Our Legal Services for the Pharmaceuticals Sector
Our experienced legal team provides comprehensive support tailored to the specific needs of pharmaceuticals businesses operating in Turkey:
- Drug registration
- Clinical trials
- Pricing and reimbursement
- Licensing agreements
- Pharmacovigilance
- Regulatory submissions
- Litigation and filing of lawsuits before Turkish courts
- Case follow-up and litigation management
- Debt collection and enforcement proceedings (icra takibi)
Key Legal & Regulatory Issues in Turkey
Companies in the pharmaceuticals sector should be aware of the following regulatory and legal considerations when operating in Turkey:
- TITCK authorization
- GMP compliance
- Reference pricing
- Patent rights and regulatory approval assessed separately
- Promotional regulations
- Parallel imports
Which Legal Route Applies?
Separate medicinal marketing authorisation, clinical-trial permission, manufacturing or import compliance, and pricing or reimbursement. TITCK handles medicine regulation; SGK reimbursement is a separate assessment. Do not treat approval in another market as automatic Turkish authorisation.
Evidence to Prepare Before the Next Step
Prepare the product classification, proposed local applicant or holder, dossier, manufacturing and GMP evidence, labels and pharmacovigilance arrangements. For a trial, assess the applicable ethics and authority approvals separately. For reimbursement, review the current SGK route after identifying the medicine and indication; approval and reimbursement have different evidence and timelines.
Sources & Authorities
Relevant statutory framework and official guidance. Applicable requirements depend on the activity, documents and current rules.
Why Work With Turkish Trade Lawyers
Industry Understanding
We understand the commercial realities and regulatory environment of the pharmaceuticals sector in Turkey.
International Perspective
Our team regularly advises international clients on Turkish market entry and ongoing operations.
Clear Communication
We provide practical, business-oriented legal advice in clear terms you can act upon.
Responsive Service
We understand the pace of business and provide timely responses to your legal needs.