§ Mr. Ashleyasked the Secretary of State for Social Services (1) whether, when a pharmaceutical company that has reformulated its product applies for (a) variation of the current licence and (b) a new licence, the company is required to submit new animal studies; and whether this requirement varies according to whether or not the studies submitted with the original application conform to the guidelines laid down in the Medicines Act leaflet No. 36 issued in 1974;
(2) what criteria are used when a pharmaceutical company informs his Department that a medicinal product is to be reformulated to decide whether the company should be requested to apply for a variation of the current licence or for a new product licence.
§ Mr. Geoffrey FinsbergWhen a pharmaceutical company seeks to reformulate one of its licensed products it will decide on the nature of the application and of the supporting data which will vary in each individual case. There is no automatic requirement to submit new animal studies solely because any such studies used to support the original application were undertaken prior to the issue of Medicines Act leaflet No. 36.
§ Mr. Ashleyasked the Secretary of State for Social Services for each year since 1979 what was the number of times pharmaceutical companies have reformulated their 588W individual products; in how many cases a new product licence was applied for; and in how many there was a variation of the current licence.
§ Mr. Geoffrey FinsbergDepartmental records are not kept in a way that would enable the information requested to be obtained without disproportionate expenditure.