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Fees

(18.10.2006)

Registration and control fees

With reference to the Norwegian Regulation on Proprietary Medicinal Products of 22nd December, 1999, ยง15-3, new registration fees are coming into force from 1. June 2005, new control fee is coming into force 1. April 2005.

Please note that both registration and control fees may be changed, at any time.

The Norwegian Medicines Agency may, under certain circumstances, waive the fees.

Change in the procedure for payment of application fees and fees for clinical trials (1. June 2007).

Application fees

The following fees shall be paid (amount in NOK)

Please note:

- For the decentralised procedure (DCP) the same fee as for Mutual recognition procedure (MRP) applies
- The procedure and fee regarding the transfer of Marketing Authorisations is changed per 1st of July 2006, please refer to the information on: Transfer of the marketing authorisation/Change in name and address of the MA-holder

 

HUMAN 

 

 

VETERINARY

    

Application

National/
RMS1)

CMS2)

Application

National/
RMS1)

CMS2)

 

 

 

 

 

 

Article 8.3(i)
- complete application

several forms or strengths applied simultaneously


100.000,-/130.000,-

 75.000,-/95.000,-

 
80.000,-

 
55.000,-

Article 12.3(j)
- complete application

 several forms or strengths applied simultaneously

 
80.000,-/100.000,-

 40.000,-/50.000,-

 
35.000,-


35.000,-

Article 10.1(b)
- fixed combination

several forms or strengths applied simultaneously

 
100.000,-/130.000,-

75.000,-/95.000,-

 
80.000,-
 

55.000,-

Article 5.10(b)
- fixed combination

several forms or strengths applied simultaneously

 
80.000,-
/100.000,-

 40.000,-
/50.000

 
35.000,-

 
35.000,-

New form/strength

75.000,-/95.000,-

55.000,-

New form/strength

40.000,-/50.000,-

35.000,-

Article 10.1(a)(i)
- abridged application (informed consent)

several forms or strengths applied simultaneously

 
80.000,-/100.000,-

 
55.000,-
/70.000,-

 
70.000,-

 

55.000,-

Article 13.1(a)(i)
- abridged application(informed consent)

several forms or strengths applied simultaneously

 
40.000,-/50.000,-


35.000,-/45.000,-

 
35.000,-



35.000,-

Article 10.1(a)(ii)
- bibliographical application

several forms or strengths applied simultaneously

 
80.000,-/100.000,-

55.000,-/70.000,-

 
70.000,-


55.000,-

Article 13.1(a)(ii)
-bibliographical application

several forms or strengths applied simultaneously

 
40.000,-/50.000,-

35.000,-/45.000,-

 
35.000,-


35.000,-

Article 10.1(a)(iii)
- abridged application  (generic application)

several forms or strengths applied simultaneously

 
80.000,-/100.000,-


55.000,-/70.000,-

 
70.000,-

 

55.000,-

Article 13.1(a)(iii)
- abridged application  (generic application)

several forms or strengths applied simultaneously

 
40.000,-/50.000,-


35.000,-/45.000,-

 
35.000,-

 

35.000,-

New form/strength

55.000,-/70.000,-

55.000,-

New form/strength

35.000,-/45.000,-

35.000,-

Annex II application3)4)

70.000,-

 

30.000,-

Annex II application3)4)5)

65.000,-  25.000,-5)

25.000,-

Variation type I4)6)7)8)

1500,-/2000,-

1500,-

Variation type I4)6)7)8)

1500,-/2000,-

1500,-

Variation type II4)6)

9000,-/12.000,-

9000,-

Variation type II4)6)

9000,-/12.000,-

9000,-

Renewal of MA9)

45.000,-

45.000,-

Renewal of MA9)

20.000,-

20.000,-

Transfer of a MA(13)

1.500,-

1.500,-

Transfer of a MA(13)

1.500,-

1.500,-

 

 1)   RMS: Norway is Reference Member State in a Mutual Recognition Procedure and Decentralised Procedure. If the application concerns an application previously paid nationally, the difference between the RMS fee and the national fee is to be paid upon the formal request of the RMS procedure 
2)   CMS: Norway is Concerned Member state in a Mutual Recognition Procedure and Decentralised Procedure
3)   Annex II applications, except new form/strength
4)   If one variation includes several forms/strengths of the same product, only one fee shall be paid
5)   The lower fee concerns Annex II application pertaining to already approved species of food producing animals.
6)   Only one fee is paid for a variation which leads to one or more consequential variations
7)   For a variation type I processed as a variation type II, the fee paid is for variation type II
8)   For variation types 1 A nr. 1 or type 1 B nr. 2 where Norway is CMS, and which not apply to Norway, no fee is to be paid.
9)   Per Marketing Authorisation Number
13) Per productname

 

 

Application

Fee

Radiopharmaceuticals

New application
Renewal of MA
Variation type I/II10)

 

 

35.000,-
35.000,-
1500,-/9000,-

 

Natural remedies

New application
Renewal of MA
Variation type I/II10)

 

 

20.000,-
20.000,-
1500,-/9000,-

 

Parallel import

New application
Renewal of MA
Variation type I11)

 

 

12000,-
12000,-
1500,-

 

Clinical trial12)

 5000,-

Chemical disinfectants

For technical use in health care and nursing
For technical use in aquaculture systems


10.000,-
30.000,-

 

10) See 4)6)7)

11) Concerns type I variation nr. 2 and 3

12) There are no fees for clinical trials performed by independent investigators

Information regarding applicant name, product, dosage form and strength must be clearly stated on all payments.

The fees are to be paid, at the latest, when the application is filed with the Norwegian Medicines Agency.

For applications in the central procedure the appropriate fee should be paid the EMEA.

 

Control fee

A control fee is to be paid for each product on the market. From 2. quarter of 2005 the fee is 0.60 % of the turnover of the holder of the MA. The amount used for calculation is the wholesalers purchasing price.

Please use the form Control Fee Report Form for Holders of Marketing Authorisations for Medicinal Products (MS Word-format, updated May 2005)

The sale of vaccines to the Norwegian Institute of Public Health, radiopharmaceuticals to the Institute for Energy Technology, chemical disinfectants and herbal medicinal products are exempt from the control fee.

 

Bank account info: 
No. 7694.05.00903 
Den norske Bank
P.O. Box 1171 Sentrum
0107 Oslo
Norway

 

Account No. IBAN: 
NO71 7694.05.00903

 Swiftaddress:
DNBANOKK
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