Market requirements · TR
Turkey
Turkey applies Law No. 1262 on Pharmaceutical and Medicinal Preparations of 1928 together with the regulation on marketing authorisation of medicinal products for human use, and the Turkish Medicines and Medical Devices Agency controls authorisation, inspection, import and price. Classification turns on the claim rather than the composition: Law 1262 reaches any product marketed, sold or advertised as diagnosing or treating disease even where it is not a medicinal preparation at all. Commercial import of an unauthorised preparation is not treated as an administrative breach but as smuggling.
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The regime
How compounds are classified in Turkey
| Governing law | Law No. 1262, adopted 14 May 1928 and published in the Official Gazette of 26 May 1928, remains the operative statute in consolidated form. Article 3 requires permission before a domestically made preparation is placed on the market and before a foreign-made one is brought into the country, and Article 8 restricts who may apply. The Regulation on the Marketing Authorisation of Medicinal Products for Human Use, Official Gazette 11 December 2021, sets the authorisation procedure and was drafted in line with the European directive. Wholesale is governed by the regulation on pharmaceutical trading houses in force from 15 June 2022, and price by the pricing decision numbered 2017/9901. |
|---|---|
| What determines classification | Article 1 defines a preparation by its form and its placing on the market for use in medicine, and Article 3 makes prior permission the gate for both manufacture and import. The decisive provision is Article 19, which punishes with one to five years' imprisonment anyone who markets, sells or advertises any product on the assertion that it is for diagnosing or treating disease, expressly including products that are not preparations. The consequence for a distributor is that the claim, and not the substance, creates the offence, so research-use wording offers no protection where the surrounding marketing implies a therapeutic effect. Article 18 adds administrative fines, and where the promotion or sale is conducted online the Ministry orders access to be blocked immediately. |
| Customs union, but not for medicines | Association Council Decision No. 1/95 completed the customs union on 1 January 1996 and liberalised trade in all industrial goods, with Turkey adopting the European common customs tariff. Medicinal products are industrial goods, so on the tariff side duties and quantitative restrictions are removed and goods in free circulation move on a movement certificate. What the customs union does not do is the whole story: it creates no mutual recognition of marketing authorisations, and Turkey is not in the EEA, so a European national or centralised authorisation has no legal effect. The agency requires its own authorisation, its own inspection of the manufacturing site and its own price, and a separate Ministry of Health control certificate is required for each consignment under the annual import inspection communique. A consignment can be tariff-free and still be refused at the border. |
| Prescription and controlled substances | Prescription status is set in the marketing authorisation itself: under Article 7 the Ministry determines whether a preparation may be sold on prescription only or freely and records that in the authorisation. Article 1 confines sale of these preparations to pharmacies and pharmaceutical trading houses, and the 2022 wholesale regulation reinforces that a trading house may not sell at retail. Narcotics and psychotropics are controlled under separate legislation and no research peptide was found scheduled there. Whether any specific peptide is prescription-only or otherwise restricted is not established, because no published list naming individual research peptides was located and there is no published position on the category. The practical answer is usually reached without a list, because an unauthorised product cannot lawfully be imported for commercial purposes whether or not it is scheduled. |
| Enforcement posture | The agency maintains a standing medicines inspection function covering import control, laboratory analysis and manufacturing inspection. Dated enforcement on point exists at international level: Interpol reported on 25 June 2025 that Operation Pangea XVII, running from December 2024 to May 2025 across 90 countries, seized 50.4 million doses of illicit pharmaceuticals and arrested 769 suspects, and that 93 per cent of what was seized lacked national regulatory approval. Turkey was a participating country and the report names peptide products as an emerging seizure category previously rare. No national enforcement decision naming research peptides was found, so this is an international operation citation rather than a national one. The statutory exposure is nonetheless the sharpest in this set, because Article 19 provides that importing preparations made abroad without authorisation for commercial purposes is smuggling. |
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Your obligations
What a buyer in Turkey needs settled
- Obtain a national marketing authorisation for each product before import or sale, and do not rely on a European or centralised authorisation, which carries no legal effect in Turkey despite the customs union.
- Hold an authorisation as a pharmaceutical trading house to trade wholesale, operate to good distribution practice, and make no retail sale under that authorisation.
- Obtain a Ministry of Health control certificate for every consignment under the current annual import inspection communique, and handle tariff clearance and regulatory clearance as two separate gates.
- Present a movement certificate for goods in free circulation to secure zero customs duty, and verify the applicable VAT band against the specific tariff code rather than assuming the reduced rate.
- Attach no therapeutic or diagnostic claim to any unauthorised product in any channel including your website, because Article 19 carries one to five years' imprisonment and Article 18 triggers mandatory blocking of online access.
- Keep import, batch, price-notification and distribution records under the pharmaceutical trading houses regulation and produce them on inspection.
We will ask about this at enquiry. We check the authorisations your activity requires before quoting, and we confirm the position per compound rather than for the market as a whole.
Sources
Check this yourself
Every position above traces to a dated public document. The authority, the document, the date and the link are below.
| Authority and document | Date | Link |
|---|---|---|
| Legislation Information System Law No. 1262 on Pharmaceutical and Medicinal Preparations, consolidated text, Articles 3, 7, 8, 18 and 19 | 1928, as amended | www.mevzuat.gov.tr/MevzuatMetin/1.3.1262.pdf |
| Turkish Medicines and Medical Devices Agency Regulation on the Marketing Authorisation of Medicinal Products for Human Use | 2021 | titck.gov.tr/mevzuat/11-12-2012-tarihli-beseri-tibbi-urunl... |
| Turkish Medicines and Medical Devices Agency Regulation on pharmaceutical trading houses and the products held in them | 2022 | www.titck.gov.tr/mevzuat/ecza-depolari-ve-ecza-depolarinda... |
| Ministry of Trade Product safety and quality control system on import and export, the control certificate | 2026 | www.trade.gov.tr/legislation/product-safety-and-technical-... |
| Directorate for EU Affairs Customs Union, scope of Decision No. 1/95 and industrial goods coverage | 2026 | www.ab.gov.tr/customs-union_46234_en.html |
| Interpol Operation Pangea XVII, 769 arrests, peptide products named as an emerging category | 2025 | www.interpol.int/en/News-and-Events/News/2025/Record-769-a... |
Links go to the issuing body wherever one exists. Positions change. If you are relying on any of this, check the source rather than this page.
Market brief
Take the Turkey brief as a PDF
The regime, the buyer obligations and all 6 sources, dated and linked, in one document you can forward.
Nearby
Eastern Mediterranean and nearby markets
Buyers supplying one of these usually supply the others. The requirements are not the same.
| Code | Market | Sources | |
|---|---|---|---|
| GR | Greece | 4 sources | EOF issued a public warning in July 2026, and related reporting names specific... |
| UA | Ukraine | 6 sources | Ukraine regulates medicines under the Law on Medicinal Products of 4 April 199... |
| MD | Moldova | 6 sources | Moldova replaced its medicines statute in 2025: Law No. 153 of 19 June 2025 wa... |
Scope
How to use this page
A summary of the published regulatory position in Turkey as at 2026-08-20, written for procurement teams deciding how to source. Every source is dated and linked so it can be checked at origin.
It is not legal advice. Full terms of supply, including where responsibility sits, are set out in our terms of supply.
Questions
Supplying into Turkey
Do you supply into Turkey?
We supply businesses that hold the authorisations their activity requires. Whether a specific compound can be supplied into Turkey depends on that compound and on your authorisations, and we confirm it per compound at the enquiry stage.
Who carries the compliance obligation?
The importer of record and the party placing the product on the market, which is the buyer. We supply the batch documentation that supports your file. We cannot hold your authorisations for you.
How current is this page?
It was reviewed on 2026-08-20 and is scheduled for review again on 2026-11-18. Every source is dated and linked, so you can check the original.
We already supply into Turkey. What changes if we source from you?
The batch documentation. You receive a Certificate of Analysis per batch, which can be issued under your own brand. The import and market-placing responsibilities stay where they are.
Is this legal advice?
No. It is a summary of the regulatory positions those authorities have published, as at the review date above. Take advice in your own market before you rely on it.
Enquire about supply into Turkey
Tell us the compounds and your authorisations. We confirm per compound before anything ships.