Some types of information must be included on all labels, regardless of whether the medicines are prescription medicines, over-the-counter (OTC) medicines or listed medicines. Other information is particular to specific types of medicines.

This guidance is divided into four parts.
• Part 1 describes the structure of the Orders and legal requirements that generally apply to all medicines.
• Part 2 provides guidance to assist you to identify the legal mandatory requirements that apply to certain types of medicines. For each type of medicine, there are references to specific relevant sections of the Orders.
• Part 3 provides guidance on the design of medicine labels and some ‘best practice principles’. This information is not mandatory, but is included to further improve the safe and quality use of medicines.
• Part 4 provides guidance on the tabulated display of Critical Health Information. This includes both mandatory requirements and best practice guidance.

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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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