Following details should be added in the application;

  1. Name of the medicines
  2. Qualitative and quantitative composition
  3. Pharmaceutical form
  4. Clinical particulars
  5. Pharmacological properties
  6. Pharmaceutical particulars
  7. Holder of certificate of registration
  8. Registration number
  9. Date of first authorisation/renewal of the authorisation
  10. Date of revision of the text
  11. Dosimetry (if applicable)
  12. Instructions for preparation of radiopharmaceuticals (if applicable)
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The primary objective of this guideline is to ensure that the PIL is written in clear and intelligible terms for the patient and is clearly legible. Applicants are requested to follow the format stipulated in this guideline.

PILs for evaluation should be typed using double line spacing. The print quality of the PIL should be clear so as to enable duplication at a later stage for inclusion into various documents, during the evaluation and registration process. The spelling and grammar in the text of the PIL should be checked thoroughly before submission of the application.

Although PILs should be submitted in English (United Kingdom) for evaluation purposes, it is currently a regulatory requirement that a PIL should be made available to consumers in English and in at least one other official language.

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