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ProjTitle.icon P.II.B.2 Management and reporting of adverse reactions.

P.II.B.2.2 Follow-up of reports  ​

​Reports where the embryo or foetus may have been exposed to (a) medicinal product(s) (either through maternal exposure and/or if the suspected medicinal product was taken by the father), should be complete. If necessary cases with incomplete information should be followed-up to obtain detailed information for comprehensive scientific evaluation of the cases. The reported source should submit additional follow up form include new relevant information. The reported source should not repeat information already provided in the initial report. Appendix 1 lists information that could be collected.​

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