Paragraph 22 Content of the risk management planF1

an identification or characterisation of the safety profile of the medicinal product concerned;

an indication of how to characterise further the safety profile of the medicinal product(s) concerned;

a documentation of measures to prevent or minimise the risks associated with the medicinal product, including an assessment of the effectiveness of those measures; and

a documentation of post-authorisation obligations that have been imposed as a condition of the UKMA(GB) F2or the UKMA(UK)(Category 1).

contain the same active substance; and

belong to the same holder.

it must indicate whether those studies are initiated, managed or financed by the holder voluntarily, or pursuant to obligations imposed by the licensing authority or an equivalent authority to the licensing authority in another country; and

all post-authorisation obligations must be listed in the summary of the risk management plan referred to in paragraph 23, together with a timeframe for meeting those obligations.