ACT No. VII of 2020 AN ACT to amend the Medicines Act, Cap. 458.

I assent.

(L.S.)

GEORGE VELLA

President

13th March, 2020

ACT No. VII of 2020

AN ACT to amend the Medicines Act, Cap. 458.

BE IT ENACTED by the President, by and with the advice and

consent of the House of Representatives, in this present Parliament

assembled, and by the authority of the same as follows:-

The short title of this Act is the Medicines (Amendment) Act,

2020 and this Act shall be read and construed as one with the

Medicines Act, hereinafter referred to as "the principal Act".

Article 106 of the principal Act shall be amended as follows

(a) paragraph (r) thereof shall be renumbered as

paragraph (t); and

(b) immediately after paragraph (q) thereof there shall be

added the following new paragraphs

"(r) the regulation of the use of medical devices for

medical and, or research purposes, but without prejudice to

the generality of this paragraph, the Minister may make

regulations for all or any of the following purposes

(i) for prescribing the conditions under

which the authorisations may be granted, renewed,

suspended, transferred or cancelled;

(ii) for providing the manner in which

applications for the grant, renewal, suspension,

transfer or cancellation of the authorisations or of any

one or more categories or classes thereof are to be

made;

(iii) for providing the manner in which

applications for such authorisations and approvals as

may be prescribed are to be publicised and for

providing the manner in which any person who may

be prejudiced by such the authorisations and

approvals may make an objection or representation

thereon;

(iv) for establishing the duration of the

validity of the authorisations or of any one or more

categories or classes thereof;

(v) for establishing the qualifications that

certain key personnel involved in or with the

premises may be required to possess;

(vi) for regulating inspections to be carried

out at the premises;

(vii) for prescribing the inventory controls,

registers, records and databases that have to be kept

by the licence holder at the premises and any

financial guarantees which the licence holder shall

have to give;

(viii) for the establishment of quality controls

and quality assurances, other than those already

established under this Act, and any matter in relation

to any activity carried on any premises or by any

person licensed under this legislation;

(ix) for establishing the fees leviable in

respect of the authorisations, approvals and for any

other service provided by the Medicines Authority

such as scientific advice or other work as may be

deemed necessary for the Medicines Authority to

carry out its function

Provided that regulations made under this

sub-paragraph may establish the minimum and the

maximum of any fees leviable in respect of the

authorisations, approvals and for any other service

provided by the Medicines Authority such as

scientific advice or other work as may be deemed

necessary for the Medicines Authority to carry out its

function; and

(x) for establishing the penalties or

administrative sanctions to which any offender

against the provisions of this Act or any regulations

made thereunder shall be liable;

(s) the establishing of offences and the relative

penalty in relation to the contravention of any provisions of

this Act or regulations issued under this Act which penalty

shall not be less than a fine (multa) of twelve thousand

euro (€12,000) and not exceeding one hundred and twenty

thousand euro (€120,000) or to imprisonment for a term

not exceeding two years, or to both such fine and

imprisonment;".

Passed by the House of Representatives at Sitting No. 308 of the

11th March, 2020.

ANĠLU FARRUGIA

Speaker

RAYMOND SCICLUNA

Clerk of the House of Representatives

€0.36