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Medicines Act 1968

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44 Provision of information to licensing authority. E+W+S+N.I.

(1)Where an application has been made to the licensing authority for a licence under this Part of this Act (including a licence of right) or for a clinical trial certificate or animal test certificate (including a certificate to which a person is entitled by virtue of section 37(4) of this Act) the licensing authority, before determining the application, may request the applicant to furnish to the licensing authority such information relating to the application as the licensing authority may consider requisite; and, where any such request has been made, the licensing authority shall not be required to determine the application until either—

(a)the information requested has been furnished to them, or

(b)it has been shown to their reasonable satisfaction that the applicant is unable to furnish the information.

(2)The licensing authority may serve on the holder of a licence under this Part of this Act, or of a clinical trial certificate or animal test certificate, a notice requiring him, within such time as may be specified in the notice, to furnish to the licensing authority information of any description specified in the notice in accordance with the following provisions of this section.

(3)Except as provided by subsection (4) of this section, a notice under subsection (2) of this section shall not be served unless it appears to the licensing authority, or it is represented to them by the Commission or by the appropriate committee, that circumstances exist by reason of which it is necessary to consider whether the licence or certificate should be varied, suspended or revoked; and the information required by such a notice shall be such as appears to the licensing authority, or is represented to them by the Commission or by the committee, to be requisite for considering that question.

(4)Subsection (3) of this section shall not have effect in the case of a licence of right, or of a certificate issued in pursuance of section 37(4) of this Act, whether the licence or certificate has been renewed or not; and, in the case of such a licence or certificate, a notice under this section may be served at any time and may require any information which, in the opinion of the licensing authority, would be relevant if—

(a)sections 25 and 37(4) of this Act had not been enacted, and

(b)the licensing authority were then dealing with an application, by the person who is the holder of the licence or certificate, for the grant or issue of a licence or certificate containing the same provisions as those contained in the licence or certificate in question.

(5)Before the end of the period of two years from the date on which a product licence, other than a licence of right, is granted, the holder of the licence shall, in respect of each description of medicinal products to which the licence relates which is effectively on the market in the United Kingdom within that period, notify to the licensing authority a date on which medicinal products of that description were effectively on that market.

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Modifications etc. (not altering text)

C1Pt. II(ss. 6–50) extended with modifications by S.I. 1985/1403, art. 3(1)

C2S. 44 extended (with modifications) (14.2.1994) by S.I. 1994/105, reg. 19, Sch.4

C3S. 44(1)(2)(3) applied (with modifications) (3.4.1992) by S.I. 1992/605, reg. 2(1)(2),Sch.

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