Part II Licences and Certificates Relating to Medicinal Products
Licences of right
27 Proceedings on application for licence of right. C1
1
Sections 19 to F122A of this Act shall not have effect in relation to any application for a licence of right.
2
If on any such application the licensing authority—
a
propose to refuse to grant a licence on that application, on the grounds that none of the provisions of subsections (2) to (5) of section 16 of this Act has been proved to have effect in relation to the applicant, or
b
propose to grant a licence which will not extend to some of the matters specified in the application.
the licensing authority shall, before the end of the period of three months from the date on which the application is received by them, serve on the applicant a notice stating their proposals and the reasons for them and, in a case falling within paragraph (b) of this subsection, the matters specified in the application to which it is proposed that the licence should not extend.
3
If, within the time allowed after the service of a notice under subsection (2) of this section, the applicant gives notice to the licensing authority of his desire to be heard under this subsection or makes representations in writing to the licensing authority with respect to their proposals, then, before determining the application, the licensing authority shall afford to him an opportunity of appearing before, and being heard by, a person appointed for the purpose by the licensing authority, or shall take those representations into account, as the case may be.
4
Where the applicant avails himself of the opportunity afforded to him in pursuance of subsection (3) of this section or makes representations in writing as mentioned in that subsection, then if—
a
the licensing authority refuse to grant a licence on the application, or
b
grant a licence otherwise than in accordance with the application, and the applicant requests the licensing authority to state their reasons.
the licensing authority shall serve on the applicant a notice stating the reasons for their decision.
C25
If, in a case where the licensing authority have served a notice under subsection (2) of this section, the application is not finally disposed of before the date which, in relation to any matters specified in the application, is the relevant date, then on and after that date, and until the application has been finally disposed of, the provisions of this Act shall have effect in relation to those matters as if the licensing authority had granted a licence of right in accordance with the application.
C26
Where, on an application for a licence of right, the licensing authority do not serve a notice under subsection (2) of this section before the end of the period mentioned in that subsection, the licensing authority shall be required to grant a licence in accordance with sections 25 and 26 of this Act as if all the matters specified in the application had been proved; and if such a licence has not been granted before the date which, in relation to any of those matters, is the relevant date, the provisions of this Act shall have effect on and after that date in relation to those matters as if the licensing authority had granted a licence of right in accordance with the application.
7
For the purposes of this section the relevant date, in relation to any matters specified in an application, is the date on which, in accordance with one or more orders made under section 17 of this Act, that subsection of section 16 of this Act which has effect in relation to those matters ceases to have effect in relation to them; and an application shall for the purposes of this section be taken to be finally disposed of on (but not before) the occurrence of whichever of the following events last occurs, that is to say—
a
the licensing authority make a decision determining the application;
b
the time within which an application under section 107 of this Act with respect to that decision can be made expires without its having been made;
c
if such an application under section 107 of this Act is made, the proceedings on the application under that section are finally determined or abandoned or otherwise disposed of;
d
if there is an appeal against the decision in any such proceedings as are mentioned in paragraph (c) of this subsection, or an appeal against the decision on such an appeal, the proceedings on that appeal are finally determined or abandoned or otherwise disposed of;
e
the time for bringing any such appeal as is mentioned in paragraph (d) of this subsection expires without its having been brought.
F28
Subsections (2), (8) and (10)(b) of section 22A of this Act shall have effect in relation to a person appointed under subsection (3) of this section and to proceedings before him and his report as they have effect for the purposes of that section.