Citation, interpretation and commencement

1. This order, which may be cited as the Medicines (Importation of Medicinal Products for Re-exportation) Amendment Order 1977, shall be read as one with the Medicines (Importation of Medicinal Products for Re-exportation) Order 1971(2) (hereinafter referred to as "the principal order") and shall come into operation on 5th May, 1977.

Amendment of article 3 of the principal order

2.-(1) 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.

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

(3) 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.".

(4) 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.".

Amendment of the Schedule to the principal order

3. In Part I of the Schedule to the principal order, for paragraphs 2 and 3 there shall be substituted the following two paragraphs:-

"2. Articles and substances to which any of the following orders apply, that is to say:-

• The Medicines (Control of Substances for Manufacture) Order 1971(3);

• The Medicines (Surgical Materials) Order 1971(4);

• The Medicines (Dental Filling Substances) Order 1975(5); and

• The Medicines (Specified Articles and Substances) Order 1976(6).

3. Articles and substances to which any order made under sections 104 or 105 of the Act subsequent to the coming into force of this order applies, being an order by virtue of which the provisions of sections 7(3) and 13(2) and (3) have effect in relation to such articles and substances as those provisions have effect in relation to medicinal products within the meaning of the Act.".

EXPLANATORY NOTE

This Order amends the Medicines (Importation of Medicinal Products for Re-exportation) Order 1971 by adding to the cases to which the exemption (conferred by the Order of 1971) from the requirement to hold a product licence applies.

The cases so added are cases where the medicinal products, articles and substances referred to in Part I of the Schedule to the Order of 1971, being imported for re-export in the form in which they were imported, are assembled in a way different from the way in which they were assembled on being imported. The exemption applies only if certain specified conditions are satisfied. Part I of the Schedule is amended so as to include in the exemption articles and substances to which sections 7(3) and 13(2) and (3) of the Medicines Act 1968 have been or will be applied by orders made under sections 104 or 105 of that Act.