Written question asked by Eric Ollerenshaw (Conservative) on Wednesday, 19 January 2011, in the House of Commons. It was due for an answer on Friday, 21 January 2011. It was answered by Simon Burns (Conservative) on Wednesday, 26 January 2011 on behalf of the Department of Health.

Lorazepam

Question: To ask the Secretary of State for Health pursuant to the answer of 21 December 2010, Official Report, columns 1265-8W, on benzodiazepines, what is meant by the term not confirmed which was given as the legislative basis for 17 generic lorazepam licenses.

Answer: The Medicines and Healthcare products Regulatory Agency holds data on medicinal products on an electronic database. The database is searchable and can be used to bring back information such as the legal basis of an application as requested in relation to the lorazepam products. Historically, the legal basis of an application has not been recorded in a searchable form and thereafter this has been established by manually reviewing available records.Where the precise legal basis has not been confirmed from the manual search that has been shown as 'not confirmed'. However, the reply of 21 December 2010, Official Report, columns 1265-8W, was clear in explaining that the applications would have been made under article 4.8a (of directive 65/65/EEC) which made provision for an abridged application, that is, an application made without supplying results of toxicological tests and clinical trials.

Secondary information

Type: Written question
Reference: 35855; 522 c374W
Session: 2010-12
Related items: Benzodiazepines
Tuesday, 21 December 2010
Written questions
House of Commons
Subjects: Lorazepam
Link: View this Written question on www.publications.parliament.uk