Active Substances (Amendment) Regulations, 2013

L.N. 350 of 2013

MEDICINES ACT

(CAP. 458)

Wholesale Distribution and Brokering of Medicinal Products and

Active Substances (Amendment) Regulations, 2013

IN exercise of the powers conferred by article 106 of the

Medicines Act, the Minister for Health, after consultation with the

Licensing Authority, has made the following regulations:-

(1) The title of these regulations is the Wholesale Citation and

Distribution and Brokering of Medicinal Products and Active scope.

Substances (Amendment) Regulations, 2013 and these regulations

shall be read and construed as one with the Wholesale Distribution S.L.458.37

and Brokering of Medicinal Products and Active Substances

Regulations, hereinafter referred to as "the principal regulations".

(2) The scope of these regulations is to transpose Article 85a

of Directive 2001/83/EC, as the said Article has been amended by

Directive 2012/26/EU of the European Parliament and of the Council

of 25 October 2012 amending Directive 2001/83/EC as regards

pharmacovigilance.

(3) These regulations shall be deemed to have come into force

on the 28th October, 2013.

Sub-regulation (2) of regulation 8 of the principal Amends

regulation 8 of

regulations shall be amended as follows

the principal

regulations.

(a)

for the proviso to paragraph (b) thereof, there shall

be substituted the following

"Provided that the requirements of this paragraph

shall not apply where a medicinal product is directly

received from a third country but not imported, that is to

say, not to be placed on any Member State market.

However, in that case wholesale distributors shall ensure

that the medicinal products are obtained only from persons

who are authorised or entitled to supply medicinal

products in accordance with the applicable legal and

administrative provisions of the third country concerned.

The wholesale distributor should also exercise all

necessary caution and precautions in order to ensure that

these medicinal products not intended to be imported,

remain in quarantine and do not in any way end up on any

Member State market;"; and

(b)

for the proviso to paragraph (c) thereof, there shall

be substituted the following

"Provided that in the case of distribution of

medicinal products to third countries this shall not apply.

However, when wholesale distributors supply medicinal

products to persons in third countries, they shall ensure

that such supplies are only made to persons who are

authorised or entitled to receive medicinal products for

wholesale distribution or supply to the public in

accordance with the applicable legal and administrative

provisions of the third country concerned;".

€0.18