Fees
- Published: November 29, 2019
- Last updated: June 8, 2023
The Swedish Medical Products Agency invoice the application fee, additional fee and annual fee.
Some of the fees were adjusted 1 January 2022.
The fees are regulated in the ordinance (SFS 2010:1167).
This is an abbreviated tabulated summary. It has been compiled for information purposes, therefore always check against the contents of the ordinance.
Payment
The fee should be paid when the applicant receives an invoice from the Swedish Medical Products Agency (Swedish 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.
Reduction of or exemption from fee
If special reasons apply, the applicant might request a reduction of the fee. The special reasons must 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.
To apply, fill out the form. In order for the application to be assessed before the invoicing for the coming year, it should be made no later than the last of October the year before.
Application for exemption from or reduction of annual fee
Annual fee
The Swedish MPA will send the first invoice after the marketing authorisation has been issued and it will cover the remaining months of the year. For each following year, the invoice will be sent in January. A few months before that, a so called “test invoice” will be sent.
The Swedish MPA also invoice the eHealth Agency's annual fees for LiiV (Supplier Information in the VARA Register).
More information: eHälsomyndigheten (Swedish)
The annual fee will not be repaid if a product is withdrawn after the last of January current year. For products to be withdrawn in order not to be issued an annual fee in the coming years, the applications need to be received by the MPA no later than the last of October the year before. If the annual fee doesn't get paid the MPA can withdraw the medicinal product. Note that an already charged annual fee has to be paid despite the withdrawal.
Medicinal products for human use |
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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) |
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The fee covers all routes of administration, strengths and pharmaceutical forms of the same medicinal product (trade name) applied for at the same occasion. |
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Complete application |
600 000 |
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Application concerning a generic medicinal product where the reference medicinal product is not authorised in Sweden (also includes hybrid and biosimilar medicinal products) |
600 000 |
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Abridged application (generic, hybrid or biosimilar medical products) where the reference medicinal product is authorised in Sweden |
300 000 |
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Application concerning a radiopharmaceutical |
65 000 |
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Application concerning an allergen product |
65 000 |
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Duplicate application |
30 000 |
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Application concerning a parallel imported or parallel distributed medicinal product |
25 000 |
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Renewal application |
Included in the annual fee |
Approval of marketing authorisation for medicinal products through the DCP or MRP including Repeat Use when Sweden is CMS (see Chapter 2, § 2) |
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The fee covers all routes of administration, strengths and pharmaceutical forms of the same medicinal product (trade name) applied for at the same occasion. |
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Complete application |
150 000 |
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Application concerning a generic medicinal product where the reference medicinal product is not authorised in Sweden (also includes hybrid and biosimilar medicinal products) |
150 000 |
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Abridged application (generic, hybrid or biosimilar medical products) where the reference medicinal product is authorised in Sweden |
85 000 |
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Duplicate application |
30 000 |
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Renewal application |
Included in the annual fee |
Extension of an existing authorisation (see Chapter 2, § 3) |
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Extension application |
200 000 |
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Extension application 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 including Repeat Use when Sweden is requested as RMS (see Chapter 3, § 1-2) |
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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 and Chapter 2, § 3) should also be paid for. |
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Complete application |
200 000 |
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Abridged application |
200 000 |
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Duplicate application (not applicable for MRP) |
30 000 |
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Extension of an existing approval |
200 000 |
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Renewal application |
Included in the annual fee |
Variation of approval of marketing authorisation (see Chapter 3, § 5-6) |
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The fee covers all routes of administration, strengths and pharmaceutical forms of the same medicinal product (trade name) applied for at the same occasion. |
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Variation type II indication national application |
129 000 |
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Variation type II indication through MRP with Sweden acting as RMS |
145 000 |
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Variation type II indication through MRP with Sweden acting as CMS |
38 000 |
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Variation type II national application |
39 000 |
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Variation type II through MRP with Sweden acting as RMS |
55 000 |
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Variation type II through MRP with Sweden acting as CMS |
8 000 |
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Change in legal status |
100 000 |
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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 |
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Variations type 1A and type 1B within all procedures |
Included in the annual fee |
Annual fees (see Chapter 4, § 1) |
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Human medicinal product |
60 000 |
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Additional strength or pharmaceutical form |
30 000 |
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Duplicate |
30 000 |
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Radiopharmaceutical and allergen product |
10 000 |
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Each additional dilution from basic extract of allergen product |
275 |
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Parallel imported medicinal product (per exporting country, pharmaceutical form, strength and MA number) |
8 500 |
Medicinal products for veterinary use
|
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. |
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Complete application |
450 000 |
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Application concerning a generic or a hybrid medicinal product where the reference medicinal product is not authorised in Sweden |
450 000 |
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Limited market |
450 000 |
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Exceptional circumstances |
450 000 |
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Abridged application (generic and hybrid medicinal products) where the reference medicinal product is authorised in Sweden |
225 000 |
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Duplicate application |
30 000 |
|
Application concerning a parallel imported or parallel distributed medicinal product |
25 000 |
Approval of marketing authorisation for medicinal products through the DCP, MRP or SRP when Sweden is CMS (see Chapter 2, § 2) |
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The fee covers all routes of administration, strengths and pharmaceutical forms of the same medicinal product (trade name) applied for at the same occasion. |
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Complete application |
112 500 |
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Application concerning a generic or a hybrid medicinal product where the reference medicinal product is not authorised in Sweden |
112 500 |
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Limited market |
112 500 |
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Exceptional circumstances |
112 500 |
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Abridged application (generic or hybrid medicinal products) where the reference medicinal product is authorised in Sweden |
63 750 |
|
Duplicate application |
30 000 |
Additional fee for an approval of marketing authorisation for medicinal products through the DCP, MRP or SRP when Sweden is requested as RMS (see Chapter 3, § 1) |
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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 and Chapter 2, § 3) should also be paid for. |
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Complete application |
150 000 |
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Limited market |
150 000 |
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Exceptional circumstances |
150 000 |
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Abridged application |
150 000 |
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Duplicate application (not applicable for MRP) |
30 000 |
Variation requiring assessment (VRA) of approval of marketing authorisation (see Chapter 3, § 5-6) |
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The fee covers all routes of administration, strengths and pharmaceutical forms of the same medicinal product (trade name) applied for at the same occasion. |
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| Variation (former extension); change of active substance, strength, pharmaceutical form, route of administration or food-producing target species national application |
150 000 |
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Variation (former extension); change of active substance, strength, pharmaceutical form, route of administration or food-producing target species through MRP with Sweden acting as RMS |
250 000 |
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Variation (former extension); change of active substance, strength, pharmaceutical form, route of administration or food-producing target species through MRP with Sweden acting as CMS |
48 750 |
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Variation, change to indication, non-food producing target species or withdrawal period national application |
129 000 |
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Variation, change to indication, non-food producing target species or withdrawal period through MRP with Sweden acting as RMS |
145 000 |
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Variation, change to indication, non-food producing target species or withdrawal period through MRP with Sweden acting as CMS |
38 000 |
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Other variations national application |
39 000 |
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Other variations through MRP with Sweden acting as RMS |
55 000 |
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Other variations through MRP with Sweden acting as CMS |
8 000 |
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Change in legal status |
50 000 |
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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 |
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Variation not affecting the product summary and only concerns package leaflet, labelling text or the design of the labelling on the medicinal product package |
Included in the annual fee |
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Change solely in the national translation of the product information |
Included in the annual fee |
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Variation not requiring assessment (VNRA) |
Included in the annual fee |
Annual fees (see Chapter 4, § 1) |
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Veterinary medicinal product |
30 000 |
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Additional strength or pharmaceutical form |
15 000 |
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Duplicate |
15 000 |
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Parallel imported medicinal product (per exporting country, pharmaceutical form, strength and MA number) |
8 500 |
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Contact us
Telephone: +46 (0)18-17 46 00
Email for general questions about fees: avgifter@lakemedelsverket.se
Email for application for a reduction of the fee: RIC@lakemedelsverket.se