xmlns:atom="http://www.w3.org/2005/Atom" xmlns:atom="http://www.w3.org/2005/Atom"
13. The risk management plan, together with a summary, that—U.K.
(a)describes the risk management system which the applicant will introduce for the medicinal product concerned; and
(b)shall be proportionate to the identified risks and the potential risks of the medicinal product, and the need for post-authorisation safety data.