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Pharmacovigilance

If you are encountering adverse reactions to our drugs, please contact us at regulatory@incomed.al.

Reporting form:

The World Health Organization defines pharmacovigilance (PV) as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.”

The goals of PV are to bolster patient safety concerning medicine use by providing a system to collect, assess, and distribute drug safety data. PV activities involve monitoring approved drugs and investigational medicinal products (IMPs) to:

  • Identify previously unknown adverse effects

  • Recognize changes in the frequency or severity of known adverse effects

  • Assess a drugs risk/benefit to determine if action is required to improve safety

  • Ensure the accuracy of information communicated to healthcare professionals and patients, and to ensure information contained in patient information leaflets (PILs) is up to date

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