Written question asked by Llew Smith (Labour), in the House of Commons. It was due for an answer on Friday, 21 March 1997. It was answered by Gerald Malone (Conservative) on Friday, 21 March 1997 on behalf of the Department of Health.

Dept of Health

Question: What factors led the licensing authority (a) to grant a product licence for the Pluserix MMR vaccine on 9th February 1995 and (b) to withdraw it from public use in 1997; what differences exist between the 1988 product and the 1995 product; if he will place in the Library a copy of all versions of the data sheets for each product. - Inc ref to "Association of the British Pharmaceutical Industry Data Sheet Compendium" 1989-90, 1990-91 and 1991-92 which can be obtained from the Library.

Answer: Mr. Llew Smith: To ask the Secretary of State for Health what factors led the licensing authority (a) to grant a product licence for the Pluserix MMR vaccine on 9 February 1995 and (b) to withdraw it from public use in 1997; what differences exist between the 1988 product and the 1995 product; if he will place in the Library a copy of all versions of the data sheets for each product; and if he will make a statement. [21560] Mr. Malone: Discussions between the Licensing Authority and marketing authorisation holder associated with the granting of a product licence are confidential. Pluserix measles, mumps and rubella vaccine still holds a licence. There are no significant differences between Pluserix vaccines licensed in 1988 and 1995 and copies of the data sheets are available in the "Association of the British Pharmaceutical Industry Data Sheet Compendium" 1989-90, 1990-91 and 1991-1992 which can be obtained from the Library.

Secondary information