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Pharmacovigilance

Pharmacovigilance is described as the continuous monitoring of the safe use of medicinal products.
In Portfarma we follow the guidelines as set out by the European Union concerning safety of medicinal products.
It covers two phases of the product cycle:

PRE – MARKETING Including:

Expedited reporting of cases during bio-equivalence studies
Liaison with authorities regarding any safety or ethical issues
SmPC, PIL on submission

POST-MARKETING Including:

Liaison for report of serious adverse reactions to the authorities
PSURs
SmPC
Communication with regulatory authorities
Risk/benefit assessment
Expert statement for license renewals
Crisis management team for license withdrawals/suspension
Risk management program
Training program for all our representatives
Contact with bio-equivalence team and safety profile review

Contact details for pharmacovigilance are:

Nína Björk Ásbjörnsdóttir, Local Safety Manager
Portfarma ehf.
Borgartuni 26
105 Reykjavík
Iceland
Telephone: (+354) 5344030
Mobile Phone: (+354) 822 0038
Fax: (+354) 5340033
Email: nina(at)portfarma.is