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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

Please, contact us for regulatory affairs support in Czech R., Slovak R., Hungary, Croatia, Serbia, Montenegro, Macednia, Albania, Bulgaria, Romania and Turkey.

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Zdravko Mauko - Valuable information

|Administrator |2008-01-26 18:11:25

Thanks to Mgr. Mihaela David for regulatory affairs news from Romania .

Regards, Zdravko

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