Regulations, 2004

L.N. 143 of 2004

MEDICINES ACT, 2003

(ACT NO. III OF 2003)

Manufacture of Medicinal Products for Human Use

Regulations, 2004

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 of

Medicinal Products for Human Use Regulations, 2004.

(2)

These regulations shall come in force on the 1st May,

2004. For the purposes of these regulations-

“Commission” means the Commission in accordance with

Council Decision 1999#468#EC of 28th 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 shall also include Iceland, Norway and

Liechtenstein.

(1) (a) No medicinal product may be manufactured in

Malta unless there is in respect of such product a manufacturing

licence, hereinafter referred to as “licence”.

(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 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 authorised to carry out such processes.

(3) In addition to the licence referred to under

subregulation (1) of this regulation an importer’s licence shall also

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.

The Licensing Authority, hereinafter referred to as the Grant or renewal

of a licence.

“Authority”, shall only grant or renew an licence, if the 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< and

(d) provides all necessary documentation in support of

his application.

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

licence.

verifying the contents of the application but in any case not later

than ninety days of 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 manufacturing licence requests a

change in any of the particulars in the application, the process of

verification of such information shall not exceed 30 days. However,

in exceptional cases this period of time may be extended to 90 days.

The holder of a manufacturing licence shall apart from his

obligations under article 44 of the Act, comply with the principles

and guidelines of good manufacturing practice and good distribution

practice for medicinal products published by the Commission.

If the manufacturing licence holder personally has the

qualifications laid down in the regulation 9 hereof, than he may

himself assume the responsibility of a qualified person.

For a person to be designated as qualified person such

person he must at least possess the following qualifications as

follows>

(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 awards 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)

applied 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 fulfil the following obligations>

(i) ensure that medicinal products have been

manufactured and checked in accordance with the

marketing licence<

(ii) ensure, in the case of medicinal products from

non Member States, that each production batch has

undergone a full qualitative analysis and a quantitative

analysis of at least three constituents and all other tests as

may be necessary to ensure that the quality of the medicinal

product is in accordance with the marketing licence>

Provided that the qualified person shall be exempt from

complying with the afore mentioned duty in those cases where the

Community has an agreement with the exporting non Member State

that the manufactured medicinal product be manufactured in

accordance with standards of good manufacturing practice equivalent

to those laid down by the Community and that the controls be carried

out in the exporting country>

Provided further that medicinal products which are accompanied

by control reports drawn up and signed by a qualified person shall

be exempt from such controls if they are marketed in another Member

State<

(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, or

quantitative analysis of any active substance 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.

(1) A person who on the date of coming into force of

these regulations and for a year thereafter, was carrying out the duties

as a qualified person for a period of at least six months, shall be

eligible to continue in those activities even though he does not fulfil

the conditions set out under regulation 9, as long as such activities

have been carried out to the satisfaction of the Authority.

(2) The holder of a diploma, certificate or other evidence

of formal qualifications awarded on completion of a university

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

in a scientific discipline, thereby allowing him to perform the duties

of a qualified person, may, if he began his course prior to 21st 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 21st May

1985, engaged with one or more undertakings authorised to

manufacture and carried out his duties, under the direct authority of

a qualified person, in connection with production, supervision and,

or qualitative and quantitative analysis of active substances, and the

necessary testing and checking in order to ensure the quality of the

medicinal products.

(3) If the person concerned has acquired the practical

experience referred to in the preceding paragraph before the 21st

May 1965, a further one year’s practical experience in accordance

with the conditions referred to in the sub-regulation (2) will be

required to be completed immediately before he engages in such

activities.

The qualified person shall be responsible to ensure that>

Responsibility of

qualified person.

(a) each batch of medicinal products has been

manufactured and checked in terms of the laws in force and is

in accordance with the requirements of the marketing

authorisation<

(b) that each production batch of medicinal products

coming from non Member States, has undergone, on

importation, a full qualitative analysis and a quantitative

analysis of at least all the active constituents and all the other

tests or checks necessary to ensure the quality of medicinal

products in accordance with the conditions of the marketing

authorisation>

Provided that when the batches of medicinal products have

already undergone the controls above mentioned, 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.

(c) 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 obliging the manufacturer of the medicinal

products to apply 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.

B

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.

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