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

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.

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

.

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:-