S.I. No. 882/2005 - Irish Medicines Board (Fees) Regulations 2005

S.I. No. 882 of 2005

Irish Medicines Board (Fees) Regulations 2005

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 2005.

2. These Regulations shall come into force on the 1st day of January 2006.

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 2004 ( S.I. No. 877 of 2004 ) are hereby revoked.

SCHEDULE

COLUMN 1	COLUMN 2
Fees for National Applications for Product Authorisations	€
National application - complex dossier, new active substance	10,824
Each additional form (same time)	4,508
Each additional strength (same time)	581
Additional drug master file submitted with any of the above	2,880
National application - reduced complex	8,124
Each additional form (same time)	4,508
Each additional strength (same time)	581
Additional drug master file submitted with any of the above	2,880
National application - reduced dossier standard	5,412
Each additional form (same time)	4,508
Each additional strength (same time)	581
Additional drug master file submitted with any of the above	2,880
Subsequent extension applications - first additional form	5,412
Each additional form (same time)	4,508
First additional strength (existing form)	2,441
Each additional strength (same time)	581
Fees for Applications for Product Authorisations using European Mutual Recognition procedure
Mutual recognition incoming - complex dossier, new active substance	7,581
Each additional form (same time)	3,242
Each additional strength (same time)	581
Outgoing mutual recognition/decentralised supplement	8,202
Decentralised Outgoing/Incoming	10,824
Each additional form (same time)	4,508
Each additional strength (same time)	581
Mutual recognition incoming - reduced complex	5,774
Each additional form (same time)	2,880
Each additional strength (same time)	581
Outgoing mutual recognition / decentralised supplement	8,202
Decentralised Outgoing/Incoming	8,124
Each additional form (same time)	4,508
Each additional strength (same time)	581
Mutual recognition incoming - reduced dossier standard	3,784
Each additional form (same time)	2,532
Each additional strength (same time)	581
Outgoing mutual recognition / decentralised supplement	4,921
Decentralised Outgoing/Incoming	5,412
Each additional form (same time)	4,508
Each additional strength (same time)	581
Subsequent extention applications
- mutual recognition incoming (first additional form)	2,532
- mutual recognition incoming (first additional strenght)	1,709
- mutual recognition incoming (subsequent additional strength)	581
Outgoing mutual recognition/decentralised supplement (additional form)	2,532
Outgoing mutual recognition/decentralised supplement ( additional strength )	581
Decentralised Outgoing / Incoming First Additional Form	5,412
Each additional form ( same time )	4,508
First additional strength ( existing form )	2,441
Each additional strength ( same time )	581
Change of address for Product Authorisation holder: 1 to 20
Product Authorisations	105
Change of address for Product Authorisation holder: more than 20 Product Authorisations	523
Fees for Parallel Product Authorisations
Application fee - per country at the same time or by variation	1,472
Each additional strength per country	439
Each additional form per country	439
Registration of parallel imports	500
Each additional strength or form	250
Fees for Variations to Product Authorisations that are nationally licensed
Type IA variation	323
Type IA variation - reduced rate	162
Type IB variation	439
Type IB variation - reduced rate	219
Type II complex variation	2,880
Type II standard variation	560
Type II standard variation - reduced rate	280
Notifications made under Article 61 (3) of Directive 2001 / 83 / EC	439
Notifications made under Article 61 (3) of Directive 2001 / 83 / EC - reduced rate	219
Fees for Variations to Product Authorisations licensed under European Mutual Recognition procedure
Type IA variation - outgoing mutual recognition / decentralised supplement	323
Type IA variation - mutual recognition incoming	323
Type IA variation - mutual recognition incoming - reduced rate	162
Type IB variation outgoing mutual recognition / decentralised supplement	374
Type IB variation - mutual recognition incoming	374
Type IB variation - mutual recognition incoming - reduced rate	193
Type II complex variation - outgoing mutual recognition / decentralised supplement	581
Type II complex variation - mutual recognition incoming	1,989
Type II standard variation - mutual recognition incoming	374
Type II standard variation - mutual recognition incoming - reduced rate	193
Type II standard variation - outgoing mutual recognition / decentralised supplement	374
Notifications made under Article 61 (3) of Directive 2001 / 83 / EC	439
Notifications made under Article 61 (3) of Directive 2001 / 83 / EC - reduced rate	219
Fees for the granting of a Product Authorisation on transfer to another company
Change of ownership - related company - per form	995
Change of ownership - related company - per strength	284
Change of ownership - non-related company - per form	2,622
Change of ownership - non-related company - per strength	284
Change of ownership - non-related company - reduced rate	1,808
Other fees relating to the granting of Product Authorisations
Service item	542
Fees for Wholesale Licences
Application fee	491
Annual fee - large site	2,454
Annual fee - medium site	1,395
Annual fee - minor site	491
Variation to licence - administrative	168
Variation to licence - technical	491
Variation to licence - minor site	168
Fees for Manufacturing Licences
Application fee	1,641
Annual fee - major site (more than 250 employees)	14,763
Annual fee - large site ( 150 - 250 employees )	9,842
Annual fee - medium site ( 50 - 149 employees )	6,562
Annual fee - small site ( less than 50 employees )	3,280
Variation to licence - administrative	193
Variation to licence - technical	595
Fees for the granting of a Manufacturing Licence or a Wholesale Licence on transfer to another company
Manufacture - related companies	981
Manufacture - unrelated companies	1,641
Wholesale - related companies	323
Wholesale - unrelated companies	491

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Given under my Official Seal this 23rd day of December 2005

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 .