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MCAZ

MCAZ

Protecting your right to human medicines and medical devices
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FAQs

Licensing and Enforcement
Medical Devices
Licensing and Enforcement

  • All
  • Licensing and Enforcement

Who can import medicines?

Please follow the MCAZ website link below to obtain information on persons and institutions allowed to import medicines;

Please note that any pharmacist, veterinary surgeon, dental practitioner, medical practitioner or any other person approved by the authority may import into Zimbabwe any medicine only for the purpose of resale to their clientele, and from authorized premises.

 1,210 total views

Are police allowed to inspect premises that are licensed by the MCAZ?

Yes.

According to Section 66 of the Medicines and Allied Substances Control Act [Chapter 15:02], an inspector, customs officer or police officer above the rank of sergeant may at all reasonable times;

4.1 Enter upon and search any premises, place, vehicle, vessel or aircraft at or in which there is or is on reasonable grounds suspected to be any medicine or any substance, device or articles to which any regulations referred to in paragraph (b) of subsection (1) of section thirty-eight apply;

4.2 Inspect any medicine or any substance, device or article to which any regulations referred to in paragraph (b) of subsection (1) of section thirty-eight apply or any book, record or document found in or upon such   premises, place, vehicle, vessel or aircraft;

4.3 Seize any such medicine, substance, device or article or any books, records or documents found in or upon such premises, place, vehicle, vessel or aircraft and appearing to afford evidence of a contravention of any provision of this Act;

4.4 Take so many samples of any such medicine, substance, device or article as he may consider necessary for the purpose of testing, examination or analysis in terms of this Act;

4.5 Enter any premises in respect of which an application for a licence has been made in terms of Part VI or which has been licensed in terms of that Part or which the inspector has reasonable grounds for believing are being used for the manufacture of a medicine or the carrying on of the business of a pharmacist in contravention of Part VI. 

An inspector, customs officer or police officer above the rank of sergeant may not enter upon or search any dwelling-house unless he believes on reasonable grounds that evidence relating to a contravention of this Act is to be found in that dwelling-house.

 

 1,178 total views

What types of inspections are conducted at retail pharmacies? How often? Are some Pharmacies inspected more than others?

here are different types of inspections that may be carried out as and when necessary and at an undefined frequency. These are:

3.1 New premises inspections

These are inspections conducted to assess compliance of a new premises to applicable legislation and guidelines upon receipt of an application for a premises licence.

3.2 Supervision inspections

Random checks carried are out to ensure licensed premises are under the continuous personal supervision of licensed persons in line with legislative requirements. Supervision inspections are conducted randomly within the premises operating times or when the premises handling medicines is open for business. In the event the premises is found without the continuous personal supervision of a licensed supervisor, the premises shall be issued an instruction to close by the inspectors. The premises will be issued instruction to open after confirmation of supervision and payment of re-inspection fees.

3.3 Investigative inspection

This is a type of inspection where it is suspected that there is contravention of the law and necessary investigations are carried out which may include speaking to the pharmacy owner, pharmacist or other staff at the pharmacy or premises in question or a members of the public

Investigations are carried out to ascertain, inter alia, whether:

i. Offences have been committed contrary to the provisions of Medicines and Allied Substances Control Act [Chapter 15:02]

ii. Offences have been committed contrary to the provisions of the Dangerous Drugs Act and its Regulations.

Investigations are carried out as a result of non-compliances identified in the inspection process or using intelligence internal to MCAZ other agencies or members of the public. Investigation activities are frequently conducted in conjunction with other agencies. The MCAZ has carried out investigations with the Zimbabwe Republic Police (ZRP) -CID Drugs. Once an investigation is concluded a report is completed and a copy may be furnished to the party (pharmacist/pharmacy owner) under investigation or inspection. The pharmacist/pharmacy owner is invited to submit their comments on the contents of the report. The report and submissions (if provided) are considered by the Licensing and Enforcement Committee.  Matters may be referred to ZRP for prosecution.

3.4 Blitz

Conducted with Interpol and or Zimbabwe Republic Police (ZRP) -CID Drugs primarily on un-licensed premises.

3.5 Routine Inspections

Our inspectorate endeavors to carry out a comprehensive inspection of every pharmacy at least once every two years. The frequency of routine inspections is ideally the same although there may be instances when a pharmacy may be inspected once every year. The target may of course be difficult to reach because the number of premises that we inspect is on the increase. The MCAZ also inspects pharmaceutical manufacturers, wholesalers, industrial clinics, medical practitioners (both Veterinary and Human), and public health institutions.

 1,157 total views

Why is it that MCAZ officers are only worried about Pharmacies and never prosecute people selling medicines in the street?

The MCAZ is equally concerned about the illicit importation, and sale of medicines on the parallel market, including medicines being sold on the street.

The MCAZ carries out blits in conjunction with the Zimbabwe Republic Police (ZRP), and works with the ZRP and National Prosecuting Authority in prosecuting perpetrators. We carry out capacity building exercises which involve the training of our stakeholders on a regular basis. We also have a dedicated enforcement team which moves around the country. To date numerous arrests have been made of persons dealing in unregistered medicines and selling from unapproved premises, of both licensed and unlicensed person. 

The MCAZ‘s primary concern is protecting public health by ensuring that the medicines that are available to the Zimbabwean public are safe, efficacious and of good quality, and that these are supplied by authorized persons and from approved premises. The sale of medicines on the street is a threat to our mandate as an Authority and we would like to reassure the Zimbabwean public that it is an area of concern to us. As MCAZ, we are putting resources to deal with this matter. In the meantime, we encourage all to acquire medicines from premises with valid licences.

 1,146 total views

How do I lodge a complaint with MCAZ?

A complaint can be received via telephone, or via email or post or can be submitted to the Authority offices.  Complaint forms are available at our reception areas or on the MCAZ website www.mcaz.co.zw. Please follow the MCAZ website links below for  submission of complaints;

http://www.mcaz.co.zw/index.php/customer-complaint-form

MCAZ also has a Deloitte Tips- offs Anonymous platform that you can make use of:

Deloitte Tip-offs Anonymous Image.

 1,269 total views

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?

The MCAZ conducts campaigns at schools and also partners with organizations such as churches. MCAZ is available on the following platforms and will continue to explore other avenues for reaching out:

1.1 Facebook: https://www.facebook.com/mcazofficial/

1.2 Twitter: https://twitter.com/mcazofficial?lang=en

1.3 Instagram: https://www.instagram.com/mcazofficial/?hl=en

1.4 Website: http://www.mcaz.co.zw/

 

 1,227 total views

Does MCAZ allow installments for renewal fees?

Where a licensee requests to pay renewal fees in instalments at least three (3) months prior to the expiry of the current licence, a licence may be issued to the applicant once the applicant has agreed to a payment plan and has made the payment of the first instalment. The licence may be cancelled if the applicant does not honor their obligations to pay the full amount within the stipulated timelines.  The applicant shall sign a contractual agreement with a clause allowing for the cancellation or revocation of the licence upon default of payment. Requests for payment in installments within the last month of the expiry of the current licence are not accepted. An administration fee may be payable.

 1,147 total views

What are the banking details for MCAZ?

Payments from within Zimbabwe can be made by cash deposits or direct transfer into the bank details obtained from the Medicines Control Authority of Zimbabwe accounts office.

All payments from external sources should be transferred into the bank details indicated on the proforma invoice issued by the Medicines Control Authority of Zimbabwe. Note that transfers usually attract a commission charged by the banks leading to a shortfall in application fees.  Provisions should be made to cover such shortfalls.

Customers are encouraged to always send scanned or physical copies after every deposit into the Medicines Control Authority of Zimbabwe account with full details of payment (e.g. registration fees)

 1,164 total views

1. What are the details for making payments via Ecocash?

To make a payment please follow the instructions below:

1.1)  Dial *151#

1.2)  Enter your pin number

1.3)  Select “Make Payment”

1.4)  Select “Pay Bill”

1.5)  Enter MCAZ Biller Code “03769”

1.6)  Enter amount to be paid to MCAZ

1.7)  Enter account number “0775 648 276”

1.8)  Provide Ecocash confirmation code and the reason for payment for receipting through the following platforms:

1.8.1 Email – mcaz@mcaz.co.zw

1.8.2 Application forms – Indicate visibly the code on the forms

1.8.3    Cellphone – 0772 609 540

 1,161 total views

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?

The MCAZ conducts campaigns at schools and also partners with organizations such as churches. MCAZ is available on the following platforms and will continue to explore other avenues for reaching out:

1.1 Facebook: https://www.facebook.com/mcazofficial/

1.2 Twitter: https://twitter.com/mcazofficial?lang=en

1.3 Instagram: https://www.instagram.com/mcazofficial/?hl=en

1.4 Website: http://www.mcaz.co.zw/

 

 1,149 total views

Does MCAZ allow installments for renewal fees?

 

Where a licensee requests to pay renewal fees in instalments at least three (3) months prior to the expiry of the current licence, a licence may be issued to the applicant once the applicant has agreed to a payment plan and has made the payment of the first instalment. The licence may be cancelled if the applicant does not honor their obligations to pay the full amount within the stipulated timelines.  The applicant shall sign a contractual agreement with a clause allowing for the cancellation or revocation of the licence upon default of payment. Requests for payment in installments within the last month of the expiry of the current licence are not accepted. An administration fee may be payable.

 

 1,205 total views

What are the banking details for MCAZ?

Payments from within Zimbabwe can be made by cash deposits or direct transfer into the bank details obtained from the Medicines Control Authority of Zimbabwe accounts office.

All payments from external sources should be transferred into the bank details indicated on the proforma invoice issued by the Medicines Control Authority of Zimbabwe. Note that transfers usually attract a commission charged by the banks leading to a shortfall in application fees.  Provisions should be made to cover such shortfalls.

Customers are encouraged to always send scanned or physical copies after every deposit into the Medicines Control Authority of Zimbabwe account with full details of payment (e.g. registration fees)

 1,640 total views

What are the details for making payments via Ecocash?

To make a payment please follow the instructions below:

1.1)  Dial *151#

1.2)  Enter your pin number

1.3)  Select “Make Payment”

1.4)  Select “Pay Bill”

1.5)  Enter MCAZ Biller Code “03769”

1.6)  Enter amount to be paid to MCAZ

1.7)  Enter account number “0775 648 276”

1.8)  Provide Ecocash confirmation code and the reason for payment for receipting through the following platforms:

1.8.1 Email – mcaz@mcaz.co.zw

1.8.2 Application forms – Indicate visibly the code on the forms

1.8.3    Cellphone – 0772 609 540

 1,305 total views

Medical Devices

  • All
  • Medical Devices

Medical Devices

How many pieces of gloves/Condoms should I submit as a sample for routine testing?

Gloves: For routine testing, 400 pieces of gloves are required per batch of gloves

Condoms: For routine testing, 1400 pieces of condoms required.

 23,070 total views

What is a type of glove/condom?

Gloves: A type of glove refers to the glove description such as; finishing dressing (powdered, powder free) use (examination, surgical), material of construction (nitrile, latex, vinyl).

Condoms: A type of condom refers to variation for example, dotted, ribbed strawberry flavor, extra-large etc.

 23,071 total views

Who can register gloves/condoms?

A manufacturer, or a local distributor can register condoms/gloves for distribution in Zimbabwe

 

 23,072 total views

How do I register gloves/condoms?

Gloves

Registration of gloves is done per brand per type and the following is required:

500 pieces (5 boxes of gloves of the same batch number), Completed duplicate MCG1 and MCG 2 forms Fees or proof of payment

     Condoms

Registration of condoms is done per brand per type and the following is required:

1400 pieces of condoms in consumer packages intended for the market, Competed duplicate MC. Con 1 and MC. Con 2 forms, fees or proof of payment

 23,073 total views

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  • 106 Baines Ave, Harare, Zimbabwe
  • +263-242-736981/5;
    708255; 792165;
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