Parallel Importation of Medicinal Products

L.N. 291 of 2014

MEDICINES ACT

(CAP. 458)

Parallel Importation of Medicinal Products

(Amendment) Regulations, 2014

IN exercise of the powers conferred by article 106 of the

Medicines Act, the Minister for Social Dialogue, Consumer Affairs

and Civil Liberties and the Parliamentary Secretary for Health have

made the following regulations:-

The title of these regulations is the Parallel Importation of

Medicinal Products (Amendment) Regulations, 2014, and these

regulations shall be read and construed as one with the Parallel

Importation of Medicinal Products Regulations, hereinafter referred

to as "the principal regulations".

In regulation 2 of the principal regulations, the definition

"Maltese-market product" shall be substituted by the following

" "Maltese-market product" means the medicinal product

for which a marketing authorisation has been granted in Malta,

with which the parallel imported medicinal product is

compared;".

Paragraph (a) of sub-regulation (2) of regulation 3 of the

principal regulations shall be substituted by the following

"(a) a wholesale dealer’s licence in

accordance with the provisions of the

Wholesale Distribution and Brokering of

Medicinal Products and Active Substances

Regulations, and".

Sub-regulation (1) of regulation 4 of the principal

regulations shall be substituted by the following

"(1)

Any application for the granting of a parallel

import licence shall be made to the Licensing Authority and

shall contain such information, documents and any other

material in accordance with the provisions of this regulation.".

Paragraph (a) of sub-regulation (1) of regulation 5 of the

principal regulations shall be substituted by the following

"(a)

Maltese-market product shall have a valid

marketing authorisation in Malta when the application for a

parallel import licence is received;".

Regulation 7 of the principal regulations shall be amended Amends

regulation 7 of

as follows

the principal

regulations.

(a)

paragraph (c) thereof shall be substituted by the

following

"(c) provide a written declaration stating that the

marketing authorisation holder of the original product

marketed in Malta has been notified about the product

being put on sale in Malta, one month prior to submitting

the application to the Licensing Authority;";

(b)

paragraph (d) thereof shall be substituted by the

following

"(d) submit, in the case of repackaging of a

medicinal product, a sample of the proposed repackaged

product to the marketing authorisation holder of the

original product marketed in Malta;"; and

(c)

immediately after paragraph (d) thereof there shall

be added the following new paragraphs

"(e) submit to the Licensing Authority a copy of

the declaration sent to the marketing authorisation holder

referred to in paragraph (c) and, in the case of re-packaging

of a medicinal product, a specimen of the proposed re-

packaged product together with the application for a

parallel import licence;

(f) ensure that the parallel import licence number

assigned by the Licensing Authority is present on the outer

packaging of the medicinal products.".

Immediately after regulation 8 of the principal regulations, Adds new

regulation to the

there shall be added the following new regulation

principal

regulations.

" Pharmaco-

The parallel importer shall have in place

vigilance

a system for handling of pharmacovigilance issues

issues.

including

(a)

a system for identifying and

reporting adverse reactions;

(b)

a system for safety recalls; and

(c)

a system for the implementation

of risk management plans (RMP) and direct

healthcare

professional

communication

letters (DHPC).".

€0.27