REGULATIONS IN TURKEY

Will be updated.

A Regulation To Amend The Regulation On Packaging And Labeling Of Medicinal Products For Human Use
Biosimilar medicinal products Guide
Fixed Combination Medicinal Products For Human Use
Guidance for the Preparation of Good Clinical Practice Inspection Reports
Guidance on Agency Pharmaceutical Warehousing Practices
Guidance on Ethical Considerations for Clinical Trials on Medicinal Products with the Pediatric Population
Guidance On Insuring Subjects In A Clinical Trial
Guidance On The Collection, Verification And Presentation of Adverse Reaction Reports Occurring During Clinical Trials
Guidance on the Format of Applications to the Ministry for a Clinical Trial
Guidance on The Good Manufacturing Practices For Pharmaceutical Products (part 1)
Guidance on The Good Manufacturing Practices For Pharmaceutical Products (part 2)
Guideline For Pharmavovigilance Inspections
Guideline on Independent Data Monitoring Committees
Guideline Regarding Application Format and Documentation to Be Submitted In an Application for Ethics Committee Opinion on Clinical Trials
Guideline Regarding Legibility of Packaging and Patient Leaflets of Medicinal Products for Human Use
List and Conditions of Type IA and Type IB Minor Variations to be Conducted in Accordance with Articles 5 and 6
Natural (Herbal, Animal-Based, Mineral-Based, Etc.) and Other Pharmaceutical Products (Borderline Products) That Are Complementary to Treatment and Maintain Health
Pharmacovigilance Guidelines for Registration Holders of Medicinal Products for Human Use
Regulation Amending the Regulation on Manufacturing Sites of Medicinal Products for Human Use
Regulation Amending The Regulation Regarding Pharmacy Warehouses and The Products Stored in Pharmacy Warehouses
Regulation On Amending The Regulation Regarding The Packaging And Labeling Of Medicinal Products For Human Use
Regulation on Manufacturing Plants of Medicinal Products for Human Use
Regulation on Packaging and Labeling of Medicinal Products for Human Use
Regulation on the Registration of Medicinal Products for Human Use
Regulation Regarding Chemical Subtances Subject to Control
Regulation Regarding the Monitoring and Assessment of Medicinal Products for Human Use
Regulation Regarding the Packaging and Labeling of Medicinal Products for Human Use
Turkish Republic Ministry Of Health Pharmaceutical General Directorate
Turkish Drugs Barcode Guidance

Omega is the first clinical trial specific depot in Turkey. We offer clinical trial storage services since 2003. Also Omega is the only one clinical trial specific depot that stored and distrubute 340.000 IMPs for Turkish Ministry of Health.