Fees - natural remedies, traditional herbal medicinal products and certain medicinal products for external use

Fees are charged in accordance with the Ordinance (2010:1167) concerning fees for the governmental control of medicinal products, and should be paid after receiving an invoice from the MPA. The tables below set out the charges in abbreviated form.

  Ordinance concerning fees for the governmental control of medicinal products

Herbal medicinal products

See the table of fees  for conventional medicinal products where information on payment of fees also is available.

Traditional Herbal Medicinal Products

 

Application type (for complete information see SFS 2010:1167)FEES (SEK)
Approval of marketing authorisation for medicinal products (see CApproval of marketing registration for traditional herbal medicinal products (see Chapter 2, § 4) hapter 2, § 1)
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* 250 000*
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 Community List of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products* 125 000*
Application concerning a recognition of a traditional herbal medicinal product through the DCP or MRP when Sweden is CMS 60 000
Duplicate applications 30 000
Application concerning a parallel imported traditional herbal medicinal product 20 000
Renewal application Included in the annual fee
Extension of an existing registration (see Chapter 2, § 5)

Extension applications

100 000
Extension applications trough DCP or MRP with Sweden as CMS 32 500 
Additional fee for application of a registration of a traditional herbal medicinal products through the DCP or MRP when Sweden is requested as RMS (see Chapter 3, § 3)
In addition to the fee below, the fee as described above should also be paid for (in accordance with Chapter 2, § 4 and 5 respectively)

Fee for registration of a traditional herbal medicinal product

100 000
Extension of an existing registration 50 000
Renewal application Included in the annual fee
Variation of an existing registration (see Chapter 3, § 7)
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. See also clarifying text to the right about fees for variations.
Variation type II national application 15 000
Variation type II through MRP with Sweden acting as RMS 27 500
Variation type II through MRP with Sweden acting as CMS 4 000
Change in prescription status 100 000
Variations type 1A and type 1B within all procedures Included in the annual fee
Annual fees (see Chapter 4, § 1)
Traditional Herbal Medicinal Product 15 000 kr


* MPA may in individual cases reduce a fee if there are special reasons for doing so (6 § 4). If an application concerns the registration of a traditional herbal medicinal product, where the active ingredient is a herbal substance or preparation covered by a HMPC-monograph and the SPC of the product is in compliance with the monograph, a reduction in the filing fee can be possible in analogy with if the application had concerned a herbal substance or preparation listed in the Commission's list. Application for a reduced fee is submitted to the MPA in connection with the application for registration. No special application form is required.

Natural Remedies and Certain Medicinal Products for External Use

Human use 

Applications type (For complete information see SFS 2010:1167) FEES (SEK)
Approval of marketing authorisation for medicinal products (see Chapter 2, § 1)
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 National Remedies 250 000
Duplicate applications 30 000
Application concerning a parallel imported medicinal product 20 000
Renewal application Included in the annual fee
Extension of an existing authorisation (see Chapter 2, § 3)

Extension applications

100 000
Variation of approval of marketing authorisation (see Chapter 3, § 5)
The fee covers all routes of administration, strengths and pharmaceutical forms of the same medicinal product (trade name) applied for at the same occasion. See also clarifying text to the right about fees for variations.
Variation type II national application 30 000
Variations type 1A and type 1B within all procedures Included in the annual fee
Annual fees (see Chapter 4, § 1)
Natural Remedies and Certain External Medicinal Products for External Use 15 000

 

Veterinary use

Applications type (For complete information see SFS 2010:1167) FEES (SEK)
Approval of marketing authorisation for medicinal products (see Chapter 2, § 1)
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 National Remedies 125 000
Duplicate applications 15 000
Application concerning a parallel imported medicinal product 10 000
Renewal application Included in the annual fee
Extension of an existing authorisation (see Chapter 2, § 3)

Extension applications

50 000
Variation of approval of marketing authorisation (see Chapter 3, § 5)
The fee covers all routes of administration, strengths and pharmaceutical forms of the same medicinal product (trade name) applied for at the same occasion. See also clarifying text to the right about fees for variations.
Variation type II national application 30 000
Variations type 1A and type 1B within all procedures Included in the annual fee
Annual fees (see Chapter 4, § 1)
Natural Remedies and Certain External Medicinal Products for External Use 15 000

 

Payment and related information

For information on payment and other related issues please see the corresponding section for Medicinal Products

 

 
 
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information