H-1051 Budapest, Zrínyi u. 3.

Tel.: (1) 8869-300, E-mail: ogyei@ogyei.gov.hu

Mail: 1372 P.O. Box: 450.

MAGYAR

Pharmacovigilance Inspection

Pharmacovigilance is the group of activities with the aim of the safe use of medicines. These include recognizing and reporting the side effects of a medicine, collecting and analysing them and preventing them with different arrangements. Doctors, pharmacists and other health professionals, furthermore manufacturers of medicinal products and distributors also take part in these activities.
The National Institute of Pharmacy supervises whether the Marketing Authorisation Holder satisfies the requirements prescribed by laws and directives concerning following the safety of authorised medicinal products with attention.

The inspector proceeds on behalf of the competent authority and is in possession of a certificate authorising to act so. Deficiencies and the deadline for the response is sent in a detailed report by the inspector in 30 days after the inspection.

Types of pharmacovigilance inspections:

Regular inspection

Inspections are generally carried out at regular intervals, stated well in advance. The Marketing Authorisation Holder (or the sponsor in case of a clinical trial) is notified beforehand by the inspector about the inspection.

Exceptional inspection

Exceptional inspection is necessary when safety concerns have arisen. E.g. in case of a suspicion that the requirements prescribed by laws and directives concerning following the safety of authorised medicinal products with attention are infringed by the Marketing Authorisation Holder.
Last updated: 2018.09.30 12:22