In this chapter you can download:
1) Information about company and other useful documents:
2) Lists of required documents for:
- New registration of medicinal preparations – simplified format of the dossier
- New registration of medicinal preparations – CTD-format
- Renewal procedure
- Registration of substances (APIs)
- Registration of medical devices and equipment
- Registration of BAS
- Registration of cosmetic products
- GMP-recognition procedure
3) Applications:
- For original medicinal product, generic or fixed combination registration
- Changes (variations) implementation
- Renewal procedure
- Registration (re-registration) of substances
- Registration (re-registration) of medicinal product (simplified application)
- GMP-recognition procedure
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