This form is to allow a rapid initial report to be made. It is not the primary ADR document. Our Pharmacovigilance Department will review all submitted data and make direct contact with you to gather more information on the suspected ADR if required.

Reports can only be accepted for consideration if the following items are included:

  • An identifier which can be used to uniquely identify a single patient to the reporter
  • Clear details of the reporter with contact email
  • Details of the suspected reaction
  • The name of the medicinal product administered.

The form cannot be submitted without all of the above information being included. Any additional information that can be provided at this stage is useful, but lack of full information should not delay the initial report being made.

It is the reporter's responsibility to obtain the patient's authority if disclosing non-anonymised details. Any information provided will be used by the Alinter Group exclusively for the purposes of ADR monitoring. This may include sharing the information with national regulatory authorities in the UK, EEA and third countries.

Submission of this form implies consent to the above.


A. PATIENT INFORMATION
Patient Identifier
Required

Patient confidentiality can be maintained if the reporter uses an identifier not based on the patient's name.
Patient Age at Time of Reaction Include years or months as appropriate
Patient Gender
Patient Weight Include units (kg or Stones/Pounds)
B. SUSPECTED ADVERSE REACTION
Date of reaction
Description of reaction or problem
Required
C. DETAILS OF MEDICINAL PRODUCT
Product Name
Required

Give product name, form & strength
Dose Dose, frequency & route
Batch number(s) and expiry dates if known Batch

 Expiry (NB. Expiry is given as mm yy on our packs)
Concomitant medicinal products (include name, dose, frequency, route and dates)
Do not include any medicinal products used to treat the adverse reaction.
D. REPORTER INFORMATION
Name
Required
 
Address
Required
Phone
(Include country code)
Fax
(Include country code)
Email
Required
Occupation
E. NATIONAL PHARMACOVIGILANCE This section is optional
Reported to local National Regulatory Authority? Yes
Authority
Country
Report reference number
F. SUBMIT REPORT
Submit report? Check here to indicate that you have the authority, and provide consent, to allow us to store and process this data.