| answer text |
<p>Multiple Commission on Human Medicines (CHM) meetings were held in the specified
period, so further information is required for question A. The role of CHM is to provide
the Licensing Authority with independent advice on the safety, efficacy and quality
of medicinal products. It is the role of the Licensing Authority, on behalf of Secretary
of State, to take a final decision to grant a marketing authorisation for a medicinal
product. Following this decision a Public Assessment Report (PAR), containing the
non-confidential parts of the MHRA’s assessment, is published on the MHRA website.</p><p>CHM
discuss high number of products and applications at each of their meetings. Information
withheld under Section 43 of the Freedom of Information (FOI) Act is withheld because
the information is either (1) a trade secret; (2) would likely prejudice the commercial
interests of any legal person. There is no time limit after which this information
can be released, moreover, any consideration of its release would be made by consideration
of whether the public interest in releasing outweighs any commercial harm that could
be caused by its release. More information on Section 43 of the FOI Act is available
from the Information Commissioner’s Office.</p>
|
|
