Following the ordinance (SFS 2010:1167) concerning fees for the governmental control of medicinal products (see hyperlink to the right), application fee additional fee and annual fee has to be paid according to the table below.
Medicinal products for human use
Medicinal products for veterinary use
Payment
The Medical Product Agency has found the need to clarify that the lower fee, as specified in Chapter 3 § 1-2 for duplicate applications (human: 30 000 SEK, veterinary: 15 000 SEK) applies only in cases where the application is a duplicate, both in Sweden and in all concerned member states.
| This is a simplified summary of application and annual fees. 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 |
400 000 |
| Application concerning a generic medicinal product where the reference medicinal product is not authorised in Sweden (also includes hybrid and biosimilar medicinal products) |
400 000 |
| Abridged application (generic, hybrid or biosimilar medical products) where the reference medicinal product is authorised in Sweden |
200 000 |
| Application concerning a radiopharmaceutical |
65 000 |
| Application concerning an allergen product |
65 000 |
| Duplicate application |
30 000 |
| Application concerning a parallel imported or parallel distributed medicinal product |
25 000 |
| Renewal application |
Included in the annual fee |
| Approval of marketing authorisation for medicinal products through the DCP or MRP when Sweden is CMS (see Chapter 2, § 2) |
| The fee covers all routes of administration, strengths and pharmaceutical forms of the same medicinal product (trade name) applied for at the same occasion. |
| Complete application |
100 000 |
| Application concerning a generic medicinal product where the reference medicinal product is not authorised in Sweden (also includes hybrid and biosimilar medicinal products) |
100 000 |
| Abridged application (generic, hybrid or biosimilar medical products) where the reference medicinal product is authorised in Sweden |
65 000 |
| Duplicate application |
30 000 |
| Renewal application |
Included in the annual fee |
| Extension of an existing authorisation (see Chapter 2, § 3) |
|
Extension application |
200 000 |
| Extension applications trough DCP or MRP with Sweden as CMS |
65 000 |
| Additional fee for an approval of marketing authorisation for medicinal products through the DCP or MRP when Sweden is requested as RMS (see Chapter 3, § 1-2) |
| The fee covers all routes of administration, strengths and pharmaceutical forms of the same medicinal product (trade name) applied for at the same occasion. In addition to the fee below, the fee for approval of marketing authorisation for medicinal products as described above (in accordance with Chapter 2, § 1) should also be paid for |
|
Complete applications |
200 000 |
| Abridged applications |
200 000 |
| Duplicate applications (note that the application must be a duplicate in both Sweden and the concerned member states) |
30 000 |
| Extension of an existing approval |
200 000 |
| Renewal application |
Included in the annual fee |
| Variation of approval of marketing authorisation (see Chapter 3, § 5-6) |
| 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 |
10 000 |
| Variation type II through MRP with Sweden acting as RMS |
20 000 |
| Variation type II through MRP with Sweden acting as CMS |
6 000 |
| Change in legal status |
100 000 |
| Change in legal status where the substance has previously been changed in the same way and where the Summary of Product Characteristics and the Package Leaflet are essentially the same |
10 000 |
| Variations type 1A and type 1B within all procedures |
Included in the annual fee |
| Annual fees (see Chapter 4, § 1) |
| Human medicinal product |
46 000 kr |
| Additional strength or pharmaceutical form |
22 500 kr |
| Duplicate |
22 500 kr |
| Radiopharmaceutical and allergen product |
8 000 kr |
| Each additional dilution from basic extract of allergen product |
250 kr |
| Parallel imported medicinal product (per exporting country, pharmaceutical form, strength and MA number) |
6 000 kr |
| This is a simplified summary af application and annual fees. 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 |
200 000 |
| Application concerning a generic medicinal product where the reference medicinal product is not authorised in Sweden (also includes hybrid and biosimilar medicinal products) |
200 000 |
| Abridged application (generic, hybrid or biosimilar medical products) where the reference medicinal product is authorised in Sweden |
100 000 |
| Duplicate application |
15 000 |
| Application concerning a parallel imported or parallel distributed medicinal product |
12 500 |
| Renewal application |
Included in the annual fee |
| Approval of marketing authorisation for medicinal products through the DCP or MRP when Sweden is CMS (see Chapter 2, § 2) |
| The fee covers all routes of administration, strengths and pharmaceutical forms of the same medicinal product (trade name) applied for at the same occasion. |
| Complete application |
50 000 |
| Application concerning a generic medicinal product where the reference medicinal product is not authorised in Sweden (also includes hybrid and biosimilar medicinal products) |
50 000 |
| Abridged application (generic, hybrid or biosimilar medical products) where the reference medicinal product is authorised in Sweden |
32 500 |
| Duplicate application |
15 000 |
| Renewal application |
Included in the annual fee |
| Extension of an existing authorisation (see Chapter 2, § 3) |
|
Extension application |
100 000 |
| Extension application trough DCP or MRP with Sweden as CMS |
32 500 |
| Additional fee for an approval of marketing authorisation for medicinal products through the DCP or MRP when Sweden is requested as RMS (see Chapter 3, § 1-2) |
| The fee covers all routes of administration, strengths and pharmaceutical forms of the same medicinal product (trade name) applied for at the same occasion. In addition to the fee below, the fee for approval of marketing authorisation for medicinal products as described above (in accordance with Chapter 2, § 1) should also be paid for |
| Complete application |
100 000 |
| Abridged application |
100 000 |
| Duplicate application (note that the application must be a duplicate in both Sweden and the concerned member states) |
15 000 |
| Extension of an existing approval |
100 000 |
| Renewal application |
Included in the annual fee |
| Variation of approval of marketing authorisation (see Chapter 3, § 5-6) |
| 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 |
10 000 |
| Variation type II through MRP with Sweden acting as RMS |
20 000 |
| Variation type II through MRP with Sweden acting as CMS |
6 000 |
| Change in legal status |
50 000 |
| Change in legal status where the substance has previously been changed in the same way and where the Summary of Product Characteristics and the Package Leaflet are essentially the same |
10 000 |
| Variations type 1A and type 1B within all procedures |
Included in the annual fee |
| Annual fees (see Chapter 4, § 1) |
| Veterinary medicinal product |
15 000 |
| Additional strength or pharmaceutical form |
7 500 |
| Duplicate |
7 500 |
| Parallel imported medicinal product (per exporting country, pharmaceutical form, strength and MA number) |
2 000 |
The application fee and additional fee should be paid when the applicant receives an invoice concerning the fee from the Medical Products Agency (MPA).
As a main rule, the application fee will not be reduced or refunded if the applicant withdraws the application, whether the MPA’s assessment of the application has started or not. If special reasons apply, the applicant might request for a reduction of the application fee. The special reasons have to be well justified by the applicant and would normally apply where a medicinal product can be expected to become of great importance for medical treatment but hard to make profitable.
For the annual fee, the MPA will send the first invoice after the marketing authorisation has been issued and will then cover the remaining months of the year. For each following year, the invoice will be sent in January, but a few months before that, a so called “test invoice” will be sent. If special reasons apply, the MAH can request for a reduction of the annual fee. If so, a specific application form including a justification for the request should be used (see link to the right). This request should be made before October 31st.
If the MPA agrees that special reasons apply, the MPA can decide to partly or fully reduce the annual fee. Such reasons can apply if a medicinal product is or can be expected to become of great importance for medical treatment but hard to make profitable.