Inclusion of information as regard the medicinal product status under additional monitoring
Instructions to marketing authorisation holders on inclusion of information as regard the medicinal product status under additional monitoring
Following to enquiries from marketing authorisation holders, HALMED is publishing instructions regarding the inclusion of information as regard the medicinal product status under additional monitoring in promotional material intended to healthcare professionals and patients.
In the existing legislation there are no special requirements for indicating information on the medicinal product status under additional monitoring in promotional material intended to healthcare professionals and patients. HALMED therefore, recommends to healthcare professionals to follow the instructions indicated in the Guideline on good pharmacovigilance practice (GVP) Module X - Additional monitoring. This guideline requires the marketing authorisation holder to include the information on the medicinal product status under additional monitoring in all promotional material intended to healthcare professionals and patients and to make any effort to encourage in collaboration with the Agency the adverse reaction reporting. Therefore it is recommended to include a standardised text of the information on medicinal product status under additional monitoring in the promotional material.
HALMED recommends the inclusion of the following text in promotional material intended to healthcare professionals:
"
This medicinal product is under additional monitoring. This enables rapid identification of new safety information. Healthcare professionals are required to report every suspected adverse reaction to this medicine. Instructions for reporting are available at www.halmed.hr."
HALMED recommends the inclusion of the following text in promotional material intended to patients and wider public:
"This medicinal product is under additional monitoring. This enables rapid identification of new safety information. You may also help by reporting all suspected adverse reactions. Instructions for reporting are available at www.halmed.hr."
