ACT No. XXIX of 2007 An ACT to amend the Malta Standards Authority Act and Various Laws.

I assent.

E DWARD F ENECH A DAMI

(L.S.)

President

21st December, 2007

ACT No. XXIX of 2007

An ACT to amend the Malta Standards Authority Act and Various Laws.

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>

(1) The short title of this Act is the Malta Standards Authority

and Various Laws (Amendment) Act, 2007.

(2) This Act shall come into force on such date as the

Minister responsible for the Malta Standards Authority may by notice

in the Gazette establish, and different dates may be so established for

different provisions and for different purposes of the Act.

Part I

This Part amends and shall be read and construed as one with

the Malta Standards Authority Act, hereinafter in this Part referred to

419. as “the principal Act”.

Article 3 of the principal Act shall be amended as follows>

(a) in subarticle (2) thereof, for the words “The Authority

shall be governed by a Council” there shall be substituted the words

“The Authority shall have a Council which shall have the functions

set out in subarticle (2A) hereof and”< and

(b) immediately after subarticle (2) thereof, there shall be

added the following new subarticles>-

“(2A) The Council shall have the following functions>-

(a) to determine the general policy and objectives

of the Authority within the context of the framework

policies established by Government<

(b) to act as a liaison point between the Authority

and the sectors it represents, and other persons having

an interest therein<

(c) to approve any agreement proposed under

subarticle (11) of this article before such agreement is

forwarded for the concurrence of the Minister in terms

of the said subarticle<

(d) to approve the financial statements of the

Authority<

(e) to guarantee the functional independence of

the Directorates.

(2B) With the exception of the Chairman, who shall

act in his own individual judgement in the interests of the

Authority, the members of the Council shall be appointed as

representatives of the sectors they represent.”.

In sub-paragraph (ii) of paragraph (b) of article 16 of the Amendment of

article 16 of the

principal Act, for the words “ensuring the availability” there shall be principal Act.

substituted the words “the availability or ensuring the availability”.

In subarticle (1) of article 19 of the principal Act, for the words Amendment of

article 19 of the

“the standards and fulfil the conditions prescribed in the standards” principal Act.

there shall be substituted words “the standards and technical regulations

and fulfil the conditions prescribed therein”.

Part II

This Part amends and shall be read and construed as one with Amendment to the

Product Safety Act,

the Product Safety Act, hereinafter in this Part referred to as “the Cap. 427.

principal Act”.

Article 2 of the principal Act shall be amended as follows>

(a) for the definition of the expression “Director” therein

there shall be substituted the following>-

“ “Director” means the Head of the Market Surveillance

Directorate of the Malta Standards Authority established by

article 3 of the Malta Standards Authority Act or such other

head of any Directorate as the Minister may by Order

designate in his stead and includes, to the extent of the

authority given, any officer authorised by such head, in

writing, to act in that behalf for any of the purposes of this

Act<”<

(b) the definition of the expression “Department” therein

shall be deleted< and

(c) for the definition “safe product” therein there shall be

substituted the following>–

“safe product” means any product which, under normal

or reasonably foreseeable conditions of use, including

duration, and, where applicable, putting into service,

installation and maintenance requirements does not present

any risk or only the minimum risks, compatible with the

product’s use, which are considered as acceptable and

consistent with a high level of protection for the safety and

health of persons, taking into account in particular the

following factors>

(a) the characteristics of the product, including

its composition, packaging, instructions for assembly and

maintenance<

(b) the effect on other products, where it is

reasonably foreseeable that it will be used with other

products<

(c) the presentation of the product, the labelling,

any instructions for its use and disposal and any other

indication or information provided by the producer<

(d) the categories of consumers at risk when using

the product, in particular children, the disabled and the

elderly>

Provided that the possibility of obtaining higher

levels of safety or the availability of other products

presenting a lesser degree of risk shall not constitute

grounds for considering a product to be an unsafe

product<”.

For article 27 of the principal Act that shall be substituted the Substitution of

article 27 of the

principal Act.

“27. Without prejudice to any other functions assigned

to it by any other law, the Malta Standards Authority, shall

also have the following functions>

(a) to establish and periodically update sectoral

surveillance programmes in respect of all categories of

products and risks<

(b) to follow up and update scientific knowledge

concerning the safety of products, as well as periodical

reports on surveillance activities, findings and results

achieved<

(c) to periodically review and assess the

functioning of the control activities and their

effectiveness, and, if necessary, revise the surveillance

approach and organisation put in place.”.

In article 22 of the principal Act, the words “of the Amendment of

article 22 of the

Department,” shall be deleted.

principal Act.

In subarticle (1) of article 28 of the principal Act, for the Amendment of

article 28 of the

words “may, with the concurrence of the Director of Market principal Act.

Surveillance, make or” there shall be substituted words “may, with the

concurrence of the head of the Regulatory Affairs Directorate established

under the Malta Standards Authority Act or such other head of any

Directorate as the Minister may by Order designate in his stead”.

Immediately after paragraph (k) of article 38 of the principal Amendment of

article 38 of the

Act there shall be added the following new paragraph>

principal Act.

“(l) designating any manufactured article, item or substance

as a ‘product’ for all or any purposes of this Act.”.

Part III

This Part amends and shall be read and construed as one

with the Pesticides Control Act, hereinafter in this Part referred to as

“the principal Act”.

Article 2 of the principal Act, shall be amended as follows>-

(a) immediately after the definition of the expression

“authorisation” therein there shall be added the following new

definition>-

“ “the Authority’’ means the Malta Standards Authority

established by article 3(1) of the Malta Standards Authority

Act or such other Directorate as the Minister may by Order

designate in its stead<”<

(b) in the definition of the expression “Director” therein,

for the words “Director of the Department” there shall be substituted

the words “the head of the Regulatory Affairs Directorate

established under the Malta Standards Authority Act or such other

head of any Directorate as the Minister may by Order designate in

his stead”< and

(c) the definition of the expression “Department” shall be

deleted.

In paragraph (d) of sub-article (2) of article 10 of the principal

Act, for the words “Malta Standards Authority” there shall be substituted

the words “Plant Health Department”.

Part IV

This Part amends and shall be read and construed as one

with the Food Safety Act, hereinafter in this Part referred to as “the

principal Act”.

Immediately after Article 7 of the principal Act there shall

be inserted the following new article>

“The

7A. (1) The Commission shall exercise its functions

Commis-

under article 7(1) (b), (c), (d), (e), (g), (h), (j) and (l) through

sion to

exercise

the Malta Standards Authority as established by article 3 of

functions

the Malta Standards Authority Act.

through the

Authority.

(2) The Malta Standards Authority shall also issue

such guidelines as may be necessary in relation to the

functions mentioned in subarticle (1) of this article.

(3) The Commission may demand from the Malta

Standards Authority any information obtained or report drawn

up by the Authority in the exercise of its functions under this

article and the Authority shall comply with any such demand.

(4) The functions of the Malta Standards

Authority under this article shall be without prejudice to any

other functions assigned to it by any other law.”.

In subarticle (1) of article 9 of the principal Act, for the words Amendment of

article 9 of the

“the Director of the Market Surveillance Directorate” there shall be principal Act.

substituted the words “the head of the Market Surveillance Directorate

of the Malta Standards Authority established under the Malta Standards

Authority Act or such other head of any Directorate as the Minister

may by Order designate in his stead.”.

Part V

This Part amends and shall be read and construed as one Amendment to the

Medicines Act, Cap.

with the Medicines Act, hereinafter in this Part referred to as “the 458.

principal Act”.

For article 4 of the principal Act there shall be substituted Substitution of

article 4 of the

the following>-

principal Act.

“4. There shall be established a Medicines Authority, or

such other authority as the Prime Minister may, after consultation

with the Minister responsible for health, designate in terms of article

110 of this Act.”.

For subarticle (5) of article 103 of the principal Act there Amendment of

article 103 of the

shall be substituted the following>

principal Act.

“(5) (a) Where any medicinal product has been seized

under the provisions of this Act, and the owner thereof consents in

writing to the destruction of such medicinal product, the Licensing

Authority may, after taking such samples as may be required to

prove the offence, direct that the said medicinal product be

destroyed without prejudice to the taking of any proceedings against

the person responsible for the offence, and the said Licensing

Authority shall recoup all the expenses involved in the destruction

of the medicinal product.

(b) In those cases where the owner fails to consent to the

destruction of the medicinal product, the Licensing Authority may,

after filing an application requesting the Court to order the

destruction at the expense of the owner, proceed with such

destruction.”.

Immediately after article 109 of the principal Act there shall

be added the following>

110. (1) The Prime Minister may, following

“Designation

of competent

consultation with the Minister responsible for health, by Order

in the Gazette designate any authority to carry out the functions

carried out by the Medicines Authority under this Act.

(2) Any such Order may delete any of the

provisions of articles 5 and 7 to 13 of this Act.

(3) Any such Order may also amend or delete

subarticle (3) of article 3 and articles 4 and 6 of this Act.”.

Passed by the House of Representatives at Sitting No. 602 of 12th December,

2007. A NTON T ABONE

Speaker

R ICHARD J. C AUCHI

Clerk to the House of Representatives

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

Lm0.32 (€0.75)

Ming[ajr pre;udizzju g[al kull funzjoni o[ra

assenjata

lilha minn xi li;i o[ra, l-Awtorità Maltija dwar l-

l-iStandards. iStandards, g[andu jkollha wkoll dawn il-funzjonijiet li ;ejjin>

(a) li tistabbilixxi u perjodikament ta;;orna l-

programmi tas-sorveljanza settorali fir-rigward tal-

kategoriji kollha ta’ prodotti u riskji<

(b) li ssegwi u tag[mel a;;ornament tat-tag[rif

xjentifiku li jirrigwarda s-sigurezza tal-prodotti, kif ukoll

rapporti perjodiçi dwar attivitajiet ta’ sorveljanza,

ri]ultan]i u ri]ultati miksuba<

(ç) li perjodikament tirrevedi u tevalwa t-twettiq

tal-attivitajiet tal-kontroll u l-effettività tag[hom, u, jekk

ikun me[tie;, tirrevedi l-approç tas-sorveljanza u l-

organizzazzjoni opportuna.”.

9. Fl-artikolu 22 ta’ l-Att prinçipali, il-kliem “tad-Dipartiment,”

g[andu ji;i m[assar.

10. Fis-subartikolu (1) ta’ l-artikolu 28 ta’ l-Att prinçipali,

minflok il-kliem “jista’, bi ftehim mad-Direttur ta’ Sorveljanza fuq is-

Suq, jag[mel jew” g[andhom jid[lu l-kliem “jista’, bi ftehim mal-kap

tad-Direttorat g[all-Affarijiet Regolatorji stabbilit ta[t l-Att dwar l-

Awtorità Maltija dwar l-iStandards jew kull kap ie[or ta’ xi Direttorat

ie[or skond ma jista’ l-Ministru ja[tar minfloku b’Ordni”.

11. Minnufih wara l-paragrafu (k) fl-artikolu 38 ta’ l-Att

prinçipali g[andu ji]died dan il-paragrafu ;did li ;ej>

“(l) biex isemmi kull [a;a, o;;ett jew sustanza manifatturati

b[ala “prodott” g[al xi jew kull ra;uni skond dan l-Att.”.

Taqsima III

12. Din it-Taqsima temenda u g[andha tinqara u tiftiehem [a;a Emenda ta’ l-Att

dwar il-Kontroll tal-

wa[da ma’ l-Att dwar il-Kontroll tal-Pestiçidi, hawn i]jed ’il quddiem Pestiçidi, Kap. 430.

f’din it-Taqsima msejja[ “l-Att prinçipali”.

13. L-artikolu 2 ta’ l-Att prinçipali, g[andu ji;i emendat kif ;ej>- Emenda ta’ l-

artikolu 2 ta’ l-Att

prinçipali.

(a) minnufih wara t-tifsira tal-kelma “awtorizzazzjoni”

f’dan l-artikolu g[andha tid[ol din it-tifsira ;dida li ;ejja>-

“ “l-Awtorità” tfisser l-Awtorità Maltija dwar l-

iStandards stabbilita permezz ta’ l-artikolu 3(1) ta’ l-Att dwar Kap. 419.

l-Awtorità Maltija dwar l-iStandards jew Direttorat ie[or

skond ma jista’ l-Ministru ja[tar minfloku b’Ordni<”<

(b) fit-tifsira tal-kelma “Direttur” f’dan l-artikolu minflok

il-kliem “Direttur tad-Dipartiment” g[andhom ji;u sostitwiti l-

kliem “kap tad-Direttorat g[all-Affarijiet Regolatorji stabbilit ta[t

l-Att dwar l-Awtorità Maltija dwar l-iStandards jew kap ta’ kull

Direttorat ie[or skond ma jista’ l-Ministru ja[tar minfloku

b’Ordni”< u

(ç)

it-tifsira tal-kelma “Dipartiment” g[andha ti;i m[assra.

14. F’paragrafu (d) tas-subartikolu (2) ta’ l-artikolu 10 ta’ l-Att Emenda ta’ l-

artikolu 10 ta’ l-Att

prinçipali, minflok il-kliem “Awtorità Maltija dwar l-iStandards” prinçipali.

g[andhom jid[lu l-kliem “Dipartiment tas-Sa[[a tal-Pjanti”.

Taqsima IV

15. Din it-Taqsima temenda u g[andha tinqara u tiftiehem [a;a Emenda ta’ l-Att

wa[da ma’ l-Att dwar is-Sigurtà fl-Ikel, hawn i]jed ’il quddiem f’din dwar

Ikel, Kap. 449.

it-Taqsima msejj[a “l-Att prinçipali”.

16. Minnufih wara l-artikolu 7 ta’ l-Att prinçipali g[andu jid[ol Emenda ta’

l-artikolu 7 dwar

dan l-artikolu ;did li ;ej>

l-Att prinçipali.

“Il-Kummis-

7A. (1) Il-Kummissjoni g[andha te]erçita l-

funzjonijiet tag[ha ta[t l-artikolu 7(1) (b), (ç), (d), (e), (g),

te]erçita

l-funzjonijiet

(h), (j) u (l) permezz ta’ l-Awtorità Maltija dwar l-iStandards

tag[ha

kif stabbilita bl-artikolu 3 ta’ l-Att dwar l-Awtorità Maltija Kap. 419.

permezz ta’

l-Awtorità.

dwar l-iStandards.

(2) L-Awtorità Maltija dwar l-iStandards

g[andha wkoll to[ro; dawk il-linji ta’ gwida li jistg[u jkunu

me[tie;a rigward il-funzjonijiet imsemmija fis-subartikolu

(1) ta’ dan l-artikolu.

(3) Il-Kummissjoni tista’ titlob lil l-Awtorità

Maltija dwar l-iStandards g[al kull informazzjoni akkwistata

jew rapport preparat mill-Awtorità waqt l-e]erçizzju tal-

funzjonijiet tag[ha ta[t dan l-artikolu u l-Awtorità g[andha

tikkonforma ru[ha ma’ din it-talba.

(4) Il-funzjonijiet ta’ l-Awtorità Maltija dwar l-

iStandards ta[t dan l-artikolu g[andhom ikunu ming[ajr

pre;udizzju g[al kull funzjoni o[ra assenjata lilha ta[t xi li;i

o[ra.”.

17. Fis-subartikolu (1) ta’ l-artikolu 9 ta’ l-Att prinçipali, minflok

il-kliem “id-Direttur tas-Sorveljanza fuq is-Suq” g[andhom jid[lu l-

kliem “il-Kap tad-Direttorat tas-Sorveljanza fuq is-Suq tal-Awtorità

Maltija dwar l-iStandards stabbilit ta[t l-Att dwar l-Awtorità Maltija

dwar l-iStandards jew kull kap ta’ kull Direttorat ie[or skond ma l-

Ministru jista’ ja[tar minfloku b’Ordni.”.

Taqsima V

18. Din it-Taqsima temenda u g[andha tinqara u tiftiehem [a;a

wa[da ma’ l-Att dwar il-Mediçini, hawn i]jed ’il quddiem f’din it-

Taqsima msejja[ “l-Att prinçipali”.

Minflok l-artikolu 4 ta’ l-Att prinçipali g[andu jid[ol dan li

19. ;ej>-

“Twaqqif ta’

4. G[andha ti;i stabbilita Awtorità dwar il-Mediçini,

l-Awtorità

jew

dik l-awtorità o[ra li l-Prim Ministru jista’, wara

dwar il-

Mediçini jew

konsultazzjoni mal-Ministru responsabbli g[as-sa[[a, ja[tar

Awtorità

skond l-artikolu 110 ta’ dan l-Att.”.

o[ra.

20. Minflok is-subartikolu (5) ta’ l-artikolu 103 ta’ l-Att prinçipali

g[andu jid[ol dan li ;ej>

“(5) (a) Meta jkun ;ie elevat xi prodott mediçinali ta[t

id-disposizzjonijiet ta’ dan l-Att u sid il-prodott jag[ti l-kunsens

tieg[u bil-miktub g[all-qirda ta’ dak il-prodott mediçinali, l-

Awtorità dwar il-Liçenzjar tista’, wara li tie[u dawk il-kampjuni

li tista’ tkun te[tie; biex tin;ieb prova tar-reat, tordna li dak il-

prodott mediçinali ji;i meqrud ming[ajr pre;udizzju g[al kull

proçediment li jista’ jsir kontra l-persuna responsabbli g[ar-reat,

u l-imsemmija Awtorità dwar il-Liçenzjar g[andha tirrimborsa l-

ispejje] kollha li jkunu saru fil-qirda tal-prodott mediçinali.

(b) F’dawk il-ka]ijiet fejn is-sid jonqos milli jag[ti l-kunsens

tieg[u g[all-qirda tal-prodott mediçinali, l-Awtorità dwar il-

Liçenzjar tista’ wara li tippre]enta rikors fejn titlob lill-Qorti tordna

l-qirda g[as-spejje] tas-sid, tg[addi biex twettaq dik il-qirda.

21. Minnufih wara l-artikolu 109 ta’ l-Att prinçipali g[andu }jieda ta’ l-artikolu

110 ;did ma’ l-Att

ji]died dan li ;ej>

prinçipali.

110. (1) Il-Prim Ministru jista’, wara konsultazzjoni

“{atra ta’

awtorità

mal-Ministru responsabbli g[as-sa[[a, b’Ordni fil-Gazzetta

kompetenti.

jsemmi lil kull awtorità biex twettaq il-funzjonijiet li kienu

ji;u esegwiti mill-Awtorità dwar il-Mediçini ta[t dan l-Att.

(2) Ordni b[al dan jista’ j[assar kull disposizzjoni

ta’ l-artikoli 5 u 7 sa 13 ta’ dan l-Att.

(3) Ordni b[al dan jista’ wkoll jemenda jew

i[assar is-subartikolu (3) ta’ l-artikolu 3 u l-artikoli 4 u 6 ta’

dan l-Att.”.

Mg[oddi mill-Kamra tad-Deputati fis-Seduta Nru. 602 tat-12 ta’ Diçembru,

2007. A NTON T ABONE

R ICHARD J. C AUCHI

Skrivan tal-Kamra tad-Deputati