PART IIIFurther Provisions relating to Dealings with Medicinal Products

Additional provisions

60Restricted sale, supply and administration of certain medicinal products

1

Subject to the following provisions of this section, regulations made by the appropriate Ministers may provide that no person shall sell by retail, or supply in circumstances corresponding to retail sale, a medicinal product of a description specified in the regulations, or falling within a class so specified, unless—

a

he is a practitioner holding a certificate issued for the purposes of this section by the appropriate Ministers in respect of medicinal products of that description or falling within that class, or a person acting in accordance with the directions of such a practitioner, and the product is so sold or supplied for the purpose of being administered in accordance with the directions of that practitioner, or

b

he is a person lawfully conducting a retail pharmacy business and the product is so sold or supplied in accordance with a prescription given by such a practitioner.

2

Any regulations made under this section may provide that no person shall administer (otherwise than to himself) a medicinal product of a description specified in the regulations, or falling within a class so specified, unless he is such a practitioner as is mentioned in subsection (1)(a) of this section or a person acting in accordance with the directions of such a practitioner.

3

The powers conferred by the preceding subsections shall not be exercisable in respect of medicinal products of a particular description, or falling within a particular class, except where it appears to the appropriate Ministers that the sale by retail, or supply in circumstances corresponding to retail sale, or the administration, of such products requires specialised knowledge on the part of the practitioner by whom or under whose directions they are sold, supplied or administered.

4

Any regulations made under this section in respect of a particular description or class of medicinal products may specify the qualifications and experience which an applicant for a certificate in respect of that description or class of medicinal products must have, and may provide for the appointment of a committee to advise the appropriate Ministers, in such cases as may be prescribed by or determined in accordance with the regulations, with respect to the grant, renewal, suspension and revocation of such certificates.

5

Any such regulations shall include provision as to the grant, duration, renewal, suspension and revocation of certificates for the purposes of this section, including provision for affording—

a

to an applicant for the grant or renewal of such a certificate, where the appropriate Ministers propose to refuse to grant or renew it, and

b

to the holder of such a certificate, where the appropriate Ministers propose to suspend or revoke it,

an opportunity of appearing before, and being heard by, a person appointed for the purpose by the appropriate Ministers or of making representations in writing to those Ministers with respect to that proposal.

6

Regulations made under this section may provide that, for the purposes of paragraph (b) of subsection (1) of this section, a medicinal product shall not be taken to be sold or supplied in accordance with a prescription as mentioned in that paragraph unless such conditions as are prescribed by the regulations are fulfilled.

7

Before making any regulations under this section the appropriate Ministers shall consult the appropriate committee, or, if for the time being there is no such committee, shall consult the Commission.