Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

The aims of PV are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programs by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.

  • As a pharmaceutical company, our primary obligation is to ensure our products are as safe as possible for the patients who use them. We gather comprehensive information about our product’s safety so that we can take proactive measures to minimize risks to our patients.
  • Through our robust commitment to pharmacovigilance, we ensure we remain focused on patient’s safety. Our Pharmacovigilance Department manages a pharmacovigilance system for the collection, collation, and evaluation of adverse events and the implementation of effective corrective and preventive actions.
  • KSPICO is responsible for reporting suspected medicines adverse reactions to health authorities of each country which are received from Health Care Professionals (HCP)
  • All spontaneous adverse events of marketed products are collected via phone, email, fax or post.
  • KSPICO will transmit all Individual Case Safety Reports (ICSRs) requiring expedited reporting promptly and no later than 15 calendar days from receipt. This applies to initial and follow-up information
  • The minimum information required for the submission of an adverse reaction report are the following:
    1 - An identifiable patient
    2 - A suspected reaction
    3 - An identifiable reporter
    4 - Suspected drug
  • Expedited reporting of serious adverse reaction will be reported as soon as possible, but in no case later than 24 hours of initial receipt of information by the healthcare provider.
  • If you have suspected adverse reaction to any of KSPICo’ s medicine, you may need to contact your healthcare professional They can report the issue to KSPICo on your behalf or you can directly report an adverse reaction resulting from using any KSPICo product through online reporting service
How Can I raise my complaints or adverse effects?

You can report a suspected side effect in a different ways:

  • Informing doctor, pharmacist or nurse who can then notify KSPICO
    Using our online form, please check below Email OR You can fill the below ADR form and submit it.
  • Phone or fax:
    KWT hotline (24/7): +965 - 2207 2416
    KSA hotline (24/7): +966 - 55 106 7994
    Fax +965 - 24745361
  • Emailing and write details of the patient affected (age, pregnancy, other medicines...) and the side effect

KSPICO pharmacovigilance experts will evaluate the data and process as per the Regulatory guidelines.

ADR Form