Medicines Authority (Fees) (Amendment) Regulations, 2012

L.N. 228 of 2012

MEDICINES ACT

(CAP. 458)

Medicines Authority (Fees) (Amendment) Regulations, 2012

IN exercise of the powers conferred by article 106 of the

Medicines Act, the Minister of Health, the Elderly and Community

Care, after consultation with the Licensing Authority, and with the

concurrence of the Minister of Finance, the Economy and Investment,

has made the following regulations:-

The title of these regulations is the Medicines Authority Citation.

(Fees) (Amendment) Regulations, 2012, and these regulations shall

be read and construed as one with the Medicines Authority (Fees) S.L. 458.46

Regulations, hereinafter referred to as the "principal regulations".

Regulation 2 of the principal regulations shall be amended Amends

regulation 2 of

as follows

the principal

regulations.

(a)

the definition "extension application" shall be

deleted;

(b) immediately after the definition "Directive 2001/83/

EC", there shall be added the following new definition

" "extension of a marketing authorisation" or

"extension" means a variation which is listed in Annex I of

Regulation 1234/2008/EC and fulfils the conditions laid

down therein;";

(c)

for the definition "marketing authorisation transfer",

there shall be substituted the following new definition

" "marketing authorisation transfer" is when a

marketing authorisation is transferred from the existing

marketing authorisation holder to another using a transfer

procedure. A transfer may occur either during or after issue

of a marketing authorisation and entails a change in legal

entity;";

(d) immediately

after

the

definition

"partial

manufacturing", there shall be added the following new

definition

" "periodic safety update report" or

"PSUR" refers to the periodical reports

containing the records referred to in

regulation 32 of the Pharmacovigilance

Regulations;";

(e)

immediately after the definition "pharmacovigilance

inspection", there shall be added the following new definition

" "post-authorisation safety study" or "PASS"

means any study relating to an authorised medicinal

product conducted with the aim of identifying,

characterising or quantifying a safety hazard, confirming

the safety profile of the medicinal product, or of measuring

the effectiveness of risk management measures;";

(f)

immediately after the definition "traditional herbal

medicinal product", there shall be added the following new

definition

" "urgent safety restriction" means an interim

change in the terms of the marketing authorisation due to

new information having a bearing on the safe use of the

medicinal product;"; and

(g) for the definition "variation to the terms of a

marketing authorisation", there shall be substituted the

following new definition

" "variation to the terms of a marketing

authorisation" means an amendment to the

contents of the particulars and documents

referred to in regulations 5 to 8 of the

Medicines

(Marketing

Authorisation)

Regulations, Article 6(2) of Regulation (EC)

No 726/2004, point (a) of Article 7(1) and

Article 34(1) of Regulation (EC) No 1901/

2006 of the European Parliament and of the

Council and Articles 7 and 14(1) of

Regulation (EC) No 1394/2007 of the

European Parliament and of the Council in the

case of medicinal products for human use

(1) "Minor variation of type IA"

means a variation which has only a

minimal impact or no impact at all, on

the quality, safety or efficacy of the

medicinal product concerned;

(2) "Minor variation of type IB"

means a variation which is neither a

minor variation of type IA nor a major

variation of type II nor an extension;

(3) "Major variation of type II"

means a variation which is not an

extension and which may have a

significant impact on the quality, safety

or efficacy of the medicinal product

concerned. Major type II variations may

be simple or complex;

(4) "Grouped variations" are

variations that can be submitted in one

application form; grouping must be in

line with Annex III of Regulation 1234/

2008 and official grouping guidelines;".

Regulation 3 of the principal regulations shall be Substitutes

regulation 3 of

substituted by the following new regulation

the principal

regulations.

" Payment of

3. (1) There shall be paid to the

fees.

Medicines Authority, in respect of marketing

authorisation activities where Malta is the

Reference Member State, the fees specified in

the Schedules to these regulations.

(2) Validation of applications will not

start unless the relevant fees are paid.

(3) Such fees shall not include any fees

charged by other competent authorities in

relation to any documentation, reports, or

services required by the Medicines Authority

for final issue of authorisations and licences,

where these are required.

(4) Any additional expenses incurred

by the Medicines Authority shall be charged

separately.".

In Schedule 1 to the principal regulations, for the table

Amends

Schedule 1 to

the principal

regulations.

"Type of Application

MUTUAL RECOGNITION PROCEDURE/

DECENTRALISED PROCEDURE

(Malta Reference Member State)

Outgoing supplement over the fee for National applications

there shall be substituted the following new tables

"Type of Application

MUTUAL RECOGNITION PROCEDURE (MRP)/

DECENTRALISED PROCEDURE (DCP)

(Malta Reference Member State)

New Applications per product

Article 8.3 of Directive 2001/83/EC: New active substance

Article 8.3 of Directive 2001/83/EC: Known active substance

Article 10 (a) of Directive 2001/83/EC

Article 10 (b) of Directive 2001/83/EC

Article 10 (1) of Directive 2001/83/EC

Article 10 (3) of Directive 2001/83/EC

Article 10 (c) of Directive 2001/83/EC

Article 10(4) of Directive 2001/83/EC

Additional strength/pharmaceutical form (applied for at the same

time)

Line extension applied for after grant of Marketing Authorisation

Parallel application (applied for at the same time)

Repeat use MRP

Application withdrawn during validation

Duplicate application

Change from Malta Concerned Member State to Reference

Member State

Type of Application

Malta Reference Member State

Renewal application per product

Mutual Recognition Procedure/Decentralised Procedure

Annual maintenance fee (for each form and strength)

Malta Reference Member State

First strength or form

Additional strengths and forms (each)

Additional parallel procedures (each)

Schedule 2 to the principal regulations shall be amended as Amends

Schedule 2 to

follows

the principal

regulations.

(a)

for the row containing the words

"Type I National 2 "

there shall be substituted a row containing the words

National 2 "

"Type I

(b) in footnote number 2 the words "For products

authorised by the mutual recognition procedure/decentralised

procedure (Malta Reference Member State) there is a 20%

additional fee to the national fee." shall be deleted; and

(c)

immediately after the current table, after the

footnotes thereto, there shall be added the following new tables

and footnotes

"VARIATION FEES PER PRODUCT

Malta Reference Member State/Rapporteur

MRP MT

Type of Application

RMS/MT

rapporteur

€ *

Type I

Type IA Annual Report

Type IA/IA IN

Type IB

Type II

Type II

Type II Complex

7,000

Article 61(3) notifications (Directive 2001/83/EC)

Included in

annual fees

* For single variations, the fee for each additional strength and form subject to same

variation is 50% of the applicable fees. Fees for grouped variations as per Annex III of

Regulation 1234/2008 are to be paid for each variation included in the group but no fees

for additional strengths and forms subject to same variation/s and acceptable groupings are

required.

Other post-authorisation activities (Malta rapporteur/

Fee

Reference Member State)

€

Assessment of PSURs

2,300

800 (400) 1

Assessment of Post Authorisation Safety Studies (PASS)

800 (400) 1

Assessment of Post Authorisation Efficacy Studies (PAES)

1 Fees in brackets are for applications for academic research without financial support

from industry. Decision will be at the discretion of the Licensing Authority . ".

€0.54