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Adalan LLP has created and maintains a system that guarantees the collection of information on all suspected adverse reactions (which are reported to company personnel and/or medical representatives), and the timely transmission of the received information to all interested participants, as well as providing feedback, both from registration holders certificates and from authorized bodies.

Only individual reports of adverse reactions that have positive validation results are subject to urgent reporting. As a result, all reports of adverse drug reactions should be validated to ensure that they have the minimum required information before they are submitted to regulatory authorities.

The minimum information required includes:
a) identifiable reporter (primary source) –
a reporter is considered identifiable if the following data is available:
- Full name/initials, address or qualification (doctor, pharmacist, pharmacist, other healthcare professional or patient/consumer, patient/consumer representative);
- contact details to enable confirmation of the report or follow-up if necessary;

b) identifiable patient –
the patient can be identified if the following data is available:
- patient’s full name/initials;
- patient identification number;
- Date of Birth;
- age or age group;
- floor;

c) one suspected drug (at least);
d) one suspected adverse reaction (at least).