Product Licensing (Hansard, 1 July 1993)

§ Mr. David Nicholson
To ask the Secretary of State for Health in what circumstances an appeal in respect of a product licensing decision may be held before a panel of persons appointed; and on what grounds a licensing authority may reasonably reject the findings of that panel.

§ Mr. Sackville
A product licence holder or an applicant for a product licence, may be heard by a person appointed for the purpose if, after consulting the appropriate Medicines Act committee or the Medicines Commission, the licensing authority proposes to give a decision which is at variance with the advice received.
Licence holders and applicants may also be heard by a person appointed where the licensing authority proposes, on grounds not relating to safety, quality or efficacy, to suspend, revoke or vary an existing product licence or refuse to grant a new product licence, or propose to grant a new licence otherwise than in accordance with the application.
The licensing authority takes into account the report of the person appointed but is not bound to accept the report's findings.

§ Mr. David Nicholson
To ask the Secretary of State for Health if she will give details of the appeal procedures under the Medicines Act 1968 that are available to pharmaceutical companies whose product licences may be suspended or revoked by the United Kingdom Licensing Authority.

§ Mr. Sackville
The procedures are laid down in schedule 2 to the Medicines Act. In summary, they provide for a product licence holder to be heard by, or make written representations to, the appropriate committee. If the committee's findings and advice are adverse to the licence holder, he may be heard by, or make written representations to the Medicines Commission. There is also provision for the matter to heard by a person appointed for the purpose.
When the licensing authority has reached a decision following these procedures, section 107 of the Medicines Act provides that its validity may not be questioned in any legal proceedings, except that it may be challenged in the High Court on the grounds that the decision is not within the powers of the Act, or that relevant requirements of the Act or regulations made under the Act, have not been complied with.