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.
