S.I. No. 617/2006 - Irish Medicines Board (Fees) Regulations 2006

S.I. No. 617 of 2006

Irish Medicines Board (Fees) Regulations 2006

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 2006.

2. These Regulations shall come into force on the 1st day of January 2007.

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 2005 ( S.I. No. 882 of 2005 ) are hereby revoked.

SCHEDULE

COLUMN 1	COLUMN 2
Fees for National Applications for Product Authorisations	€
National application - complex dossier, new active substance	11,149
Each additional form ( same time )	4,643
Each additional strength (same time)	598
Additional drug master file submitted with any of the above	2,966
National application - reduced complex	8,368
Each additional form (same time)	4,643
Each additional strength (same time)	598
Additional drug master file submitted with any of the above	2,966
National application - reduced dossier standard	5,574
Each additional form (same time)	4,643
Each additional strength (same time)	598
Additional drug master file submitted with any of the above	2,966
Subsequent extension applications - first additional form	5,574
Each additional form (same time)	4,643
First additional strength ( existing form )	2,514
Each additional strength ( same time )	598

Fees for Applications for Product Authorisations using European Mutual Recognition procedure

Mutual recognition incoming - complex dossier, new active substance	7,808
Each additional form (same time)	3,339
Each additional strength (same time)	598
Outgoing mutual recognition/decentralised supplement	10,000
Decentralised Outgoing/Incoming	11,149
Each additional form (same time)	4,643
Each additional strength (same time)	598
Mutual recognition incoming - reduced complex	5,947
Each additional form (same time)	2,966
Each additional strength (same time)	598
Outgoing mutual recognition / decentralised supplement	10,000
Decentralised Outgoing/Incoming	8,368
Each additional form (same time)	4,643
Each additional strength (same time)	598
Mutual recognition incoming - reduced dossier standard	3,898
Each additional form (same time)	2,608
Each additional strength (same time)	598
Outgoing mutual recognition / decentralised supplement	6,500
Decentralised Outgoing/Incoming	5,574
Each additional form (same time)	4,643
Each additional strength (same time)	598
Subsequent extension applications
- mutual recognition incoming (first additional form)	2,608
- mutual recognition incoming (first additional strength)	1,760
- mutual recognition incoming (subsequent additional strength)	598
Outgoing mutual recognition/decentralised supplement (additional form)	2,608
Outgoing mutual recognition/decentralised supplement
(additional strength)	598
Decentralised Outgoing / Incoming First Additional Form	5,574
Each additional form (same time)	4,643
First additional strength (existing form)	2,514
Each additional strength (same time)	598
Change of address for Product Authorisation holder: 1 to 20
Product Authorisations	108
Change of address for Product Authorisation holder: more than
20 Product Authorisations	539

Fees for Parallel Product Authorisations

Application fee - per country at the same time or by variation	1,516
Each additional strength per country	452
Each additional form per country	452
Registration of parallel imports	515
Each additional strength or form	258

Fees for Variations to Product Authorisations that are nationally licensed

Type IA variation	333
Type IA variation - reduced rate	167
Type IB variation	452
Type IB variation - reduced rate	226
Type II complex variation	2,966
Type II standard variation	577
Type II standard variation - reduced rate	288
Notifications made under Article 61 (3) of Directive 2001 / 83 / EC	452
Notifications made under Article 61 (3) of Directive 2001 / 83 / EC - reduced rate	226

Fees for Variations to Product Authorisations licensed under European Mutual Recognition procedure

Type IA variation - outgoing mutual recognition / decentralised supplement	333
Type IA variation - mutual recognition incoming	333
Type IA variation - mutual recognition incoming - reduced rate	167
Type IB variation outgoing mutual recognition / decentralised supplement	385
Type IB variation - mutual recognition incoming	385
Type IB variation - mutual recognition incoming - reduced rate	199
Type II complex variation - outgoing mutual recognition / decentralised supplement	598
Type II complex variation - mutual recognition incoming	2,049
Type II standard variation - mutual recognition incoming	385
Type II standard variation - mutual recognition incoming - reduced rate	199
Type II standard variation - outgoing mutual recognition / decentralised supplement	385
Notifications made under Article 61 (3) of Directive 2001 / 83 / EC	452
Notifications made under Article 61 (3) of Directive 2001 / 83 / EC - reduced rate	226

Fees for the granting of a Product Authorisation on transfer to another company

Change of ownership - related company - per form	1,025
Change of ownership - related company - per strength	293
Change of ownership - non-related company - per form	1,500
Change of ownership - non-related company - per strength	293

Other fees relating to the granting of Product Authorisations

Service item

558

Fees for Wholesale Licences

Application fee	506
Annual fee - large site	2,528
Annual fee - medium site	1,437
Annual fee - minor site	506
Variation to licence - administrative	200
Variation to licence - technical	550
Variation to licence - minor site	200

Fees for Manufacturing Licences

Application fee	1,690
Annual fee - major site ( more than 250 employees )	15,206
Annual fee - large site ( 150 - 250 employees )	10,137
Annual fee - medium site ( 50 - 149 employees )	6,759
Annual fee - small site ( less than 50 employees )	3,378
Variation to licence - administrative	250
Variation to licence - technical	700

Fees for the granting of a Manufacturing Licence or a Wholesale Licence on transfer to another company

Manufacture - related companies	1,010
Manufacture - unrelated companies	1,690
Wholesale - related companies	333
Wholesale - unrelated companies	506

	Given under my Official Seal this 12^th day of December 2006

	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 .