Medicine safety

A safety signal begins with one clear report.

If you suspect an unwanted effect may be related to a medicine, please tell us. You do not need to prove that the medicine caused the reaction before reporting it.

  • Patients & caregivers
  • Healthcare professionals
  • Dedicated safety channel

Report a suspected reaction

Contact the pharmacovigilance team directly.

Please send suspected adverse-reaction reports to our dedicated safety mailbox. Do not use the general business enquiry form for information about an identifiable patient or their health.

This channel is not an emergency service.

For an urgent or life-threatening situation in Türkiye, call 112 or seek immediate medical care. In another country, contact the local emergency service. Do not delay care while preparing a report.

What to include

Four essentials help a report become assessable.

Share what you know, even when some details are unavailable. The following information helps distinguish the report and supports appropriate follow-up.

  1. 01

    A way to contact the reporter

    Your name or initials, contact details and relationship to the patient. This allows the report to be verified and followed up when necessary.

  2. 02

    A distinguishable patient

    Initials, age or age group, and sex or gender if known are usually sufficient. Do not send a national identity number.

  3. 03

    The suspected medicine

    Product name, strength and form, why it was used, dose and dates if known. Add the batch number only when it is readily available.

  4. 04

    The suspected reaction

    Describe what happened, when it began, what action was taken and the current outcome. Mention relevant medicines or medical context when known.

Who may report

A report can come from the person closest to the event.

Suspected reactions may be reported directly by patients and caregivers as well as by healthcare professionals. Reporting a suspicion does not establish that a medicine caused the event.

01

Patients

You may report an experience involving yourself. Use the minimum patient details needed to distinguish the case.

02

Family members & caregivers

You may report on behalf of someone you support and explain your relationship to that person.

03

Healthcare professionals

Share the clinical course and relevant medicine information available to you. Certainty about causality is not required for an initial report.

After the first message

Clear follow-up supports a usable safety record.

A short initial report is valuable. Further questions may be needed to complete or clarify the four essential elements.

01

Clarification

The safety team may ask for missing product, patient, event or reporter details relevant to the case.

02

Safety assessment

A report records a suspicion for pharmacovigilance assessment; it is not, by itself, proof of a causal relationship.

03

No medical advice

The reporting channel does not replace a doctor, pharmacist or emergency service and cannot provide patient-specific treatment advice.

Share only information that is relevant to the safety report.

Safety reports may contain sensitive health information. Avoid sending national identity numbers, unrelated medical records or unnecessary documents. Include contact information because follow-up may be required, and use the dedicated pharmacovigilance mailbox rather than the general enquiry form.

National reporting

You may also report through Türkiye’s official channel.

Patients, caregivers and healthcare professionals can consult the current official guidance for reporting suspected adverse reactions to the Turkish Pharmacovigilance Center (TÜFAM).

View official Türkiye guidance
Regulatory reference

The content framework follows the four minimum case elements described in EMA Good Pharmacovigilance Practices Module VI. Public wording remains subject to Turkistan Pharma’s medical, regulatory and privacy review before launch.

EMA GVP Module VI