Fees

Application type

FEES (SEK)

Approval of marketing authorisation

The fee covers all routes of administration, strengths and pharmaceutical forms of the same traditional herbal medicinal product (trade name) applied for at the same occasion.

The fee for applications for parallel imported traditional herbal medicinal products, however, cover all strengths and pharmaceutical forms of the same medicinal product (trade name) from the same exporting country, applied for at the same occasion

Complete application for registration of a herbal traditional medicinal product

300 000

Application concerning a traditional herbal medicinal product containing a herbal substance, a herbal preparation or a combination of those, which are included in the European Union list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products, or for which the Committee on Herbal Medicinal Products (HMPC) has established a European Union monograph.

150 000

Application concerning a recognition of a traditional herbal medicinal product through the DCP or MRP when Sweden is CMS

75 000 

Duplicate applications

25 000

Application concerning a parallel imported traditional herbal medicinal product

20 000

Renewal application

Included in the annual fee

Extension of an existing registration

Extension applications

100 000

Extension applications through DCP or MRP with Sweden as CMS

32 500

Fee for registration of a traditional herbal medicinal product

100 000

Extension of an existing registration

50 000

Variation of an existing registration

The fee covers all routes of administration, strengths and pharmaceutical forms of the same traditional herbal medicinal product (trade name) applied for at the same occasion.

Variation type II,  where an addition is made to the indication, national application

64 500

Variation type II, other than the above, national application

19 500

Variation type II where an addition is made to the indication, through MRP with Sweden acting as RMS

72 500

Variation type II,where an addition is made to the indication, through MRP with Sweden acting as CMS

19 000

Variations type 1A and type 1B within all procedures

Included in the annual fee

Annual fees

Traditional Herbal Medicinal Product

20 000

Application type

FEE (SEK)

Approval of marketing authorisation

The fee covers all routes of administration, strengths and pharmaceutical forms of the same medicinal product (trade name) applied for at the same occasion. The fee for applications for parallel imported medicinal products, however, cover all strengths and pharmaceutical forms of the same medicinal product (trade name) from the same exporting country, applied for at the same occasion.

Complete application concerning Natural medicinal products

300 000

Duplicate applications

30 000

Application concerning a parallel imported medicinal product

25 000

Renewal application

Included in the annual fee

Extension of an existing authorisation
The fee covers all routes of administration, strengths and pharmaceutical forms of the same medicinal product (trade name) applied for at the same time and which concerns the same type of change of the terms of the authorisation.

Extension applications concerning Natural medicinal products or Certain Medicinal Products for External Use

100 000

Variation of approval of marketing authorisation

The fee covers all routes of administration, strengths and pharmaceutical forms of the same medicinal product (trade name) applied for at the same occasion.

Variation type II, where an addition is made to the indication

129 000

Variation type II, other than the above

39 000

Variations type 1A and type 1B within all procedures

Included in the annual fee

Annual fees

Natural medicinal products and Certain External Medicinal Products for External Use

20 000

Application type

FEE (SEK)

Approval of marketing authorisation

The fee covers all routes of administration, strengths and pharmaceutical forms of the same medicinal product (trade name) applied for at the same occasion.

The fee for applications for parallel imported medicinal products, however, cover all strengths and pharmaceutical forms of the same medicinal product (trade name) from the same exporting country, applied for at the same occasion.

Complete application concerning Natural medicinal products

225 000

Duplicate applications

30 000

Application concerning a parallel imported medicinal product

25 000

Renewal application

Included in the annual fee

Extension of an existing authorisation
The fee covers all routes of administration, strengths and pharmaceutical forms of the same medicinal product (trade name) applied for at the same time and which concerns the same type of change of the terms of the authorisation

Extension applications concerning Natural medicinal products or Certain Medicinal Products for External Use

75 000

Variation of approval of marketing authorisation

The fee covers all routes of administration, strengths and pharmaceutical forms of the same medicinal product (trade name) applied for at the same occasion.

Variation type II, where an addition is made to the indication, national application

129 000

Variation type II, other than the above

39 000

Variations type 1A and type 1B within all procedures

Included in the annual fee

Annual fees

Natural medicinal products and Certain External Medicinal Products for External Use

20 000