Article 2 Amendment of article 3 of the principal order

Article 3 of the principal order (removal of restriction on importation of certain medicinal products) shall be amended in accordance with the following paragraphs of this article.

In paragraph (1) for the words “paragraph (2)” there shall be substituted the words “the following provisions”.

For paragraph (2) there shall be substituted the following paragraph—

“(2)

The exemption conferred by paragraph (1) of this article shall take effect only in relation to medicinal products, articles and substances which, having been imported, are to be exported in the form in which they were imported and either—

(a)

they are not assembled in a way different from the way in which they were assembled on being imported, or

(b)

if they are assembled in a way different from the way in which they were assembled on being imported, the conditions specified in the following paragraphs of this article are satisfied.”.

After paragraph (2) there shall be added the following two paragraphs—

“(3)

The conditions referred to in sub-paragraph (b) above are—

(a)

that the person so assembling the medicinal products, articles and substances is the holder of a manufacturer's licence;

(b)

that the person to whom, but for the provisions of this order, the restrictions imposed by section 7(3) of the Act would apply, has notified the licensing authority of his intention to import the medicinal products, articles and substances and has supplied that authority with such information as to the medicinal products, articles and substances and their assembly as that authority may from time to time require; and

(c)

that the licensing authority have directed that the provisions of this article may apply to the importation of such products, articles and substances and the person referred to in sub-paragraph (b) of this paragraph has been notified in writing of that direction.

(4)

Where after a direction under sub-paragraph (c) above has been notified it appears to the licensing authority that in the interests of safety the said exemption ought not to apply and the licensing authority have so notified the person referred to in sub-paragraph (c) above in writing, the said exemption shall not apply so long as the notification under this paragraph has not been withdrawn by the licensing authority.”.