§ Mr. CousinsTo ask the Secretary of State for Health what proportion of pharmaceutical imports by value are subject to regulation by the Medicine Controls Agency; what is the number of import licences issued by the medicine control agencies; if he will publish a list of those holding such licences; and in each case what is the number of inspection visits that have been made by the agency to the warehousing and stores of those importers.
§ Mrs. Virginia BottomleyThe information is not available in the form requested. The Medicines Control Agency issues product licences for medicinal products in 403W accordance with the Medicines Act and European directives. Such a licence must be obtained before a medicinal product may be marketed in the United Kingdom. No separate licence to import is needed, nor is the value of the product a factor in licensing decisions.
Currently there are over 18,000 product licences in existence of which over 5,000 list a foreign manufacturer. In addition the MCA issues manufacturers licences and wholesale dealers licences of which there are currently 780 and 1,200 respectively. Wholesale dealers trading in medicinal products which originate from outside the EC are subject to site inspection every two years; those who trade from within the EC every five years.