Registration of Original composition Medicine
Registration of Generic medicines
The Services we provide:
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Registration of Pharmaceutical products in the territory of Azerbaijan
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Re-registration of Pharmaceutical products in the territory of Azerbaijan
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Changes process of already registered products in the territory of Azerbaijan
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Addition of required dose, pack, design & ETC in registered product
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Registration of herbal products & food supplements in the territory of Azerbaijan
– All services go according to the guidelines of the (Ministry of Health Azerbaijan).
– The process starts by checking the shared CTD Dossier by the Manufacturer.
– All admin documents like WHO-GMP, Manufacturing license, and COPP, Artwork, pack insert according to the guidelines of MOH (Ministry of Health Azerbaijan).
– Samples and Working standards should be according to the rules and active.
1st step is the submission of the dossier to (the Ministry of Health Azerbaijan) if the documents are according to guidelines process goes further. 1st official fee contract is made after paying the fee and starts the primary expertise.If there are incomplete documents in the submitted dossier Experts share the query officially. That must be submitted as a reply officially in MOH according to the given timelines. If the reply to the query is submitted and there is no missing part.
After that, the 2nd official fee contract is given for the payment. Which have to be paid within 30 working days.In the main process, the testing of samples in the lab of MOH and on the other hand all modules are checked by the experts of MOH (Ministry of Health). All processes are according to the European guidelines.
If there is no other query or problem in the submitted dossier, Samples, and WS the approval letter is given then the fee is paid and the application for RC is submitted. After the submission, we receive the RC in 10-15 days and share with you all the set of approval documents the artwork, the pack insert, and the Registration certificate. For exact timelines and guidelines drafts and other details, please feel free to contact us we will be happy to guide you just drop us an email on our home page “Get in touch with us” section.