Fees - medicinal products

Following the ordinance (SFS 2010:1167) concerning fees for the governmental control of medicinal products (see hyperlink to the right), the application fee, additional fee and annual fee has to be paid according to the table below.

The wording of the ordinance has as of January 1, 2017 been amended in some parts. Certain fees and i.a. the definition of a duplicate application has been changed. The changed definition will affect when the lower fee for duplicate applications is applicable, see 2 § 7 of the ordinance. For guidance concerning duplicate, see hyperlink to the right.

According to the Ordinance Chapter 4, § 6 the Medical Products Agency also invoice the eHealth Agency´s annual fees for LiiV (Supplier Information in the VARA Register).

For more information  eHälsomyndigheten

 Medicinal products for human use
 Medicinal products for veterinary use
 Payment

Below is an abbreviated tabulated summary. It has been compiled for information purposes, therefore always check against the contents of the ordinance.

Application and annual fees for medicinal products for human 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.
Complete application 500 000
Application concerning a generic medicinal product where the reference medicinal product is not authorised in Sweden (also includes hybrid and biosimilar medicinal products) 500 000
Abridged application (generic, hybrid or biosimilar medical products) where the reference medicinal product is authorised in Sweden 250 000
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 20 000
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)
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 120 000
Application concerning a generic medicinal product where the reference medicinal product is not authorised in Sweden (also includes hybrid and biosimilar medicinal products) 120 000
Abridged application (generic, hybrid or biosimilar medical products) where the reference medicinal product is authorised in Sweden 75 000
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 including Repeat Use 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 and Chapter 2, § 3) should also be paid for

Complete applications

200 000
Abridged applications 200 000
Duplicate applications (not applicable for MRP) 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 30 000
Variation type II through MRP with Sweden acting as RMS 55 000
Variation type II through MRP with Sweden acting as CMS 8 000
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 51 000 kr
Additional strength or pharmaceutical form 25 000 kr
Duplicate 25 000 kr
Radiopharmaceutical and allergen product 9 000 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) 7 000 kr

Application and annual fees for medicinal products for veterinary use

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 250 000
Application concerning a generic medicinal product where the reference medicinal product is not authorised in Sweden (also includes hybrid and biosimilar medicinal products) 250 000
Abridged application (generic, hybrid or biosimilar medical products) where the reference medicinal product is authorised in Sweden 125 000
Duplicate application 15 000
Application concerning a parallel imported or parallel distributed medicinal product 10 000
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)
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 60 000
Application concerning a generic medicinal product where the reference medicinal product is not authorised in Sweden (also includes hybrid and biosimilar medicinal products) 60 000
Abridged application (generic, hybrid or biosimilar medical products) where the reference medicinal product is authorised in Sweden 37 500
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 including Repeat Use 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 and Chapter 2, § 3) should also be paid for
Complete application 100 000
Abridged application 100 000
Duplicate application (not applicable for MRP) 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 30 000
Variation type II through MRP with Sweden acting as RMS 55 000
Variation type II through MRP with Sweden acting as CMS 8 000
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 17 000
Additional strength or pharmaceutical form 8 000
Duplicate 8 000
Parallel imported medicinal product (per exporting country, pharmaceutical form, strength and MA number) 2 000

 

Payment

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.

 
 

New fees

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

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

 Duplicate application

 

Related information

   
 

Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | phone: +46 18 174600, fax: +46 18 548566 | Contact information