Use Regulations, 2005

L.N. 381 of 2005

MEDICINES ACT, 2003

(ACT NO.III OF 2003)

Manufacture and Importation of Medicinal Products for Human

Use Regulations, 2005

IN exercise of the powers conferred by article 106 of the Medicines

Act, 2003, the Minister of Health, the Elderly and Community Care has

made the following regulations>-

(1) The title of these regulations is the Manufacture and Title and

commencement.

Importation of Medicinal Products for Human Use Regulations, 2005.

(2) These regulations shall come in force on the 30 th October,

2005. (1) For the purposes of these regulations-

Interpretation.

“the Act” means the Medicines Act<

“active substance (API)” means any substance or mixture of

substances intended to be used in the manufacture of a medicinal

product and that when used in the production of a medicinal

product, becomes an active ingredient of the said product. These

substances are intended to furnish pharmacological activity or other

direct effect in the diagnosis, cure, mitigation, treatment or

prevention of disease or to affect the structure and function of the

body<

“the Agency” means the European Medicines Agency

established by Regulation (EC) No. 726#2004<

“the Commission” means the Commission in accordance with

Council Decision 1999#468#EC of 28 th June, 1999<

“the Community” means the European Community and the

European Economic Area<

“imported medicinal products” means medicinal products

obtained from a source outside the European Union or the European

Economic Area<

“Member State” means a State which is a member of the

European Union and includes Iceland, Norway and Liechtenstein.

(2) The provisions of these regulations shall not apply to>

(a) any medicinal product prepared in a pharmacy in

accordance with a medical prescription for an individual patient

(commonly known as the magistral formula)<

(b) any medicinal product which is prepared in a pharmacy

in accordance with the prescriptions of a pharmacopoeia and is

intended to be supplied directly to the patients served by the

pharmacy in question, (commonly known as the officinal formula)<

(c) medicinal products intended for research and

development trials but without prejudice to the provisions of the

Clinical Trials Regulations, 2004 or Directive 2001#20#EEC of the

European Parliament and of the Council of the 4 th April, 2001 on

the approximation of the laws, regulations and administrative

provisions of the Member States relating to the implementation of

good clinical practice in the conduct of clinical trials on medicinal

products on human use<

(d) intermediate products intended for further processing

by an authorised manufacturer<

(e)

any radionuclides in the form of sealed sources<

(f) whole blood, plasma or blood cells of human origin,

except for plasma which is prepared by a method involving an

industrial process<

(g) medicinal products supplied in response to a bona fide

unsolicited order, formulated in accordance with the specifications

of an authorised health-care professional and for use by an

individual patient under his direct personal responsibility.

(1) (a) No medicinal product, biological active substance,

or active substance to be used directly as an investigational medicinal

product, may be manufactured in Malta unless there is, in respect of

such product or substance, a manufacturing licence, hereinafter referred

to as “licence”, to that effect. This manufacturing licence shall also be

required for the processes of sterilisation of active substances.

(b) This manufacturing licence shall be required

notwithstanding that the medicinal products manufactured are intended

for export.

(2) (a) A licence, which shall remain in force for a period

to be determined by the Licensing Authority, hereinafter referred to as

“the Authority”, shall be required for both total and partial manufacture,

and for the various processes of dividing up, packaging or presentation.

(b) A licence shall not be required for preparation,

dividing up, changes in packaging or presentation where such processes

are carried out solely for retail supply, by pharmacists in pharmacies,

or by persons legally authorised to carry out such processes.

(3) An importer’s licence, hereinafter also referred to as

“licence”, shall be required for the importation of medicinal products.

(4) A licence shall include a licence to distribute by

wholesale the medicinal products in respect of which the licence has

been issued.

(5) The Authority shall forward to the Agency a copy of

the licence referred to in sub-regulation (1) hereof.

The Authority, shall only grant or renew a licence, if the Grant or renewal of

a licence.

applicant>

(a) specifies the medicinal products and pharmaceutical

forms which are to be manufactured or imported and the place

where they are to be manufactured and, or controlled<

(b) has at his disposal, for the manufacture or import of

medicinal products, suitable and sufficient premises, technical

equipment and control facilities complying with requirements set

by the Authority<

(c) has at his disposal the services of at least one qualified

person within the meaning of regulation 8< and

(d) provides all necessary documentation in support of his

application.

(1) (a) The Authority shall issue the licence after verifying Processing of

licence.

the contents of the application but in any case not later than ninety days

from receipt of the application.

(b) This time period shall be suspended when the

Authority requests additional information from the applicant.

(c) The Authority may grant a conditional licence subject

to the carrying out of certain obligations imposed on the applicant.

(2) The licence shall apply only to the premises, medicinal

products and pharmaceutical forms specified in the application.

When the holder of the licence requests a change in the

particulars specified in regulation 4(a) and (b), the process of verification

of such information shall not exceed thirty days. However, in exceptional

cases, this period of time may be extended to ninety days.

(1) The holder of a licence shall apart from his obligations

under article 44 of the Act, comply with Community principles and

guidelines of good manufacturing practice and any annexes thereof for

medicinal products, and use as starting materials only active substances,

which have been manufactured in accordance with the detailed

Community guidelines on good manufacturing practice for starting

materials.

(2) For the purposes of this regulation, manufacture of active

substances used as starting materials shall include both total and partial

manufacture or import of an active substance used as a starting material

as defined in Part I, point 3.2.1.1 (b) Annex I of Directive 2001#83, and

the various processes of dividing up, packaging or presentation prior to

its incorporation into a medicinal product, including repackaging or re-

labelling, such as are carried out by a distributor of starting materials.

(1) The holder of the licence shall have permanently and

qualified person and

continuously at his disposal the services of at least one qualified person,

in accordance with the conditions laid down in regulation 9 hereof,

responsible in particular for carrying out the duties specified in regulation

Biex persuna tistemma b[ala persuna kwalifikata, hija g[andu Persuna kwalifikata.

jkollha dawn il-kwalifiki li ;ejjin>

(a) (i) ikollha diploma, çertifikat jew xi evidenza o[ra ta’

kwalifiki formali mog[tijin lilha wara li ttemm kors ta’ studju

f’Università jew kors rikonoxxut b[ala ekwivalenti, mifrux fuq

mill-anqas perjodu ta’ erba’ snin ta’ studju prattiku u teoretiku

f’xi wa[da minn dawn id-dixxiplini xjentifiçi li ;ejjin> farmaija,

mediçina, mediçina veterinarja, kimika, kimika farmaçewtika,

teknolo;ija farmaçewtika, biolo;ija<

(ii) meta l-kors ikun segwit minn perijodu ta’ ta[ri;

fit-teorija u l-prattika li jdum mill-inqas sena u jkun jinkludi ]mien

ta’ ta[ri; ta’ mhux anqas minn sitt xhur fi spi]erija miftu[a g[all-

pubbliku, u dak i]-]mien ikun korroborat minn e]ami f’livell

universitarju, allura l-kors universitarju jista’ mill-inqas idum g[al

tliet snin u nofs<

(iii) meta ]ew; korsijiet universitarji jew ]ew; korsijiet

rikonoxxuti b[ala ekwivalenti ikunu je]istu fi Stat Membru, u meta

wie[ed minn dawn jifirex fuq erba’ snin u l-ie[or fuq tliet snin, il-

kors ta’ tliet snin li jwassal g[al diploma, çertifikat jew xi prova

o[ra ta’ kwalifika formali mog[tija mat-tlestija tal-kors

universitarju jew l-ekwivalenti rikonoxxut tieg[u, jitqies b[ala li

jissodisfa l-kundizzjoni tat-tul tieg[u kif imsemmi hawn aktar

qabel, ;aladarba d-diplomi, çertifikati u prova o[ra ta’ kwalifika

formali mog[tija mat-tlestija ta]-]ew; korsijiet ikunu rikonoxxuti

b[ala li huma ekwivalenti<

(b) il-korsijiet g[andhom jinkludu studju teoretiku u prattiku

dwar ta’ l-anqas wie[ed minn dawn is-su;;etti ba]içi li ;ejjin>

(i) fi]ika esperimentali<

(ii) kimika ;enerali u inorganika<

(iii) kimika organika<

(iv) kimika analitika<

(v) kimika farmaçewtika li tinkludi analisi ta’ prodotti

mediçinali<

(vi) biokimika (medika) ;enerali u applikata<

(vii) fi]jolo;ija<

(viii) mikrobiolo;ija<

(ix) farmakolo;ija<

(x) teknolo;ija farmaçewtika<

(xi) tossikolo;ija<

(xii) farmakonjosi (l-istudju tal-komposizzjoni u l-

effetti ta’ sustanzi naturali attivi ;ejjin minn pjanti u annimali)<

(ç) studji f’dawn is-su;;etti g[andhom ikunu hekk bilanjati

li jg[inu lill-persuna kwalifikata biex tissodisfa l-obbligazzjonijiet

speçifikati fir-regolament 11<

(d) f’dawk il-ka]ijiet fejn diplomi, çertifikati u evidenza o[ra

ta’ kwalifiki formali ma jissodisfawx il-kriterji msemmijin hawn

qabel, l-Awtorità g[andha ti]gura li l-persuna konçernata ;;ib provi

ta’ tag[lim adegwat fis-su;;etti involuti.

(e) (i) Il-persuna kwalifikata g[andha tkun akkwistat

esperjenza prattika ta’ mill-anqas sentejn, f’xi wie[ed jew aktar

mill-impri]i li jkunu awtorizzati jimmanifatturaw prodotti

mediçinali, fl-attivitajiet ta’ analisi kwalitattiva ta’ prodotti

mediçinali, ta’ analisi kwantitattiva ta’ sustanzi attivi, u fl-ittestjar

u l-g[amil ta’ verifiki neçessarji biex ti;i ]gurata l-kwalità tal-

prodotti mediçinali<

(ii) it-tul ta’ ]mien ta’ esperjenza prattika jista’

jitnaqqas b’sena meta kors universitarju jdum ta’ l-anqas [ames

snin, u b’sena u nofs meta l-kors idum ta’ l-anqas sitt snin.

(1) Id-detentur ta’ diploma, çertifikat jew prova o[ra ta’

kwalifiki formali mog[tija mat-tlestija ta’ kors universitarju, jew kors

rikonoxxut b[ala ekwivalenti, f’dixxiplina xjentifika li tippermetti li

jesegwixxi d-dmirijiet tieg[u ta’ persuna kwalifikata, jista’, jekk ikun

beda l-kors qabel il-21 ta’ Mejju, 1975, ji;i kunsidrat b[ala li kien

kwalifikat biex jaqdi d-dmirijiet tieg[u ta’ persuna kwalifikata, sakemm

kien, g[al ta’ l-anqas sentejn qabel il-21 ta’ Mejju, 1985, ja[dem ma’ xi

impri]a wa[da jew aktar awtorizzati biex jimmanifatturaw, u li jkun

qeda d-dmirijiet ta’ supervi]joni tal-produzzjoni u, jew ta’ analisi

kwalitattiva u kwantitattiva ta’ sustanzi attivi, u g[amel l-ittestjar u l-

verifiki me[tie;a ta[t l-awtorità diretta ta’ persuna kwalifikata sabiex

ti;i ]gurata l-kwalità ta’ l-prodotti mediçinali.

(2) Jekk dik il-persuna tkun akkwistat l-esperjenza prattika

msemmija fis-subregolament (1) qabel il-21 ta’ Mejju, 1965, tkun

me[tie;a li ssir sena o[ra ta’ esperjenza prattika skond il-kundizzjonijiet

imsemmija fis-subregolament (1) immedjatament qabel ma jibda dawk

l-attivitajiet.

(3) Persuna li tkun qeg[da tag[mel l-attivitajiet ta’ persuna

kwalifikata minn meta ti;i applikata d-Direttiva 75#319#KE fi Stat

Membru ming[ajr ma tikkonforma ru[ha mad-disposizzjonijiet tar-

regolament 9 tkun eli;ibbli biex tkompli twettaq dawk l-attivitajiet fi

[dan il-Komunità.

(2) If the manufacturing licence holder personally has the

qualifications laid down in regulation 9 hereof, then he may himself

assume the responsibility of a qualified person.

9. For a person to be designated as qualified person, he must

possess the following qualifications>

(a) (i) be in possession of a diploma, certificate or other

evidence of formal qualifications awarded on completion of a

university course of study, or a course recognised as equivalent,

extending over a period of at least four years of theoretical and

practical study in any of the following scientific disciplines<

pharmacy, medicine, veterinary medicine, chemistry,

pharmaceutical chemistry and technology, biology <

(ii) where the course is followed by a period of

theoretical and practical training of a minimum duration of one

year and including a training period of at least six months in a

pharmacy open to the public, such period being corroborated by

an examination at university level, then the minimum duration of

the university course may be three and half years<

(iii) where two university courses or two courses

recognised as equivalent co-exist in a Member State, and where

one of these extends over four years and the other over three years,

the three-year course leading to a diploma, certificate or other

evidence of formal qualifications awarded on completion of a

university course or its recognised equivalent shall be considered

to fulfil the condition of duration referred to above, in so far as the

diplomas, certificates or other evidence of formal qualifications

awarded on completion of both courses are recognised as

equivalent<

(b) the course shall include theoretical and practical study

on at least the following basic subjects>

(i) experimental physics<

(ii) general and inorganic chemistry<

(iii) organic chemistry<

(iv) analytical chemistry<

(v) pharmaceutical chemistry, including analysis of

medicinal products<

(vi) general and applied biochemistry (medical)<

(vii) physiology<

(viii) microbiology<

(ix) pharmacology<

(x) pharmaceutical technology<

(xi)

toxicology<

(xii) pharmacognosy (study of the composition and

effects of the natural active substances of plants and animal

origin)<

(c) studies in these subjects shall be so balanced as to enable

the qualified person to fulfil the obligations specified in regulation

11 hereof<

(d) in those cases where diplomas, certificates or other

evidence of formal qualifications do not fulfil the criteria above

mentioned, the Authority shall ensure that the person concerned

provides evidence of adequate knowledge of the subjects involved<

(e) (i) the qualified person shall have acquired practical

experience over at least two years, in one or more undertakings

which are authorised to manufacture medicinal products, in the

activities of qualitative analysis of medicinal products, of

quantitative analysis of active substances, and of the testing and

checking necessary to ensure the quality of medicinal products<

(ii) the duration of practical experience may be reduced

by one year where a university course lasts for at least five years,

and by a year and a half where the course lasts for at least six

years.

10. (1) The holder of a diploma, certificate or other evidence

of formal qualifications awarded on completion of a university course,

or a course recognised as equivalent, in a scientific discipline allowing

him to perform the duties of a qualified person, may, if he began his

course prior to the 21 st May, 1975, be considered as qualified to carry

out the duties of a qualified person, provided that he was, for at least

two years before the 21 st May, 1985, engaged with one or more

undertakings authorised to manufacture, and as having carried out the

duties of production supervision and, or qualitative and quantitative

analysis of active substances, and the necessary testing and checking

under the direct authority of a qualified person in order to ensure the

quality of the medicinal products.

(2) If the person concerned has acquired the practical

experience referred to in sub-regulation (1) before the 21 st May, 1965, a

further one year’s practical experience in accordance with the conditions

referred to in sub-regulation (1) will be required to be completed

immediately before he engages in such activities.

(3) A person engaging in the activities of a qualified person

from the time of the application of Directive 75#319#EEC in a Member

State without complying with the provisions of regulation 9 shall be

eligible to continue to engage in those activities within the Community.

11. (1) The qualified person, without prejudice to his Responsibility of

qualified person.

relationship with the holder of the licence, shall be responsible to ensure

that>

(a) each batch of medicinal products manufactured in Malta

has been manufactured and checked in terms of the laws in force

and is in accordance with the requirements of the marketing

authorisation<

(b) in the case of medicinal products coming from third

countries, irrespective of whether the product has been

manufactured in the Community, each production batch has

undergone in a Member State a full qualitative analysis, a

quantitative analysis of at least all the active substances and all the

other tests or checks necessary to ensure the quality of the medicinal

product in accordance with the requirements of the marketing

authorisation>

Provided that when the batches of medicinal products have

already undergone the controls above mentioned in a Member State,

they shall be exempt from further controls if they are accompanied

by the control reports signed by the qualified person, and are

marketed within the Community.

(2) The qualified person need not carry out the controls

above mentioned in the case of imported medicinal products, where

arrangements have been made by the Community with the exporting

country to ensure that the manufacturer of the medicinal products applies

standards of good manufacturing practice at least equivalent to those

laid down by the Community, and to ensure that the controls referred to

above have been carried out in the exporting country.

Keeping of

(1) It shall be the duty of the qualified person to keep a

registers.

register to document and certify that each production batch satisfies the

provisions of these regulations.

(2) The said register shall be kept up to date as operations

are carried out and must be made available for inspection by the

Authority for at least five years.

Repeals L.N. 143 of

The Manufacture of Medicinal Products for Human Use

2004. Regulations, 2004, are hereby repealed.

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