Article 3 Temporary provisions

(1)

Notwithstanding the provisions of paragraphs (2)(c)(ii) and (3) of Article 2 of the principal order, as amended by this order, during the periods set out in paragraph (2) below, the exemption conferred by Article 2(1) of the principal order shall apply to a medicinal product to which the said paragraphs (2)(c)(ii) or (3) apply, if—

(a)

that product was effectively on the market in the United Kingdom immediately before the date of the coming into operation of this order, and

(b)

dealings in or manufacture of that product would have been subject to the restrictions imposed by sections 7 or 8 of the Act as from that date but for the provisions of this Article.

(2)

The periods referred to in the preceding paragraph are as follows:—

(a)

the period of 28 days, or such extended period as the licensing authority may in a particular case allow, from the date of the coming into operation of this order;

(b)

the period of 3 months or such extended period as aforesaid from that date, if during the period under (a) above the licensing authority have been notified of the intention to apply for a product licence in respect of the medicinal product to which paragraph (1) above relates;

(c)

the period until the application for such product licence has been finally disposed of, if the licensing authority have been notified in accordance with (b) above and the application for such product licence is made during the period under the said sub-paragraph.

(3)

For the purposes of this Article an application shall be taken as finally disposed of on (but not before) the occurrence of whichever of the events specified in paragraphs (a) to (e) of section 27(7) of the Act last occurs.