Quality Assurance Measures in University Contracting Agreements

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Questions and Answers

What is required for non-pharmacist ownership of pharmacies, according to the text?

  • Part-time management by a pharmacist
  • No management requirement
  • Full-time management by a registered pharmacist (correct)
  • Management by a lay person

In terms of inspection functions, what will be devolved to provincial authorities?

  • Inspection of wholesale premises
  • Inspection of manufacturing facilities only
  • Inspection of government depots, hospital stores, and private pharmacies (correct)
  • Specialized inspectoral functions only

What will the drug quality control laboratory be linked to?

  • Manufacturing facilities
  • Local health clinics
  • The MCC (correct)
  • National drug stores

What will be incorporated into one set of regulations according to the text?

<p>Uniform norms and standards for drug dispensing (B)</p> Signup and view all the answers

Who will set guidelines for provincial inspection services?

<p>MCC (A)</p> Signup and view all the answers

What is expected regarding the conditions for the retail sale of pharmaceuticals?

<p>Meeting the requirement of rational, effective, and safe drug supply (A)</p> Signup and view all the answers

What is the role of the Medicines Control Council in Southern Africa?

<p>Harmonizing drug regulation and control (C)</p> Signup and view all the answers

What is a requirement for companies to import, produce, store, export, and sell drugs in South Africa?

<p>Registration of their products in South Africa (C)</p> Signup and view all the answers

Which system will be introduced to regulate drug licensing over a five-year period?

<p>Five-year re-licensing system (B)</p> Signup and view all the answers

What is emphasized when upgrading the drug registration procedures?

<p>Safety, quality, and efficacy of drugs (D)</p> Signup and view all the answers

What aspect of drug registration will be computerized?

<p>Evaluation system (A)</p> Signup and view all the answers

Which regulatory measure will be introduced to prioritize certain drug registrations?

<p>Prioritization based on need (C)</p> Signup and view all the answers

What guidelines will donated drugs need to follow?

<p>WHO guidelines for drug donations (D)</p> Signup and view all the answers

What aspect must donated drugs match in order to be considered appropriate?

<p>Health needs of the country (B)</p> Signup and view all the answers

How will clinical trials of drugs be conducted according to the text?

<p>In compliance with Good Clinical Practice Guidelines and WHO protocols (C)</p> Signup and view all the answers

What criteria will drug promotion and marketing need to comply with?

<p>WHO Ethical Criteria for Medicinal Drug Promotion (A)</p> Signup and view all the answers

What will be investigated in relation to marketed traditional medicines?

<p>Their safety and quality (C)</p> Signup and view all the answers

What will be set for medical devices and disposable items that appear on an Essential Equipment List?

<p>Norms and standards (D)</p> Signup and view all the answers

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