Romania - Tariffs for products authorised through mutual recognition procedure or decentralised procedure
Ther Framavita.Net members and visitors please be informed that in Romania for registration of medicinal product two separate fees should be paid:
-one is called tax for evaluation and is in amount of 1000 euros, no matter the type of registration
-the other one is a fee for registration which depends on the type of the application (registration, variation by national procedure/ MRP/ DCP).
Please find attached a list of fees for registration of medicinal products by NMA, depending on the type of the application. This list of prices is valid from December 2006 and if suffers modifications I will let you know!
Valid from 28.12.2006
Tariffs for performances of the Evaluation-Authorisation Department for products authorised through mutual recognition procedure or decentralised procedure
|
Nr. |
Performance |
Tariff EURO |
|
1. |
Authorisation of medicinal products for human use with new active substance proposed through mutual recognition procedure or decentralised procedure having ROMANIA as a reference Member State |
7500 |
|
2. |
Authorisation of medicinal products for human use resulted through a new association of known substances (fixed dose combinations) proposed through mutual recognition procedure or decentralised procedure having ROMANIA as a reference Member State |
6400 |
|
3 |
Authorisation of medicinal products for human use with well-established medicinal use proposed through mutual recognition procedure or decentralised procedure having ROMANIA as a reference Member State |
5800 |
|
4. |
Authorisation of generic medicinal products proposed through mutual recognition procedure or decentralised procedure having ROMANIA as a reference Member State |
5155 |
|
5. |
Authorisation of medicinal products for human use with new active substance proposed through mutual recognition procedure or decentralised procedure having ROMANIA as a first wave Member State concerned |
5000 |
|
6. |
Authorisation of medicinal products for human use resulted through a new association of known substances (fixed dose combinations) proposed through mutual recognition procedure or decentralised procedure having ROMANIA as a first wave Member State concerned |
4265 |
|
7. |
Authorisation of medicinal products for human use with well-established medicinal use proposed through mutual recognition procedure or decentralised procedure having ROMANIA as a first wave Member State concerned |
3865 |
|
8. |
Authorisation of generic medicinal products proposed through mutual recognition procedure or decentralised procedure having ROMANIA as a first wave Member State concerned |
3435 |
|
9. |
Authorisation of medicinal products for human use with new active substanceauthorised in ROMANIA through national procedure and proposed through "repeat use" procedure having ROMANIA as a second wave Member State concerned |
3750 |
|
10. |
Authorisation of medicinal products for human use resulted through a new association of known substances (fixed dose combinations) authorised in ROMANIA through national procedure and proposed through "repeat use" procedure having ROMANIA as a second wave Member State concerned |
3200 |
|
11. |
Authorisation of medicinal products for human use with well-established medicinal use authorised in ROMANIA through national procedure and proposed through "repeat use" procedure having ROMANIA as a second wave Member State concerned |
2900 |
|
12. |
Authorisation of generic medicinal productsauthorised in ROMANIA through national procedure and proposed through "repeat use" procedure having ROMANIA as a second wave Member State concerned |
2580 |
|
13. |
Authorisation of medicinal products for human use with new active substanceauthorised in ROMANIA through CADREAC simplified procedure and proposed through "repeat use" procedure for harmonisation with the initial mutual recognition procedure |
2500 |
|
14. |
Authorisation of medicinal products for human use resulted through a new association of known substances (fixed dose combinations) authorised in ROMANIA through CADREAC simplified procedure and proposed through "repeat use" procedure for harmonisation with the initial mutual recognition procedure |
2135 |
|
15. |
Authorisation of medicinal products for human use with well-established medicinal use authorised in ROMANIA through CADREAC simplified procedure and proposed through "repeat use" procedure for harmonisation with the initial mutual recognition procedure |
1935 |
|
16. |
Authorisation of generic medicinal productsauthorised in ROMANIA through CADREAC simplified procedure and proposed through "repeat use" procedure for harmonisation with the initial mutual recognition procedure |
1720 |
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