Instructions to fill the Adverse Event/Product Complaint Reporting Form

Dear Consumer/Healthcare professional,

You have been provided here with instructions to fill all the sections of the form. Apart from this, there is a ready access to
specific instructions in different sections of the form when you fill the form online. It is compulsory to fill all the information
marked with an asterix (*).

Reporter’s Details

Reporter Type *:

Enter the type of reporter.

Name/Initial of the Reporter:

Please provide your name/initials since you are reporting the event.

Mobile Number:

Enter the mobile number of the reporter.

Country *:

Enter the Reporter's country.

Email *:

Enter the Reporter’s Email ID.

Patient's Information

Name or Initials*:

Enter name or initials accurately. This is essential to facilitate identification and to locate the patient if needed.

Gender*:

Select the appropriate option of gender.

Date of Birth or Age *:

Provide the most precise information available. Enter the birth date, if known, or age in years.

Suspect Products Information
  • Please provide information on suspect Biocon Biologics products*.
  • Please provide accurate names of the suspected medicinal product (brand name and generic name), the dosage form it is available for use tablet/injection/liquid/syrup/solution etc.), and strength in mg or mg/ml or as appropriate (example 500mg or 25 mg/ml).
  • Provide accurate lot no / batch no.
  • Country where the medicinal product was purchased.
  • If accurate dates of use are not known, please provide the approximate duration of use in hours/days/weeks/months or years.
Select the type of the event

Adverse Event/Side Effect Information, Product problem, others. Enter the date and time of onset of adverse event/side effect, date and time of end of adverse event (if the adverse event is stopped). If accurate dates are not known please provide the approximate duration of the event. Country of occurrence should be added.

Event Description or product complaint description
  • If you are lodging a product complaint explain here in detail the same.
  • Indicate clearly the adverse event name or diagnosis of the event (if you are health care professional).
  • Describe the event with detailed description of what happened and a summary of all relevant clinical information *
Outcome of the event
  • Check the appropriate block to indicate the outcome of the event - whether recovered completely, not recovered, recovered with sequelae or fatal and provide dates where ever they are required to be filled in the form.
  • If the information for all of the above is not available, check in the block for unknown.
  • If you consider the adverse event/side effect as serious, please select as yes; if it is a non-serious, select as No.