Medicines (Marketing Authorisation) (Amendment) Regulations,

L.N. 72 of 2005

MEDICINES ACT, 2003

(ACT NO. III OF 2003)

Medicines (Marketing Authorisation) (Amendment) Regulations,

IN exercise of the powers conferred conferred by article 106 of

the Medicine’s Act, 2003, the Minister of Health, the Elderly and

Community Care, has made the following regulations>-

The title of these regulations is the Medicines (Marketing

Authorisation) (Amendment) Regulations, 2005 and they shall be read

and construed as one with the Medicines (Marketing Authorisation)

Regulations, 2004, hereinafter referred to as “the principal regulations”.

Regulation 2 of the principal regulations, shall be amended as

follows –

(a) after the definition “the Authority”, there shall be inserted

the following new definition>-

“ “generic medicinal product” means a medicinal product

which has the same qualitative and quantitative composition

in active substances and the same pharmaceutical form as the

reference medicinal product, and whose bioequivalence with

the reference medicinal product has been demonstrated by

appropriate bioavailability studies. The different salts, esters,

ethers, isomers, mixtures of isomers, complexes or derivatives

of an active substance shall be considered to be the same active

substance, unless they differ significantly in properties with

regard to safety and, or efficacy. In such cases, additional

information providing proof of the safety and, or efficacy of

the various salts, esters or derivatives of an authorised active

substance must be supplied by the applicant. The various

immediate-release oral pharmaceutical forms shall be

considered to be one and the same pharmaceutical form.

Bioavailability studies need not be required of the applicant

if he can demonstrate that the generic medicinal product meets

the relevant criteria as defined in the appropriate detailed

guidelines<”< and

(b) after the definition “Member State” there shall be

inserted the following> -

“ “reference medicinal product” means a medicinal

product authorised under regulation 4(1) and in accordance

with the provisions of regulations 5 and 6<”.

For regulation 7 of the principal regulations there shall be Substitutes

regulation 7 of the

substituted the following>

principal

regulations.

“ (1) By way of derogation from regulation 5 and without

prejudice to the law relating to the protection of industrial and

commercial property, the applicant shall not be required to provide

the results of pre-clinical tests and of clinical trials if he can

demonstrate that>

(a) the medicinal product is essentially similar to

another already authorised in Malta, and that the holder of

the marketing authorisation of such similar product has

consented to the toxicological, pharmacological and, or

clinical references contained in the file of such product being

used for the purpose of examining the application in question<

(b) the constituent or constituents of the medicinal

product have a well-established medicinal use, with

recognised efficacy and an acceptable level of safety by means

of a detailed scientific bibliography< or

(c) the medicinal product is a generic of a reference

medicinal product which is or has been authorized under

regulation 4(1) of these regulations for not less than six years

in a Member State or in the Community>

Provided that –

(i) subregulation (c)(i) shall also apply if the

reference medicinal product was not authorised in

accordance with articles 4(1) of these regulations, in

which case the applicant shall indicate in the application

form the name of the Member State in which the

reference medicinal product is or has been authorised<

(ii) a generic medicinal product authorised

pursuant to this provision shall not be placed on the

market until the established period for data exclusivity

has elapsed from the initial authorisation of the reference

product<

(iii) in cases where the medicinal product does

not fall within the definition of a generic medicinal

product or where the bioequivalence cannot be

demonstrated through bioavailability studies or in case

of changes in any active substance, therapeutic

indications, strength, pharmaceutical form or route of

administration, vis-à-vis the reference medicinal product,

the results of the appropriate pre-clinical tests or clinical

trials shall be provided<

(iv) where a biological medicinal product which

is similar to a reference biological product does not meet

the conditions in the definition of generic medicinal

products owing to, in particular, differences relating to

raw materials or differences in manufacturing processes

of the biological medicinal product and the reference

biological medicinal product, the results of appropriate

pre-clinical tests or clinical trials relating to these

conditions must be provided. The type and quantity of

supplementary data to be provided must comply with

the relevant criteria stated in Annex I of EU directive

2003#63 and the related detailed guidelines. The results

of other tests and trials from the reference medicinal

product’s dossier shall not be provided.

(2) In the case of new medicinal products containing known

constituents not hitherto used in combination for therapeutic

purposes, the results of toxicological and pharmacological tests

and of clinical trials relating to that combination must be provided,

but it shall not be necessary to provide references relating to each

individual constituent>

Provided that conducting the necessary studies and trials with

a view to the application of subregulation (1) and (2) and the

consequential practical requirements shall not be regarded as

contrary to patent rights or to supplementary protection certificates

for medicinal products.”.

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press