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20. If the product is already authorised in other countries—
(a)information in respect of adverse drug reactions to the product and products containing the same active ingredient (in relation to the usage rates if possible) and information from worldwide studies relevant to the safety of the product;
(b)in the case of vaccines, information on the monitoring of vaccinated subjects to evaluate the prevalence of the disease in question as compared to non-vaccinated subjects, when such information is available; and
(c)for allergen products, details of response in periods of increased antigen exposure.
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