By 1 January 2011, a new fee ordinance will come into force (SFS 2010:1167). A translation into English will be published soon.
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 |
4 000 |
| Application concerning a recognition of a registration of a homeopathic medicinal product through the DCP or MRP when Sweden is CMS |
2 000 |
| 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 |
4 000 |
| 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 |
2 000 |
| 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.