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