Fees - medicinal products

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.

Applications fees for medicinal products for human use

Application type (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	400 000
Application concerning a radiopharmaceutical	65 000
Application concerning an allergen product	65 000
Abridged application where the reference medicinal product is authorised in Sweden	200 000
Duplicate applications	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 applications	100 000
Application concerning a generic medicinal product where the reference medicinal product is not authorised in Sweden	100 000
Abridged application where the reference medicinal product is authorised in Sweden	65 000
Duplicate applications	30 000
Renewal application	Included in the annual fee
Extension of an existing authorisation (see Chapter 2, § 3)
Extension applications	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 prescription status	100 000
Change in prescription 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

Applications fees for medicinal products for veterinary use

Applications type (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	200 000
Abridged application where the reference medicinal product is authorised in Sweden	100 000
Duplicate applications	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 applications	50 000
Application concerning a generic medicinal product where the reference medicinal product is not authorised in Sweden	50 000
Abridged application where the reference medicinal product is authorised in Sweden	32 500
Duplicate applications	15 000
Renewal application	Included in the annual fee
Extension of an existing authorisation (see Chapter 2, § 3)
Extension applications	100 000
Extension applications 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 applications	100 000
Abridged applications	100 000
Duplicate applications (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 prescription status	50 000
Change in prescription 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

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 extraordinary 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 2011, a new fee ordinance come into force (SFS 2010:1167).

Ordinance concerning fees for the governmental control of medicinal products

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

Related information

Annual fee and handling of withdrawals (2011-02-16)

Information on fees for variation applications (2011-01-03)

Application for exemption from or reduction of annual fees

Application for reduction of or exemption from the annual fee shall be made before October 31st.

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