ACT No. V of 2013 AN ACT to amend the Medicines Act, Cap. 458.

I assent.

G EORGE A BELA

(L.S.)

President

28th June, 2013

ACT No. V of 2013

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, 2013, and this Act shall be read and construed as one with the

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

(2) The purpose of this Act is to transpose the provisions of

Directive 2011/62/EU of the European Parliament and of the Council

of 8 June 2011 amending Directive 2001/83/EC on the Community

Code relating to medicinal products for human use, as regards the

prevention of the entry into the legal supply chain of falsified

medicinal products.

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

responsible for health may by notice in the Gazette appoint, and

different dates may be so appointed for different purposes and for

different provisions of this Act.

Article 2 of the principal Act shall be amended as follows

Amendment of

article 2 of the

principal Act.

(a) for the definition "adverse reaction" there shall be

substituted the following

" "adverse reaction" means a response to a

medicinal product which is noxious and unintended;";

(b) immediately before the definition "advertising"

there shall be added the following new definition

" "active substance" means any substance or

mixture of substances intended to be used in the

manufacture of a medicinal product and that, when used in

its production, becomes an active ingredient of that

product intended to exert a pharmacological,

immunological or metabolic action with a view to

restoring, correcting or modifying physiological functions

or to make a medical diagnosis;";

(c) immediately after the definition "authorised officer"

there shall be inserted the following new definition

" "brokering of medicinal products" means all activities in

relation to the sale or purchase of medicinal products, except for

wholesale distribution, that do not include physical handling

and that consist of negotiating independently and on behalf of

another legal or natural person;";

(d) immediately after the definition "dental practitioner"

there shall be added the following new definition

" "designated Minister" means the Minister who is

designated by the Prime Minister as being responsible for

the Medicines Authority;";

(e) for the definition "dispensing" there shall be

substituted the following

" "dispensing” means the sale or supply of

medicinal products from a pharmacy;";

(f)

immediately after the definition "dispensing" there

shall be added the following new definition

" "excipient" means any constituent of a medicinal product

other than the active substance and the packaging material;";

(g) in the Maltese text, in the definition "prova klinika",

for the words "reazzjonijiet kuntrarji" there shall be substituted

the words "reazzjonijiet avversi";

(h) immediately after the new definition "excipient"

there shall be added the following new definition

" "falsified medicinal product" means

any

medicinal product with a false representation of

(a) its identity, including its packaging and

labelling, its name or its composition as regards

any of the ingredients including excipients and the

strength of those ingredients;

(b) its source, including its manufacturer,

its country of manufacturing, its country of origin

or its marketing authorisation holder; or

(c) its history, including the records and

documents relating to the distribution channels

used,

but excludes unintentional quality defects and is without

prejudice to infringements of intellectual property rights;”;

(i)

in the Maltese text, in the definition "reazzjoni

kuntrarja gravi", for the words "reazzjoni kuntrarja gravi" there

shall be substituted the words "reazzjoni avversa gravi", and for

the words "reazzjoni kuntrarja" there shall be substituted the

words "reazzjoni avversa";

(j)

in the Maltese text, in the definition "reazzjoni

kuntrarja mhux mistennija", for the words "reazzjoni kuntrarja

mhux mistennija" there shall be substituted the words "reazzjoni

avversa mhux mistennija", and for the words "reazzjoni

kuntrarja" there shall be substituted the words "reazzjoni

avversa";

(k) in the Maltese text, in sub-paragraph (iii) of the

proviso to the definition "reklamar", for the words "reazzjonijiet

kuntrarji" there shall be substituted the words "reazzjonijiet

avversi";

(l)

immediately after the definition "immunological

medicinal product" there shall be added the following new

definition

" "importation" means any one or more of the

following activities: procuring, holding, selling and release

of imported medicinal products in any part of Malta

notwithstanding any provisions in any other Act, but does

not include imported medicinal products that are in transit

where the whole consignment of the said products remains

fully intact and its status is not changed for free

circulation;";

(m) immediately after the definition "pharmacy

technician" there shall be added the following new definition

" "post-authorisation safety study" means any study

relating to an authorised medicinal product conducted with

the aim of identifying, characterising or quantifying a

safety hazard, confirming the safety profile of the

medicinal product, or of measuring the effectiveness of

risk management measures;"; and

(n) for the definition "wholesale distribution" there shall

be substituted the following

" "wholesale distribution", in relation to a

medicinal product and active substances, includes any one

or all activities consisting of procuring, holding, supplying

or exporting medicinal products and active substances,

apart from supplying medicinal products to the public.".

In article 4 of the principal Act, for the words "the Minister Amendment of

responsible for health" there shall be substituted the words "the article

principal Act.

Minister and the designated Minister".

In paragraph (i) of sub-article (1) of article 6 of the Amendment of

principal Act, for the words "its functions.", there shall be substituted article

principal Act.

the words "its functions;", and immediately thereafter there shall be

added the following new paragraph

"(j) to notify the EU Commission of non-prescription

medicinal products which in its judgement are at risk of

falsification and may inform the EU Commission of medicinal

products which may be deemed not to be at risk according to the

criteria set out in Article 54a(2b) of Directive 2001/83/EC as

amended.".

In paragraph (b) of sub-article (4) of article 8 of the Amendment of

principal Act, for the words "the Minister" wherever they occur, there article

principal Act.

shall be substituted the words "the designated Minister".

Article 9 of the principal Act shall be amended as follows

(a) in sub-article (1) thereof, for the words "of the

Minister," there shall be substituted the words "of the

designated Minister,"; and

(b) in sub-article (2) thereof, for the words "with the

Minister" there shall be substituted the words "with the

designated Minister".

Article 10 of the principal Act shall be amended as

follows

(a)

in sub-article (2) thereof, for the words "to the

Minister" there shall be substituted the words "to the designated

Minister"; and

(b) in sub-article (3) thereof, for the words "by the

Minister" there shall be substituted the words "by the designated

Minister".

In article 11 of the principal Act, for the words "the

Minister" wherever they occur, there shall be substituted the words

"the designated Minister".

Sub-article (1) of article 16 of the principal Act shall be

substituted by the following

"(1) It shall be the function of the Medicines Review

Board to hear an appeal submitted by the applicant of a

marketing authorisation on any recommendation of the

Medicines Authority in relation to the safety, quality and

efficacy of a medicinal product and to provide advice and make

its recommendations to the Licensing Authority in this regard.".

Article 28 of the principal Act shall be amended as

follows

(a)

in sub-article (1) thereof

(i)

for paragraph (a) there shall be substituted the

following

"(a) the medicinal product is harmful;"; and

(ii)

for paragraph (c) there shall be substituted the

following

"(c) the

risk

benefit

balance

is

not

favourable;"; and

(b) in sub-article (2) thereof, immediately after the

words "under this Act have not been carried out." there shall be

added the words "This provision also applies in cases where the

manufacture of the medicinal product is not carried out in

compliance with the particulars provided pursuant to the

description of the manufacturing method submitted in the

application for a marketing authorisation, or where controls

employed by the manufacturer are not carried out in compliance

with the control methods described in the application for a

marketing authorisation.".

Immediately after article 31 of the principal Act there shall Addition of new

article to the

be added the following new article

principal Act.

" Marketing

Marketing authorisation holders

authorisation

shall

abide

by

the

standards

on

holders to

pharmacovigilance, marketing authorisations

abide by

standards.

as well as labelling and packaging as may be

established by or under this Act.".

12. In article 37 of the principal Act, immediately after the Amendment of

words "no person shall" there shall be added the words "import from article

principal Act.

countries which are outside the European Union or European

Economic Area," and in the Maltese text of the proviso thereto for the

words "għall-fini ta’ bejgħ" there shall be substituted the words

"għall-fini ta’ dispensa".

13. Article 43 of the principal Act shall be substituted by the Substitution of

article 43 of the

following

principal Act.

"43. (1) Subject to the provisions of this Act, every

licence granted under this Part shall, unless previously renewed

or revoked, continue to be valid until such time as it is renewed

by the Licensing Authority following an inspection.

(2) The Licensing Authority shall establish the period of

validity of any licence issued under this Part.

(3) Following the inspection mentioned in sub-article

(1), the Licensing Authority

(a) may renew the licence, with or without

modifications, for such a further period as specified; or

(b) if, having regard to the provisions of this Act,

it considers it necessary or expedient to do so, may refuse

to renew the licence.".

14. For Title III in Part III of the principal Act there shall be

substituted the following new Title

"Title III - Wholesale Distribution and Brokering of

Medicinal Products for Human Use".

15. Immediately after article 54 of the principal Act, there

shall be added the following new article

" Brokering.

(1) Persons may only broker

medicinal products if they are established in

Malta with a permanent address and are

registered with the Licensing Authority.

Those persons shall submit, at least, their

name, corporate name and permanent address

in order to register. They shall notify the

Licensing Authority of any changes thereof

without unnecessary delay. Persons brokering

medicinal products who have commenced

their activity on the date of coming into force

of this Act shall register with the Licensing

Authority by the 2 March, 2013.

(2) The Licensing Authority shall

enter the information referred to in sub-article

(1) in a register that shall be publicly

accessible.".

16. Article 58 of the principal Act shall be substituted by the

following

"58. (1) Subject to the provisions of this Act, every

licence granted under this Part shall, unless previously renewed

or revoked, continue to be valid until such time as it is renewed

by the Licensing Authority following an inspection.

(2) The Licensing Authority shall establish the period of

validity of any licence issued under this Part.

(3) Following the inspection mentioned in sub-article

(1), the Licensing Authority

(a) may renew the licence, with or without

modifications, for such a further period as specified; or

(b) if, having regard to the provisions of this Act,

it considers it necessary or expedient to do so, may refuse

to renew the licence.".

17. Immediately after article 60 of the principal Act, there Addition of new

article to the

shall be added the following new article

principal Act.

" Suspension of

The Licensing Authority may, if it

responsible

has reasonable suspicion to believe that any

person.

responsible person is acting in contravention

of any of the provisions of this Act, suspend

the activity of such responsible person by

notice in writing specifying the reasons for

such suspension until such person has

complied with any requirement of the

Licensing Authority to remedy the non-

compliance.".

18. Immediately after article 66 of the principal Act, there Addition of new

article to the

shall be added the following new article

principal Act.

" Internet or

It shall not be lawful for any person

mail order

to open or keep an internet or mail order

pharmacy.

pharmacy unless he is in possession of a

licence issued in accordance with conditions

and criteria established by or under this Act.".

19. Sub-article (1) of article 67 of the principal Act shall be Amendment of

article 67 of the

amended as follows

principal Act.

(a)

paragraph (d) thereof shall be deleted; and

(b) paragraphs (e) and (f) thereof shall be renumbered

as paragraphs (d) and (e) respectively.

20. Sub-article (1) of article 68 of the principal Act shall be Amendment of

article 68 of the

substituted by the following

principal Act.

"(1) The Licensing Authority shall, before determining

an application, inspect the premises indicated in the application

and shall not issue a licence until it is satisfied that such

premises are suitable and adequate, and that there are suitable

facilities, installations, and equipment so as to ensure proper

conservation and dispensing of medicinal products

Provided that a licence may be made conditional to the

carrying out of such obligations as may be imposed therein.".

21. Article 70 of the principal Act shall be substituted by the Substitution of

article 70 of the

following

principal Act.

"70. (1) Subject to the provisions of this Act, every

licence granted under this Part shall, unless previously renewed

or revoked, continue to be valid until such time as it is renewed

by the Licensing Authority following an inspection.

(2) The Licensing Authority shall establish the period of

validity of any licence issued under this Part.

(3) Following the inspection mentioned in sub-article

(1), the Licensing Authority

(a) may renew the licence, with or without

modifications, for such a further period as specified; or

(b) if, having regard to the provisions of this Act,

it considers it necessary or expedient to do so, may refuse

to renew the licence.".

22. Paragraph (g) of article 74 of the principal Act shall be

renumbered as paragraph (h) thereof, and immediately after

paragraph (f) there shall be added the following new paragraph

"(g) ensure that a pharmacist is present at all times

during the time when the pharmacy is open;".

23. Paragraph (b) of sub-article (2) of article 75 of the

principal Act shall be substituted by the following

"(b) ensure that he or another pharmacist is present in the

pharmacy at all times in order to sell or supervise the sale of

medicinal products and to keep records of the pharmacist who

was present while the pharmacy was open;".

24. Immediately after article 75 of the principal Act, there

shall be added the following new article

" Suspension of

The Licensing Authority may, if it

managing

has reasonable suspicion to believe that any

pharmacist.

managing

pharmacist

is

acting

in

contravention of any of the provisions of this

Act, suspend the activity of such managing

pharmacist by notice in writing specifying the

reasons for such suspension until such person

has complied with any requirement of the

Licensing Authority to remedy the non-

compliance.".

25. Immediately after sub-article (2) of article 81 of the

principal Act, there shall be added the following new sub-article

"(3) It shall be lawful for a pharmacist to dispense any

medicinal product on the prescription of a medical practitioner,

dentist or veterinary surgeon from an EU member state provided

that the pharmacist can ascertain that such medical practitioner,

dentist or veterinary surgeon is licensed to practice his

profession in the member state of origin.".

26. Paragraph (b) of article 98 of the principal Act shall be Amendment of

article 98 of the

substituted by the following

principal Act.

"(b) knowingly or unknowingly sell or supply, or offer or

expose for sale or supply, or have in his possession for the

purpose of sale or supply

(i) any medicinal product whose composition

has been injuriously affected by the addition or abstraction

of any substance;

(ii) any medicinal product which is deliberately

and fraudulently mislabeled with respect to identity and, or

source including products with the correct ingredients,

with the wrong ingredients, without active ingredients, in

an insufficient quantity or excessive quantity of active

ingredients or with fake packaging.".

27. Article 99 of the principal Act shall be substituted by the Amendment of

article 99 of the

following

principal Act.

"99. (1) Without prejudice to any other liability under

any other law, any person who fails to comply with any of the

provisions of this Act or any regulations or rules made

thereunder shall be guilty of an offence and shall, on conviction,

be liable, in the case of an offence against

(a) the provisions of articles 20(1), 37, 54, 54A,

98 and 104A, to a fine (multa) of not less than eleven

thousand and six hundred and forty-six euro and eighty

seven cents (11,646.87) and not exceeding one hundred

and sixteen thousand and four hundred and sixty-eight euro

and sixty-seven cents (116,468.67) or to imprisonment for

a term not exceeding two years, or both such fine and

imprisonment;

(b) the provisions of articles 31A, 44 and 56(3),

to a fine (multa) of not less than five thousand eight

hundred and twenty-three euro and seventy-five cents

(5,823.75) and not exceeding sixty-nine thousand and eight

hundred and eighty-one euro and twenty cents (69,881.20)

or to imprisonment for a term not exceeding six months, or

both such fine and imprisonment;

(c) the provisions of articles 32(4), 45, 66(1),

66(5), 66(6), 66A, 71, 75(3), 75(4), 76(1), 81(1) and 91, to

a fine (multa) of not less than two thousand and three

hundred and twenty-nine euro and thirty-eight cents

(2,329.38) and not exceeding forty-six thousand and five

hundred and eighty-seven euro and forty-seven cents

(46,587.47) or to imprisonment for a term not exceeding

three months, or to both such fine and imprisonment;

(d) the provisions of articles 59, 60, 74, 75(1),

75(2), 84, 93, 94(1) and 96, to a fine (multa) of not less

than one thousand and one hundred and sixty-four euro and

sixty-nine cents (1,164.69) and not exceeding twenty-three

thousand and two hundred and ninety-three euro and

seventy-three cents (23,293.73);

(e) the provisions of articles 78, 83, 85(1), 85(2),

86, 87 and 94(2), to a fine (multa) of not less than four

hundred and sixty-five euro and eighty-seven cents

(465.87) and not exceeding eleven thousand and six

hundred and forty-six euro and eighty-seven cents

(11,646.87);

(f) the provisions of articles 31, 73(1), 79(1),

79(2), 80(1), 80(2) and 94(3), to a fine (multa) of not less

than two hundred and thirty-two euro and ninety-four cents

(232.94) and not exceeding two thousand and three

hundred and twenty-nine euro and thirty-seven cents

(2,329.37).

(2) Without prejudice to the powers of the Licensing

Authority under this Act, where any person who has committed

an offence is the holder of a licence or an authorisation under

this Act, the Court shall, at the request of the prosecution, order

the revocation or suspension of the aforesaid licence or

authorisation.".

28. Sub-articles (2), (3) and (4) of article 100 of the principal

Act shall be renumbered as sub-articles (3), (4) and (5) thereof

respectively, and immediately after sub-article (1) thereof, there shall

be added the following new sub-article

"(2) The provisions of sub-article (1) shall not apply in

offences where there is a breach of articles 20(1), 37, 44, 54,

56(3), 98 and 104A.".

29. Immediately after article 101 of the principal Act, there Addition of new

article to the

shall be added the following new article

principal Act.

" Requirements

(1) Mingħajr preġudizzju għal kull responsabbiltà

oħra taħt kull liġi oħra, kull min jonqos milli jħares xi

dispożizzjoni ta’ dan l-Att jew ta’ xi regolamenti jew regoli

magħmulin taħtu jkunu ħati ta’ reat u jista’, meta jinsab ħati,

jeħel, fil-każ ta’ reat kontra

(a) id-dispożizzjonijiet tal-artikoli 20(1), 37, 54,

54A, 98 u 104A, multa ta’ mhux anqas minn ħdax-il elf u

sitt mija u sitta u erbgħin euro u sebgħa u tmenin ċenteżmu

(11,646.87) u mhux iżjed minn mija u sittax-il elf u erba’

mija u tmienja u sittin euro u sebgħa u sittin ċenteżmu

(116,468.67) jew priġunerija għal żmien mhux iżjed minn

sentejn, jew dik il-multa u priġunerija flimkien;

(b) id-dispożizzjonijiet tal-artikoli 31A, 44 u

56(3), multa ta’ mhux anqas minn ħamest elef tmien mija u

tlieta u għoxrin euro u ħamsa u sebgħin ċenteżmu

(5,823.75) u mhux iżjed minn disgħa u sittin elf u tmien

mija u wieħed u tmenin euro u għoxrin ċenteżmu

(69,881.20) jew priġunerija għal żmien mhux iżjed minn

sitt xhur, jew dik il-multa u priġunerija flimkien;

(ċ) id-dispożizzjonijiet tal-artikoli 32(4), 45,

66(1), 66(5), 66(6), 66A, 71, 75(3), 75(4), 76(1), 81(1) u

91, multa ta’ mhux anqas minn elfejn u tliet mija u disgħa

u għoxrin euro u tmienja u tletin ċenteżmu (2,329.38) u

mhux iżjed minn sitta u erbgħin elf u ħames mija u sebgħa

u tmenin euro u sebgħa u erbgħin ċenteżmu (46,587.47)

jew priġunerija għal żmien mhux iżjed minn tliet xhur, jew

dik il-multa u priġunerija flimkien;

(d) id-dispożizzjonijiet tal-artikoli 59, 60, 74,

75(1), 75(2), 84, 93, 94(1) u 96, multa ta’ mhux anqas

minn elf u mija u erbgħa u sittin euro u disgħa u sittin

ċenteżmu (1,164.69) u mhux iżjed minn tlieta u għoxrin elf

u mitejn u tlieta u disgħin euro u tlieta u sebgħin ċenteżmu

(23,293.73);

(e) id-dispożizzjonijiet tal-artikoli 78, 83, 85(1),

85(2), 86, 87 u 94(2), multa ta’ mhux anqas minn erba’

mija u ħamsa u sittin euro u sebgħa u tmenin ċenteżmu

(465.87) u mhux iżjed minn ħdax-il elf u sitt mija u sitta u

erbgħin euro u sebgħa u tmenin ċenteżmu (11,646.87);

(f) id-dispożizzjonijiet tal-artikoli 31, 73(1),

79(1), 79(2), 80(1), 80(2) u 94(3), multa ta’ mhux anqas

minn mitejn u tnejn u tletin euro u erbgħa u disgħin

ċenteżmu (232.94) u mhux iżjed minn elfejn u tliet mija u

disgħa u għoxrin euro u sebgħa u tletin ċenteżmu

(2,329.37).

(2) Mingħajr preġudizzju għas-setgħat tal-Awtorità

dwar il-Liċenzjar taħt dan l-Att, meta xi ħadd jagħmel reat u

jkun id-detentur ta’ liċenza jew ta’ xi awtorizzazzjoni taħt dan l-

Att, il-Qorti għandha, fuq talba tal-prosekuzzjoni, tordna r-

revoka jew is-sospensjoni tal-liċenza jew awtorizzazzjoni hawn

qabel imsemmija.".

28. Is-subartikoli (2), (3) u (4) tal-artikolu 100 tal-Att

prinċipali għandhom jiġu enumerati mill-ġdid bħala s-subartikoli (3),

(4) u (5) tiegħu rispettivament, u minnufih wara s-subartikolu (1)

tiegħu, għandu jiżdied is-subartikolu ġdid li ġej

"(2) Id-dispożizzjonijiet

tas-subartikolu

(1)

m’għandhomx japplikaw għal reati meta jkun hemm ksur tal-

artikoli 20(1), 37, 44, 54, 56(3), 98 u 104A.".

29. Minnufih wara l-artikolu 101 tal-Att prinċipali, għandu

jiżdied l-artikolu ġdid li ġej

" Ħtiġiet għall-

(1) The Licensing Authority

for testing and

shall, in cooperation with the European

inspections of

Medicines Agency, ensure that the legal

manufacturers,

importers,

requirements governing medicinal products

brokers and

distributors of

are complied with, by means of inspections, if

medicinal

necessary

unannounced,

and,

where

products,

including

appropriate, by asking an Official Medicines

APIs,

excipients and

Control Laboratory or a laboratory designated

other starting

for that purpose to carry out tests on samples.

materials.

This cooperation shall consist in sharing

information with the European Medicines

Agency on both inspections that are planned

and that have been conducted as well as in the

coordination of inspections in third countries.

(2)

The inspections shall include but

not be limited to the ones mentioned in

paragraphs (a) and (b) as follows

(a)

manufacturers, located in the

European Union or in third countries,

and wholesale distributors of medicinal

products shall be subject to repeated

inspections;

(b) the Licensing Authority

shall have a system of supervision

including by inspections at an

appropriate frequency based on risk, at

the premises of the manufacturers,

importers, or distributors of active

substances, located in Maltese territory,

and effective follow-up thereof.

(3)

Whenever it considers that there

are grounds for suspecting non-compliance

with the legal requirements laid down in this

Act and subsidiary legislation made

thereunder, including the European Union

principles

and

guidelines

of

good

manufacturing practice and good distribution

practices, the Licensing Authority may carry

out inspections at the premises of

(a)

manufacturers or distributors

of active substances located in third

countries;

(b) manufacturers or importers

of excipients.

(4)

Inspections referred to in sub-

articles (2) and (3) may also be carried out in

the European Union and in third countries at

the request of a European Union Member

State, the European Union Commission or the

European Medicines Agency.

(5)

Inspections may also take place

at the premises of marketing authorisation

holders and of brokers of medicinal products.

(6)

Inspections shall be carried out

by officials representing the Licensing

Authority who shall be empowered to inspect

the premises, records, documents and

pharmacovigilance system master file of the

marketing authorisation holder or any firms

employed by the marketing authorisation

holder to perform any pharmacovigilance

activities.

(7)

Inspections shall be carried out in

accordance with the guidelines and provisions

referred to in articles 101 to 104.

(8)

After every inspection, the

Licensing Authority shall report on whether

the inspected entity complies with the

European Union principles and guidelines of

good manufacturing practice and good

distribution as applicable, or on whether the

marketing authorisation holder complies with

the pharmacovigilance requirements laid

down in this Act and subsidiary legislation

made thereunder.

(9)

The Licensing Authority shall

communicate the content of those reports to

the inspected entity. Before adopting the

report, the Licensing Authority shall give the

inspected entity concerned the opportunity to

submit comments.

(10)

Without prejudice to any

arrangements which may have been

concluded between the European Union and

third countries, a Member State, the European

Union Commission or the European

Medicines

Agency

may

require

a

manufacturer established in a third country to

submit to an inspection as referred to in this

article.

(11)

Within ninety days of an

inspection as referred to in sub-article (1), a

certificate of good manufacturing practice or

good distribution practices shall, when

applicable, be issued to the inspected entity if

the outcome of the inspection shows that it

complies with the principles and guidelines of

good manufacturing practice or good

distribution practices as provided for by

European Union legislation.

(12) If inspections are performed as

part of the certification procedure for the

monographs of the European Pharmacopoeia,

a certificate shall be drawn up.

(13) Certificates

of

good

manufacturing practice and good distribution

practices issued shall be entered in the

European Union database managed by the

European Medicines Agency on behalf of the

European Union. Information shall also be

entered in that database regarding the

registration of importers, manufacturers and

distributors of active substances.".

30. Article 102 of the principal Act shall be amended as Amendment of

article 102 of

follows

the principal

Act.

(a) in paragraph (c) of sub-article (1) thereof, for the

words "after they have been subjected to those processes:",

there shall be substituted the words "after they have been

subjected to those processes;", and immediately thereafter there

shall be added the following new paragraph

"(d) any premises, records, documents and

pharmacovigilance system master file of the marketing

authorisation holder or any firms employed by the

marketing

authorisation

holder

to

perform

pharmacovigilance activities as established under article

31A:"; and

(b) in sub-article (2) thereof, immediately after the

words "An authorised officer may, for the purpose specified in

the preceding sub-article, take a sample" there shall be added

the words ", including with a view to independent tests being

carried out by an Official Medicines Control Laboratory or a

laboratory designated for that purpose by an European Union

Member State,".

31. Article 104A of the principal Act shall be renumbered as

article 104B thereof.

32. Immediately after article 104 of the principal Act, there

shall be added the following new article

" Hindering,

(8)

Wara kull spezzjoni, l-Awtorità

dwar il-Liċenzjar għandha tirrapporta dwar

jekk entità spezzjonata tkunx tikkonforma

mal-prinċipji tal-Unjoni Ewropea u mal-linji

gwida tal-prattiċi tajba ta’ manifattura u

distribuzzjoni li jkunu japplikaw, jew dwar

jekk id-detentur ta’ awtorizzazzjoni għat-

tqegħid fis-suq ikunx konformi mal-ħtiġiet ta’

farmakoviġilanza stipulati f’dan l-Att u fil-

leġislazzjoni sussidjarja magħmula taħtu.

(9)

L-Awtorità dwar il-Liċenzjar

għandha twassal il-kontenut ta’ dawk ir-

rapporti lill-entità spezzjonata. Qabel ma

tadotta r-rapport, l-Awtorità dwar il-Liċenzjar

għandha tagħti lill-entità spezzjonata involuta

l-opportunità li tippreżenta l-kummenti

tagħha.

(10)

Mingħajr preġudizzju għal kull

arranġament li seta’ sar bejn l-Unjoni

Ewropea u pajjiżi terzi, Stat Membru, il-

Kummissjoni tal-Unjoni Ewropea jew l-

Aġenzija tal-Mediċini Ewropea tista’ titlob lil

manufattur stabbilit f’pajjiż terz jippreżenta

spezzjoni kif imsemmija f’dan l-artikolu.

(11)

Fi żmien disgħin jum minn

spezzjoni kif imsemmija fis-subartikolu (1),

ċertifikat dwar prattiċi tajba ta’ manifattura

jew distribuzzjoni għandhom, meta dawn

ikunu

japplikaw,

jinħarġu

lill-entità

spezzjonata jekk l-eżitu tal-ispezzjoni jkun

juri li jikkonforma mal-prinċipji u l-linji

gwida ta’ prattiċi tajba ta’ manifattura jew

distribuzzjoni kif previst fil-liġijiet tal-Unjoni

Ewropea.

(12) Jekk isiru spezzjonijiet bħala parti

mill-proċedura ta’ ċertifikazzjoni għall-

monografi tal-farmakopoeia Ewropea, għandu

jintgħamel ċertifikat.

(13) Iċ-ċertifikati ta’ prattiċi tajba ta’

manifattura u distribuzzjoni li jinħarġu

għandhom jiddaħħlu fid-database tal-Unjoni

Ewropea kif maniġġata mill-Aġenzija tal-

Mediċini Ewropea f’isem l-Unjoni Ewropea.

L-informazzjoni dwar ir-reġistrazzjoni ta’

importaturi, manufatturi u distributuri ta’

sustanzi attivi għandha wkoll tiddaħħal f’dik

id-database.".

30. L-artikolu 102 tal-Att prinċipali għandu jiġi emendat kif Emenda tal-

artikolu 102 tal-

Att prinċipali.

(a) fil-paragrafu (ċ) tas-subartikolu (1) tiegħu, minflok

il-kliem "wara li jkunu għaddew minn dawk il-proċessi:",

għandhom jidħlu l-kliem "wara li jkunu għaddew minn dawk il-

proċessi;", u minnufih wara għandu jiżdied il-paragrafu ġdid li

ġej

"(d) kull fond, record, dokument u master file tas-

sistema

ta’

farmakoviġilanza

tad-detentur

ta’

awtorizzazzjoni għat-tqegħid fis-suq jew ta’ ditti mqabbda

mid-detentur ta’ awtorizzazzjoni għat-tqegħid fis-suq biex

iwettqu attivitajiet ta’ farmakoviġilanza kif stabbiliti taħt l-

artikolu 31A:"; u

(b) fis-subartikolu (2) tiegħu, minnufih wara l-kliem

"Uffiċjal awtorizzat jista’, għal kull fini speċifikata fis-

subartikolu preċedenti, jieħu kampjun" għandhom jiżdiedu l-

kliem ", inkluż bil-għan li jsiru provi indipendenti f’Laboratorju

ta’ Kontroll tal-Mediċini Uffiċjali jew f’laboratorju li jagħmel

dak ix-xogħol għal xi Stat Membru tal-Unjoni Ewropea,".

31. L-artikolu 104A tal-Att prinċipali għandu jiġi enumerat Enumerazzjoni

mill-ġdid tal-

mill-ġdid bħala l-artikolu 104B tiegħu.

artikolu 104A

tal-Att

prinċipali.

32. Minnufih wara l-artikolu 104 tal-Att prinċipali, għandu Żjieda ta’

artikolu ġdid

jiżdied l-artikolu ġdid li ġej

mal-Att

prinċipali.

" Ostakoli,

Any person who, by any means

etc., the

whatsoever, hinders or obstructs the

Licensing

Licensing Authority or an authorised officer

Authority.

from exercising any of his powers and

functions under this Act shall be guilty of an

offence against this Act.".

33. Immediately after article 104B of the principal Act, as

renumbered, there shall be added the following new article

" Recalls and

(1) The Licensing Authority

rapid alerts.

shall ensure that there is a system in place

which aims at preventing medicinal products

that are suspected to present a danger to

health from reaching the patient.

(2)

The system referred to in sub-

article (1) shall cover the receipt and handling

of notifications of suspected falsified

medicinal products as well as of suspected

quality defects of medicinal products. The

system shall also cover recalls of medicinal

products by marketing authorisation holders

or withdrawals of medicinal products from

the market ordered by national competent

authorities from all relevant actors in the

supply chain both during and outside normal

working hours. The system shall also make it

possible to recall, where necessary with the

assistance of health professionals, medicinal

products from patients who received such

products.

(3)

If the medicinal product in

question is suspected of presenting a serious

risk to public health, the Licensing Authority

shall, without any delay, transmit a rapid alert

notification to all European Union Member

States and all actors in the supply chain in

Malta. In the event of such medicinal products

being deemed to have reached patients, urgent

public announcements shall be issued within

twenty-four hours in order to recall those

medicinal products from the patients. Those

announcements shall contain sufficient

information on the suspected quality defect or

falsification and the risks involved.".

Passed by the House of Representatives at Sitting No. 34 of the

24th June, 2013.

A NĠLU F ARRUGIA

Speaker

R AYMOND S CICLUNA

Clerk to the House of Representatives