Country · Europe
Pharmaceutical exports to Bulgaria, ready for BDA authorisation
Progene Pharma supplies Bulgarian marketing authorisation holders, importers and wholesalers 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 Bulgarian Drug Agency asks for, label in Bulgarian, and ship to Varna and Burgas.
- Regulator
- BDA
- Labels
- Bulgarian (Cyrillic)
- Stability
- Zone II, 25 °C / 60% RH
- Main ports
- Varna, Burgas
The Bulgarian medicines market in brief
Bulgaria is a small EU market in south-eastern Europe where generics account for a large share of the volume sold, because price matters to patients and to the national health insurance fund. Prices are among the lowest in the EU, and prices and reimbursement are managed through a national council.
The insurance fund reimburses medicines on a positive list, and hospitals buy through tenders and central procurement, while pharmacies buy from wholesalers. A manufacturer needs a competitive price and a dependable supply chain.
The authorisation is held by a company established in the EU or EEA, and labels and leaflets are in Bulgarian, in the Cyrillic alphabet.
Medicines we supply to Bulgaria
These are the medicines Bulgarian distributors ask us for most. We make any human formulation to your specification, under your brand. See all human formulations
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Generic prescription medicines
Metformin, amlodipine, atorvastatin, losartan and similar generics in tablets and capsules made to the European Pharmacopoeia, for marketing authorisation holders.
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Generics for the positive list
High-volume active substances such as metformin, amlodipine and atorvastatin, in the packs pharmacies dispense under reimbursement.
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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.
BDA registration, step by step
A medicine cannot be sold in Bulgaria 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 the EU or EEA, usually the importer or distributor, acting as the marketing authorisation holder. It applies to BDA, or to another EU authority through a shared procedure.
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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
BDA reviews it
BDA assesses the dossier, or acts as a reference or concerned authority in a shared procedure, and may ask questions, which we answer with you.
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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 BDA issues an authorisation with a number, which goes on every pack. The price is then agreed and 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 BDA updates its requirements from time to time, so check the current guidelines with BDA or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Bulgaria
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The BDA application, as the marketing authorisation holder
- The import and wholesale authorisations your business needs
- Bioequivalence studies for generics, where the route requires them
- The Qualified Person who certifies each batch
- 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 BDA's questions during assessment
Made for Bulgarian 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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Bulgarian labels and leaflets
Cartons and patient leaflets in Bulgarian, following the EU product information template, 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 European authorities ask for, so the shelf life on the pack is valid.
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Safety features
Braille on the carton and room for the unique identifier and anti-tampering device that prescription medicines carry.
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Packs for every channel
Pharmacy packs, hospital packs and tender packs in the quantities pharmacies and hospitals buy.
Shipping to Bulgaria
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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Varna and Burgas
Bulgaria's Black Sea ports, with road and rail freight across the country
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Via Piraeus or Thessaloniki
Some cargo arrives through a Greek port and continues by road
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Sofia
By air to Sofia 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 Bulgarian distributors sell
The same registered product moves through several channels, and each needs its own pack.
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Pharmacies and wholesalers
Pharmacies buy from wholesalers, which stock the registered packs.
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Hospital tenders
Hospitals buy through tenders and central procurement, and ask for the full document set.
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Reimbursed generics
The positive list shapes demand.
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Regional distributors
Some distributors also supply neighbouring Balkan markets.
Questions about supplying Bulgaria
Something else? Email [email protected].
Do you export medicines to Bulgaria?
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 Bulgaria.
Can you help us obtain an authorisation from BDA?
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 Bulgarian company files the application, and we answer BDA's questions with you.
Do I need a local company to hold the authorisation?
Yes. The authorisation is held by a company established in the EU or EEA, usually the importer or distributor. Check the current requirements with BDA.
Which route should we use for Bulgaria?
Bulgaria can authorise a generic nationally, or through the decentralised or mutual recognition procedures that let one assessment serve several EU countries. The right route depends on the product and on where else you plan to sell. Tell us the product and the countries and we will say which fits.
Which documents does BDA 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. BDA updates its requirements from time to time, so confirm the current list with BDA or your regulatory consultant. We tell you what we can provide with your quotation.
Who certifies each batch?
A Qualified Person at an authorised importing site in the EU or EEA tests and certifies each batch before it goes on sale. Your importer normally holds that authorisation, and we supply the batch documents the Qualified Person needs. Check the current rules with BDA.
Do the packs need the Cyrillic alphabet?
Yes. Bulgarian labels and leaflets use Cyrillic. We prepare the artwork to match your authorisation, and you approve a proof before printing.
Must the packs be in Bulgarian?
Yes. Labels and leaflets for the Bulgarian market are in Bulgarian, following the EU templates. We prepare the artwork to match your authorisation, and you approve a proof before printing.
What must the packs carry for Bulgaria?
Bulgarian text following the EU product information template, the authorisation number, batch number, expiry date, storage conditions, Braille on the carton and the safety features prescription medicines carry. 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 Bulgaria?
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 Bulgaria?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Varna or Burgas, or by air to Sofia 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