Pharmacovigilance

ATC’s Role in Pharmacovigilance and Medical Device Vigilance

At ATC, patient safety and product quality are our top priorities. We are dedicated to ensuring that our pharmaceutical products and medical devices meet the highest safety standards throughout their lifecycle. Our pharmacovigilance and medical device vigilance teams actively monitor, assess, and manage potential risks to safeguard public health.

Pharmacovigilance (PV)

We are committed to the ongoing safety of our pharmaceutical products through:

• Monitoring and reporting adverse drug reactions (ADRs)
• Detecting safety signals and conducting risk assessments
• Ensuring regulatory compliance by timely reporting serious adverse events (SAEs)
• Performing continuous post-market surveillance to evaluate benefit-risk profiles
• Providing training to our staff on safety management

Medical Device Vigilance

We ensure the safety and performance of our medical devices by:

• Collecting and evaluating adverse event reports
• Taking corrective actions, including product recalls or field safety corrective actions (FSCA)
• Educating our employees on the importance of vigilance and safety reporting

Commitment to Patient Safety

Our dedication to pharmacovigilance and medical device vigilance ensures that our products remain safe, effective, and reliable. We continually monitor, assess, and improve the safety of our products to protect the health and well-being of those who rely on them.

Adverse Reaction Reporting and Product Recall

ATC is committed to prompt and efficient reporting of adverse reactions and product recalls requiring expedited reporting. All reports will be transmitted within 15 calendar days from receipt, including both initial and follow-up information.

The minimum information required for submitting an adverse reaction report includes:

• Identifiable patient
• Suspected reaction
• Identifiable reporter
• Suspected product

Serious adverse reactions will be reported as quickly as possible, and no later than 24 hours from initial receipt of information by the healthcare provider.

If you suspect an adverse reaction to any ATC product, please contact your healthcare professional. They can report the issue to ATC on your behalf. Alternatively, you can directly report the adverse reaction using our online reporting service.

How to Report Complaints or Adverse Effects

If you experience an adverse effect related to any ATC product, you can report it through the following channels:

• Informing your healthcare provider (doctor, pharmacist, or nurse), who can then notify ATC on your behalf.
• Online Reporting: Fill out and submit the ADR form available on our website.

Phone:
General Inquiries: +965 22247444
QPPV: +965 66910035

Fax: +965 24745361
Email: PV@atc.com.kw