Regulations, 2012

L.N. 444 of 2012

MEDICINES ACT

(CAP. 458)

Medicines Authority (Fees) (Amendment) (No. 2)

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) (No. 2) Regulations, 2012, and these regulations

shall be read and construed as one with the Medicines Authority S.L. 458.46

(Fees) Regulations, hereinafter referred to as the "principal

regulations".

The definition "variation to the terms of a marketing Amends

authorisation" in regulation 2 of the principal regulations shall be regulation

the principal

amended as follows

regulations.

(a)

paragraph (4) thereof shall be renumbered as

paragraph (5); and

(b) immediately after paragraph (3) thereof, there shall

be added the following new paragraph

"(4) "Type II Complex variation" means a

variation, when it falls within one or more of the following

descriptions

(a)

the application relates to the results of

clinical

trials

or

other

data

(including

pharmacological and toxicological tests as well as

extensive evidence from post marketing experience

or publications) that need to be newly assessed;

(b) the application is supported by

substantial amounts of data, that have not previously

been assessed;

(c) the application relates to changes in

indications for use in a therapeutic area for which the

product was not previously indicated for use;

(d) the application relates to changes in

indications for use in respect of an organ, or any

other part, of the human body for which the product

was not previously indicated for use;

(e) the application is supported by data

which comprises or includes the results of clinical

trials or physico-chemical, microbiological or

pharmacological and toxicological tests;

(f) the application relates to an increase in

the maximum dose;

(g)

the application relates to a new dosage

regimen;

(h) the application relates to a change in

the method of sale or supply of an active ingredient

from prescription only to pharmacy sale;

(i) the application relates to a change in

the conditions of prescribing;

(j) the application relates to the removal of

a contra-indication;

(k) the application relates to an increased

duration of treatment;

(l) the application relates to a change in

the route of administration of the same dosage form;

(m) the application relates to a new route of

synthesis that has not previously been assessed and a

European Pharmacopoeia Certificate of Suitability is

not available for the active ingredient;

(n) the application relates to a new method

of sterilisation of the product;

(o) the application relates to a new

container materials for a sterile product;

(p) the application relates to a new active

ingredient manufacturer not previously approved to

manufacture the active ingredient concerned and

who does not hold a European Pharmacopoeia

Certificate of Suitability for the substance

concerned;

(q) the application relates to a major

formulation change which affects more than one

section in Module 3 of the dossier and, or requires a

re-evaluation of the safety or efficacy of the product,

such as -

(i)

a change in more than one

excipient, except for a change in a key

excipient (such as a preservative, release-

controlling excipient, or stabiliser);

(ii) when a change in the key

excipient alone will be regarded as a major

formulation change;

(iii) the inclusion for the first time of

a novel excipient not used before in any

product;

(iv) a change which requires an in-

vivo bioavailability study to be carried out;

(v) a change which results in a

change to the therapeutic characteristics of

the product;

(r) the application relates to change in the

method of manufacture of the active ingredient

which introduces new impurities or changes the level

of impurities and which requires further qualification

in safety studies;

(s) the application relates to any change in

the source materials, method of manufacture or

analytical procedures for a product of biological or

biotechnological origin which might significantly

affect the quality of the product;

(t) the application relates to a change in

the qualitative composition of the immediate

packaging of a sterile product, where the container

material has not been previously approved for such

use;

(u) the application relates to

the

introduction of a novel method of analysis;

(v) the application relates to a new

manufacturer or process for a flu vaccine;".

Schedule 1 to the principal regulations shall be amended as

follows

(a)

the Table starting with the words "NATIONAL

PROCEDURE" and ending with the figure "6,988.12" shall be

deleted; and

(b) for the words "MUTUAL RECOGNITION

PROCEDURE (MRP)/DECENTRALISED PROCEDURE

(DCP) (Malta Reference Member State)" in the next following

Table, there shall be substituted the words "NATIONAL AND

MUTUAL

RECOGNITION

PROCEDURE

(MRP)/

DECENTRALISED PROCEDURE (DCP) (Malta Reference

Member State)".

€0.36