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December 1, 2022
A A

 Tariffs for state registration of medicines and drugs
 № Service Type Unit Tariffs
(Without VAT, azn)
1. Preliminary examination with the purpose of state registration
1.1 Medicines and drugs (medicinal substances) 1 pc 200
2. Specialized expertise for the purpose of state registration
2.1 Original drugs 1 pc 2600
2.1.1 Each additional dose 1 pc 385
2.1.2 Each additional packing 1 pc 385
2.2 Generic medicines 1 pc 2100
2.2.1 Each additional dose 1 pc 385
2.2.2 Each additional packing 1 pc 385
2.3 New combinations of registered medicines 1 pc 2600
2.3.1 Each additional dose 1 pc 385
2.3.2 Each additional packing 1 pc 385
2.4 API 1 pc 700
3. Specialized expertise with the purpose of re-registration
3.1 Medicines 1 pc 1300
3.1.1 Each additional dose 1 pc 385
3.1.2 Each additional packing 1 pc 385
3.2 API 1 pc 350
4. Specialized expertise for the purpose of registration of changes in registration documents
4.1 Medicines 1 pc
4.1.1 Type IA changes 1 pc 200
4.1.2 Type IB changes 1 pc 400
4.1.3 Type II changes 1 pc 600
4.1.4 Technical changes 1 pc 100
4.2 API 1 pc 120
Fees for laboratory tests of medicines and medicines imported into the country or produced locally
 № Service Type Unit Tariffs
(Without VAT, azn)
Preliminary expertise with the purpose of state registration
1. Injection 1 expertise 45
2. Capsules (tablets) 1 expertise 18
3. Soluton 1 expertise 21
4. Liniment 1 expertise 39
5. Suppository 1 expertise 36
6. API 1 expertise 40

Appendix 3

to the Decision of the Tariff (Price) Council

of the Republic of Azerbaijan

dated December 5, 2023 No. 10

Tariffs for services for expertise of documents on pharmacovigilance provided after state registration of a medicinal product

 

 

№

 

Name of service

Unit of measurement Tariffs

In manats

(Excluding VAT)

I II III IV
  Expertise of pharmacovigilance documents (when conducting an expertise of pharmacovigilance documents provided after state registration of a medicinal product)    
1. Original medicinal products    
 

1.1.

Expertise of Periodic Safety Update Report (PSUR) documents  

1 pс

 

400

1.1.1. Each additional dose * 1 pc 50
1.1.2. Each additional form * 1 pc 50
1.2. Expertise of Risk Management Plan (RMP) documents 1 pc 300
1.2.1. Each additional dose * 1 pc 50
1.2.2. Each additional form * 1 pc 50
2. Generic medicinal products    
2.1. Expertise of Periodic Safety Update Report (PSUR) documents 1 pc 360
2.1.1. Each additional dose * 1 pc 50
2.1.2. Each additional form * 1 pc 50
2.2. Expertise of Risk Management Plan (RMP) documents 1 pc 280
2.2.1. Each additional dose * 1 pc 50
2.2.2. Each additional form * 1 pc 50
3. Expertise of Pharmacovigilance System Master File (PSMF) 1 pc 620

 

* This refers different doses and different forms based on the active substance of the medicinal product registered in the Republic of Azerbaijan in relation to the same marketing authorization holder.

Note: The tariffs listed in Appendix 3 come into force from 01.05.2025.

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  • RURU
No Result
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  • About Us
  • Import
    • Documents
    • Letter samples
  • Control
    • Control on Medicines
    • Legislation
  • Registration
    • Department of Registration
    • Legislation
  • Laboratory
    • About the Quality Control Laboratory
  • Pharmacovigilance
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    • Legislation
    • Information for healthcare professionals
    • Information for Patients
    • Pharmacovigilance dictionary
    • Reporting forms
    • Online reporting
    • Contacts
    • For MAH
    • Medicines under additional monitoring
  • Private medical institutions
    • Legislation
  • FS
    • Expertise of FS
    • Result of the Expertise of FS
  • Medical devices
    • Application form
    • MD Documents
    • Results of examination of medical devices
    • Legislation
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