Services​

Pharmacovigilance services include:

• a local pharmacovigilance contact with 24-hour availability,
• collecting and reporting suspected adverse events and other safety information,
• maintaining the pharmacovigilance system,
• preparing and maintaining standard operating procedures (SOPs),
• communication with the competent authority and our partners,
• reviewing nationally prescribed literature,
• monitoring of local legislation and HA website,
• preparation of applications for review of educational material (under the RMP) and preparation of DHPCs.

As part of our medical device vigilance services, we provide:

• local contact with 24-hour standby,
• communication with the competent authority (reporting to the competent authority about incidents with medical devices)
• informing customers in case of field safety notices and incidents with medical devices.