Application fees for homeopathic medicinal products

By 1 January 2017, a new fee ordinance will come into force (SFS 2010:1167). 

 Förordning (2010:1167) om avgifter för den statliga kontrollen av läkemedel

  

Application type (for complete information see SFS 2010:1167)FEES (SEK)
Approval of registration for homeopathic medicinal products (see Chapter 2, § 6) 

The fee covers a single-component product, single-component products in a diulution series, or a combined product.

National application 4 400
Application concerning a recognition of a registration of a homeopathic medicinal product through the DCP or MRP when Sweden is CMS 2 200
Application conserning extension of an existing registration 4 400
Renewal application Included in the annual fee
Additional fee for application of a registration of a homeopathic medicinal product through the DCP or MRP when Sweden is requested as RMS (see Chapter 3, § 4)
In addition to the fee below, the fee as described above should also be paid for (in accordance with Chapter 2, § 6)

Fee for registration of a homeopathic medicinal product

4 400
Variation of an existing registration (see Chapter 3, § 7)
The fee covers a single-component product, single-component products in a diulution series, or a combined product. 
Variation type II national application 2 200
Variations type 1A and type 1B within all procedures Included in the annual fee
Annual fees (see Chapter 4, § 1)
Homeopathic medicinal product (a single-component product, single-component products in a diulution series, or a combined product) 250

 

Payment and related information

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

 
 

Related information

   
 

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