S.I. No. 731/2003 - Irish Medicines Board (Fees) Regulations, 2003

I, Micheál Martin, 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, 2003.

2. These Regulations shall come into force on the 1^st day of January 2004.

3. In these Regulations:-

“the Act” means the Irish Medicines Board Act, 1995 ;

“the Board” means the Irish Medicines Board;

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

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

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

“certificate of registration” means a certificate granted, in respect of homeopathic medicinal products, pursuant to the Medical Preparations (Licensing and Sale) Regulations, 1998 ( S.I. No. 142 of 1998 ).

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, product authorisations and certificates of registration, 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) (Medicinal Products for Human Use Regulations, 2002 ( S.I. No. 262 of 2002 ) are hereby revoked.

SCHEDULE

COLUMN 1	COLUMN 2
	Euro
Fees for National Applications for Product Authorisations
National application — complex dossier, new active substance	10,056
Each additional form (same time)	4,188
Each additional strength (same time)	540
Additional drug master file submitted with any of the above	2,676
National application — reduced complex	7,548
Each additional form (same time)	4,188
Each additional strength (same time)	540
Additional drug master file submitted with any of the above	2,676
National application — reduced dossier standard	5,028
Each additional form (same time)	4,188
Each additional strength (same time)	540
Additional drug master file submitted with any of the above	2,676
Subsequent extension applications - first additional form	5,028
Each additional form (same time)	4,188
First additional strength (existing form)	2,268
Each additional strength (same time)	540
Fees for Applications for Product Authorisations using European Mutual Recognition procedure
Mutual recognition incoming — complex dossier, new active substance	7,044
Each additional form (same time)	3,012
Each additional strength (same time)	540
Outgoing mutual recognition supplement	7,620
Mutual recognition incoming — reduced complex	5,364
Each additional form (same time)	2,676
Each additional strength (same time)	540
Outgoing mutual recognition supplement	7,620
Mutual recognition incoming — reduced dossier standard	3,516
Each additional form (same time)	2,352
Each additional strength (same time)	540
Outgoing mutual recognition supplement	4,572
Subsequent extension applications
— mutual recognition incoming (additional form)	2,352
Mutual recognition incoming (additional strength)	540
Outgoing mutual recognition supplement (additional form)	2,352
Outgoing mutual recognition supplement (additional strength)	540
Fees for Parallel Product Authorisations
	Euro
Application fee - per country at the same time or by variation	1,368
Each additional strength per country	408
Each additional form per country	408
Fees for Variations to Product Authorisations that are nationally licensed
Type 1A variation	300
Type 1A variation — reduced rate	150
Type 1B variation	408
Type 1B variation — reduced rate	204
Type II complex variation	2,676
Type II standard variation	520
Type II standard variation — reduced rate	260
Notifications made under Article 61 (3) of Directive 2001 / 83 / EC	408
Fees for Variations to Product Authorisations licensed under European Mutual Recognition procedure
Type 1A variation — outgoing mutual recognition supplement	300
Type 1A variation — mutual recognition incoming	300
Type 1A variation — mutual recognition incoming — reduced rate	150
Type 1B variation - outgoing mutual recognition supplement	348
Type 1B variation — mutual recognition incoming	348
Type 1B variation — mutual recognition incoming — reduced rate	180
Type II complex variation - outgoing mutual recognition supplement	540
Type II complex variation — mutual recognition incoming	1,848
Type II standard variation — mutual recognition incoming	348
Type II standard variation — mutual recognition incoming — reduced rate	180
Notifications made under Article 61 (3) of Directive 2001 / 83 / EC	408
Fees for the granting of a Product Authorisation on transfer to another company
Change of ownership — related company - per form	924
Change of ownership - related company - per strength	264
Change of ownership — non-related company - per form	2,436
Change of ownership — non-related company - per strength	264
Change of ownership — non-related company - reduced rate	1,680
Other fees relating to the granting of Product Authorisations	Euro
Service item	504
Application for certificate of registration in respect of homeopathic medicinal products
New application standard fee — single stock	600
New application standard fee — 2-5 stocks	800
New application standard fee — 6 or more stocks	1,000
New application stock already assessed — single stock	450
New application stock already assessed — 2-5 stocks	600
New application stock already assessed — 6 or more stocks	700
New application formulation already assessed — single stock	450
New application formulation already assessed — 2-5 stocks	600
New application formulation already assessed — 6 or more stocks	700
New application stock & formulation already assessed — single stock	350
New application stock & formulation already assessed — 2-5 stocks	450
New application stock & formulation already assessed — 6 or more stocks	500
Technical variation	330
Technical variation — reduced rate	165
Administrative variation	230
Administrative variation — reduced rate	115
Fees for Wholesale Licences
Application fee	456
Annual fee - large site	2,280
Annual fee - medium site	1,296
Annual fee - minor site	456
Variation to licence - administrative	156
Variation to licence - technical	456
Variation to licence - minor site	156
Fees for Manufacturing Licences
Application fee	1,524
Annual fee - major site (> 250 employees)	13,716
Annual fee - large site ( 150 — 250 employees)	9,144
Annual fee - medium site (50 - 149 employees)	6,096
Annual fee - small site ( < 50 employees)	3,048
Variation to licence — administrative	180
Variation to licence - technical	552
Fees for the granting of a Manufacturing Licence or a Wholesale Licence on transfer to another company	Euro
Manufacture — related companies	912
Manufacture — unrelated companies	1,524
Wholesale - related companies	300
Wholesale - unrelated companies	456

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Given under the official seal of the Minister for Health and Children this 30th day of December, 2003.

Micheál Martin

________________________

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 payment of fees to the Irish Medicines Board pursuant to Section 13 of the Irish Medicines Board Act, 1995 .