The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005

4.—(1) Section 24 of the Act (duration and renewal of licence)(1) is amended as follows.

(2) For subsection (1), substitute—

“(1) A licence granted under this Part expires—

(a) in accordance with the provisions of the licence, or

(b) if there is no such provision, at the end of the period of five years beginning with the date on which the licence was granted, or if it has been renewed the date on which it was last renewed.

(1AA) But so far as the licence relates to a medicinal product to which the 2001 Directive applies, it remains in force until—

(a) revoked by the licensing authority; or

(b) surrendered by the holder.”.

(3) After subsection (2), insert—

“(2A) Subsection (2) does not apply to a licence insofar as it relates to a medicinal product to which the 2001 Directive applies.”.

(4) After subsection (3) insert—

“(3A) References to a licence in subsection (3) are to be read as references to a licence only insofar as that licence relates to a medicinal product to which the 2001 Directive does not apply.”.

(5) After subsection (5), insert—

“(5A) Subsection (5) does not apply to a licence insofar as it relates to a medicinal product to which the 2001 Directive applies.”.

(1)

Section 24 was amended by S.I. 1977/1050, 1994/276, 2002/236 and 2005/1094.