S.I. No. 542/2008 - Irish Medicines Board (Fees) Regulations 2008


S.I. No. 542 of 2008

IRISH MEDICINES BOARD (FEES) REGULATIONS 2008

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 19th December, 2008.

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 2008.

2. These Regulations shall come into force on the 1st day of January 2009.

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 2007 ( S.I. No. 866 of 2007 ) are hereby revoked.

SCHEDULE

COLUMN 1 COLUMN 2

Fees for National Applications for Product Authorisations

National application — complex dossier, new active substance

15,211

Each additional form (same time)

5,090

Each additional strength (same time)

656

Additional drug master file submitted with any of the above

3,251

National application — reduced complex

11,329

Each additional form (same time)

5,090

Each additional strength (same time)

656

Additional drug master file submitted with any of the above

3,251

National application — reduced dossier standard

7,658

Each additional form (same time)

5,090

Each additional strength (same time)

656

Additional drug master file submitted with any of the above

3,251

Subsequent extension applications — first additional form

7,658

Each additional form (same time)

5,090

First additional strength (existing form)

2,756

Each additional strength (same time)

656

Additional drug master file submitted with any of the above

3,251

Fees for Applications for Product Authorisations using European Mutual Recognition procedure

Mutual recognition incoming — complex dossier, new active substance

10,647

Each additional form (same time)

3,660

Each additional strength (same time)

656

Outgoing mutual recognition/decentralised supplement

10,962

Decentralised Outgoing/Incoming

15,211

Each additional form (same time)

5,090

Each additional strength (same time)

656

Additional supplement DCP outgoing greater than 10 countries

5,000

Mutual recognition incoming — reduced complex

8,077

Each additional form (same time)

3,251

Each additional strength (same time)

656

Outgoing mutual recognition / decentralised supplement

10,962

Decentralised Outgoing/Incoming

11,329

Each additional form (same time)

5,090

Each additional strength (same time)

656

Additional supplement DCP outgoing greater than 10 countries

5,000

Mutual recognition incoming — reduced dossier standard

5,350

Each additional form (same time)

2,859

Each additional strength (same time)

656

Outgoing mutual recognition / decentralised supplement

7,126

Decentralised Outgoing/Incoming

7,658

Each additional form (same time)

5,090

Each additional strength (same time)

656

Additional supplement DCP outgoing greater than 10 countries

5,000

Subsequent extension applications

— mutual recognition incoming (first additional form)

5,350

— mutual recognition incoming (first additional strength)

1,929

— mutual recognition incoming (subsequent additional strength)

656

Outgoing mutual recognition/decentralised supplement (additional form)

2,859

Outgoing mutual recognition/decentralised supplement (additional strength)

656

Decentralised Outgoing / Incoming First Additional Form

7,658

Each additional form (same time)

5,090

First additional strength (existing form)

2,756

Each additional strength (same time)

656

Additional supplement DCP outgoing greater than 10 countries

5,000

Change of address for Product Authorisation holder: 1 to 20

Product Authorisations

119

Change of address for Product Authorisation holder: more than

20 Product Authorisations

591

Fees for Parallel Product Authorisations

Application fee — per country at the same time or by variation

1,662

Each additional strength per country

495

Each additional form per country

495

Dual pack registration of parallel imports

564

Each additional strength or form

283

Change of Ownership

525

Fees for Variations to Product Authorisations that are nationally licensed

Type IA variation

365

Type IA variation — reduced rate

184

Type IB variation

495

Type IB variation — reduced rate

248

Type II complex variation

3,251

Type II standard variation

633

Type II standard variation — reduced rate

316

Notifications made under Article 61 (3) of Directive 2001 / 83 / EC

495

Notifications made under Article 61 (3) of Directive 2001 / 83 / EC— reduced rate

248

Bulk variation to multiple changes to the SPC (per product range)

8,000

Bulk variation for multiple changes to the same document

6,000

Introduction of standard statements from PHV working party — 1 to 5licences

1,500

Introduction of standard statements from PHV working party — 6 to 10 licences

3,000

Introduction of standard statements from PHV working party — 11 to 20 licences

6,000

Introduction of standard statements from PHV working party — 21 to 40 licences

12,000

Introduction of standard statements from PHV working party — 41 to 100 licences

20,000

Introduction of standard statements from PHV working party — 101 and above

30,000

Fees for Variations to Product Authorisations licensed under European Mutual Recognition procedure

Type IA variation — outgoing mutual recognition / decentralised supplement

365

Type IA variation — mutual recognition incoming

315

Type IA variation — mutual recognition incoming — reduced rate

184

Type IB variation outgoing mutual recognition / decentralised supplement

365

Type IB variation — mutual recognition incoming

422

Type IB variation — mutual recognition incoming — reduced rate

218

Type II complex variation — outgoing mutual recognition / decentralised supplement

656

Type II complex variation — mutual recognition incoming

2,246

Type II standard variation — mutual recognition incoming

422

Type II standard variation — mutual recognition incoming — reduced rate

218

Type II standard variation — outgoing mutual recognition / decentralised supplement

422

Notifications made under Article 61 (3) of Directive 2001 / 83 / EC

495

Notifications made under Article 61 (3) of Directive 2001 / 83 / EC— reduced rate

248

Fees for the granting of a Product Authorisation on transfer to another company

Change of ownership — related company — per form

1,123

Change of ownership — related company — per strength

321

Change of ownership — non-related company — per form

1,645

Change of ownership — non-related company — per strength

321

Other fees relating to the granting of Product Authorisations

Service item

612

Fees for Wholesale Licences

Application fee

555

Annual fee — large site

2,771

Annual fee — medium site

1,576

Annual fee — minor site

555

Variation to licence — administrative

219

Variation to licence — technical

603

Fees for Manufacturing Licences

Application fee

1,853

Annual fee — major site (more than 250 employees)

16,669

Annual fee — large site (150 — 250 employees)

11,112

Annual fee — medium site (50 — 149 employees)

7,409

Annual fee — small site (less than 50 employees)

3,703

Variation to licence — administrative

274

Variation to licence — technical

768

Fees for Blood and Tissue Establishments

Application fee

1,853

Annual fee — major site (more than 250 employees)

16,669

Annual fee — large site (150 — 250 employees)

11,112

Annual fee — medium site (50 — 149 employees)

7,409

Annual fee — small site (less than 50 employees)

3,703

Variation to licence — administrative

274

Variation to licence — technical

768

Fees for Laboratory Approvals

Application fee

555

Annual fee — minor site

555

Variation to licence — administrative

219

Variation to licence — technical

603

Fees for the granting of a Manufacturing Licence or a Wholesale Licence on transfer to another company

Manufacture — related companies

1,107

Manufacture — unrelated companies

1,853

Wholesale — related companies

365

Wholesale — unrelated companies

555

Fees for Notifications of Exempt Medicinal Products

Per notification

2

Cap on total notifications

10,000

Fees for Medical Devices

Certificates of free sale

Certificates of free sale issued within 2 days (4 certs per request)

147

Certificates of free sale issued within 1 day (4 certs per request)

277

Additional certificates (available at the time of the initial request)

23

Registration of Devices

Registration of In-vitro Diagnostic medical device

153

First registration of a general medical device

153

Re-registration of items currently on the market

153

Changes to registration thereafter

153

Electronic registration

131

Annual Verification Fee — up to 5 employees

153

Annual Verification Fee — between 6-20 employees

384

Annual Verification Fee — between 21-100 employees

768

Annual Verification Fee — Over 100 employees

1,645

Clinical Investigations

Clinical Investigations — active implantable medical devices

3,837

Clinical Investigations — Class III and class IIb medical devices

3,837

Clinical Investigations — Class IIa and class I medical device

1,645

Clinical Investigations — Technical amendment to a previously

approved clinical investigation

1,129

Clinical Investigations — Administrative amendment to a previously

approved clinical investigation

219

Audits / Inspections

Audits/ Inspections (including Notified Body) per day

1,489

Audits/Inspections (including Notified Body) per hour

234

Classifications

Classification of a product (1 product per request)

250

Classification of additional products (available at the time of the initial request)

200

Appeal of a classification decision

250

Designation Fee for a Notified Body

Designation Fee

3,672

Extension to the scope (per extension)

1,836

Medicinal Product/Medical Device — Drug Consultation fees

New active substance

41,960

Established active in new therapeutic area

33,568

Established active and therapeutic area

29,372

Variations — Minor

839

Variations — Major

3,776

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GIVEN under my Official Seal ,

15 December 2008

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 .