ACT No. XI of 2007 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>-

I assent.

E DWARD F ENECH A DAMI

(L.S.)

President

20th July, 2007

ACT No. XI of 2007

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>-

(1)

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

Act, 2007.

(2) This Act shall be read and construed as one with the

Medicines Act, hereinafter referred to as “the principal Act”.

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

Amendment of

article

2 of the principal

Act.

(a) immediately before the definition “advertising” there

shall be inserted the following new definition>-

“ “adverse reaction” means a response to a medicinal

product which is noxious and unintended and which occurs

at doses normally used in man for the prophylaxis, diagnosis

or therapy of disease or for the restoration, correction or

modification of physiological function<”<

(b) immediately after the definition “clinical trial”, there

shall be added the following new definition>-

“ “common name” means the international non-

proprietary name recommended by the World Health

Organization, or, if one does not exist, the usual common

name<”<

(c) in the Maltese text of the definition “esperiment kliniku”,

for the words “esperiment kliniku” there shall be substituted the

words “prova klinika”<

(d) for the definition “herbal medicinal product” there shall

be substituted the following>-

““herbal medicinal product” means any medicinal

product, exclusively containing as active ingredients one or

more herbal substances or one or more herbal preparations,

or one or more such herbal substances in combination with

one or more such herbal preparations<”<

(e) for the definition “herbal preparations” there shall be

substituted the following>-

“ “herbal preparations” means preparations obtained by

subjecting herbal substances to treatments such as extraction,

distillation, expression, fractionation, purification,

concentration or fermentation. These include comminuted or

powdered herbal substances, tinctures, extracts, essential oils,

expressed juices and processed exudates<”<

(f) for the definition “herbal substances” there shall be

substituted the following>-

“ “herbal substances” means all mainly whole,

fragmented or cut plants, plant parts, algae, fungi, lichen in

an unprocessed, usually dried, form, but sometimes fresh.

Certain exudates that have not been subjected to a specific

treatment are also considered to be herbal substances. Herbal

substances are precisely defined by the plant part used and

the botanical name according to the binomial system (genus,

species, variety and author)<”<

(g) in the definition “homeopathic medicinal product”, for

the words “in Malta” there shall be substituted the words “in the

Member States”<

(h) for the definition “immunological medicinal product”

there shall be substituted the following>-

“immunological medicinal product” means any

medicinal product consisting of vaccines, toxins, serums or

allergen products, where –

(a) vaccines, toxins and serums shall cover in

particular>

(i) agents used to produce active immunity,

such as cholera vaccine, BCG, polio vaccines,

smallpox vaccine<

(ii) agents used to diagnose the state of

immunity, including in particular tuberculin and

tuberculin PPD, toxins for the Schick and Dick

Tests, brucellin<

(iii) agents used to produce passive

immunity, such as diphtheria antitoxin, anti-

smallpox globulin, antilymphocytic globulin<

(b) ‘allergen product’ shall mean any medicinal

product which is intended to identify or induce a specific

acquired alteration in the immunological response to an

allergizing agent<”<

(i) in the definition “magistral formula” for the words “with

a prescription” there shall be substituted the words “with a medical

prescription”<

(j) in the definition “medicinal prescription” for the words

“any prescription” there shall be substituted the words “any

medicinal prescription”<

(k) for the definition “medicinal product” there shall be

substituted the following>-

“ “medicinal product” means any substance or

combination of substances -

(a) presented as having properties for treating or

preventing disease in human beings< or

(b) which may be used in or administered to

human beings either with a view to restoring, correcting

or modifying physiological functions by exerting a

pharmacological, immunological or metabolic action, or

to making a medical diagnosis<”<

(l) immediately after the definition “medicinal product”,

there shall be added the following new definition>-

“ “medicinal products derived from human blood or

human plasma” means medicinal products based on blood

constituents which are prepared industrially by public or

private establishments, such medicinal products including,

in particular, albumin, coagulating factors and

immunoglobulins of human origin<”<

(m) immediately after the definition “Minister” there shall

be added the following new definition>-

“ “name of the medicinal product” means the name,

which may be either an invented name not liable to confusion

with the common name, or a common or scientific name

accompanied by a trade mark or the name of the marketing

authorisation holder<”<

(n) the definitions “official formula” and “pre-packaging”

shall be deleted<

(o) immediately after the new definition “name of the

medicinal product” there shall be inserted the following new

definition>-

“ “officinal formula” means 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 such pharmacy<”<

(p) in the Maltese text of the definition “prodott medi/inali

investigattiv”, for the words “l-esperiment kliniku” there shall be

substituted the words “fi prova klinika”<

(q) in the definition “radionuclide generator” for the word

“removed” there shall be substituted the word “obtained”<

(r) in the definition “radionuclide kit” for the words

“radionuclide kit” there shall be substituted the word “kit”, and

the said definition “kit” shall now be inserted immediately after

the definition “investigational medicinal product”<

(s) in the definition “radionuclide precursor”, for the words

“radionuclide kit” there shall be substituted the words “kit”<

(t) for the definition “radiopharmaceutical” there shall be

substituted the following>-

“ “radiopharmaceutical” means any medicinal product

which, when ready for use, contains one or more radionuclides

(radioactive isotopes) included for a medicinal purpose<”<

(u) immediately after the definition “responsible person”

there shall be added the following new definition>-

“ “risk-benefit balance” means an evaluation of the

positive therapeutic effects of the medicinal product in relation

to the risks as defined in paragraph (a) of the definition”“risks

related to use of the medicinal product<”<

(v) immediately after the definition “risk-benefit balance”

there shall be added the following new definition>-

“ “risks related to use of the medicinal product” means>-

(a) any risk relating to the quality, safety or

efficacy of the medicinal product as regards patients’

health or public health<

(b) any risk of undesirable effects on the

environment< ”<

(w) immediately after the definition “rules” there shall be

added the following new definition>-

“ “serious adverse reaction” means an adverse reaction

which results in death, is life-threatening, requires inpatient

hospitalisation or prolongation of existing hospitalisation,

results in persistent or significant disability or incapacity, or

is a congenital anomaly or birth defect”<

(x) immediately after the definition “serious adverse

reaction” there shall be added the following new definition>-

“ “strength of the medicinal product” means the content

of the active substances expressed quantitatively per dosage

unit, per unit of volume or weight according to the dosage

form<”<

(y) for the definition “substance” there shall be substituted

the following>-

“ “substance” means any matter irrespective of origin

be it human (including human blood and human blood

products), animal (including micro-organisms, whole animals,

parts of organs, animal secretions, toxins, extracts, blood

products), vegetable (including micro-organisms, plants, parts

of plants, vegetable secretions, extracts), or chemical

(including elements, naturally occurring chemical materials

and chemical products obtained by chemical change or

synthesis)<”<

(z) immediately after the definition “Superintendent of

Public Health” there shall be inserted the following new definition>-

“ “unexpected adverse reaction” means an adverse

reaction, the nature, severity or outcome of which is not

consistent with the summary of product characteristics<”

(aa) for the definition “wholesale distribution” there shall

be substituted the following>-

“ “wholesale distribution”, in relation to a medicinal

product, includes all activities consisting of procuring,

holding, supplying or exporting medicinal products, apart

from supplying medicinal products to the public. Such

activities are carried out with manufacturers or their

depositories, importers, other wholesale distributors or with

pharmacists and persons authorised or entitled to supply

medicinal products to the public in Malta.”<

(bb) in the Maltese text only thereof>

(i) the definition “leaflets ;o pakkett” shall be deleted<

(ii) immediately after the definition “farmakopeia

rikonoxxuta” there shall be added the following new

definition>-

“ “fuljett ta’ tag[rif” tfisser il-fuljett li jkun fih l-

informazzjoni kollha g[al min ikun se juzah u li jkun

jinsab flimkien mal-prodott mediçinali<”

(iii) in the definition “reklamar”, and in article 28(3),

for the words “leaflets” and “leaflets ;o pakkett” wherever

they occur there shall be substituted the words “fuljetti ta’

tag[rif” and “fuljett ta’ tag[rif” respectively< and

(iv) in article 102 (1)(b), for the word “leaflet” there

shall be substituted the word “fuljett”.

Amendment

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

of article 3 of

the principal Act.

(a) in the Maltese text of paragraph (f) of subarticle (2), for

the words “esperimneti klini/i” there shall be substituted the words

“provi klini/i”< and

(b) for sub-article (3), there shall be substituted the

following>

“(3) The Licensing Authority may by rules delegate

any of its functions referred to in paragraphs (l), (m), (n) and

(o) of sub-article (2) hereof to the Medicines Authority.”.

In sub-article (2) of article 10 of the principal Act, for the Amendment of

article 10 principal

word “agency”, wherever it occurs, there shall be substituted the word Act.

“Authority”.

5 For paragraph (a) of sub-article (2) of article 16 of the principal Amendment of

article 16 of the

Act, there shall be substituted the following>-

principal Act.

“(a) 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”.

Minflok il-paragrafu (a) tas-subartikolu (2) ta’ l-artikolu 16 Emenda ta’ l-

artikolu

ta’ l-Att prinçipali, g[andu jid[ol dan li ;ej>-

16 ta’ l-Att

prinçipali.

“(a) li jisma’ appell mag[mul minn applikant g[al

awtorizzazzjoni g[at- tqeg[id fis-suq fuq xi rakkomandazzjoni ta’

l-Awtorità dwar il-Mediçini dwar is-sigurezza, il-kwalità u l-

effikaçja ta’ xi prodott mediçinali.”.

Minflok l-artikolu 19 ta’ l-Att prinçipali, g[andu jid[ol dan li Sostituzzjoni

For article 19 of the principal Act, there shall be substituted Substitution of

article 19 of the

the following>

principal Act.

“19.

(1) The provisions of Titles I, II and III shall apply>

(a) to medicinal products for human use intended to

be placed on the market in Member States and either prepared

industrially or manufactured by a method involving an

industrial process<

(b) in cases of doubt, where, taking into account all its

characteristics, a product may fall within the definition of a

medicinal product and within the definition of a product

covered by other Community legislation.

(2) Titles I, II and III of this Act shall not apply to –

(a) any medicinal product prepared in accordance with

a magistral formula<

(b) any medicinal product prepared in accordance with

an officinal formula<

(c) medicinal products intended for research and

development trials, but without prejudice to the provisions of

the Clinical Trials Regulations, 2004<

(d) radionuclides in the form of sealed sources<

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

except for plasma prepared by a method involving an

industrial process<

(f) intermediate products intended for further

processing by an authorised manufacturer.

(3) (a) The Authority may, in accordance with

legislation in force and to fulfill special needs, exclude from the

provisions of this Act 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.

(b) The Authority may temporarily authorise the

distribution of an unauthorised medicinal product in response to

the suspected or confirmed spread of pathogenic agents, toxins,

chemical agents or nuclear radiation any of which could cause

harm>

Provided that marketing authorisation holders, manufacturers

and health professionals are not subject to civil or administrative

liability for any consequences resulting from the use of a medicinal

product otherwise than for the authorised indications or from the

use of an unauthorised medicinal product, when such use is

recommended or required by the Authority in response to the

suspected or confirmed spread of pathogenic agents, toxins,

chemical agents or nuclear radiation any of which could cause

harm. This shall apply irrespective of whether or not national or

Community authorisation has been granted>

Provided further that liability for defective products, as

provided for by Council Directive 85#374#EEC of 25 July, 1985

on the approximation of the laws, regulations and administrative

provisions of the Member States, concerning liability for defective

products shall not be affected by the preceding proviso.”.

Title I of part III of the principal Act shall be deleted from Amendment to Title

I of Part III of the

appearing before article 19 and shall be inserted to appear immediately principal Act.

before article 20.

Article 28 of the principal Act shall be amended as follows>- Amendment

article 28 of the

principal Act.

(a) for sub-articles (1) and (2) thereof, there shall be

substituted the following>

“(1) The Licensing Authority shall suspend, revoke,

withdraw or vary the marketing authorization for a medicinal

product, ensure that the supply of the medicinal product is

prohibited and order its withdrawal from the market if>

(a) the medicinal product is harmful under normal

conditions of use< or

(b) it lacks therapeutic efficacy, where such lack

of therapeutic efficacy shall be deemed as occurring

when it is concluded that therapeutic results cannot be

obtained from the medicinal product< or

(c) the risk benefit balance is not favourable under

the authorised conditions of use< or

(d) its qualitative and quantitative composition is

not as declared< or

(e) the controls on the medicinal product and, or

on the ingredients and the controls at an intermediate

stage of the manufacturing process have not been carried

out, or if the requirement or obligation relating to the

grant of the manufacturing authorisation has not been

fulfilled>

Provided that the Licensing Authority may limit

the prohibition to supply the medicinal product, or its

withdrawal from the market, to those batches which are

the subject of dispute.

(2) An authorisation shall also be suspended, revoked,

withdrawn or varied where the particulars supporting the

application as provided for in this Act are found to be incorrect

or have been amended without authorisation or when the

requisite controls required by or under this Act have not been

carried out.”< and

(b) immediately after sub-article (5) thereof shall be added

the following new articles>

“(6) The Licensing Authority shall suspend or revoke

the marketing authorization for a category of preparations or

all preparations where the provisions of Title II are not

complied with.

(7) The provisions of this article and of articles 99 to

104, shall apply to homeopathic medicinal products.”.

Article 32 of the principal Act shall be amended as follows>–

(a) in sub-article (1) for the words “Homeopathic medicinal

products” there shall be substituted the words “Without prejudice

to article 28 of this Act, homeopathic medicinal products”< and

(b) in the Maltese text of subarticle (5), for the words

“esperimenti klini/i” there shall be substituted the words “provi

klini/i”.

In sub-article (1) of article 41 of the principal Act, the words

“under this Act” shall be deleted.

For article 49 of the principal Act, there shall be substituted

the following>-

“49. The provisions of articles 37 to 48 shall apply to the

manufacture and assembly of homeopathic medicinal products.”.

In articles 50, 51, 52 and 53 of the principal Act, the words

“other than the products listed in article 32(a) (b) and (c)”, wherever

they occur shall be deleted.

For article 77 of the principal Act, there shall be substituted

the following>–

“77. The conditions and criteria where any person can have

or not have a direct or indirect interest in a pharmacy shall be

prescribed under this Act.”.

In sub-article (2) of article 80 of the principal Act, the words

“, formulation” shall be deleted.

In article 83 of the principal Act, for the words “or official

formula” there shall be substituted the words “or officinal formula”.

In article 87 of the principal Act, for the words “official Amendment of

article 87 of the

formulas” there shall be substituted the words “officinal formulas” and principal Act.

for the word “pre-packing” there shall be substituted the words “division

of authorised packs into smaller units”.

In paragraph (e) of subarticle (1) of article 99 of the principal Amendment of

article 102 of the

Act, the words “66(2)” shall be deleted.

principal Act.

In article 101 of the principal Act, in sub-article (1) thereof, Amendment of

article 99 of the

for the words “to enter any premises>” there shall be substituted the principal Act.

words “to enter and carry out repeated and unannounced inspections at

any premises>”.

Article 102 of the principal Act shall be amended as follows> Amendment of

article 101 of the

principal Act.

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

“to those processes.” there shall be substituted the words “to those

processes>” and, immediately thereafter, there shall be added the

following provisos to the whole sub-article>-

“Provided that an authorized officer may also carry out

inspections of starting material manufacturers after a specific

request for the purpose is made by such manufacturer himself>

Provided further that the samples that may be collected

may be analysed at a designated laboratory identified by the

Authority.”<

(b) immediately after paragraph (b) of sub-article (3) thereof,

there shall be added the following new paragraph>

“(c) to take photographs of any equipment, premises,

records and documents.”< and

(c) immediately after sub-article (7) thereof, there shall be

inserted the following new sub-articles>

“(8) After every inspection the authorized officer shall

report on whether the manufacturer complies with the

principles and guidelines of good manufacturing practice or,

where appropriate, with the requirements relating to

pharmacovigilance. The content of such reports shall be

communicated to the manufacturer or marketing authorisation

holder who has undergone the inspection.

(9) Within 90 days of an inspection a certificate of good

manufacturing practice shall be issued to a manufacturer if

the outcome of the inspection shows that the manufacturer

complies with the principles and guidelines of good

manufacturing practice as provided for by legislation in force

at the time.”.

Immediately after sub-article (4) of article 103 of the principal

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

“(5) 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.”.

Immediately after article 104 of the principal Act, there shall

be added the following new articles>

104A. (1) The holder of the marketing authorization

for a medicinal product and, where appropriate, the holder of

the manufacturing authorization, shall furnish proof of the

controls carried out on the medicinal product and, or the

ingredients and of the controls carried out at an intermediate

stage of the manufacturing process, in accordance with the

methods laid down in Article 8(3)(h) of Directive 2001#83

EC and any amendments thereto.

(2) Manufacturers of immunological products

shall submit to the Authority copies of all the control reports

signed by the qualified person.

(3) Where the Authority considers it necessary

in the interests of public health, it may require the holder of

an authorization for marketing>

(a)

live vaccines,

(b) immunological medicinal products used in the

primary immunization of infants or of other groups at

risk<

(c) immunological medicinal products used in

public health immunization programmes,

(d) new immunological medicinal products or

immunological medicinal products manufactured using

new or altered kinds of technology or new for a particular

manufacturer, during a transitional period normally

specified in the marketing authorization,

to submit samples from each batch of the bulk and, or the

medicinal product for examination by a laboratory designated

for that purpose before release on to the market unless, in the

case of a batch manufactured in another Member State, the

competent authority of that Member State has previously

examined the batch in question and declared it to be in

conformity with the approved specifications. The Authority

shall ensure that any such examination is completed within

60 days of the receipt of the samples.

(4) In the interests of public health, the Authority

may require the marketing authorization holder for medicinal

products derived from human blood or human plasma to

submit samples from each batch of the bulk and, or the

medicinal product for testing by a laboratory designated for

that purpose before being released into free circulation, unless

the competent authorities of another Member State have

previously examined the batch in question and declared it to

be in conformity with the approved specifications. The

Authority shall ensure that any such examination is completed

within 60 days of the receipt of the samples.”.

Article 106 of the principal Act shall be amended as follows>– Amendment of

article 106 of the

principal Act.

(a) in the Maltese text of paragraph (h), for the words

“esperimenti klini/i” there shall be substituted the words “provi

klini/i”< and

(b) for paragraph (q), there shall be substituted the

following>-

“(q) the fees that may be levied and the funds wherein

such fees may be deposited by the Licensing Authority, the

Medicines Authority and any other Committee established

by or under this Act or regulations made thereunder<”.

Immediately after article 109 of the principal Act, there shall

be added the following new article>

110. (1) Nothing in this Act shall in any way derogate

from any Acts or regulations for the radiation protection of

persons undergoing medical examination or treatment, or from

the Community rules laying down the basic safety standards

for the health protection of the general public and workers

against the dangers of ionizing radiation.

(2) This Act shall be without prejudice to Council

Decision 86#346#EEC of 25 June 1986 accepting on behalf

of the Community the European Agreement on the Exchange

of Therapeutic Substances of Human Origin.

(3) The provisions of this Act shall not affect the

powers of the Authority either as regards the setting of prices

for medicinal products or their inclusion in the scope of

national health insurance schemes, on the basis of health,

economic and social conditions.

(4) This Act shall not affect the application of any

law prohibiting or restricting the sale, supply or use of

medicinal products as contraceptives or abortifacients.”.

The Third Schedule to the principal Act shall be repealed.

Passed by the House of Representatives at Sitting No. 551 of the 16th July,

2007. A NTON T ABONE

Speaker

R ICHARD J. C AUCHI

Clerk to the House of Representatives