1. Introduction: Why Turkey Matters for Global Pharma
Turkey has become a strategically important market for global pharmaceutical groups. It combines:
- A large and relatively young population,
- A social security system that reimburses a significant portion of prescribed medicines, and
- A geographic position that connects Europe, the Middle East, Central Asia and North Africa.
For many foreign manufacturers, Turkey is not only a final market but also a potential regional hub for distribution, clinical research and manufacturing.
However, no medicinal product for human use can be legally placed on the Turkish market without a marketing authorization issued by the competent authority. This rule applies regardless of where the product is manufactured, how well known it is worldwide, or whether it is already approved by the EMA or FDA.
Because of that, foreign pharmaceutical companies must understand:
- Which legal entities can hold a marketing authorization in Turkey,
- How the application process works in practice,
- How local rules on pharmacovigilance, promotion, pricing and reimbursement interact with authorization, and
- What kind of contractual structures are needed with Turkish partners.
This article provides a practical and legal roadmap, written from the perspective of a foreign pharmaceutical company that plans to introduce its products into Turkey for the first time or expand an existing portfolio.
2. Regulatory Landscape and Key Actors
2.1. The main authority: Turkish Medicines and Medical Devices Agency
The central public authority responsible for pharmaceutical products in Turkey is the Turkish Medicines and Medical Devices Agency (commonly referred to by its Turkish abbreviation). It operates under the Ministry of Health and is entrusted with:
- Granting and renewing marketing authorizations,
- Assessing quality, safety and efficacy of medicinal products,
- Supervising pharmacovigilance systems,
- Conducting inspections (including GMP and GDP inspections),
- Approving variations and line extensions, and
- Ordering recalls, suspensions and other safety measures.
From the point of view of a foreign company, this agency is the main interlocutor throughout the life cycle of the product, from the first regulatory strategy discussions until the end of commercialisation.
2.2. Main sources of law and guidance
The regulatory framework is composed of:
- The general pharmaceutical law,
- A detailed regulation on licensing of medicines for human use,
- Implementing communiqués and guidelines on topics such as:
- Good Manufacturing Practice (GMP),
- Good Distribution Practice (GDP),
- Pharmacovigilance and risk management,
- Variations and line extensions,
- Labelling, packaging and patient information leaflets.
Although Turkish rules are inspired by the European model, they are not identical. There are local procedural details, specific timelines and practical expectations that foreign companies must take seriously.
3. Who Can Hold a Marketing Authorization in Turkey?
3.1. Requirement of a Turkish legal entity
One of the most important points for foreign companies is that the marketing authorization holder must be established in Turkey. A company that is incorporated abroad cannot directly hold a marketing authorization for a product that will be sold on the Turkish market.
In practice, foreign manufacturers usually choose between three main models:
- Wholly-owned subsidiary
- The global group incorporates a local company in Turkey.
- This local company becomes the marketing authorization holder (MAH).
- Distribution can be conducted by the same entity or outsourced.
- Local distributor as MAH
- A Turkish distributor or partner is appointed as MAH.
- The distributor imports and markets the product under a commercial and regulatory agreement.
- This model reduces initial set-up costs but requires strong contractual protection for the foreign manufacturer.
- Hybrid or “registration holder” models
- A Turkish company is used mainly as a formal MAH, while the foreign manufacturer retains broad control through contractual and technical arrangements.
Each structure has different implications for control of the dossier, pricing strategy, termination scenarios and transfer of the authorization. Choosing the right model is a strategic decision that should be evaluated at an early stage.
3.2. Responsibilities of the marketing authorization holder
The MAH is responsible for much more than obtaining the initial approval. Its core obligations include:
- Ensuring that the authorized product placed on the market is consistent with the approved dossier,
- Implementing and maintaining a pharmacovigilance system,
- Appointing qualified persons for pharmacovigilance and for quality-related activities,
- Notifying variations and keeping the authorization up to date,
- Cooperating fully with inspections and providing requested documentation,
- Initiating recalls when necessary and executing them in a timely manner.
From a foreign company’s perspective, the fact that the MAH is legally responsible means that intra-group agreements and distributor contracts must allocate tasks and liabilities very clearly.
4. Types of Authorization Pathways Relevant for Foreign Companies
4.1. Standard marketing authorization
The basic route is the standard marketing authorization, based on a complete or abridged dossier submitted to the agency. This pathway covers:
- Original products with new active substances,
- Fixed-dose combinations,
- Generics,
- Biosimilars,
- Line extensions such as additional strengths, new pharmaceutical forms or new indications (subject to specific rules).
The assessment focuses on quality, safety and efficacy, with a structure that mirrors the Common Technical Document (CTD). The applicant must provide both global data and local administrative elements such as Turkish language labelling and package leaflet.
4.2. Abridged applications (generic and similar products)
When the reference product is already authorized and data protection periods have expired, a generic or similar product can be authorized through an abridged application. In that case:
- The applicant relies on the reference product’s safety and efficacy data,
- Bioequivalence or comparability studies must be presented,
- The dossier still needs complete quality documentation.
Foreign manufacturers of generics who export to multiple markets usually already have robust CTD documentation and bioequivalence data. Nevertheless, they must adapt the application to Turkish expectations, including local language requirements and specific technical formats.
4.3. Special access routes and early access mechanisms
For products that are not yet authorized in Turkey but are needed for individual patients or special programs, there are special access mechanisms. These routes allow importation and supply in controlled conditions. Foreign companies often use them:
- To address urgent medical needs,
- To offer early access to innovative therapies,
- To prepare for a later full marketing authorization and gather real-world experience.
These mechanisms are tightly regulated and should not be seen as a permanent substitute for full registration. For a long-term commercial presence, obtaining a standard marketing authorization remains the main objective.
5. Preparing for Marketing Authorization: Strategic Considerations
5.1. Aligning global and Turkish regulatory strategies
Many products are developed with the European Union and the United States in mind as primary reference markets. When Turkey is added to the list of target countries, the foreign company should:
- Analyse how the global regulatory strategy can be adapted to Turkey,
- Decide whether Turkey will follow shortly after EMA/FDA approvals or be part of a later wave,
- Ensure that the data package used internationally is also suitable for Turkish requirements.
Early alignment avoids unnecessary duplication of studies or fragmented labelling strategies. It also helps in designing a consistent benefit–risk communication for regulators and healthcare professionals across jurisdictions.
5.2. Choosing the MAH model and local partners
Before any dossier is filed, the company should finalise its local structure:
- If a subsidiary will hold the MA, the group must plan corporate, tax and employment aspects, as well as the timeline for incorporating the entity.
- If a distributor will hold the MA, the licensing and distribution agreements must contain specific clauses on:
- Ownership of regulatory data and know-how,
- Rights and obligations related to variations and renewals,
- Conditions and procedure for transferring the marketing authorization if the collaboration ends,
- Quality and pharmacovigilance obligations,
- Information sharing and audit rights.
This step is fundamental. Many disputes in practice arise because the foreign manufacturer underestimated the leverage that the MAH has once the product is authorized and commercially successful.
5.3. Mapping the product portfolio and priorities
Foreign companies rarely bring their entire global portfolio into Turkey at once. Prioritisation is needed based on:
- Medical need and therapeutic value,
- Reimbursement prospects and price expectations,
- Complexity of manufacturing and supply chain,
- Degree of competition and generic presence in the Turkish market.
Preparing a launch roadmap enables the company to allocate regulatory resources effectively, coordinate pricing and reimbursement steps, and avoid bottlenecks in dossier preparation.
6. Dossier Preparation and Submission
6.1. CTD structure and documentation
The application is submitted in a CTD-based format with five modules. Broadly:
- Module 1 contains administrative and product information specific to Turkey, including application forms, mock-ups of packaging and patient information leaflets in Turkish.
- Module 2 provides overviews and summaries of quality, non-clinical and clinical data.
- Module 3 deals with pharmaceutical quality, including manufacturing, specifications, stability and analytical methods.
- Module 4 covers non-clinical study reports.
- Module 5 contains clinical study reports and supporting clinical documentation.
Foreign companies should carefully check consistency between these modules and ensure that modifications made for other markets have also been reflected in the Turkish version.
6.2. Language, format and technical requirements
All documentation that will be used by healthcare professionals or patients, such as the summary of product characteristics, package leaflet and labelling, must be provided in Turkish. Administrative forms and some sections of Module 1 also require Turkish.
Technical requirements include:
- Use of specific electronic formats and application portals,
- Compliance with structure and naming conventions for electronic submission,
- Inclusion of up-to-date certificates and signatories authorised to represent the MAH.
Foreign applicants commonly work with local regulatory affairs teams or consultants to manage these practical aspects.
6.3. Manufacturing sites, GMP and inspections
The agency requires evidence that the manufacturing sites comply with Good Manufacturing Practice. Depending on the plant’s location and certifications:
- An existing GMP certificate from a recognised authority may support the application;
- Additional documentation or inspections can be requested;
- On-site inspections may be planned, especially if the agency has limited familiarity with the facility or product type.
Because GMP assessments can influence the overall approval timeline, foreign companies are well advised to plan them early, rather than treating them as a last-minute technical formality.
7. Evaluation Process and Timelines
7.1. Validation phase
After submission, the application goes through a validation phase. During this phase, the agency checks:
- Whether the dossier is complete and structured correctly,
- Whether all required administrative documents are present,
- Whether fees have been paid and forms correctly signed.
If deficiencies are identified, the applicant is invited to correct them within a specified period. This stage is important, because avoidable delays here can shift the entire regulatory schedule.
7.2. Scientific and technical assessment
Once validated, the dossier is forwarded for detailed assessment. The reviewers examine:
- Pharmaceutical quality, including impurity profiles and stability,
- Non-clinical data, especially regarding safety,
- Clinical evidence for efficacy and safety, including design of pivotal studies, results and risk–benefit assessment,
- Risk management plans and pharmacovigilance system.
The authority may send lists of questions to the MAH. Precise and timely responses are crucial. Unclear or incomplete answers can lead to multiple rounds of questions and lengthen the time to decision.
7.3. Decision and post-authorization steps
If the agency is satisfied, it issues a marketing authorization decision. However, the product is not immediately ready to be shipped and sold. Several further steps usually follow:
- Technical arrangements for inclusion of the product in relevant registries,
- In some cases, batch release formalities or separate sales permits,
- Launch planning, including alignment with pricing and reimbursement status.
It is therefore practical to treat marketing authorization as a core milestone within a wider market access project, not as the final isolated step.
8. Post-Authorization Obligations
8.1. Pharmacovigilance and risk management
Once the medicinal product is on the market, the MAH must operate an effective pharmacovigilance system. In practice, this includes:
- Having a qualified person responsible for pharmacovigilance, with clear contact details,
- Collecting and evaluating reports of adverse events from healthcare professionals, patients, distributors and other sources,
- Submitting individual case safety reports and periodic safety update reports in accordance with applicable timelines,
- Implementing risk minimisation measures described in the risk management plan, such as educational materials or controlled distribution systems if needed.
Foreign companies should ensure solid integration between their global safety databases and the Turkish local system to avoid inconsistencies or missed signals.
8.2. Variations, renewals and lifecycle management
Over the life of the product, changes are inevitable: manufacturing sites may change, excipients may be updated, indications expanded or restricted, packaging modified. Many of these changes require variations to the marketing authorization.
Lifecycle management also includes:
- Renewal of the authorization after the initial period and then at specified intervals,
- Management of line extensions (for example new strengths or routes of administration),
- Decisions about withdrawing or temporarily suspending marketing for commercial or safety reasons.
Poorly managed variations can lead to regulatory non-compliance, stock issues or discrepancies between the marketed product and the approved dossier.
8.3. Promotion, information and ethical rules
The rules on promotion of medicinal products in Turkey are strict, particularly for prescription medicines. In general:
- Direct advertising of prescription medicines to the public is prohibited,
- Promotional activities are limited to healthcare professionals and must respect content and hospitality restrictions,
- Use of digital channels and social media is closely scrutinised.
Foreign companies must adapt global campaigns to local requirements and train their sales and medical teams on Turkish rules. Contracts with local distributors or contract sales organisations should clearly allocate responsibilities for compliance and monitoring.
9. Interaction with Pricing and Reimbursement
Marketing authorization and market access in the economic sense are closely linked but distinct:
- Marketing authorization focuses on quality, safety and efficacy;
- Pricing and reimbursement determine whether the medicine will be included in the publicly funded system and under what conditions.
Turkey operates a reference pricing system, comparing prices to those in selected reference countries, and a separate reimbursement decision process carried out mainly by the social security institution and related committees.
For foreign pharmaceutical companies, this means:
- Pricing and reimbursement strategies should be designed in parallel with the regulatory strategy, not afterwards;
- Timelines for price approval and reimbursement listing can affect the optimal launch date;
- Health economics and outcomes data, budget impact models and real-world evidence can play an important role.
A product with marketing authorization but no realistic reimbursement prospects may face very limited uptake, especially in therapy areas dominated by public funding.
10. Common Pitfalls for Foreign Pharmaceutical Companies
10.1. Underestimating the MAH’s strategic importance
One of the most frequent mistakes is to treat the choice of marketing authorization holder as a purely administrative choice. In reality, the MAH:
- Controls the relationship with the agency,
- Has the legal right to initiate variations, renewals and transfers,
- Is directly exposed to sanctions and inspections.
If the MAH is a local distributor, disagreements about pricing, marketing or future strategy may become harder to resolve once the authorization is in that company’s name. Carefully drafted contracts and thoughtful structuring from the start can prevent major problems later.
10.2. Treating Turkey as a “copy-paste” of EU or US processes
Although there is strong alignment with international standards, Turkey has its own procedural rules, timelines and administrative culture. Foreign companies sometimes:
- Submit dossiers that are technically correct but not fully adapted to local formats,
- Neglect the importance of Turkish translations and clear communication in Turkish,
- Expect decisions to follow automatically from European or American approvals.
A more realistic approach is to see Turkey as an important but separate jurisdiction with its own decision-making logic, while taking advantage of overlaps with global development programs.
10.3. Insufficient coordination between regulatory, commercial and supply teams
Marketing authorization, pricing, supply chain and commercial planning are closely connected. Problems may arise if:
- The authorization is granted but stock is not ready,
- Price approval is delayed and the launch plan has to be revised,
- Forecasts do not reflect realistic regulatory timelines.
To avoid this, foreign companies should create cross-functional launch teams that include regulatory affairs, medical, market access, finance and logistics specialists, as well as local partners.
11. Practical Recommendations for Foreign Manufacturers
For a foreign pharmaceutical company considering entry into Turkey, the following practical steps can serve as a checklist:
- Clarify objectives and product priorities
- Which products have the greatest strategic value in Turkey?
- How do they fit into the current reimbursement and competitive landscape?
- Choose an appropriate MAH structure
- Carefully evaluate pros and cons of a local subsidiary vs. distributor as MAH.
- Reflect the choice in detailed agreements, especially on MA transfer and data ownership.
- Engage with experienced Turkish regulatory experts
- Local expertise is vital for navigating detailed procedural requirements, language issues and practical expectations of the agency.
- Plan GMP, dossier preparation and translations early
- Avoid leaving technical and linguistic adaptation to the last moment.
- Integrate regulatory and pricing strategies
- Design a coherent path from authorization to reimbursement, with realistic timelines.
- Prepare robust pharmacovigilance and compliance systems
- Ensure that global policies are adapted to Turkish rules, and that responsibilities and reporting lines are clearly defined.
- Monitor legal and policy developments
- Guidelines, forms and regulatory practice may evolve; continuous monitoring helps prevent surprises and allows proactive adaptation.
12. Conclusion
Turkey offers foreign pharmaceutical companies a dynamic and sizeable market, but one that demands careful preparation and respect for local regulatory detail. Marketing authorization is the central legal gate that every human medicinal product must pass through before reaching patients. Because the marketing authorization holder must be a Turkish entity, foreign manufacturers need to make early strategic decisions about their local organisational model and partnership structure.
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