Documents required for the examination of medical devices produced in pharmaceutical form with a certain dosage, containing substances of natural, synthetic, mineral origin and their complexes
1) Application letter
2) Drug packaging layout design (En/Ru/Tr) (primary and secondary packaging)
3) İnstruction for use (Original (En/Ru/Tr) and AZ)
4) Composition / Ingredient list
5) Certificate of analysis (with methods) (to the presented series)
6) Specification
7) Free Sale certificate
8) Certificate of registration
9) It should be marked on the packaging as a medical device/not a drug – or must have CE/EAC mark in which case Conformita CE or CE declaration must be submitted –
10) Sample -2
Note: Instructions for use and composition document must be submitted in Electronıc format (word). The main and auxiliary items must be the same as the Composition document.
The required documents are submitted to the One Window Service (Bir Pəncərə xidməti) of Analytical Expertise Center.
