Products Regulations, 2004

L.N. 154 of 2004

MEDICINES ACT, 2003

(ACT NO. III OF 2003)

Importation and Wholesale Distribution of Medicinal

Products 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 Importation and Title and

Wholesale Distribution of Medicinal Products Regulations, 2004. commancement.

(2)

These regulations shall come into force on the 1st

May, 2004.

For the purposes of these regulations-

Interpretation.

“applicant” includes a holder or licencee<

“the Commission” means the Commission in accordance

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

“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<

“qualified person” means a person who fulfills the

conditions set under the Manufacture of Medicinal Products

for Human Use Regulations, 2004<

“responsible person” means a person registered as a

pharmacist with the Pharmacy Council and recognised as

suitable by the Medicines Authority since such person possesses

adequate knowledge of the conditions required for the storage

and distribution of medicinal products in order to avoid their

deterioration or damage, has adequate knowledge of the

regulations concerning the distribution of medicinal products,

and has knowledge and understanding of good distribution

practice.

Wholesale dealer’s

(1) No person shall engage in the wholesale distribution of

medicinal products unless he is in possession of a wholesale dealer’s

licence, hereinafter referred to as “licence”, to that effect.

(2) No person shall engage in the wholesale distribution

of imported medicinal products unless such person –

(a) apart from a license is also in possession of an import

authorisation<

(b)

employs a qualified person.

(1) The Licensing Authority, hereinafter referred to as

“the Authority”, may inspect any premises and check any person

authorised to engage in the activity of wholesaler in medicinal

products.

(2) If the Authority deems that any of the conditions of

the licence issued by it has not been met, it shall suspend or revoke

such licence.

(3) If a licence has been granted in another Member State

and the Authority deems that the licensee is not fulfilling the

conditions set therein, it shall inform the Commission and the

Member State concerned.

(1) The Authority shall process an application for a

wholesale dealer’s licence within ninety days of receipt of the

application. This period shall be suspended in those cases where the

applicant is requested to furnish additional data.

(2) The application shall, apart from the particulars listed

under article 55(1) of the Act, also include the pharmaceutical forms

of the products to be distributed, in particular any sterile products

and products requiring storage below 8 degrees Centigrade and

details of narcotic or psychotropic substances, blood, immunological

medicinal products, or radiopharmaceuticals.

(1) A wholesale distribution licence shall only be granted

if the Authority is satisfied that the applicant has at least >

(a) suitable and adequate premises, installations and

equipment, so as to ensure proper conservation and distribution

of the medicinal products<

(b)

adequate staff, and in particular, a responsible person.

(2)

A licence shall not be granted or renewed unless the

applicant>

(a) makes the premises, installations and equipment

accessible at all times for inspection<

(b) obtains the supplies of medicinal products from

persons who are themselves in possession of the distribution

licence or who are otherwise in possession of a manufacturing

licence, which includes a wholesale distribution licence, or who

are exempt from obtaining such authorsation<

(c) supplies medicinal products to persons who are

themselves in possession of the wholesale distribution licence

or who are otherwise authorised or entitled to supply medicinal

products to the public<

(d) has an emergency plan which ensures effective

implementation of any recall of medicinal products from the

market as ordered by the Authority or carried out in co-operation

with the manufacturer or marketing authorization holder for the

medicinal product concerned<

(e) keeps records available for inspection by the

Authority, for a period of five years of any transaction in

medicinal products received or dispatched containing the

following information>

(i) date,

(ii) name and pharmaceutical form of the medicinal

product,

(iii)

quantity received or supplied,

(iv) name and address of the supplier or consignee,

as appropriate<

(f) complies with the principles and guidelines of good

distribution practice for medicinal products as published by the

Commission.

It shall be the duty of the wholesale dealer, when supplying Duty of wholesale

medicinal products to a person authorised or entitled to supply them dealer.

to the public, to enclose a document thereby making it possible to

ascertain the date, name of the medicinal product, quantity supplied

and the name and address of the supplier or consignee.

It shall be the duty of the responsible person to>

(a)

ensure that the licence conditions are adhered to<

(b) ensure that the conditions for storage of medicinal

products is in accordance with the requirements of the marketing

authorisation and labelling<

(c)

monitor all areas used for storage and distribution <

(d)

maintain records as required by these regulations.

(e) ensure that a quality system is maintained by the

licensee in accordance with good distribution practice.

The qualified person shall be responsible to ensure that>

(a) each production batch of medicinal products coming

from countries which are not Member States has, on importation,

undergone a full qualitative analysis of at least all the active

constituents and all the other tests or checks necessary to ensure

that the quality of the medicinal products is 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<

(b) in the case of imported medicinal products, the

qualified person need not carry out the controls above

mentioned, 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 which are 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.

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

register and document that each production batch satisfies the

provisions of these regulations.

(b) 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