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Medicines Act (Licences)

Volume 892: debated on Monday 12 May 1975

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asked the Secretary of State for Social Services (1) if she is satisfied with the appeal procedure under Section 22(3) of the Medicines Act 1968; and if she will consider amending the Act so that the person holding the inquiry under the appeal procedure should be a qualified member of the legal profession;(2) whether she has any plans to change the appeal procedure under the Medicines Act 1968 in light of experience; and if she will make a statement.

asked the Secretary of State for Social Services how many medicine manufacturers have had their licences to manufacture medicines withdrawn or curtailed since the passing of the Medicines Act 1968; how many of them have invoked the existing appeal procedure: and with what result.

The right to invoke the procedure for a hearing or written representations arises when the licensing authority formally notifies to the manufacturer concerned a proposal to issue an adverse decision. Information about the total number of such cases and of their outcome is not immediately available, but I will circulate it in the Official Report as soon as possible.As regards hearings the information is as follows. Since licensing began in 1971 three manufacturers have invoked the procedure, with these results after the licensing authority had considered the report of the person appointed:

  • (1) A proposal to refuse to renew a licence was implemented.
  • (2) A proposal to vary a licence so as to limit manufacturing to particular products was implemented in a modified form.
  • (3) A proposal to authorise the manufacture and assembly of a restricted range of products only was implemented.
  • In each case the manufacturer subsequently applied for further authorisations. In the first case the application has not yet been finally determined. In the others further authorisations were issued, but in one the licence so granted was later suspended on grounds of safety.