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

Reports, where the embryo or fetus may have been exposed to medicinal products (either through maternal exposure or transmission of a medicinal product via semen following paternal exposure), should be followed-up in order to collect information on the outcome of the pregnancy and development of the child after birth. When an active substance (or one of its metabolites) has a long half-life, this should be considered when assessing the possibility of exposure of the embryo, if the medicinal product was taken before conception.

Not infrequently, pregnant women or healthcare professionals will contact MAHs to request information on the teratogenicity of a medicinal product and/or experience of use during pregnancy. Reasonable attempts should be made to obtain information on any possible medicinal product exposure to an embryo or fetus and to follow-up on the outcome of the pregnancy.

Reports of exposure to medicinal products during pregnancy should contain as many detailed elements as possible in order to assess the causal relationships between any reported adverse events and the exposure to the suspected medicinal product. In this context the use of standard structured questionnaires is recommended.

Individual cases with an abnormal outcome associated with a medicinal product following exposure during pregnancy are classified as serious reports and should be reported, in accordance with the requirements outlined in VI.B.7.

This especially refers to:

• Reports of congenital anomalies or developmental delay, in the fetus or the child;

• Reports of fetal death and spontaneous abortion; and

• Reports of suspected adverse reactions in the neonate that are classified as serious.

Other cases, such as reports of induced termination of pregnancy without information on congenital malformation, reports of pregnancy exposure without outcome data or reports which have a normal outcome, should not be reported since there is no suspected adverse reaction. These reports should however be collected and ​discussed in the PSUR/PBRERs (See Module VII).

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