本文主要内容由 Moroğlu Arseven 律师事务所提供，锦天城资深律师李瑶瑶整理，旨在为中国投资者清晰解读土耳其药品原料进口合规中的模式选择、监管路径与过境安排。

The main content of this article is provided by Moroğlu Arseven Law Firm and organized by Li Yaoyao, a senior lawyer at AllBright Law Firm, aiming to provide Chinese investors with a clear interpretation of the compliance rules for importing pharmaceutical raw materials into Türkiye, including model selection, regulatory pathways, and transit arrangements.

本指南旨在介绍中国企业将药品原料（不属于管控物质）出口至土耳其所受到当地的主要法律与监管要求。土耳其对药品原料的进口实行分类监管，取决于该原料是用于人用药品还是兽用药品。此外，进口安排（是否以土耳其本地实体作为进口商）以及最终用途（市场销售或过境转运）将直接影响适用的义务范围。

This guide provides an overview of key legal and regulatory requirements for importing pharmaceutical raw materials into Türkiye. Türkiye applies a differentiated regulatory framework depending on whether the raw material is intended for human or veterinary pharmaceutical use. Furthermore, the import arrangement (whether a local Turkish entity acts as importer of record) and the intended use (domestic market placement or transit) directly affect the scope of applicable obligations.

1. 土耳其规范药品原料进口的基础性立法包括：

(1) 第 1262 号《药品与医药制剂法》（人用药品）

(2) 第 5996 号《兽医服务、植物健康、食品与饲料法》（兽用药品）

(3) 各部委发布的配套法规、公告及行政指南（如《进口申请及市场投放许可指南》、年度进口检验公告等）

(1) The foundational legislation includes:

(2) Law No. 1262 on Pharmaceutical and Medicinal Preparations (human use)

(3) Law No. 5996 on Veterinary Services, Plant Health, Food and Feed (veterinary use)

(4) Implementing regulations, communiqués, and administrative guidelines issued by relevant ministries (e.g., Guideline on Import Applications and Market Placement Authorisation, annual Import Inspection Communiqués).

2. 主管机关方面：人用药品原料由土耳其药品和医疗器械局（TİTCK）监管；兽用药品原料由农林部（TAGEM）监管。土耳其贸易部对进口检验及海关程序负有综合监督职责。

The competent authorities are: the Turkish Medicines and Medical Devices Agency (TİTCK) for human pharmaceutical raw materials; and the Ministry of Agriculture and Forestry (TAGEM) for veterinary pharmaceutical raw materials. The Ministry of Trade exercises overarching supervisory authority over import inspections and customs procedures.

根据土耳其交易对手（买方/代理）的角色，进口安排分为两种模式，其法律后果不同。

Depending on the role of the Turkish counterparty (buyer/agent), two distinct legal models arise with different consequences.

1. 模式一：土耳其主体作为独立进口商（以自身名义、自身账户）

Model 1: Turkish Company as Independent Importer (in its own name and on its own account)

在此模式下，土耳其交易对手是登记进口商，承担向海关和监管机关申报的全部法律义务。委托方（境外生产商）不承担直接监管责任，但作为生产商仍需履行以下文件和质量义务：

①　逐批次提供经批准的分析证书（CoA）；

②　持有并维护有效的 GMP 证书；

③　持有并维护欧洲药典适用性证书（CEP）或 TİTCK 出具的符合性函件。

In this model, the Turkish counterparty is the importer of record and bears all legal obligations for customs and regulatory filings. The foreign manufacturer (Client) does not bear direct regulatory responsibility but must still fulfill certain documentation and quality obligations as the manufacturer, including:

①　Providing a perbatch approved Certificate of Analysis (CoA);

②　Holding and maintaining a valid GMP Certificate;

③　Holding and maintaining a Certificate of Suitability to the Monographs of the European Pharmacopoeia (CEP) or a conformity letter issued by TİTCK.

2. 模式二：土耳其公司仅作为代理人或报关行（以委托方名义、委托方账户）

Model 2: Turkish Company as Agent or Customs Broker (in the Client’s name and on the Client’s account)

在此模式下，委托方被视为登记进口商，直接承担所有适用的土耳其监管要求，包括取得管控证书、符合性函件、进行海关申报等。该模式对境外生产商的风险和义务显著增加。

In this model, the Client is treated as the importer of record and assumes direct responsibility for all applicable Turkish regulatory requirements, including obtaining control certificates, conformity letters, and making customs declarations. This model significantly increases the risks and obligations for the foreign manufacturer.

如出口至土耳其的药品原料用于人类使用的药品，须遵守以下核心要求：

If the pharmaceutical raw material exported to Türkiye is intended for use in medicinal products for human use, the following core requirements must be complied with:

A. 本地代表要求Local Representation Requirement

境外生产商必须指定一家在 TİTCK 注册的土耳其实体（授权进口商）作为本地代表。实现方式包括：(i) 在土耳其设立子公司并注册为授权进口商；或 (ii) 与已获 TİTCK 许可的土耳其公司签订分销/进口代理协议。实践中方案 (ii) 更为便捷。

A foreign manufacturer must designate a Turkish entity registered with TİTCK (authorised importer) as its local representative. This can be done by either (i) incorporating a Turkish subsidiary and registering it as an authorised importer, or (ii) signing a distribution/import agency agreement with a Turkish firm already licensed by TİTCK. Option (ii) is generally more expedient.

B. 管控证书Control Certificate

即使未被列为管控物质，适用人类药品的原料进口仍须取得TİTCK 签发的管控证书。该证书主要发挥常规进口监管功能（确保产品质量和安全）。申请须通过 EBS-ESY 电子系统提交，并附上形式发票、GMP 证书、CEP 或符合性函件、成品上市许可等文件。无有效管控证书的，海关不予放行。

Even if the raw material is not classified as a controlled substance, its importation for use in human pharmaceutical products remains subject to obtaining a Control Certificate issued by TİTCK. This certificate primarily serves a routine import control function (ensuring product quality and safety). Applications must be submitted through the EBS-ESY electronic system, accompanied by documents such as a proforma invoice, GMP certificate, CEP or a conformity letter, and the marketing authorization for the finished product. Customs will not release the goods without a valid Control Certificate.

C. 海关程序Customs Procedures

进口人（或持牌报关行）须通过土耳其海关单一窗口系统提交电子报关单，申报 GTİP 编码（HS 税则号）、完税价格、原产国等信息。UDCA 通常归入 HS 2918.19 项下，但具体子目须由海关当局最终确认。

The importer (or licensed customs broker) must file an electronic customs declaration via the Turkish Single Window System, declaring the GTİP code (HS tariff number), customs value, country of origin, etc. UDCA generally falls under HS heading 2918.19, but the precise subheading must be confirmed by the customs authority.

如土耳其进口药品属于兽用，须遵守以下核心要求：

If the pharmaceutical product imported into Türkiye is for veterinary use, the following core requirements must be complied with:

(1) 本地注册与授权Local Registration and Authorisation

与人用路径类似，境外生产商须与在农林部注册并授权的土耳其公司合作，或自行在土耳其设立实体并完成注册。

Similar to the human pathway, the foreign manufacturer must either cooperate with a Turkish company registered and authorised by TAGEM, or incorporate and register its own Turkish entity.

(2) 符合性函件 Conformity Letter

如进口原料未列入兽用公告附件中的 GTİP 编码列表，只要其构成兽用药品或用于兽用药品生产，仍须取得农林部签发的符合性函件。申请时需提交申请书、形式发票、GMP 证书、分析证书等。无符合性函件的，海关不予进口。

If the raw materials are not listed among the GTİP codes in the annexes to the Veterinary Communiqué, a Conformity Letter from TAGEM is mandatory as long as the substance constitutes or is used in the manufacture of a veterinary medicinal product. The application requires a petition, proforma invoice, GMP certificate, CoA, etc. Customs will not permit importation without a Conformity Letter.

(3) 海关程序Customs Procedures

与人用路径类似，进口商须通过单一窗口系统报关，并可能需在进口完成后向农业部提交进口通知及信息表格。

Similar to the human pathway, the importer must file a customs declaration via the Single Window System, and may be required to submit import notification and information forms to TAGEM within 45 days after importation.

如原料仅过境土耳其领土转运至第三国，且不进入土耳其自由流通，则不被视为“进口”，因此无需取得TİTCK管控证书或农业部符合性函件。但仍须遵守一般过境程序：提交过境申报单、提供海关担保（如需）、遵守规定路线和时限。一旦货物转入自由流通，所有进口管控要求将全面适用。

If the raw materials merely transits through Turkish territory to a third country without being released into free circulation, it is not considered an “import” and therefore does not require a TİTCK Control Certificate or a TAGEM Conformity Letter. However, general transit procedures apply: filing a transit declaration, providing a customs guarantee (if required), and following prescribed routes and time limits. If the goods are diverted into free circulation, all import control requirements become fully applicable.

1. 明确进口模式：境外生产商应首先确认土耳其交易对手是作为独立进口商还是仅作为代理人，以厘清各自的法律义务。

Clarify import model – Foreign manufacturers should first confirm whether the Turkish counterparty acts as an independent importer or merely as an agent, to define each party’s legal obligations.

2. 本地代表安排：无论人用还是兽用路径，均建议与已获许可的土耳其本地公司签订分销/代理协议（方案二），以降低合规成本和时间。

Local representative arrangement – For both human and veterinary pathways, it is advisable to enter into a distribution/agency agreement with a duly licensed Turkish company (Option ii) to reduce compliance costs and time.

3. 文件准备：确保持有有效的 GMP 证书、CEP 或符合性函件，并能为每一批次出具经批准的分析证书。

Documentation readiness – Maintain valid GMP certificates, CEP or conformity letters, and be able to issue approved Certificates of Analysis for each batch.

4. 提前GTİP 确认：在首次进口前，建议通过报关行或海关预先裁定程序确认UDCA 适用的准确GTİP编码。

Advance GTİP confirmation – Before the first import, confirm the exact GTİP code for UDCA through a customs broker or advance ruling procedure.

5. 过境 vs 内销：如仅为转运目的，应严格维持过境程序，避免货物进入土耳其自由流通，否则将触发完整的进口管控要求。

Transit vs. domestic placement – If only transiting, strictly adhere to transit procedures and avoid releasing the goods into free circulation, which would trigger full import control requirements.

本文仅为介绍土耳其药品原料进口法律框架的一般性指南，不构成具体法律意见。实务操作中请务必咨询持有土耳其执业资格的法律顾问。

This article is a general guide to the legal framework for importing pharmaceutical raw materials into Türkiye and does not constitute legal advice. In practice, qualified Turkish legal counsel should always be consulted.