Türkiye is two regulatory markets wearing one flag. A medicine can only be authorised in the name of someone resident here, so choosing a distributor is choosing the owner of your licence. A medical device, under the customs union, may need no Turkish representative at all. We establish which side of that line each of your products falls on, build the candidate list for it, and rank what comes back against the evidence each firm produced.
The industry association’s own 2025 figures give the clearest picture of what kind of market this is. Imported medicines account for 44.6% of market value and 7.2% of packs; domestic production is 55.4% of value and 92.8% of packs. Read those two pairs together and the shape is obvious. Everything routine is made here. What arrives from abroad is the expensive end — originators, biologics, specialist therapies — sold in small quantities at high unit value. If your product is a commodity generic, there is already a Turkish factory making it more cheaply than you can ship it.
Devices are the opposite case. The US Commercial Service put the market at about 3.3 billion dollars at the end of 2024 and estimated roughly three quarters of it is imported. That is a government estimate rather than a regulator’s statistic, and we would treat the number as an order of magnitude rather than a measurement, but the direction is not in doubt and it matches what the regulatory architecture would predict.
The reason the two halves behave so differently is the customs union, and it is worth being precise about what it does. For devices, the European Commission’s notice of March 2022 records that the parties confirmed Turkish law aligned with the EU device regulations, that references to territory in those regulations cover the customs union territory, and that a manufacturer established in the EU therefore need appoint no Turkish authorised representative. Notified body certificates issued on either side are good on both. A manufacturer from outside the union appoints one representative, in Türkiye or in Europe, and that single appointment serves both markets.
None of that reaches medicines, which sit outside the customs union arrangement and inside a purely national authorisation regime. So the same company can walk into one negotiation holding all the cards and another holding none, depending on which half of its range is on the table. We have watched both halves negotiated as a single deal more than once, and it is an expensive way to find out.
The rule that decides everything is one sentence in the marketing authorisation regulation of 11 December 2021: an application may be made only by a real or legal person resident in Türkiye, and nowhere else. Your authorisation is held by a Turkish entity, and the file has to prove that entity is your sole authorised importer. Getting it back is not a letter. Transfer runs through a notarised contract, a court decision or an enforcement office, with the agency then taking thirty days to evaluate — and the clock restarts each time it asks a question. If the relationship is not working, the licence does not simply follow you out.
Devices run the other way, and the reason is the customs union rather than anything Turkish. The Commission’s own 2022 notice records that a manufacturer established in the EU has no obligation to appoint a Turkish authorised representative, and that certificates from Turkish and EU notified bodies circulate in both territories. A manufacturer outside the union appoints one representative, in Türkiye or in Europe, and that one appointment covers both markets. So the same company can be locked into its Turkish partner on the pharmaceutical side and entirely free on the device side, and we have seen both halves negotiated as though they were one deal.
Pharmaceutical wholesaling here is concentrated and, unusually, partly transparent, because the leader is a company quoted on Borsa İstanbul and therefore has to publish. Selçuk Ecza Deposu’s investor presentation of March 2026 describes itself as the industry leader on approximately 38% market share, drawn from lira-based IQVIA data; puts the number of wholesalers operating at economic scale at around fifteen alongside numerous local players; and reports 110 warehouses at the end of 2025, down from 112 a year earlier. We take those as the company’s own figures rather than independent ones, and the share carries no stated measurement period, but a listed issuer’s disclosure is the best available description of this trade and there is nothing comparable for the rest.
Downstream of the wholesalers, the pharmacy estate is structurally unlike anything in Western Europe. There are no chain pharmacies, because a pharmacist may not own or manage more than one. The same presentation puts the count at roughly thirty thousand, about one per three thousand people, with the typical pharmacy working with two or three wholesalers. What follows commercially is that there is no key account to negotiate with at retail. Coverage is a function of which wholesalers carry you, and nothing else.
The hospital side splits again. Public institutions buy mainly through competitive tender, with standard products available through the state supply office; private groups contract directly, and the larger ones run their own requests for quotation. Devices add a third counterparty in the authorised sales centres, which are a licensed retail-type channel with their own trained and certificated staff. The firm that is strong in one of these is frequently weak in the others, which is why a single national appointment so often under-delivers on one channel and nobody notices for two years.
These are documents, not assurances. Each one is issued by a named body, each can be produced on request, and a candidate that cannot produce the relevant ones is telling you something. Which list applies depends on whether you are selling a medicine or a device, and that is the first thing to settle.
Each of these asks for a document or a verifiable fact. None of them depends on anyone’s self-description, and most can be done before a first meeting.
Split the range at the medicine and device line and work out, for each item, whether the Turkish authorisation would sit in your name or theirs. For medicines the answer is theirs, because the regulation requires a resident applicant. For EU-made devices the answer may be that no Turkish holder is needed at all. Firms routinely negotiate both halves as one, and the leverage is completely different on each side.
Ask for the ecza ticarethanesi permit document itself and check the addresses and activities written on it against where the candidate says it operates. Branches need their own permits and activities are confined to what is listed. A profile page is not evidence of either.
The responsible manager must be a named pharmacist holding a certificate in their own name. Ask who it is, how long they have been there, and what happened the last time the post was vacant — a vacancy has to be reported within five business days and filled within fifteen, and missing that suspends the permit.
For a medicine, transfer of the authorisation runs through a notarised contract, a court decision or an enforcement office, followed by a thirty-day agency review that restarts whenever a question is asked. Ask the candidate to describe that process in its own words. A firm that has done it will describe it accurately; a firm that has not will say it is a formality.
An import has to be notified within forty-five days of the last customs entry and a late notification is not accepted. Ask how many notifications the candidate filed late last year and what happened. The honest answer is rarely zero, and the firms that handle it well have a process rather than a person.
The supply office requires the bidder to be the manufacturer or importer, or the documented sole authorised seller for that product code in that province. If you are planning a non-exclusive, multi-distributor appointment, confirm it does not lock every one of them out of the public channel.
The regulation describes sales centres as retail-type outlets, and whether importers and hospital distributors need one is genuinely contested between advisers here. We would rather put the question to the provincial directorate for your specific device and channel than take either answer on trust.
Pricing is set off a euro rate fixed by formula rather than by the market. Ask the candidate what it currently assumes for that rate, what it assumed a year ago, and what it does when the two diverge. The answer tells you whether you are dealing with a trading firm or a brand builder.
You end the distribution agreement and discover the marketing authorisation is in the other party’s name, because the regulation requires a resident holder. Recovering it means a notarised transfer, a court decision or an enforcement sale, and then a thirty-day review. A partner who does not want to cooperate has considerable room not to.
An authorisation can be suspended if the first commercial batch is not marketed within thirty months of registration, or after thirty uninterrupted months off the market. A distributor that registers your product to block a competitor and never launches it can lose the registration for you without either of you noticing until it is gone.
Missing the forty-five-day import notification is an administrative error by someone you will never meet, and the published consequence runs all the way to suspension of the authorisation. This is the clearest case on the page of your market access depending on another firm’s filing discipline.
Prices are set from a euro rate calculated as a percentage of the previous year’s average, which in a devaluing currency is always behind. The manufacturers’ association reported that the rate ran at about 43% of the market rate through 2025, with no adjustment for fourteen months. Shortages followed, reported in oncology and antibiotics. Several companies are said to have withdrawn products over it; none is named in any source we would publish.
Low regulated prices here create a parallel export incentive outward, and Türkiye is formally referenced by a number of other countries in their own price setting. A price agreed for this market does not necessarily stay in it, in either sense.
The competition authority has looked at supply restrictions in this sector and, in a 2021 decision, accepted selection criteria based on financial standing, legal compliance, size and capacity as reasonable grounds for choosing who to supply. Export restrictions are a more delicate question and the published reasoning is thin. We would not treat either point as settled without counsel.
Not as a foreign company. The regulation of 11 December 2021 requires the applicant to be a real or legal person resident in Türkiye, and a legal-person applicant must employ a qualified authorised person. The usual routes are a Turkish subsidiary that holds the authorisation while a separate distributor handles logistics, or accepting that your distributor holds it. The first costs more and is why most serious entrants do it.
If you are established in the EU, no. The European Commission’s March 2022 notice on the customs union states it directly: there is no obligation to appoint one, and a notified body certificate from either side allows circulation in both. If you are outside the customs union you appoint one representative, in Türkiye or in Europe, and it covers both markets. This is the single biggest structural difference between devices and medicines here.
By formula, off the lowest ex-factory price in a set of reference countries, converted at a euro rate that is itself set by formula — a percentage of the previous year’s average central bank rate, announced in the first weeks of each year. As at the communiqué of 29 August 2026 the reference countries were France, Spain, Italy, Portugal and Greece. The wholesale margin is a regulated ladder that falls as the price rises, from 8% at the bottom band to 3% at the top.
Yes, and since March 2025 more easily than before. The restriction on foreign-currency contracting only ever applied between residents of Türkiye, so your own supply agreement was never caught. A 2025 communiqué then allowed sales of movable goods between residents to be denominated, indexed and paid in foreign currency, which removes a real mismatch for your distributor’s onward sales. Service elements bundled into a resident-to-resident contract are still restricted, so how the agreement is structured matters.
In devices, demonstrably. The social security institution’s own listing procedure exempts holders of a domestic goods certificate from the apostilled reference-country reimbursement proof that other applicants must provide, and gives domestic products priority within the evaluation period. On the medicines side, a localisation requirement was found inconsistent with trade rules by a WTO panel and upheld on appeal in July 2022. We could not establish what Türkiye did about that afterwards, and we would not tell you the requirement has gone.
Check the public channel before you decide. The state supply office requires a bidder to be the manufacturer, the importer, or the documented sole authorised seller for that product code in that province. A non-exclusive appointment spread across several firms can therefore disqualify all of them from the public tender channel at once. It is the kind of constraint that does not appear in any distribution agreement template and is expensive to find out late.
On the pharmaceutical side, the firm you appoint becomes the registered owner of your right to sell here, and winning it back runs through a notary or a court. That is worth an evidence pass before signature rather than after.
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