§ Mr. Michael Morris
To ask the Secretary of State for Health what is the difference between a suspension of a product licence and a withdrawal.
§ Mrs. Virginia Bottomley
[holding answer 21 October 1991]: Section 28 of the Medicines Act 1968 enables the Licensing Authority, which is a body of Ministers, to suspend, revoke or vary a product licence for a medicinal 600W product issued under the Act. Under schedule 2 to this Act, Licensing Authority decisions for action under section 28 will only take effect after the licence holder has exhausted the rights provided in the Act to object to the proposal. However, the Licensing Authority may, in the interests of safety, suspend a product licence with immediate effect. In these circumstances, the licence holder is precluded forthwith from selling or supplying the product. Suspensions can only initially be for a period not exceeding three months.
Section 62 of the same Act enables the Health Ministers, in the interests of safety, to make an order prohibiting the sale, supply or importation of any class or description of medicinal products. The particular circumstances of use are specified in the section.
Under the standard provisions for product licences, a licence holder may be directed to withhold a batch of a medicinal product from sale or supply if it has been found not to conform with certain licensed specifications or with the provisions of the Act or any regulations made under the Act.
The holder of a product licence may decide for commercial reasons, independent of any action by the Licensing Authority, to withdraw the product from the market. In such circumstances the licence holder notifies the Licensing Authority of its action.