Country · Europe
Pharmaceutical exports to Serbia, ready for ALIMS authorisation
Progene Pharma supplies Serbian importers, authorisation holders and tender suppliers with generic medicines we manufacture in an EU-GMP and WHO-GMP certified facility. We prepare the CTD dossier, the stability data and the GMP evidence the Medicines and Medical Devices Agency asks for, label in Serbian, and ship via Adriatic and Aegean ports for the road and rail inland.
- Regulator
- ALIMS
- Labels
- Serbian
- Stability
- Zone II, 25 °C / 60% RH
- Route in
- Koper, Rijeka, Thessaloniki
The Serbian medicines market in brief
Serbia is the largest market in the western Balkans, outside the EU, with its own regulatory system aligned with European standards. A Serbian authorisation is needed on top of any European one. It has a strong local generics industry that supplies much of the volume.
The national health insurance fund reimburses medicines on an approved list, and the state manages prices, so a competitive price matters. Hospitals buy through public tenders, and pharmacies and chains buy from wholesalers, so imported generics fit best where there is no local equivalent, or where the product is a specialised form or a hospital supply.
The authorisation is held by a company established in Serbia, and Serbian is the language of labels and leaflets. The country has no seaport, so cargo arrives through Adriatic or Aegean ports and continues by road, rail or the Danube.
Medicines we supply to Serbia
These are the medicines Serbian distributors ask us for most. We make any human formulation to your specification, under your brand. See all human formulations
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Specialised generics
Generics and dosage forms with limited local competition, in the strengths and packs Serbian importers ask for.
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Hospital and tender supplies
IV fluids, injectable antibiotics, anaesthetics and analgesics in hospital packs for public tenders.
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Antibiotics and anti-infectives
Amoxicillin, amoxicillin and clavulanic acid, azithromycin and ciprofloxacin, and injectable antibiotics for hospitals.
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Stomach and allergy
Omeprazole, pantoprazole, cetirizine and montelukast, for prescription and pharmacy sale.
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Hospital and tender supplies
IV fluids, injectable antibiotics, anaesthetics and analgesics in hospital packs for tenders.
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Food supplements
Vitamins, minerals, omega-3, probiotics and protein products for brands selling supplements.
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Traditional herbal products
Herbal tablets, capsules and powders for the traditional herbal route or for sale as supplements.
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Cosmetics
Creams, washes, soaps and shampoos with INCI ingredient lists and the data your responsible person needs.
ALIMS registration, step by step
A medicine cannot be sold in Serbia until it has been authorised. This is the usual route for a generic medicine made outside Europe, and the page explains it step by step.
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01
A local company applies
The authorisation is held by a company established in Serbia that holds the right licences, acting for the manufacturer. It applies to ALIMS.
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02
The manufacturer authorises it
The manufacturer gives the applicant a letter of authorisation that names the product and the company, which we provide.
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03
The dossier goes in
The applicant submits the CTD dossier with stability data at Zone II conditions, bioequivalence data where required, the GMP certificate and the product information, in the format the route requires. We prepare the manufacturer's documents.
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04
ALIMS reviews it
ALIMS assesses the dossier and may ask questions, which we answer with you. It also checks the manufacturing site, and may inspect it or rely on its GMP evidence.
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05
GMP and batch release
The authority relies on the manufacturer's GMP certificate or inspects the site, and a Qualified Person at the importing site in Europe tests and certifies each batch before it goes on sale.
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06
Registration and renewal
On approval ALIMS issues an authorisation with a number, which goes on every pack. The price is then agreed, the product can be listed for reimbursement, and the authorisation is renewed as the rules require.
Registration takes from several months to more than a year, and ALIMS updates its requirements from time to time, so check the current guidelines with ALIMS or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Serbia
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The ALIMS application, through a licensed Serbian company
- The licences your business needs to import and distribute medicines
- Bioequivalence studies for generics, where ALIMS asks for them
- The import documents and customs declaration, through your customs broker
- Pricing and reimbursement applications
Progene Pharma handles
- The CTD dossier, stability data and bioequivalence data where required
- The EU GMP certificate and the manufacturing details
- The information the Qualified Person needs to certify each batch
- A Certificate of Analysis for every batch
- Labels and leaflets in the product information template, ready for your authorisation number
- Answers to ALIMS's questions during assessment
Made for Serbian conditions
Heat, humidity, long journeys and several languages: what a medicine needs to stay good from the port to the patient.
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Serbian labels and leaflets
Cartons and patient leaflets in Serbian, with the authorisation number, batch number and expiry date, and an approved proof before printing.
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Stability for Europe
Stability studies at 25 °C and 60% relative humidity (Zone II), the condition ALIMS asks for, so the shelf life on the pack is valid.
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GMP evidence
Documents that show the manufacturing site complies with GMP, prepared to match the dossier, because inconsistencies slow review.
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Packs for every channel
Pharmacy packs, hospital packs and tender packs in the quantities pharmacies and public hospitals buy.
Shipping to Serbia
Orders leave from Nhava Sheva (JNPT) near Mumbai by sea, or by air when they are urgent, with the documents your clearing agent needs.
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Koper and Rijeka
The Adriatic gateways, with onward rail and road freight to Belgrade
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Thessaloniki
The Aegean port, with road and rail links north through North Macedonia
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Belgrade
By air to Nikola Tesla Airport for urgent orders and samples
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Terms and documents
FOB, CFR or CIF, with invoice, packing list, certificate of origin and COA, and the import documents and customs declaration from your side
Where Serbian distributors sell
The same registered product moves through several channels, and each needs its own pack.
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Public hospitals and the insurance fund
Public hospitals buy through tenders and the insurance fund, and ask for the full document set.
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Pharmacies and wholesalers
Pharmacies and chains buy from wholesalers, which stock the registered packs.
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Private hospitals
Private hospitals buy in hospital packs through importers.
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Regional distributors
Some distributors supply neighbouring Balkan markets from Serbia.
Questions about supplying Serbia
Something else? Email [email protected].
Do you export medicines to Serbia?
Yes. Progene Pharma manufactures generic medicines in an EU-GMP and WHO-GMP certified facility and supplies them to marketing authorisation holders, importers, wholesalers and tender suppliers in Serbia.
Can you help us obtain an authorisation from ALIMS?
Yes. Progene Pharma prepares the manufacturing and quality documents an application needs: the CTD dossier, stability data, the GMP certificate and the manufacturing details. Your Serbian company files the application, and we answer ALIMS's questions with you.
Do I need a local company to hold the authorisation?
Yes. ALIMS grants an authorisation to a company established in Serbia that holds the right licences. Check the current requirements with ALIMS.
Is a European authorisation enough for Serbia?
No. Serbia is outside the EU and runs its own system, aligned with European standards, so a medicine needs a Serbian authorisation. Documents prepared for a European dossier can often be reused, and we prepare them to fit both. Check the current requirements with ALIMS.
Which documents does ALIMS ask for?
The usual set is the CTD dossier, stability data at European conditions, the manufacturer's GMP certificate and manufacturing details, bioequivalence data for most generics, the active substance master file details and product information. ALIMS updates its requirements from time to time, so confirm the current list with ALIMS or your regulatory consultant. We tell you what we can provide with your quotation.
Where do imported generics fit in Serbia?
Local manufacturers supply a large share of the volume, so imported generics fit best where there is no local equivalent, or where the product is a specialised form or a hospital supply. Tell us the product and we will say how it fits.
How do medicines reach Serbia?
Serbia is landlocked, so shipments go by sea to an Adriatic or Aegean port and then by road, rail or the Danube. Your customs broker handles import, and we confirm the schedule with your quotation.
Does ALIMS inspect foreign manufacturers?
It may inspect the manufacturing site or rely on GMP evidence, depending on the product. We prepare the GMP documents and support any inspection. Check the current requirements with ALIMS.
What must the packs carry for Serbia?
Serbian text, the ALIMS authorisation number, batch number, manufacture and expiry dates, storage conditions and the other details ALIMS requires. We prepare the artwork to match your authorisation and you approve a proof before printing.
Are your medicines tested for European conditions?
Yes. Progene Pharma tests products at 25 °C and 60% relative humidity (climate Zone II), the condition European authorities ask for, and packs them in moisture-resistant blisters or bottles, so the shelf life on the pack is valid.
Can you supply tenders in Serbia?
Yes. Progene Pharma supplies tender packs and the product documents tenders usually ask for. Tell us the tender requirements and we will confirm what we can provide.
How are orders shipped to Serbia?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Koper, Rijeka or Thessaloniki, with onward road or rail freight, or by air to Belgrade for urgent orders, on FOB, CFR or CIF terms. We confirm the schedule with your quotation.
What is the minimum order quantity?
It depends on the product, the dosage form and the packaging. We work with large importers and tender suppliers as well as smaller distributors, and confirm the minimum quantity with your quotation.
Related pages
Request a quote
Send us your product requirements and target country. Our team will reply with a quotation and next steps.
- [email protected]
- Phone
- +91 22 49793146
- +91 90829 70494