Country · Europe
Pharmaceutical exports to Romania, ready for ANMDMR authorisation
Progene Pharma supplies Romanian 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 National Agency for Medicines and Medical Devices asks for, label in Romanian, and ship to Constanța.
- Regulator
- ANMDMR
- Labels
- Romanian
- Stability
- Zone II, 25 °C / 60% RH
- Main port
- Constanța
The Romanian medicines market in brief
Romania is a mid-sized 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 house. Medicine prices are among the lowest in the EU.
Reimbursed medicines are bought through the national insurance system, with a clawback mechanism that returns part of sales above a budget to the state, and hospitals buy through tenders and framework agreements. 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 Romanian is the language of labels and leaflets. Importers in Bucharest supply pharmacies, wholesalers and hospitals across the country.
Medicines we supply to Romania
These are the medicines Romanian 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 reimbursed lists
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.
ANMDMR registration, step by step
A medicine cannot be sold in Romania 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 the ANMDMR, 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
ANMDMR reviews it
The ANMDMR 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 the ANMDMR 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 ANMDMR updates its requirements from time to time, so check the current guidelines with ANMDMR or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Romania
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The ANMDMR 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 listing
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 ANMDMR's questions during assessment
Made for Romanian 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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Romanian labels and leaflets
Cartons and patient leaflets in Romanian, 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 Romania
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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Constanța
Romania's Black Sea port, the main entry for cargo arriving via the Suez Canal
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Via Piraeus or Trieste
Some cargo arrives through a Mediterranean port and continues by road or rail
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Bucharest
By air to Henri Coandă 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 Romanian distributors sell
The same registered product moves through several channels, and each needs its own pack.
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Pharmacy chains
Large pharmacy chains buy in volume and sell reimbursed and own-label products.
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Hospital tenders
Hospitals buy through tenders and framework agreements, and ask for the full document set.
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Wholesalers
Wholesalers supply pharmacies and hospitals across the country.
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Regional distributors
Distributors also supply neighbouring south-eastern European markets.
Questions about supplying Romania
Something else? Email [email protected].
Do you export medicines to Romania?
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 Romania.
Can you help us obtain an authorisation from ANMDMR?
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 Romanian company files the application, and we answer ANMDMR'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 the ANMDMR.
Which route should we use for Romania?
Romania 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 ANMDMR 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. ANMDMR updates its requirements from time to time, so confirm the current list with ANMDMR 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 the ANMDMR.
What is the clawback in Romania?
It is a payment that manufacturers of reimbursed medicines make to the state when sales exceed a budget. It affects the margin of reimbursed products, so the authorisation holder prices with it in mind.
Must the packs be in Romanian?
Yes. Labels and leaflets for the Romanian market are in Romanian, 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 Romania?
Romanian 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 Romania?
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 Romania?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Constanța, or by air to Bucharest 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