Created, through Ministerial Ordinance No. 292, within the National Pharmacovigilance System, the additional surveillance modality as an intermediate category between passive (spontaneous report) and active (intensive) pharmacovigilance, foreseen in Ordinance No. 798 of 12 December 2014.

The medicines to which the additional surveillance modality is applied will be defined by the Department of Medicines, which may include those containing a new active ingredient, biotechnological medicines and the medicines to which data related to the post authorization are required.

This condition will be provided when granting the registration of a product or its renewal. It may also be determined later, in the event that warnings arise that warrant it, after having seen the marketing authorization holders.

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