Romanian CA new fees
Starting with May 19th 2008, the National Medicine Agency in Romania has increased the tariffs for evaluation of all types of applications (obtaining marketing authorizations via national procedure/ MRP and DCP, for variations, for renewals of MA, for clinical trials etc.).
So, the new tariffs for obtaining MA through European procedures (MRP and DCP) are as follows:
| No. | Performance | Tariff- euro - |
| 1. | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Reference Member State - full dossier [Article 8(3) of Directive 2001/83 EC or Article 702(4) of Law 95/2006, with further amendments and additions] | 11.500 |
| 1.a) | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Reference Member State - full dossier - different pharmaceutical form submitted at the same time with submission of full dossier application [Article 8(3) of Directive 2001/83 EC or Article 702(4) of Law 95/2006, with further amendments and additions] | 6.900 |
| 1.b) | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Reference Member State - full dossier - the second and following strengths submitted at the same time with initial application [Article 8 (3) of Directive 2001/83 EC or Article 702(4) of Law 95/2006, with further amendments and additions] | 3.450 |
| 2. | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Reference Member State – generic medicinal products [Article 10 (1) of Directive 2001/83 EC or Article 704(1) and (2) of Law 95/2006, with further amendments and additions] | 8.050 |
| 2.a) | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Reference Member State – generic medicinal products - different pharmaceutical form submitted at the same time with submission of generic application [Article 10 (1) of Directive 2001/83 EC or Article 704(1) and (2) of Law 95/2006, with further amendments and additions] | 4.830 |
| 2.b) | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Reference Member State – generic medicinal products - the second and following strengths submitted at the same time with initial application [Article 10 (1) of Directive 2001/83 EC or Article 704(1) and (2) of Law 95/2006, with further amendments and additions] | 2.420 |
| 3. | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Reference Member State – “hybrid” (mixed) application [Article 10 (3) of Directive 2001/83 EC or Article 704(3) of Law 95/2006, with further amendments and additions] | 9.200 |
| 3.a) | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Reference Member State – “hybrid” (mixed) application - different pharmaceutical form submitted at the same time with initial “hybrid” (mixed) application [Article 10 (3) of Directive 2001/83 EC or Article 704(3) of Law 95/2006, with further amendments and additions] | 5.520 |
| 3.b) | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Reference Member State – “hybrid” (mixed) application - the second and following strengths submitted at the same time with initial application [Article 10 (3) of Directive 2001/83 EC or Article 704(3) of Law 95/2006, with further amendments and additions] | 2.760 |
| 4. | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Reference Member State - “medicament biologic similar” [Article 10 (4) of Directive 2001/83 EC or Article 704(4) of Law 95/2006, with further amendments and additions] | 9.200 |
| 4.a) | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Reference Member State – “medicament biologic similar” - different pharmaceutical form submitted at the same time with initial “hybrid” (mixed) application [Article 10 (4) of Directive 2001/83 EC or Article 704(4) of Law 95/2006, with further amendments and additions] | 5.520 |
| 4.b) | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Reference Member State – “medicament biologic similar” - the second and following strengths submitted at the same time with initial application [Article 10 (4) of Directive 2001/83 EC or Article 704(4) of Law 95/2006, with further amendments and additions] | 2.760 |
| 5. | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Reference Member State – “bibliographic” application [Article 10 (a) of Directive 2001/83 EC or Article 705 of Law 95/2006, with further amendments and additions] | 9.200 |
| 5.a) | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Reference Member State – “bibliographic” application - different pharmaceutical form submitted at the same time with initial “hybrid” (mixed) application [Article 10 (a) of Directive 2001/83 EC or Article 705 of Law 95/2006, with further amendments and additions] | 5.520 |
| 5.b) | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Reference Member State – “bibliographic” application - the second and following strengths submitted at the same time with initial application [Article 10 (a) of Directive 2001/83 EC or Article 705 of Law 95/2006, with further amendments and additions] | 2.760 |
| 6. | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Reference Member State – fixed combinations [Article 10 (b) of Directive 2001/83 EC or Article 706 of Law 95/2006, with further amendments and additions] | 9.780 |
| 6.a) | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Reference Member State – fixed combinations - different pharmaceutical form submitted at the same time with initial “hybrid” (mixed) application [Article 10 (b) of Directive 2001/83 EC or Article 706 of Law 95/2006, with further amendments and additions] | 5.870 |
| 6.b) | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Reference Member State – fixed combinations - the second and following strengths submitted at the same time with initial application [Article 10 (b) of Directive 2001/83 EC or Article 706 of Law 95/2006, with further amendments and additions] | 2.930 |
| 7. | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Reference Member State - “informed consent” [Article 10 (c) of Directive 2001/83 EC or Article 707 of Law 95/2006, with further amendments and additions] | 6.900 |
| 7.a) | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Reference Member State - “informed consent” - different pharmaceutical form submitted at the same time with initial “hybrid” (mixed) application [Article 10 (c) of Directive 2001/83 EC or Article 707 of Law 95/2006, with further amendments and additions] | 4.140 |
| 7.b) | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Reference Member State - “informed consent” - the second and following strengths submitted at the same time with initial application [Article 10 (c) of Directive 2001/83 EC or Article 707 of Law 95/2006, with further amendments and additions] | 2.070 |
| 8. | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Concerned Member State - full dossier [Article 8 (3) of Directive 2001/83 EC or Article 702(4) of Law 95/2006, with further amendments and additions] | 7.500 |
| 8.a) | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Concerned Member State – full dossier - different pharmaceutical form submitted at the same time with initial “hybrid” (mixed) application [Article 8 (3) of Directive 2001/83 EC or Article 702(4) of Law 95/2006, with further amendments and additions] | 4.500 |
| 8.b) | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Concerned Member State – full dossier - the second and following strengths submitted at the same time with initial application [Article 8 (3) of Directive 2001/83 EC or Article 702(4) of Law 95/2006, with further amendments and additions] | 2.250 |
| 9. | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Concerned Member State – generic medicinal products [Article 10 (1) of Directive 2001/83 EC or Article 704(1) and (2) of Law 95/2006, with further amendments and additions] | 5.200 |
| 9.a) | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Concerned Member State – generic medicinal products - different pharmaceutical form submitted at the same time with initial “hybrid” (mixed) application [Article 10 (1) of Directive 2001/83 EC or Article 704(1) and (2) of Law 95/2006, with further amendments and additions] | 3.120 |
| 9.b) | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Concerned Member State – generic medicinal products - the second and following strengths submitted at the same time with initial application [Article 10 (1) of Directive 2001/83 EC or Article 704(1) and (2) of Law 95/2006, with further amendments and additions] | 1.560 |
| 10. | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Concerned Member State – “hybrid” (mixed) application [Article 10 (3) of Directive 2001/83 EC or Article 704(3) of Law 95/2006, with further amendments and additions] | 6.000 |
| 10.a) | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Concerned Member State – “hybrid” (mixed) application - different pharmaceutical form submitted at the same time with initial “hybrid” (mixed) application [Article 10 (3) of Directive 2001/83 EC or Article 704(3) of Law 95/2006, with further amendments and additions] | 3.600 |
| 10.b) | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Concerned Member State – “hybrid” (mixed) application - the second and following strengths submitted at the same time with initial application [Article 10 (3) of Directive 2001/83 EC or Article 704(3) of Law 95/2006, with further amendments and additions] | 1.800 |
| 11. | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Concerned Member State - “medicament biologic similar” [Article 10 (4) of Directive 2001/83 EC or Article 704(4) of Law 95/2006, with further amendments and additions] | 6.000 |
| 11.a) | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Concerned Member State - “medicament biologic similar”- different pharmaceutical form submitted at the same time with initial “hybrid” (mixed) application [Article 10 (4) of Directive 2001/83 EC or Article 704(4) of Law 95/2006, with further amendments and additions] | 3.600 |
| 11.b) | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Concerned Member State – “medicament biologic similar”- the second and following strengths submitted at the same time with initial application [Article 10 (4) of Directive 2001/83 EC or Article 704(4) of Law 95/2006, with further amendments and additions] | 1.800 |
| 12. | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Concerned Member State – “bibliographic” application [Article 10 (a) of Directive 2001/83 EC or Article 705 of Law 95/2006, with further amendments and additions] | 6.000 |
| 12.a) | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Concerned Member State – “bibliographic” application - different pharmaceutical form submitted at the same time with initial “hybrid” (mixed) application [Article 10 (a) of Directive 2001/83 EC or Article 705 of Law 95/2006, with further amendments and additions] | 3.600 |
| 12.b) | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Concerned Member State – “bibliographic” application - the second and following strengths submitted at the same time with initial application [Article 10 (a) of Directive 2001/83 EC or Article 705 of Law 95/2006, with further amendments and additions] | 1.800 |
| 13. | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Concerned Member State – fixed combinations [Article 10 (b) of Directive 2001/83 EC or Article 706 of Law 95/2006, with further amendments and additions] | 6.400 |
| 13.a) | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Concerned Member State – fixed combinations - different pharmaceutical form submitted at the same time with initial “hybrid” (mixed) application [Article 10 (b) of Directive 2001/83 EC or Article 706 of Law 95/2006, with further amendments and additions] | 3.840 |
| 13.b) | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Concerned Member State – fixed combinations - the second and following strengths submitted at the same time with initial application [Article 10 (b) of Directive 2001/83 EC or Article 706 of Law 95/2006, with further amendments and additions] | 1.920 |
| 14. | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Concerned Member State - “informed consent” [Article 10 (c) of Directive 2001/83 EC or Article 707 of Law 95/200, with further amendments and additions] | 3.750 |
| 14.a) | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Concerned Member State - “informed consent” - different pharmaceutical form submitted at the same time with initial “hybrid” (mixed) application [Article 10 (c) of Directive 2001/83 EC or Article 707 of Law 95/2006, with further amendments and additions] | 2.250 |
| 14.b) | Authorisation of medicinal products proposed for marketing authorisation through mutual recognition procedure or decentralised procedure with Romania as Concerned Member State - “informed consent” - the second and following strengths submitted at the same time with initial application [Article 10 (c) of Directive 2001/83 EC or Article 707 of Law 95/2006, with further amendments and additions]. | 1.130 |
| 15. | Approval of type IA variations for medicinal products authorised for marketing through mutual recognition procedure or decentralised procedure with Romania as Concerned Member State | 300 |
| 16. | Approval of type IB variations for medicinal products authorised for marketing through mutual recognition procedure or decentralised procedure with Romania as Concerned Member State | 500 |
| 17. | Approval of type II variations for medicinal products authorised for marketing through mutual recognition procedure or decentralised procedure with Romania as Concerned Member State | 1.600 |
| 18. | Marketing authorisation renewal of medicinal products authorised for marketing through mutual recognition procedure or decentralised procedure with Romania as Concerned Member State | 2.100 |
| 19. | Approval of type IA variations for medicinal products authorised for marketing through mutual recognition procedure or decentralised procedure with Romania as Reference Member State | 460 |
| 20. | Approval of type IB variations for medicinal products authorised for marketing through mutual recognition procedure or decentralised procedure with Romania as Reference Member State | 760 |
| 21. | Approval of type II variations for medicinal products authorised for marketing through mutual recognition procedure or decentralised procedure with Romania as Reference Member State | 2.400 |
