S.I. No. 262/2002 - Irish Medicines Board (Fees) (Medicinal Products For Human Use) Regulations, 2002

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) (Medicinal Products for Human Use) Regulations, 2002.

2. These Regulations shall come into force on the 1^st day of June 2002.

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 Article 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 Article 5 hereof.

7. The Irish Medicines Board (Fees) Regulations, 1996 ( S.I. No. 44 of 1996 ) and the Irish Medicines Board (Fees) (Amendment) Regulations, 2000 ( S.I. No. 233 of 2000 ) are hereby revoked.

SCHEDULE

COLUMN 1	COLUMN 2
Fees for National Applications for Product Authorisations	€
National application — full dossier complex	8,380
Each additional form (same time)	3,490
Each additional strength (same time)	450
National application — reduced dossier complex	6,290
Each additional form (same time)	3,490
Each additional strength (same time)	450
National application — reduced dossier standard	4,190
Each additional form (same time)	3,490
Each additional strength (same time)	450
First additional form	4,190
Each additional form (same time)	3,490
First additional strength (existing form)	1,890
Each additional strength (same time)	450
Fees for Applications for Product Authorisations using European Mutual Recognition procedure
Incoming decentralised — full dossier complex	5,870
Each additional form (same time)	2,510
Each additional strength (same time)	450
Outgoing decentralised supplement	6,350
Incoming decentralised — reduced dossier complex	4,470
Each additional form (same time)	2,230
Each additional strength (same time)	450
Outgoing decentralised supplement	6,350
Incoming decentralised — reduced dossier standard	2,930
Each additional form (same time)	1,960
Each additional strength (same time)	450
Outgoing decentralised supplement	3,810
Incoming decentralised (additional form)	1,960
Incoming decentralised (additional strength)	450
Outgoing decentralised supplement (additional form)	1,960
Outgoing decentralised supplement (additional strength)	450
Fees for Parallel Product Authorisations
Application fee - per country	1,140
Each additional strength/form per country	340
Fees for Variations to Product Authorisations that are nationally licensed
Simple variation	340
Simple variation reduced rate	170
Complex variation — Type II	2,230
Type II standard variation	340
Type II standard variation — reduced rate	170
Change of distributor: Company with >51 P.A.s	1,400
Change of distributor: Company with <51 P.A.s	700
Fees for Variations to Product Authorisations licensed under European Mutual Recognition procedure
Simple variation outgoing decentralised supplement	290
Simple variation incoming decentralised	290
Simple variation incoming decentralised reduced rate	150
Complex variation outgoing decentralised supplement	450
Complex variation incoming decentralised	1,540
Complex variation incoming decentralised reduced rate	290
Type II simple variation incoming decentralised reduced rate	150
Fees for the granting of a Product Authorisation on transfer to another company
Change of Owner — related company - per form	770
Change of Owner - related company - per additional strength	220
Change of Owner — non-related company - per form	2,030
Change of Owner — non-related company — additional strength	220
Change of Owner — non-related company — reduced rate	1,400
Other fees relating to the granting of Product Authorisations
Service item	420
Application for certificate of registration in respect of homeopathic medicinal products	500
Fees for Wholesale Licences
Application fee	380
Annual fee - main site	1,900
Annual fee - medium site	1,080
Annual fee - minor site	380
Variation to licence - administrative	130
Variation to licence - technical	380
Variation to licence - minor site	130
Fees for Manufacturing Licences
Application fee	1,270
Annual fee - major site	11,430
Annual fee - large site	7,620
Annual fee - medium site	5,080
Annual fee - small site	2,540
Variation to licence — administrative	150
Variation to licence - technical	460
Fees for the granting of a Manufacturing Licence or a Wholesale Licence on transfer to another company
Manufacture - related companies	760
Manufacture —unrelated companies	1,270
Wholesale - related companies	250
Wholesale - unrelated companies	380

Given under the official seal of the Minister for Health and Children this 29th day of May, 2002.

/images/seal.jpg

Micheál Martin

_________________________

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 .