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Friday, 15 November 2019
Medicines Control Authority of Zimbabwe
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WHO Pharmacovigilance Toolkit
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ReCore Training Introduction
Evaluations and Registration
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Friday, 15 November 2019
Frequently Asked Questions - All FAQs
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Licencing and Enforcement
1. What are the details for making payments via Ecocash?
2. What are the banking details for MCAZ?
3. Does MCAZ allow installments for renewal fees?
4. How do I lodge a complaint with MCAZ?
5. We are only getting to know about the existence of MCAZ now when you have come to ‘arrest us’. What are you doing about public awareness?
6. Why is it that MCAZ officers are only worried about Pharmacies and never prosecute people selling medicines in the street?
7. What types of inspections are conducted at retail pharmacies? How often? Are some Pharmacies inspected more than others?
8. Are police allowed to inspect premises that are licensed by the MCAZ?
9. Who can import medicines?
10. What are the requirements for importing medicines?
11. I am a VMGD operator, how can I import medicines for resale in the country?
12. What is the procedure to be followed when an institution wants to import an unregistered medicine?
13. What are the requirements for importing donations into the country?
14. What are the requirements when travelling to Zimbabwe pertaining to medicines for personal use? Can patients who are on prescribed narcotics for treatment bring them into the country?
15. What are the requirements for importing Hydrochloric acid and Sulphuric acid into the country?
16. What are the requirements for importing dietary supplements?
17. Are skin lightening products allowed in Zimbabwe?
18. What are the requirements for opening a pharmacy?
19. We operate a private clinic and there are a number of pharmacies in the 5km radius and we would like to dispense medicines to the patients we attend, what are the requirements?
20. What are the requirements for being licensed as an industrial Clinic?
21. What are the requirements for being licensed as a nurse at an industrial clinic?
22. For pharmacists who obtained their qualifications outside the country, what is the process of sitting for the forensic examination so that they can be registered with Pharmacists Council of Zimbabwe?
23. What are the requirements for opening a retail shop which sells veterinary medicines?
24. What is the procedure for resigning as a supervisor of a licensed premises?
25. What should I do if the substantive supervisor resigns?
26. What is the procedure when one of the directors of a company resigns and a new one is appointed?
27. How do you authenticate whether a premises or a person is indeed licensed by the Authority?
28. What are the requirements for operating a retail outlet which sells household remedies?
29. What medicines can be kept in an emergency tray?
30. What are the guidelines for inspection of manufacturing plants?
31. What are the guidelines for setting up a manufacturing plant in Zimbabwe?
32. What are the requirements for setting up a plant for manufacturing Pharmacopeia preparations?
33. Where do I get information for GMP inspection fees?
34. How long is the validity of the GMP approval?
35. Does MCAZ inspect my facility if the site is approved by WHO or other SRAs?
Evaluations and Registration Division
1. How do I access the list of registered veterinary medicines in Zimbabwe?
2. If we currently own a licence in Zimbabwe for a Veterinary Medicinal Product which is distributed by a Zimbabwean company, is it possible for another company to import this same product on permission from our company without being the registered distributor for this product?
3. What are Veterinary Section 75 applications?
4. What are the requirements for operating a Veterinary Medicines General Dealer (VMGD) outlet?
5. How do I get my medicine registered/approved?
6. How long will it take for my medicines to be registered?
7. What is the difference between applicant, principal and manufacturer?
8. Can a medicine which is not registered be found on the market in Zimbabwe?
9. Does MCAZ register medical devices such as BP machines, Glucometers and other diagnostic devices?
10. What is ZAZIBONA and how can we participate?
11. How do I access the list of registered human medicines in Zimbabwe?
12. What are complementary medicines?
13.What is the difference between complementary medicine, alternative medicine and integrative health care?
14.Should the manufacturing site of the complementary medicine be inspected before the product is registered?
15. What does the registration process of complementary medicine entail?
16. What are the requirements at submission to the Authority?
17 My product contains a vitamins, minerals and herbal substances. Which sections should I complete in my dossier?
18. Are all herbal medicines permitted under this procedure?
19. Are body building products registerable with the Authority?
20. Are cosmetic preparations containing vitamins and/or herbal substances registerable with the Authority?
21. May I advertise my complementary medicine?
22. Where can I sell my approved product?
23. The country of origin does not regulate complementary medicines. Can I still submit my product for registration to the Authority?
24. What are the maximum (Upper limits) Recommended Daily Allowances (RDA) for Vitamins and Minerals permitted by the authority?
25. How can I follow up on medicines submitted for registration at MCAZ?
Pharmacogivilance and Clinical Trials
No faqs found in this category
1. How do I register gloves/condoms?
2. Who can register gloves/condoms?
3. What is a type of glove/condom?
4. How many pieces of gloves/Condoms should I submit as a sample for routine testing?
5. How long does it take for my product to be registered?
6. What is the cost of registration?
7. What is a clearance letter?
8. How long does it take to have a clearance letter ready and how much does it cost?
9. Does MCAZ regulate other medical devices other than condoms and gloves?
10. Can I import and distribute a product registered by another distributor?
11. Who is responsible for the cost of a GMP inspection of a manufacturer?
12. Can I distribute my gloves if the manufacturer has not been inspected?
13. If my products fail analysis what happens to the consignment?
14. Are there storage conditions that I have to adhere to when distributing my products?
15. What are the key labelling requirements for gloves/condoms?
16. Do I get a certificate of approval when I register my products?
17. How long is the product approval valid for?
18. Do I need to have a registered business for me to distribute gloves?
19. What are the consequences of distributing unapproved products?
20. What payment methods are available for services at MCAZ?
FAQs - All FAQs
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