Fees
TARIFF No. 765/2009 for marketing authorisations, annual fees and other licence fees for medicinal products and related products, collected by the Icelandic Medicines Agency, as amended by Regulation No. 765/2009.
Please note that fees should be paid upon receipt of an invoice from the Icelandic Medicines Agency.
An invoice will be issued once an application has been received by the IMC.
| Group: Medicinal products for humans |
Fees in ISK. |
|---|---|
|
Complete/full application (one pharmaceutical form in one strength). Concerned member state in DCP or MRP. Additional pharmaceutical form (in one strength)/strength. |
160,000
|
|
Abridged, bibliographic application for a new generic medicinal product, (one pharmaceutical form in one strength). National registration. Additional pharmaceutical form (in one strength)/strength. |
1,820,000 200,000 |
|
Abridged, bibliographic application for a new generic medicinal product, (one pharmaceutical form in one strength). Concerned member state in DCP or MRP. Additional pharmaceutical form (in one strength)/strength. |
115,000
23,000 |
|
Application for the same proprietary medicinal product, one pharmaceutical form in one strength under a different name (Duplicate). National registration. Additional pharmaceutical form (in one strength)/strength. |
115,000
23,000 |
|
Application for a new pharmaceutical form/strength for a currently registered medicinal product, change in active ingredients, new indication, new method of administration. National registration. Additional pharmaceutical form/strength. |
78,000
15,000 |
|
Application for a new pharmaceutical form/strength for a currently registered medicinal product, change in active ingredients, new indication, new method of administration. Concerned member state in DCP or MRP. Additional pharmaceutical form/strength. |
78,000
|
|
Changes in terms of marketing authorisations |
|
| Application for a change in terms of the marketing authorisation, variation Type IA. |
8,000 |
| Application for a change in terms of the marketing authorisation, variation Type IB. |
14,000 |
| Application for a change in terms of the marketing authorisation, variation Type II, minor change. |
20,000 |
| Application for a change in terms of the marketing authorisation, variation Type II, major change. |
40,000 |
| Other fees |
|
| Application for a change in package insert leaflet and/or labelling, which is not a part of another application. |
30,000 |
| Corrections/amendments of texts |
10,000 |
| Safety assessment of a medicinal product (Periodic Safety Update Report/PSUR). |
10,000 |
| Update of an application dossier into a CTD format, without a change in content. |
7,000 |
| Transfer of marketing authorisation to a third party. |
18,000 |
| Annual fee for each strength/pharmaceutical form. |
22,000 |
| Withdrawal of a marketing authorisation, pharmaceutical form or strength. |
7,000 |
|
Renewal of a medicinal product’s marketing authorisation. |
|
|
Renewal of a medicinal product’s marketing authorisation. Additional pharmaceutical form (in one strength)/strength. |
46,000 15,000 |
| Group: Parallel medicinal products (human and veterinary) |
Fees in ISK. |
|---|---|
|
Application for parallel medicinal product (one country of origin), (one pharmaceutical form in one strength). Additional pharmaceutical form (in one strength)/strength. |
46,000
10,000 |
| Group: Iceland acting as a Reference Member State |
Fees in ISK. |
|---|---|
|
Application for a new proprietary medicinal product (one pharmaceutical form in one strength) in a Mutual Recognition Procedure, with Iceland acting as a Reference Member State (RMS). National registration already granted (MR procedure). Additional pharmaceutical form (in one strength)/strength. |
1,260,000
150,000 |
|
Application for a new proprietary medicinal product (one pharmaceutical form in one strength) in a Mutual Recognition Procedure, with Iceland acting as a Reference Member State. Concurrent application to all states concerned. (DC procedure). Additional pharmaceutical form (in one strength)/strength (DC procedure). |
3,080,000
350,000 |
|
Application for the same proprietary medicinal product, one pharmaceutical form in one strength under a different name (Duplicate) in a Mutual Recognition Procedure, with Iceland acting as a Reference Member State (RMS). Additional pharmaceutical form (in one strength)/strength (MRP). |
1,145,000
327,000 |
|
Application for the same proprietary medicinal product, one pharmaceutical form in one strength under a different name (Duplicate) in a Mutual Recognition Procedure, with Iceland acting as a Reference Member State (RMS). Additional pharmaceutical form (in one strength)/strength (DCP). |
1,260,000
350,000 |
|
Application for a new pharmaceutical form/strength, of a medicinal product, which has been granted a marketing authorisation in a Mutual Recognition Procedure, with Iceland acting as a Reference Member State (RMS). Additional pharmaceutical form (in one strength)/strength. |
1,260,000
350,000 |
| Application for change in terms of the marketing authorisation in a Mutual Recognition Procedure, with Iceland acting as a Reference Member State (RMS), variation Type IA. |
49,000 |
| Application for change in terms of the marketing authorisation in a Mutual Recognition Procedure, with Iceland acting as a Reference Member State (RMS), variation Type IB. |
77,000 |
| Application for change in terms of the marketing authorisation in a Mutual Recognition Procedure, with Iceland acting as a Reference Member State (RMS), variation Type II, minor change. |
308,000 |
| Application for change in terms of the marketing authorisation in a Mutual Recognition Procedure, with Iceland acting as a Reference Member State (RMS), variation Type II, major change. |
630,000 |
|
Application for renewal of a marketing authorisation for a medicinal product granted a marketing authorisation in a Mutual Recognition Procedure, with Iceland acting as a Reference Member State (RMS). Additional pharmaceutical form (in one strength)/strength. |
630,000
168,000 |
| Annual fee for each strength/pharmaceutical form. |
22,000 |
| Safety assessment of a medicinal product (PSUR) with Iceland acting as a Reference Member State. |
385,000 |
| Group: Medicinal products for veterinary use |
Fees in ISK. |
|---|---|
|
Complete/full application (one pharmaceutical form in one strength). Participating state in the Mutual Recognition Procedure (DCP or MRP). Additional pharmaceutical form (in one strength)/strength. |
60,000
16,000 |
|
Abridged, bibliographic application for a new generic medicinal product (one pharmaceutical form in one strength). National registration. Additional pharmaceutical form (in one strength)/strength. |
1,820,000
200,000 |
|
Abridged application for a new generic medicinal product (one pharmaceutical form in one strength). Participating country in the Mutual Recognition Procedure. (DCP or MRP) Additional pharmaceutical form (in one strength)/strength. |
30,000
16,000 |
|
Application for the same proprietary medicinal product, one pharmaceutical form in one strength under a different name (Duplicate). National registration. Additional pharmaceutical form (in one strength)/strength. |
30,000
16,000 |
|
Application for a new pharmaceutical form/strength for a currently registered medicinal product, change in active ingredients, new indication, new method of administration. National registration. Additional pharmaceutical form (in one strength)/strength. |
30,000 |
|
Application for a new pharmaceutical form/strength for a currently registered medicinal product, change in active ingredients, new indication, new method of administration. Participating state in the Mutual Recognition Procedure (DCP or MRP). Additional pharmaceutical form/strength. |
30,000
9,000 |
| Application for a change in terms of the marketing authorisation, variation Type IA. |
5,000 |
| Application for a change in terms of the marketing authorisation, variation Type IB. |
9,000 |
| Application for a change in terms of the marketing authorisation, variation Type II, minor change. |
13,000 |
| Application for a change in terms of the marketing authorisation, variation Type II, major change. |
23,000 |
| Application for Maximum Residue Limits (MRL) and new target species. |
30,000 |
| Application for a change in package insert leaflet and/or labelling, which is not a part of another application. |
15,000 |
| Corrections/amendments of texts |
10,000 |
| Safety assessment of a medicinal product (Periodic Safety Update Report/PSUR). |
5,000 |
| Transfer of the marketing authorisation to a third party. |
14,000 |
| Annual fee for veterinary products for each strength of the product. |
16,000 |
| Withdrawal of a marketing authorisation, pharmaceutical form or strength. |
5,000 |
|
Application for renewal of a medicinal product’s marketing authorisation. Additional pharmaceutical form (in one strength)/strength. |
30,000 16,000 |
| Group: Herbal medicinal products |
Fees in ISK. |
|---|---|
|
Application for a new herbal medicinal product, new substance (one pharmaceutical form in one strength). National registration. Additional pharmaceutical form (in one strength)/strength. |
1,820,000
|
|
Application for a new herbal medicinal product, new substance (one pharmaceutical form in one strength). Participating in the Mutual Recognition Procedure. Additional pharmaceutical form (in one strength)/strength. |
46,000
24,000 |
|
Application for a new herbal medicinal product with the active ingredient currently registered (one pharmaceutical form in one strength). National registration. Additional pharmaceutical form (in one strength)/strength. |
1,820,000
200,000 |
|
Application for a new herbal medicinal product with the active ingredient currently registered (one pharmaceutical form in one strength). Participating in the Mutual Recognition Procedure. Additional pharmaceutical form (in one strength)/strength. |
34,000
9,000 |
|
Application for a new pharmaceutical form/strength with the herbal medicinal product currently registered, change in the active ingredient, new indication, new method of administration. National registration. Additional pharmaceutical form/strength. |
840,000
84,000 |
|
Application for a new pharmaceutical form/strength with the herbal medicinal product currently registered, change in the active ingredient, new indication, new method of administration. Participating state in the Mutual Recognition Procedure. Additional pharmaceutical form/strength. |
23,000
7,000 |
| Application for a change in terms of the marketing authorisation for a herbal medicinal product, variation Type II, minor change. |
13,000 |
| Application for a change in terms of the marketing authorisation for a herbal medicinal product, variation Type II, major change. |
20,000 |
| Application for a change in terms of the marketing authorisation for a herbal medicinal product, variation Type IA. |
5,000 |
| Application for a change in terms of the marketing authorisation for a herbal medicinal product, variation Type IB. |
9,000 |
|
Application for renewal of a herbal medicinal product’s marketing authorisation. Additional pharmaceutical form (in one strength)/strength. |
23,000 12,000 |
| Annual fee for each strength/pharmaceutical form. |
7,000 |
| Transfer of marketing authorisation to a third party. |
13,000 |
| Group: Homeopathic medicinal products |
Fees in ISK. |
|---|---|
| Registration of a homeopathic medicinal product. |
11,500 |
| Registration of a homeopathic medicinal product, which does not have a marketing authorisation in another EEA-member state. |
40,000 |
| Group: Classification og products/substances |
Fees in ISK. |
|---|---|
| Application for a professional evaluation of whether a substance has a pharmacological effect. |
70,000 |
| Assessing whether a product falls under the Medicinal Procucts Act |
25,000 |
| Group: Clinical trials etc. |
Fees in ISK. |
|---|---|
| Clinical trial. |
130,000 |
| Clinical bio-availability study. |
70,000 |
| Substantial amendment to a clinical trial. |
20,000 |
| Group: Officinal formulae |
Fees in ISK. |
|---|---|
| Application for evaluation of an officinal formula. |
29,000 |
| Group: Certificates |
Fees in ISK. |
|---|---|
| Certificate of a Pharmaceutical Product. |
18,000 |
| Certificate of a Good Manufacturing Practice (GMP Certificate). |
12,000 |
| Statement of Licensing Status of Pharmaceutical Products. |
11,000 |
| Group: Advice etc. |
Fees in ISK. |
|---|---|
| Scientific Advice. Fees/hour. |
20,000 |
| GMP certification upon request by firms not falling within the scope of obligatory inspections by the Icelandic Medicines Agency, cf. Art. 3 of the Medicinal Products Act No 93/1994. Hourly rate. |
20,000 |
