§ Paul FlynnTo ask the Secretary of State for Health if he will give the Medicines and Healthcare Products Regulatory Agency powers to require pharmaceutical companies to provide all available data and reports on products submitted for licensing. [132316]
§ Miss Melanie JohnsonThe Medicines and Healthcare Products Regulatory Agency (MHRA), already has the necessary powers to require pharmaceutical companies to provide all available data and reports when submitting an application for product licensing.
The Medicines for Human Use (Marketing Authorisation Etc.) Regulations 1994 require companies to make applications in accordance with the relevant European Community legislation, including Directive 2001/83/EC on the Community code relating to medicinal products for human use. All information which is relevant to the evaluation of the medicinal product concerned must be included in the application, whether favourable or unfavourable to the product.