Description of procedure towards registration of medicinal products in Azerbaijan.
Step 1. Once you’ve decided to register the products with us, we sign the CDA (Confidential Agreement).
Step 2. You send the documents to our office, so we can perform the primary control of received information.
Step 3. We carefully look through your documents, prepare a list of missing ones and define the amount of work to be done.
Step 4. We announce the primary price and negotiate discounts and terms of payment ; if they are suitable for you, we can start the registration procedure and you pay the first instalment (25%) for services our Agency provided. If not, we send you back all received documentation.
Step 5. We perform the translation of the documents according to local requirements, and prepare the missing documentation.
Step 6. We submit the application form and two copies of the final version of the dossier to the Innovation and Supply Center (ISC). You send us the samples of the finished products plus standards. We submit these samples to the laboratory for expertise. ISC issue the invoices for State Fees and Expertise which are sent to you with eLigne Agency’s invoice for second instalment (50%).
Step 7. We answer any questions from the ISC.
Step 8. The original registration certificate is being issued within 2 weeks following products’ agreement.
Step 9. We send you the original registration certificate (market authorisation) and you give us the last instalment (25%).