Importation and Wholesale Distribution of Medicinal Products

L.N. 378 of 2004

MEDICINES ACT, 2003

(ACT NO. III OF 2003)

Importation and Wholesale Distribution of Medicinal Products

(Amendment) 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>–

The title of these regulations is the Importation and Wholesale Title.

Distribution of Medicinal Products (Amendment) Regulations, 2004

and they shall be read and construed as one with the Importation and

Wholesale Distribution of Medicinal Products Regulations, 2004 L.N. 154 of 2004.

hereinafter referred to as “the principal regulations”.

In regulation 2 of the principal regulations, after the definition Amends regulation

“imported medicinal products” there shall be inserted the following> 2 regulations.

“ “medicinal product” means a medicinal product in respect

of which a marketing authorization has been issued by the

competent authority of a Member State or pursuant to Regulation

(EC) No 726#2004<”.

(1) The present whole regulation 7 of the principal Amends regulation

7 of the principal

regulations shall be renumbered as sub- regulation (1) thereof.

regulations.

(2) Immediately after sub-regulation (1) as renumbered,

there shall be inserted the following>-

“(2) Every wholesale dealer shall ensure that an appropriate

and continuous supply of medicinal products is furnished to

pharmacies and persons authorized to supply medicinal products

in order to satisfy the needs of patients.”

(3) In addition, the wholesale dealer shall, in respect of

each product he is distributing, furnish to the Authority an authenticated

copy of a valid marketing authorization in Malta, together with a letter

of access, both issued by the marketing authorization holder, granting

the wholesale dealer the right of use of such marketing authorization>

Provided that a wholesale dealer may only engage in the

wholesale distribution of medicinal products in respect of which

no such authenticated copy of a valid marketing authorization in

Malta and letter of access have been forwarded to the Authority, if

he is in possession of a parallel import licence issued in terms of

the law in force at the time.”.

Immediately after regulation 10 of the principal regulations

there shall be inserted the following new regulation 11>

It shall be the duty of any distributor, not being the

“Duty of any

marketing

authorization holder, who imports a product from

not being the

another Member State to notify the marketing authorization

authorization

holder and the Authority of his intention to import such

product. In the case of products which have not been granted

an authorization in terms of Regulation (EC) No726#2004,

the notification to the Authority shall be without prejudice to

additional procedures provided for by the law in force at the

time.”.

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