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Guideline for Professional Information for Human Medicines  

MedicinesHerbal Cosmetic Nutra | South Africa

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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Guideline for Patient Information Leaflet for Human Medicines  

Medicines | South Africa

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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Guidance and FAQs for eCTD Submission – Qatar  

Medicines | Qatar

It is the responsibility of the product license holder to ensure the quality, safety and efficacy of the product before the submission, as well as the preparation of the dossier in the right eCTD format. This responsibility lasts even after the approval and as long as the product is licensed to be placed in the Qatari market. The local agent is the one responsible for the product in Qatar and he is the only authorized body to deal with MOPH as per Qatari law. However, PDCD has the right to communicate directly with the product license holder in certain cases. The product license holder should inform PDCD through his local agent with any variation on the product, as well as any emerged safety signal, as soon as possible.

Any local Qatari organization has the right to register itself as an agent for pharmaceutical companies after fulfilling MOPH requirements. The local agent should ensure the registration of the product license holder; known as marketing authorization holder in most cases (MAH), as well as the manufacturing sites before submission of any product application as per MOPH requirements.

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The Drugs (Imports & Exports) Rules, 1976  

Medicines | Pakistan

This guideline describes following chapters:

  1. Introduction
  2. Import of drugs
  3. Export of drugs

Below listed application forms are given in the guideline:

  1. Intimation regarding import
  2. Application for license to import drug(s)
  3. Form of undertaking to accompany an application for license to import drugs
  4. Application for license to import drugs for the purpose of clinical trial, examination, test or analysis
  5. License to import drug(s)
  6. License to import drug(s) for clinical trial, examination, test or analysis
  7. Batch certification
  8. Intimation of arrival of consignment(s) of imported drug(s) other than those imported for personal use.
  9. License to export drug(s)
  10. Application for a license to export drug
  11. Form of undertaking to accompany an application for an export license
  12. Application for export of small quantities of drugs(s) for the purpose of clinical trials, examination, test or analysis or for personal use.
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The Drugs (Labeling and Packing) Rules, 1986  

Medicines | Pakistan

Following details are given in the guideline:

  1. Manner of labeling
  2. Labelling of drugs for internal use
  3. Labelling of drugs of external use only
  4. Labelling of physician’s sample
  5. Labelling of drugs for government supply
  6. Labelling of drugs for veterinary use
  7. Outer transparent wrapper not to require labeling
  8. Labelling of non‐sterile surgical ligature and suture
  9. Use of letters to indicate specifications
  10. Packing of finished drugs
  11. Labelling of drugs manufactured for export
  12. Exemption
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