Türkiye has always paid for medicines in a euro of its own. Since March 2026 that euro is defined by a statutory equation — last year's average market rate, multiplied by an adaptation coefficient set at sixty-five per cent. The thirty-five per cent haircut is no longer an artefact of a delayed revision. It is the law.
On 12 March 2026 the Council of Ministers decision numbered 11031 was published in the Official Gazette and repealed the 2017 pricing decision that had governed Turkish medicine prices for nine years. The replacement does something the old one never did: it stops naming a euro rate and starts defining one.
Article 2(3) provides that the euro value used in pricing is the previous calendar year's daily average rate published by the central bank, multiplied by an adaptation coefficient — and sets that coefficient at 65 per cent. Applied to 2025, this produced 1 EUR = 29,1164 TL, effective 1 April 2026 under transitional Article 3.
Read the two halves separately, because they bite differently. The lag means you are always paid at last year's rate in a currency that has not been stable for a decade. The coefficient means that even that lagged rate is then cut by more than a third. Previously the erosion came from the gap between revisions — the rate simply sat still while the market moved, and was occasionally caught up. Now the gap is built into the formula and will not close.
Turkish prices are referenced by other countries, and a low Turkish price travels. Before you model volumes, model what the ceiling price actually becomes in sterling after the coefficient, the tier percentage and the public-sector discounts — in that order. We have seen files where the arithmetic answer was to register and not launch, and that is a legitimate answer.
| Effective from | 1 EUR, in lira | Instrument |
|---|---|---|
| 1 April 2026 | 29,1164 | Karar 11031, transitional art. 3 — first rate set by formula |
| 19 December 2025 | 25,3346 | revision under the 2017 decision |
| 24 October 2024 | 21,6721 | revision under the 2017 decision |
| 16 December 2023 | 17,5483 | revision under the 2017 decision |
| 23 July 2023 | 14,0387 | revision under the 2017 decision |
| 14 December 2022 | 10,7577 | revision under the 2017 decision |
| 9 July 2022 | 7,8656 | revision under the 2017 decision |
Seven revisions in four years, each one a step change rather than a drift. Note what the column does not show: the market rate over the same period. The pricing euro has never caught it, and under article 2(3) it is no longer trying to.
A sourcing caveat we would rather state than hide. The Turkish Official Gazette, the national legislation portal and the Agency's own site all refused automated access on the day we checked. The text of decision 11031 and of the August 2026 communiqué was read from professional-database reproductions of the gazette text, which we regard as reliable but not primary. Re-pull both from resmigazete.gov.tr before you rely on a number from this section in a filing. The pre-2026 adaptation coefficient is genuinely disputed — Turkish firms publish 70 per cent and 60 per cent with equal confidence — so we publish only the current one, which the decree states.
Article 14(1) of the licensing regulation gives the Agency 210 days to evaluate a marketing authorisation application. Every timeline you will be quoted is built on that figure, and every one of them is built wrong, because article 12(1) sits two pages earlier and says when the 210 days may begin.
In its own words: "Ruhsatlandırma süreci … sadece Şubat, Mayıs, Ağustos ve Kasım aylarında … başlatılabilir" — the registration process may be started only in February, May, August and November. And within each of those four windows the Agency admits a fixed number of files per category, published in guideline İRD-KLVZ-22.
Per applicant, per round, from guideline İRD-KLVZ-22, revision 4, in force 4 June 2026. Four rounds a year means a single company can start at most twenty ordinary applications in a calendar year, and at most twelve first-generic files. Plan the portfolio, not the product.
What this means in practice. The critical path to a Turkish launch is almost never the 210 days. It is the GMP inspection queue plus the scheduling quota, and neither has a published length. Any adviser who gives you a Turkish timeline without naming both has quoted you article 14(1) and stopped reading.
Article 6(1) of the licensing regulation is unambiguous: an application may be made only by "Türkiye'de yerleşik bulunan" — natural persons or trading companies established in Türkiye. There is no non-resident holder, no overseas applicant with a local agent on the file, no arrangement in which a UK company is named as the authorisation holder.
Two further provisions close the circle. Article 7 requires the holder to employ a qualified yetkili kişi — a named responsible person with prescribed qualifications and continuous availability. Article 8(1)(n) requires the dossier to contain a yetkili tek temsilci document: a sole authorised representative instrument from the manufacturer.
This is the same ownership question the devices side of this site treats at length, and it has the same answer: the entity on the certificate controls the market position. In Türkiye the regulation forecloses the option of keeping it yourself unless you incorporate. Decide that before you choose a partner, not after.
Türkiye acceded to the Pharmaceutical Inspection Co-operation Scheme on 1 January 2018, and the MHRA is a founding participant. That shared membership is real and it is worth money. It is not, however, an exemption from being inspected.
Guideline İDD-KLVZ-21, revision 10, dated 22 September 2025, together with the PIC/S list of participating authorities. The desktop route mattered: until October 2023 a site with a strong certificate could in some circumstances be assessed on paper. Its removal is why the inspection queue now sits on the critical path of every new Turkish file from a foreign site.
TİTCK publishes a consolidated tariff. The 2026 edition, dated 23 March 2026, is the one below. Read the second table first: a first foreign GMP inspection costs roughly twice a first marketing authorisation application, and it is payable before the authorisation clock starts.
| Marketing authorisation | Fee, TRY |
|---|---|
| Application, category MA-1 (new molecule / reference product) | 816.512 |
| Application, category MA-2 (generic / equivalent) | 489.908 |
| Renewal of a marketing authorisation | 24.360 |
| Variation, type IA | 5.174 |
| Variation, type IB | 12.318 |
| Variation, type II | 24.360 |
| Foreign GMP inspection, first time | Fee, TRY |
|---|---|
| Application | 41.153 |
| Site inspection | 1.542.896 |
| Per product assessed | 100.663 |
| Certificate issue | 100.663 |
| Indicative total, one site, one product | ≈ 1.785.375 |
It is written into the tariff itself and it applies across the schedule. Combined with the pricing tiers and the procurement preferences described below, it is the clearest published statement of what Turkish policy wants you to do with your manufacturing.
All amounts in Turkish lira, from the TİTCK tariff of 23 March 2026, which is revised annually. We checked specifically for a per-inspector-per-day line and for a travel-and-subsistence line, and there is none — the inspection fee above is a single figure. Convert at the market rate, not the pricing rate: fees are paid in lira at what lira actually cost you.
Turkish pricing is external reference pricing against a basket. The new communiqué published on 29 August 2026 replaced the 2017 one and kept the basket unchanged: France, Spain, Italy, Portugal and Greece. What changed is above it — decision 11031 article 2(1) now permits the basket to be set at between five and ten EU countries by communiqué, on two months' notice. The basket is no longer fixed in a decree; it is a parameter.
This applies only published percentages to a reference price you supply. It is arithmetic over the communiqué, not a forecast — and it stops before reimbursement, which is a separate negotiation covered below.
Reference product with no equivalent on the market. The full basket price applies. This is the only tier at 100 per cent, and it ends the day a competitor is authorised.
There is no 40 per cent tier in the current framework, despite its wide circulation in secondary commentary. The first-equivalent taper runs 80, then 75, then 70 per cent as further equivalents enter. Price-protected products — those below a threshold the communiqué sets — sit at 80 per cent.
A price approved by the Agency is a ceiling, not a sale. Inclusion on the reimbursement list is decided by the Social Security Institution under its own health implementation communiqué, on its own timetable, with its own discounts stacked on top of the tier percentage.
Applications are accepted twice a year, closing on the last business day of March and of August
Reaches 41 per cent where the price sits above the top threshold
The discount applies to the price already reduced by the tier percentage and already converted at the coefficient euro
A negotiated alternative reimbursement agreement is the only lawful route out of both the 60 per cent tier and the 65 per cent coefficient
If a Turkish launch is going to work commercially for a UK originator, in our experience it works through an alternative reimbursement agreement or it does not work. Budget the negotiation as a workstream with its own calendar, not as a step after registration.
The asymmetry is worth naming plainly: Türkiye gives you a shorter and earlier-starting exclusivity period than you are used to, and a longer authorisation life than almost anywhere. Losing a Turkish authorisation is hard. Holding exclusivity in one is easy to get wrong by a year.
Turkish policy has for a decade favoured locally manufactured medicines in public procurement and in the reimbursement decision. We looked for the legal instrument that establishes this and there is none to find — no decree, no communiqué, no published criterion.
What exists instead is a World Trade Organization dispute. In Türkiye — Pharmaceutical Products, case DS583, the panel examined the localisation requirement and the prioritisation measures applied to products that agreed to localise, and found they breached Article III:4 of the GATT. The Article 25 arbitrators upheld the core findings in their award of 25 July 2022, document WT/DS583/ARB25. The compliance position remains unresolved.
Plan on the assumption that local manufacture improves your position in reimbursement and in tender, that nobody will put the rule in writing for you, and that the 40 per cent fee reduction for Turkish-manufactured products is the only part of it that appears in an official document.
Sources: WTO dispute settlement record for DS583, including the panel report and the arbitration award WT/DS583/ARB25 of 25 July 2022. On currency: the lira floats, and export surrender requirements and swap limits remain in force, but we found nothing restricting an importer's payment to a foreign supplier.
An abridged reliance pathway was inserted into the licensing regulation as article 37/A on 24 September 2022, with an evaluation period of 90 days. It is the shortest published clock in the Turkish system and the only one that meaningfully shortens the review itself rather than the queue in front of it.
We state its existence and its period because both are in the regulation. We are not going to tell you whether your product qualifies, because the eligibility criteria and the operating practice around it are the part we could not verify from a primary source, and this is precisely the kind of question where a confident secondary answer is worse than no answer.
resmigazete.gov.tr, mevzuat.gov.tr and titck.gov.tr all refused automated access. Decision 11031 and the August 2026 communiqué were read from professional-database reproductions of the gazette text, not from the gazette.
Turkish law firms publish 70 per cent and 60 per cent with equal confidence. We publish only the current 65 per cent, which decision 11031 states in terms.
Studies must run at Agency-authorised centres. The only list we located is a 2018 PDF that is plainly stale, and no current list is published.
No published length, no published position, no service standard. It is the longest item on the critical path and the least visible.
Article 12(1) creates it; nothing measures it. How long a complete dossier waits before admission to a round is not published in any form we found.
The article and its 90-day period are in the regulation. The criteria that decide who may use it are not something we were able to read from the source.
Everything stated as fact above was read from the regulation, the tariff, a TİTCK guideline, or the WTO dispute record. Everything read from a reproduction rather than the gazette is marked as such on the page, and everything absent is listed here rather than filled in.
Türkiye is the market where the device and medicine stories diverge most sharply. On the device side the UKCA mark is not recognised at all and a Turkish notified body route to CE is the way in. On the medicines side the MHRA is a PIC/S participant whose inspection findings count — different instruments, different answers, one country.
The medical devices page for Türkiye → · What an MHRA approval is worth in all six markets →
Türkiye rewards companies that do the pricing arithmetic first and the regulatory plan second. Send us the product, the basket price and the manufacturing site, and we will tell you what the ceiling becomes in sterling, where the inspection sits on your critical path, and whether the scheduling quota makes your launch year realistic.
Or reach us directly — mail@bcabusiness.co.uk · +44 7342 901002 · WhatsApp
Re-checked quarterly, and immediately on any revision of the adaptation coefficient or the basket — either of which changes the commercial case for this market outright. Biological and advanced-therapy products follow additional requirements this page does not cover. The three official Turkish domains this page needed were inaccessible on the day of checking; where that affected a statement, the page says so.