The Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and NonMedical Products) (Amendment) Regulations, 2023

This section names the Regulations and says 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 (Laboratory Analysis of Medical and NonMedical Products) (Amendment) Regulations, 2023
Version: Undated source snapshot
Language: en
Official source: View official record ↗

appeal process laboratory analysis medical products medical products regulation regulatory amendment regulatory amendments regulatory forms regulatory notice sample disposal

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About this statute

This section names the Regulations and says they are to be read together with the 2021 principal Regulations. The principal Regulations are amended by deleting regulation 2 and replacing it with new text. These Regulations apply to laboratory analysis of medical and related products in Mainland Tanzania. This provision amends regulation 21(2) by replacing one phrase with another phrase. The Authority may dispose of analysed samples if they comply with specifications, including by donation, return to the owner, or destruction depending on the reason the samples were analysed.

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Provisions of The Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and NonMedical Products) (Amendment) Regulations, 2023

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1
These Regulations may be cited as the Tanzania
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AI-assisted research summary: This section names the Regulations and says they are to be read together with the 2021 principal Regulations.

1. These Regulations may be cited as the Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) (Amendment) Regulations, 2022 and shall be read as one with the Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) Regulations, 2021 hereinafter referred as the “principal Regulations”. “Application
2
The principal Regulations are amended by
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AI-assisted research summary: The principal Regulations are amended by deleting regulation 2 and replacing it with new text.

2. The principal Regulations are amended by deleting regulation 2 and substituting for it the following:
2
These Regulations shall apply
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AI-assisted research summary: These Regulations apply to laboratory analysis of medical and related products in Mainland Tanzania.

2. These Regulations shall apply in the laboratory analysis of medical and related products in the Mainland Tanzania.”. Amendment of regulation 21
3
The principal Regulations are amended in
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AI-assisted research summary: This provision amends regulation 21(2) by replacing one phrase with another phrase.

3. The principal Regulations are amended in regulation 21(2) by deleting the words “specified under the 1 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) (Amendment) GN. NO. 1 (Contd.) Fifth and Sixth Schedule to these Regulations” and substituting for them the words “or conformity subject to regulation 17”. Amendment of regulation 22
4
The principal Regulations are amended in
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AI-assisted research summary: The Authority may dispose of analysed samples if they comply with specifications, including by donation, return to the owner, or destruction depending on the reason the samples were analysed.

4. The principal Regulations are amended in (2) and regulation 22 by deleting subregulation substituting for it the following: “(2) Subject to subregulation (1), where analysed samples have been found to comply with specifications, the Authority may dispose the samples by- (a) donating to the public institutions or health facilities upon both parties signing the handing over note with detailed information of the samples donated the quantity, value, generic name and reasons thereby; including, (b) in case of samples analysed upon request by the owner for export or any other commercial purpose, return and handover to the owner; and (c) for samples that were analysed as result of violation of the Act, conduct destruction in accordance with the disposal regulations.”. Amendment of regulation 33
5
The principal Regulations are amended in
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AI-assisted research summary: The principal Regulations are amended by inserting the words “under these Regulations” before the word “offence” in regulation 33 paragraph (e).

5. The principal Regulations are amended in regulation 33 by inserting the words “under these Regulations” the word “offence” appearing in paragraph (e). immediately after Amendment of regulation 62
6
The principal Regulations are amended in
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AI-assisted research summary: The Minister must notify the Appellant of the decision within 30 days of the decision under subregulation (3).

6. The principal Regulations are amended in regulation 62 by adding immediately after subregulation (3) the following: 2 Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and Non-Medical Products) (Amendment) GN. NO. 1 (Contd.) “(4) The Minister shall, within thirty days from the date of the decision under subregulation (3), give notice of the decision made to the Appellant.”. Amendment of First Schedule
7
The principal Regulations are amended in the
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AI-assisted research summary: This section amends the First Schedule of the principal Regulations by replacing a reference to regulation 56 with regulation 55 in the enabling phrase after Form No. 5.

7. The principal Regulations are amended in the First Schedule by deleting reference to “regulation 56” in the enabling phrase appearing immediately after the heading “FORM NO. 5” and substituting for it a reference to “regulation 55”. Dodoma, 30th December, 2022 UMMY A. MWALIMU, Minister of Health 3

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The Tanzania Medicines and Medical Devices (Laboratory Analysis of Medical and NonMedical Products) (Amendment) Regulations, 2023

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