Fees for homeopathic medicinal products
- Published: November 28, 2019
- Last updated: February 15, 2022
Registration and annual fees for homeopathic medicinal products shall be paid following the ordinance (SFS 2010:1167) concerning fees for the governmental control of medicinal products.
The fees for homeopathic medicinal products (human and veterinary) are tabulated below in short.
The fees are applicable from 1 January 2022.
For complete information see SFS 2010:1167 (in Swedish):
Application type |
FEE (SEK) |
|
Application for registration of homeopathic medicinal products (see Chapter 2, § 6). The fee covers a single-component product, single-component products in a dilution series, or a combined product. |
|
|
National application |
90 000 |
|
Application concerning a recognition of a registration of a homeopathic medicinal product through the DCP or MRP when Sweden is CMS |
20 000 |
|
Renewal application |
Included in the annual fee |
|
Application concerning extension of an existing registration |
45 000 |
|
Additional fee for application for registration of a homeopathic medicinal product through the DCP or MRP when Sweden is requested as RMS (see Chapter 3, § 4). The fee covers a single-component product, single-component products in a dilution series, or a combined product. In addition to the fee below, the fee as described above should also be paid for (in accordance with Chapter 2, § 6). |
|
|
Fee when Sweden is requested to act as RMS in a DCP or MRP for registration of a homeopathic medicinal product. |
22 500 |
|
Variation of an existing registration (see Chapter 3, § 8). The fee covers a single-component product, single-component products in a dilution series, or a combined product. |
|
|
Variation type II |
10 000 |
|
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 dilution series, or a combined product) |
1 300 |