The Tanzania Medicines and Medical Devices (Good Storage and Distribution Practices (Amendment) Regulations, 2022

This section gives the citation name of the Regulations and states they are to be read together with the 2021 principal Regulations.

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Jurisdiction: Tanzania
Instrument: Regulation
Citation: The Tanzania Medicines and Medical Devices (Good Storage and Distribution Practices (Amendment) Regulations, 2022
Version: Undated source snapshot
Language: en
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amendment complaints handling corrective actions public information sharing recalls regulatory drafting storage and distribution practices

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This section gives the citation name of the Regulations and states they are to be read together with the 2021 principal Regulations. This provision amends regulation 10(a) by inserting the words “manufacturing date” into the listed text. The Authority must keep a written procedure for handling complaints and, after the relevant procedure is completed, take corrective and preventive actions; when required, it must also share information publicly to help initiate recalls.

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Provisions of The Tanzania Medicines and Medical Devices (Good Storage and Distribution Practices (Amendment) Regulations, 2022

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1
These Regulations may be cited as the Tanzania
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AI-assisted research summary: This section gives the citation name of the Regulations and states they are to be read together with the 2021 principal Regulations.

1. These Regulations may be cited as the Tanzania Medicines and Medical Devices (Good Storage and Distribution Practices) (Amendment) Regulations, 2022 and shall be read as one with the Tanzania Medicines and (Good Storage and Distribution Medical Devices Practices) Regulations, 2021 hereinafter referred to as the principal Regulations. Amendment of regulation 10
2
The Principal Regulations are amended in
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AI-assisted research summary: This provision amends regulation 10(a) by inserting the words “manufacturing date” into the listed text.

2. The Principal Regulations are amended in regulation 10(a) by inserting the word “manufacturing date” between the words “expiry date” and “product.” Amendment of regulation 28
3
The Principal Regulations are amended in
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AI-assisted research summary: The Authority must keep a written procedure for handling complaints and, after the relevant procedure is completed, take corrective and preventive actions; when required, it must also share information publicly to help initiate recalls.

3. The Principal Regulations are amended in regulation 28, by- (a) deleting subregulation (1) and substituting for it the following: 1 Tanzania Medicines and Medical Devices (Good Storage and Distribution Practices (Amendment) “(1) the Authority shall establish written procedure for handling of complaints.”; and (b) deleting subregulation (4) and substituting for it the following: “(4) After completion of the procedure referred to under subregulation (3), the Authority shall cause to be taken corrective and preventive actions, and when so required, such information shall be shared to the public with a view, where necessary, to initiate recalling.”. Dodoma, 21st March, 2022 UMMY A. MWALIMU Minister for Health 2

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The Tanzania Medicines and Medical Devices (Good Storage and Distribution Practices (Amendment) Regulations, 2022

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