Turkey: TİTCK Pharmaceuticals, Tarım Bakanlığı Supplementary Food and Turkish Labelling Discipline
Turkey operates a bifurcated regulatory regime: dietary supplements (takviye edici gıda) are governed by the Ministry of Agriculture and Forestry (Tarım ve Orman Bakanlığı) under the Turkish Food Codex and Communiqué on Supplementary Foods (Communiqué 2013/49), while medicinal products and medical devices fall under TİTCK (Türkiye İlaç ve Tıbbi Cihaz Kurumu — Turkish Medicines and Medical Devices Agency) within the Ministry of Health.
In Short
- The Communiqué on Supplementary Foods (Türk Gıda Kodeksi Takviye Edici Gıdalar Tebliği, Communiqué 2013/49 and subsequent amendments) defines supplementary food as…
- TİTCK regulates medicinal products under the Regulation on Marketing Authorisation of Medicinal Products for Human Use (2005, with subsequent amendments aligning to…
- Turkish-language labelling is mandatory for all food, supplements, pharmaceuticals and medical devices placed on the Turkish market.
Cosmetics follow EU-aligned legislation with Ministry of Health oversight. Supplementary foods require pre-marketing notification with the Ministry of Agriculture; medicinal products require TİTCK marketing authorisation; medical devices require UTS (Ürün Takip Sistemi) registration and reference-country approval recognition. Turkish-language labelling is mandatory, halal certification is commercially important for the domestic market and increasingly for export, and customs clearance through Turkish Customs requires the appropriate authorisation document on every shipment. This guide covers the regulatory map, supplement and pharma pathways, labelling discipline and customs realities.
Supplementary food (takviye edici gıda) notification with Tarım Bakanlığı
The Communiqué on Supplementary Foods (Türk Gıda Kodeksi Takviye Edici Gıdalar Tebliği, Communiqué 2013/49 and subsequent amendments) defines supplementary food as concentrated sources of nutrients or other substances with nutritional or physiological effect, marketed in dose form to supplement normal diet. Pre-marketing notification with the General Directorate of Food and Control of the Ministry of Agriculture and Forestry is required for each SKU before placement on market.
More on supplementary food (takviye edici gıda) notification with Tarım Bakanlığı
The notification dossier covers ingredient list with quantitative declaration of active substances, manufacturing site GMP evidence (Turkish GMP or recognised equivalent), finished-product specification including microbiological and heavy-metals limits per the Turkish Food Codex, label artwork in Turkish, target population, recommended daily dose with safety substantiation, and supporting evidence for nutrition and structure-function claims. The Ministry operates positive lists for vitamins and minerals with upper daily-intake limits broadly aligned with EU food supplements directive 2002/46 plus Turkey-specific national positions; novel botanicals, amino-acid blends, probiotic strains and bioactive ingredients require case-by-case scientific evaluation. Disease-treatment, prevention and drug-like claims trigger reclassification to medicinal product (requiring TİTCK marketing authorisation — a far heavier pathway). Typical notification timeline is 30-60 working days for routine vitamin/mineral combinations, extending to 6+ months for novel ingredients or contested claims.
Turkish labelling, halal certification and the import customs reality
Turkish-language labelling is mandatory for all food, supplements, pharmaceuticals and medical devices placed on the Turkish market. Mandatory elements align with the Turkish Food Codex Labelling Regulation (broadly EU FIC-aligned) — product name, ingredient list with quantitative declaration where claimed, allergen declaration for the 14 allergens, nutrition information, net quantity, manufacturer and importer details, country of origin, manufacturing/expiry date, storage conditions, supplement-specific recommended daily dose and any notified claims, plus the prescribed supplement statement ('Takviye edici gıdalar normal beslenmenin yerine geçemez' / 'Supplementary foods are not a substitute for a balanced diet').
More on turkish labelling, halal certification and the import customs reality
Halal certification is commercially important for the Turkish domestic market (>99% Muslim population) and increasingly for export to Gulf and broader Muslim markets — TSE (Türk Standardları Enstitüsü) and HAK (Helal Akreditasyon Kurumu) operate the Turkish halal accreditation framework with recognition arrangements covering GCC SMIIC standards, JAKIM (Malaysia), MUI (Indonesia) and others. Halal-sensitive ingredients include gelatin (must be bovine/fish from halal slaughter, never porcine), magnesium stearate (must not be porcine-derived), alcohol-containing flavour carriers, certain enzymes and any animal-derived processing aid. Customs clearance through Turkish Customs requires the appropriate authorisation document (supplementary food notification, marketing authorisation, UTS registration) on every shipment plus commercial invoice, certificate of origin, certificate of analysis and halal certificate where claimed. Non-compliance triggers shipment hold, product seizure, notification or authorisation suspension and administrative fines.
Questions
Can a foreign company hold the supplementary food notification?
The notification applicant must be a Turkish-resident legal entity — typically the importer of record, Turkish distributor or wholly-owned subsidiary. Non-Turkish brand-owners contract with a Turkish notification holder under a written agreement that defines notification ownership, change-control rights, exclusivity and exit provisions. As with EAEU/Russia, the notification is the asset of the holder, so distribution-agreement structuring needs careful attention to avoid trapping the brand inside a single distributor.
Does TİTCK accept FDA or EU CE approvals for medical devices?
Yes — reference-country approval (EU MDR CE marking, FDA 510(k)/PMA, Health Canada, PMDA, TGA) is recognised as the technical basis for ÜTS registration under the 2021 Medical Devices Regulation. The Turkish-specific elements (Turkish IFU, Turkish authorised representative, ÜTS registration, post-market surveillance commitment, incident reporting to TİTCK) still apply. Pharmaceutical reference-country reliance is more limited and follows specific TİTCK pathways for generics, well-established-use products and reference-product reliance, not blanket recognition.
Is halal certification required in Turkey?
Halal certification is not legally mandatory for most food and supplements but is commercially essential for the Turkish domestic market and increasingly required by major Turkish retailers (Migros, BİM, A101, ŞOK) for shelf placement. The exception is products with explicit halal claims — these are legally controlled and require accredited halal certification (TSE/HAK-accredited or internationally-recognised SMIIC/JAKIM/MUI). For export to GCC markets via Turkish supply chains, halal certification is effectively mandatory for any animal-derived or contested ingredient.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
The Dietary Supplement Operations Guide
What the label says. What the batch proves.
- The rules and who decides
- Specification to finished batch
- Test, review, investigate
- Labels, samples and recall
Plus Evidence map and four worksheets.
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The Dietary Supplement Operations Guide
What the label says. What the batch proves.
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