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 1st 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 .