BIIB-GEN Meeting August 2009. prepared for. about us…. Our Partners. Pr oduct L icensing & B usiness D evelopment - 1. Marketed. P roduct l icensing & B usiness d evelopment - 2. Pipeline. P roduct l icensing & B usiness d evelopment - 2. Pipeline. Offices.
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• After the submission of the registration dossier,registration approval will be in 18 to 24 months.
• FDA or EMEA files are accepted.
• As of January 1st 2006, only CTD format is accepted byTurkish MOH.
The cheapest ex-factory price (hospital price if ex-factory is not available) in reference countries(France, Italy, Portugal, Spain, Greece) and country of origin will be accepted as Turkish ex-factory price.
For all reimbursed products 24% reimbursement discount is by law. Additional discount may be asked in some cases. Registered products may apply for reimbursement (fully or partly) which is a very difficult process. It takes time and huge effort is necessary.