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).
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.