Country · Europe
Pharmaceutical exports to Türkiye, ready for TİTCK authorisation
Progene Pharma supplies Turkish 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 Turkish Medicines and Medical Devices Agency asks for, label in Turkish, and ship to Mersin and Ambarlı.
- Regulator
- TİTCK
- Labels
- Turkish
- Stability
- Zone II, 25 °C / 60% RH
- Main ports
- Mersin, Ambarlı, İzmir
The Turkish medicines market in brief
Türkiye is a large pharmaceutical market of more than 80 million people, with a national health insurance system and a well-developed local generics industry. It runs its own regulatory system, aligned with European standards but separate from the EU, so a Turkish authorisation is needed on top of any European one.
Prices are set by the state using a reference to prices in European countries, and the public insurer reimburses medicines on an approved list. Local manufacturers supply most 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.
Hospitals buy through public tenders and the insurer, and pharmacies buy from wholesalers. The authorisation is held by a company established in Türkiye, and Turkish is the language of labels and leaflets.
Medicines we supply to Türkiye
These are the medicines Turkish 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 Turkish 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.
TİTCK registration, step by step
A medicine cannot be sold in Türkiye 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 Türkiye that holds the right licences, acting for the manufacturer. It applies to the TİTCK.
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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
TİTCK reviews it
The TİTCK 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 the TİTCK issues an authorisation with a number, which goes on every pack. The price is then set with reference to European prices, 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 TİTCK updates its requirements from time to time, so check the current guidelines with TİTCK or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Türkiye
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The TİTCK application, through a licensed Turkish company
- The licences your business needs to import and distribute medicines
- Bioequivalence studies for generics, where the TİTCK 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 TİTCK's questions during assessment
Made for Turkish 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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Turkish labels and leaflets
Cartons and patient leaflets in Turkish, with the authorisation number, batch number and expiry date, and the track-and-trace code the system uses, with 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 the TİTCK 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 Türkiye
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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Mersin
The main port in the south-east, with road freight across Anatolia
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Ambarlı and İzmir
The Marmara and Aegean container ports, closer to Istanbul and the west
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Istanbul
By air to Istanbul 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 Turkish distributors sell
The same registered product moves through several channels, and each needs its own pack.
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Public hospitals and the insurer
Public hospitals buy through tenders and the social insurer, and ask for the full document set.
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Pharmacies and wholesalers
Pharmacies buy from wholesalers, which stock the registered packs.
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Private hospitals
Private hospital groups buy in hospital packs through importers.
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Regional distributors
Some distributors supply neighbouring markets from Türkiye.
Questions about supplying Türkiye
Something else? Email [email protected].
Do you export medicines to Türkiye?
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 Türkiye.
Can you help us obtain an authorisation from TİTCK?
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 Turkish company files the application, and we answer TİTCK's questions with you.
Do I need a local company to hold the authorisation?
Yes. The TİTCK grants an authorisation to a company established in Türkiye that holds the right licences. Check the current requirements with the TİTCK.
Is a European authorisation enough for Türkiye?
No. Türkiye has its own regulatory system, aligned with European standards but separate from the EU, so a medicine needs a Turkish authorisation. Documents prepared for a European dossier can often be reused, and we prepare them to fit both. Check the current requirements with the TİTCK.
Which documents does TİTCK 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. TİTCK updates its requirements from time to time, so confirm the current list with TİTCK or your regulatory consultant. We tell you what we can provide with your quotation.
Where do imported generics fit in Türkiye?
Local manufacturers supply most 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 are prices set?
The state sets the price of each medicine with reference to prices in European countries. The authorisation holder handles the price application, and we help with the documents the manufacturer provides.
Does the TİTCK 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 the TİTCK.
What must the packs carry for Türkiye?
Turkish text, the TİTCK authorisation number, batch number, manufacture and expiry dates, storage conditions, the track-and-trace code and the other details the TİTCK 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 Türkiye?
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 Türkiye?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Mersin or Ambarlı, or by air to Istanbul 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