Temporary and transitional provisions
7
1
The requirements imposed by these regulations shall not apply until 1st January 1982 to a contact lens substance when it is sold or supplied by, or so long as it is in the possession of, a person who, on 1st January 1980, is exempt—
a
by virtue of section 16(2) or (3) of the Act from the requirement to hold a product licence relating to that substance, or
b
by virtue of section 16(4) of the Act from the requirement to hold a manufacturer's licence relating to that substance.
2
Subject to paragraph (3), the requirements imposed by these regulations shall not apply to a contact lens substance—
a
until 1st July 1982, when it is sold or supplied by way of wholesale dealing or so long as it is in the possession of a person for the purpose of such sale or supply, and
b
until 1st January 1983, when it is sold by retail or supplied in circumstances corresponding to retail sale or so long as it is in the possession of a person for the purpose of such sale or supply.
3
The provisions of paragraph (2) shall not apply to a contact lens substance when it is sold or supplied by, or so long as it is in the possession of, a person who—
a
has manufactured or assembled it, or
b
in the case of an imported contact lens substance, has imported it or procured its importation, or
c
in the case of a contact lens substance which has not been imported, is responsible for its composition.
4
For the purposes of paragraph (3)(c) the responsibility of a person for the composition of a contact lens substance shall be determined by the application of section 7(6) of the Act to that substance as though it were a medicinal product the responsibility for the composition of which was being determined for the purposes of section 7(5) of the Act.