begin this process in parallel with your dossier preparation, not after.
Budget for local fees and representation. Beyond ALIMS and Ministry fees, you will need a local representative, potentially warehousing, and qualified personnel for pharmacovigilance. Factor these into your market entry budget from day one.
Do not assume EU approval equals Serbian approval. While Serbia has harmonised much of its legislation with the EU, there is no automatic mutual recognition for medicines. Each product requires a national procedure. For medical devices with CE marking, the process is simpler but still requires local registration.
Plan for the RFZO list if relevant. If you want your medicine covered by public health insurance (which drives the majority of prescription drug volume in Serbia), you will need to apply separately for inclusion on the RFZO Positive List after obtaining your marketing authorisation. This requires pharmacoeconomic analysis and price negotiation.
Keep track of regulatory changes. A new Medicines Act is in development. ALIMS regularly updates its requirements, particularly for medical device registration under EU MDR alignment. Having a legal partner who monitors these developments saves you from costly surprises.
Why Work with IVVK Lawyers
IVVK Lawyers has guided pharmaceutical companies and medical device manufacturers through the Serbian regulatory landscape for years. We handle the full scope of legal work involved in market entry: from setting up your local entity, through regulatory filings with ALIMS and the Ministry of Health, to drafting distribution and licence agreements, managing IP protection, and advising on pricing and reimbursement strategy.
Through our partnership with LexQuire Tax & Law LLP, we also provide coordinated legal and tax support across the Netherlands, Germany, Belgium, Romania, and the wider European network, so companies entering Serbia from the EU have a single point of contact for both sides of the border.