S.I. No. 877/2004 - Irish Medicines Board (Fees) Regulations 2004

I, Mary Harney, Minister for Health and Children, in exercise of the powers conferred on me by sections 13 and 32 of the Irish Medicines Board Act 1995 (No. 29 of 1995), as adapted by the Health (Alteration of Name of Department and Title of Minister) Order 1997, ( S.I. No. 308 of 1997 ) and of all other powers enabling me in that behalf, hereby make the following Regulations:

1. These Regulations may be cited as the Irish Medicines Board (Fees) Regulations 2004.

2. These Regulations shall come into force on the 1st day of January 2005.

3. In these Regulations —

“Board” means the Irish Medicines Board;

“manufacturing licence” means a licence granted pursuant to the Medical Preparations (Licensing of Manufacture) Regulations 1993 to 1996;

“product authorisation” means an authorisation granted pursuant to the Medical Preparations (Licensing and Sale) Regulations 1998 ( S.I. No. 142 of 1998 );

“wholesale licence” means a licence granted pursuant to the Medical Preparations (Wholesale Licences) Regulations 1993 to 1996.

4. These Regulations shall apply to the fees that may be charged by the Board, in pursuit of its statutory duties, in relation to applications for the grant or renewal of manufacturing licences, wholesale licences and product authorisations in respect of medicinal products for human use.

5. Subject to Regulation 6 hereof, there shall be paid to the Board in respect of each and every matter set out in column 1 of the schedule hereto the fee as set out in column 2 of the said schedule.

6. The Board may, in circumstances where it considers it appropriate to do so, waive, remit or refund, either in whole or in part, any fee that would otherwise be payable to it under Regulation 5 hereof.

7. The Irish Medicines Board (Fees) Regulations 2003 ( S.I. No. 731 of 2003 ) and the Irish Medicines Board (Fees) (Amendment) Regulations 2004 ( S.I. No. 524 of 2004 ) are hereby revoked.

SCHEDULE

COLUMN 1	COLUMN 2
Fees for National Applications for Product Authorisations	€
National application - complex dossier, new active substance	10,358
Each additional form (same time)	4,314
Each additional strength (same time)	556
Additional drug master file submitted with any of the above	2,756
National application - reduced complex	7,774
Each additional form (same time)	4,314
Each additional strength (same time)	556
Additional drug master file submitted with any of the above	2,756
National application - reduced dossier standard	5,179
Each additional form (same time)	4,314
Each additional strength (same time)	556
Additional drug master file submitted with any of the above	2,756
Subsequent extension applications - first additional form	5,179
Each additional form (same time)	4,314
First additional strength (existing form)	2,336
Each additional strength (same time)	556
Fees for Applications for Product Authorisations using European Mutual Recognition procedure
Mutual recognition incoming - complex dossier, new active substance	7,255
Each additional form (same time)	3,102
Each additional strength (same time)	556
Outgoing mutual recognition supplement	7,849
Mutual recognition incoming - reduced complex	5,525
Each additional form (same time)	2,756
Each additional strength (same time)	556
Outgoing mutual recognition supplement	7,849
Mutual recognition incoming - reduced dossier standard	3,621
Each additional form (same time)	2,423
Each additional strength (same time)	556
Outgoing mutual recognition supplement	4,709
Subsequent extension application
- mutual recognition incoming (first additional form)	2,423
- mutual recognition incoming (first additional strength)	1,635
- mutual recognition incoming (subsequent additional strength)	556
Outgoing mutual recognition supplement (additional form)	2,423
Outgoing mutual recognition supplement (additional strength)	556
Change of address for Product Authorisation holder: 1 to 20 Product Authorisations	100
Change of address for Product Authorisation holder: more than 20 Product Authorisations	500
Fees for Parallel Product Authorisations
Application fee - per country at the same time or by variation	1,409
Each additional strength per country	420
Each additional form per country	420
Fees for Variations to Product Authorisations that are nationally licensed
Type IA variation	309
Type IA variation - reduced rate	155
Type IB variation	420
Type IB variation - reduced rate	210
Type II complex variation	2,756
Type II standard variation	536
Type II standard variation - reduced rate	268
Notifications made under Article 61 (3) of Directive 2001 / 83 / EC	420
Fees for Variations to Product Authorisations licensed under European Mutual Recognition procedure
Type IA variation - outgoing mutual recognition supplement	309
Type IA variation - mutual recognition incoming	309
Type IA variation - mutual recognition incoming - reduced rate	155
Type IB variation - outgoing mutual recognition supplement	358
Type IB variation - mutual recognition incoming	358
Type IB variation - mutual recognition incoming - reduced rate	185
Type II complex variation - outgoing mutual recognition supplement	556
Type II complex variation - mutual recognition incoming	1,903
Type II standard variation - mutual recognition incoming	358
Type II standard variation - mutual recognition incoming - reduced rate	185
Type II standard variation - outgoing mutual recognition supplement	358
Notifications made under Article 61 (3) of Directive 2001 / 83 / EC	420
Fees for the granting of a Product Authorisation on transfer to another company
Change of ownership - related company - per form	952
Change of ownership - related company - per strength	272
Change of ownership - non-related company - per form	2,509
Change of ownership - non-related company - per strength	272
Change of ownership — non-related company - reduced rate	1,730
Other fees relating to the granting of Product Authorisations
Service item	519
Fees for Wholesale Licences
Application fee	470
Annual fee - large site	2,348
Annual fee - medium site	1,335
Annual fee - minor site	470
Variation to licence - administrative	161
Variation to licence - technical	470
Variation to licence - minor site	161
Fees for Manufacturing Licences
Application fee	1,570
Annual fee - major site (more than 250 employees)	14,127
Annual fee - large site (150 — 250 employees)	9,418
Annual fee - medium site (50 — 149 employees)	6,279
Annual fee - small site (less than 50 employees)	3,139
Variation to licence - administrative	185
Variation to licence - technical	569
Fees for the granting of a Manufacturing Licence or a Wholesale Licence on transfer to another company
Manufacture - related companies	939
Manufacture - unrelated companies	1,570
Wholesale - related companies	309
Wholesale - unrelated companies	470

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Given under my Official Seal this 22^nd day of December 2004.

___________

Mary Harney

Minister for Health and Children

Explanatory Note

(This note is not part of the instrument and does not purport to be a legal instrument.)

The purpose of these Regulations is to provide for the revision of fees payable to the Irish Medicines Board pursuant to Section 13 of the Irish Medicines Board Act 1995 .