For alle lægemidlers vedkommende skal produktresuméet ligeledes indeholde en standardformulering, hvormed sundhedspersoner udtrykkeligt anmodes om at indberette eventuelle formodede bivirkninger i overensstemmelse med det nationale system for spontan indberetning som omhandlet i artikel 107a, stk. 1.
For all medicinal products, a standard text shall be included expressly asking healthcare professionals to report any suspected adverse reaction in accordance with the national spontaneous reporting system referred to in Article 107a(1).