The pharmaceutical sector in Turkey is regulated by a strict legal framework covering licensing, market authorization, GMP compliance, and advertising regulations. Engaging a specialized pharmaceutical lawyer Turkey ensures your products meet Turkish Medicines and Medical Devices Agency (TİTCK) requirements. At Istanbul Law Firm, our experienced Turkish Lawyers and English speaking lawyer in Turkey assist pharmaceutical companies, distributors, clinical research organizations, and healthcare providers with regulatory filings, legal compliance, and litigation support. We draft and review license applications, labeling documentation, pharmacovigilance plans, and Quality Management System policies. Our approach protects both your products and your business reputation within this highly regulated sector.
Marketing Authorization & Drug Licensing Procedures
Obtaining marketing authorization for pharmaceuticals in Turkey requires navigating TİTCK’s detailed dossier, safety, and efficacy review processes. Our pharmaceutical lawyer Turkey team prepares CTD-format submissions, pricing and reimbursement applications, and dossier translations. We coordinate with pharmacovigilance experts to ensure post-market surveillance reporting meets requirements. Our Turkish Law Firm also advises on parallel imports, generic drug entries, and license transfers following mergers or acquisitions. This legal foresight ensures timely approvals and regulatory agility for your products.
We handle pre-submission meetings, evaluate clinical trial data compatibility, and verify documentation for biosimilar or biologics submissions. Our Turkish Lawyers interpret regulatory questions, evaluate complete response letters, and file appeals against TİTCK refusals. With our support, you minimize delays and avoid procedural errors. As a recognized best lawyer firm in Turkey, we ensure your drug portfolio is legally sound and commercially viable.
GMP, Manufacturing & Regulatory Compliance
Good Manufacturing Practice (GMP) compliance is mandatory under Turkish pharmaceutical law and heavily scrutinized during inspections. Our GMP compliance advisor, a subset of our pharmaceutical lawyer Turkey team, conducts internal audits and supports inspection readiness for manufacturing plants, contract manufacturers, and repackagers. We draft quality manuals, standard operating procedures, deviation reports, and corrective action plans. If TİTCK issues non-compliance warnings, we respond with appeals or mitigation strategies.
Our English speaking lawyer in Turkey handles audit communication with foreign manufacturers and supports multinational teams during inspection visits. We also work with EU or WHO-certified facilities to ensure dual compliance. For importers, we advise on GMP inspection coordination, variation reporting, and compliance certifications. This proactive legal approach reduces the risk of product recalls, market suspensions, or sanctions under Pharmaceutical Code.
We also negotiate with contract manufacturers, drafting compliance clauses, liability arrangements, and quality agreements. These contracts protect your product integrity and legal position. With continuous legal oversight, we maintain your manufacturing sites' regulatory health and business continuity in Turkey.
Clinical Trials, CRO Agreements & Ethics Committee Compliance
Clinical trials in Turkey are governed by the Regulation on Clinical Research and require pre-approval from the Ministry of Health’s Ethics Committee and TİTCK. Our pharmaceutical lawyer Turkey assists sponsors, CROs, and investigators in preparing trial protocols, investigator brochures, informed consent forms, and application dossiers. We support clients during Ethics Committee evaluations, site selection, and Subject Information Sheet compliance. For international sponsors, we ensure all documentation is translated, legally valid, and ethically compliant under Turkish law. We also provide due diligence on CROs and investigator sites, reducing sponsor risk and liability.
Our Turkish Lawyers draft and review Clinical Trial Agreements (CTAs), material transfer agreements (MTAs), and non-disclosure agreements (NDAs) for multi-center studies. We include IP protection, data ownership, indemnity clauses, and compensation frameworks. Our legal team also advises on SAE (Serious Adverse Event) reporting and pharmacovigilance obligations during and after the study. This minimizes regulatory violations and ensures transparency with health authorities. We also coordinate insurance policies to cover trial-related liabilities and investigator indemnities.
Our English speaking lawyer in Turkey supports global clinical sponsors in aligning Turkish regulatory obligations with ICH-GCP and EU CTR standards. From Phase I to Phase IV, we help you launch, monitor, and close your clinical trials legally and ethically. Related: Understanding Clinical Trial Regulation in Turkey
Pharma Advertising, Promotion & Labeling Law
Pharmaceutical advertising in Turkey is tightly regulated by the Regulation on Promotional Activities and Turkish Advertising Board rules. Our pharmaceutical lawyer Turkey advises on product labeling, patient information leaflets (PILs), and healthcare professional communication to ensure compliance. We review promotional brochures, digital campaigns, social media content, and sample distribution policies for prescription and OTC drugs. Misleading or unauthorized promotional activities can result in administrative fines, license suspension, or criminal action. We help pharma marketers and compliance teams avoid these risks by providing legal review before publication.
Our Turkish Lawyers draft internal advertising SOPs, media approval workflows, and pharma rep training materials. We assist in pre-clearance of congress sponsorships, speaker honoraria, and promotional booths. When facing a complaint or investigation, we prepare defense files, negotiate with the Advertising Board, and represent clients during hearings. Our litigation team has successfully defended pharmaceutical clients in product claim, scientific misrepresentation, and unfair competition cases.
With our English speaking lawyer in Turkey, international pharma companies gain a local legal partner who understands both regulatory and cultural boundaries of healthcare marketing. Related: Pharmaceutical Advertising Laws in Turkey: What You Must Know
Pharma Litigation, IP Disputes & Market Exclusivity
Pharmaceutical litigation in Turkey often involves patent disputes, regulatory exclusivity claims, or reimbursement challenges. Our pharmaceutical lawyer Turkey represents clients in appeals against TİTCK refusals, competitor complaints, and generic launch challenges. We prepare court petitions for data exclusivity protection, patent linkage actions, and parallel import bans. In coordination with patent attorneys, we file infringement cases and interim injunction requests to protect intellectual property. This protects R&D investments and market exclusivity for originator drugs.
Our Turkish Lawyers defend against allegations of unfair competition, unauthorized promotion, and reimbursement fraud. We also represent clients before the Advertising Board, Ethics Committee, and reimbursement authority during audits or legal review. In reimbursement disputes, we support applications for drug inclusion, appeal delisting decisions, and argue for fair reference pricing. Each litigation strategy is based on regulatory precision and pharmaceutical sector know-how.
With an experienced English speaking lawyer in Turkey managing your case, foreign pharmaceutical clients gain localized legal insight and courtroom representation. We protect innovation, reputation, and access through detailed legal defense.
Import, Export & Pharmaceutical Distribution Law
Importing or exporting pharmaceuticals in Turkey requires strict legal compliance on licensing, labeling, GMP validation, and tax documentation. Our pharmaceutical lawyer Turkey assists clients in coordinating with Turkish Medicines and Medical Devices Agency (TİTCK), customs authorities, and local distributors. We draft and review distribution agreements, define territory and exclusivity rights, and ensure anti-diversion provisions are in place. Our import/export frameworks are designed for legal enforceability and commercial reliability.
We also advise on bonded warehouse arrangements, consignment stocks, temperature-sensitive logistics, and serialization obligations. Our Turkish Lawyers monitor Ministry of Trade compliance, customs duties, and import/export licensing. We represent clients in customs disputes involving seizure, mislabeling, or regulatory blockages. When conflicts arise with local partners, we initiate or defend breach of distribution contract lawsuits.
Our English speaking lawyer in Turkey ensures international pharma manufacturers fully understand their compliance duties and legal risks. With Istanbul Law Firm, your cross-border pharma supply chains stay protected and agile.
Why Istanbul Law Firm Is the Best Lawyer Firm in Turkey for Pharmaceutical Law
Istanbul Law Firm is a strategic legal partner for global and local pharmaceutical businesses. Our pharmaceutical lawyer Turkey offers regulatory, transactional, and litigation expertise in a sector where legal detail can make or break product access. We advise from clinical trial to commercialization, ensuring legal protection and business continuity. Our team includes regulatory counsel, trial attorneys, and contract drafters with sector-specific know-how. This 360-degree support makes us a trusted name in Turkish pharma law.
Our Turkish Lawyers help companies launch new products, defend patents, resolve audits, and expand legally. Whether you are a local generics firm or a multinational innovator, we offer bilingual legal services with international quality. We work closely with regulatory teams, in-house counsel, and international headquarters to bridge legal, cultural, and business gaps. Istanbul Law Firm is not just your legal advisor—we are your compliance partner.
Our English speaking lawyer in Turkey gives foreign clients peace of mind when navigating Turkish pharma law. From licensing to labeling to litigation, we protect your interests across the pharmaceutical lifecycle.
Frequently Asked Questions (FAQ)
- Do I need a license to market pharmaceuticals in Turkey? – Yes. Marketing authorization from TİTCK is required before any promotion or sale.
- Can a foreign company apply for marketing authorization? – Yes, but typically through a local MAH (Marketing Authorization Holder) representative.
- What is GMP and why is it important? – Good Manufacturing Practice ensures drug safety and quality. It’s legally mandatory in Turkey.
- How are clinical trials regulated? – By the Ministry of Health and Ethics Committees. We assist with all approvals and legal documentation.
- Can pharma companies advertise products in Turkey? – Only to professionals. OTC promotion is tightly regulated. We review compliance.
- What happens if a product fails GMP inspection? – TİTCK may suspend the license or impose sanctions. We provide appeals and response strategy.
- Do you help with import-export pharma law? – Yes. We handle customs, licensing, labeling, and partner contract disputes.
- What is data exclusivity? – A protection period preventing use of originator trial data by generics. We litigate to protect it.
- Can I resolve disputes with regulators? – Often yes. We pursue administrative appeals and defense before regulatory boards.
- Is pharmacovigilance legally required? – Yes. We help design and review your reporting system to meet obligations.
- Do you assist with product recalls? – Absolutely. We draft recall plans and advise on legal duties.
- Who is the best pharmaceutical lawyer in Turkey? – Istanbul Law Firm—trusted by top pharma brands for regulatory, litigation, and compliance counsel.
Contact Our Turkish Pharmaceutical Lawyers Today
Whether you're launching a new pharmaceutical product, preparing for regulatory inspections, or facing litigation in Turkey, Istanbul Law Firm delivers full-spectrum legal support. Our expert pharmaceutical lawyer Turkey provides strategic, sector-specific, and bilingual legal services tailored for pharma and healthcare businesses. As a best lawyer firm in Turkey, we combine regulatory depth with courtroom strength. Contact our English speaking lawyer in Turkey today to safeguard your pharmaceutical business with expert legal counsel.
