REPORT SUSPECT SUBSTANDARD AND FALSIFIED

MEDICAL PRODUCTS

2017 CALENDAR

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WWW.TFDA.OR.TZ
 IDENTIFYING SUSPECT SUBSTANDARD AND FALSIFIED MEDICAL PRODUCTS
THERAPEUTIC EFFECT:
 Is there an unexpected lack of efficacy? Often the product will not cause a toxic reaction, but will fail to treat the condition for which it was intended, with potentially
devastating consequences. For example, a patient failing to respond to their anti-malarial will rarely consider that the cause of the problem may be their medicine.
 Is there an unexpected adverse reaction? Some substandard and falsified medical products do cause adverse reactions and sometimes fatalities. A patient may
experience an unexpected or unusual worsening of their medical condition.
OUTER (SECONDARY) PACKAGING AND INNER (PRIMARY) PACKAGING:
 Is the packaging in good condition? The container should appropriately protect the medical product inside (e.g. properly sealed, airtight, etc.).
 Are the manufacturer’s details clearly stated and in correct language? The manufacturer’s details (name, logo, hologram, full address, registration number, etc.) should
be correct and in the appropriate language for the market/country in which the product is distributed.
 Are there any spelling or grammatical errors? There should be no spelling or grammatical errors, particularly for the trade (brand) name and active ingredient(s).
 Are the batch/lot numbers and manufacturing and expiry dates altered? They should be clearly indicated, should not be possible to erase, be easily readable, and there
should be no irregularity in the embossing, impressing or imprinting.
 Is the dosage form or medicine strength clearly indicated on the label? They should be the appropriate strength and dosage form for the medicine and be the same on
all parts of the packaging.
 Is the information the same on the inner and outer packaging? This information should be the same on all parts of the packaging (with no signs of alteration and
discrepancies).
 Is there a patient information leaflet and is it in the correct language? The information on the patient information leaflet should be clearly indicated and should match
the information on other parts of the packaging and product container. There should be no irregularity in how it is printed and the quality of the colour, shape, texture,
and size of paper (e.g. ink should not be smudged, paper is not too rough, etc.).
SOURCE OF SUPPLY:
 Is there any suspicion on the source, price, quantities available, regularity of products that are usually in short supply or authenticity of accompanying documents?
Those engaged in the manufacture, distribution and supply of substandard and falsified medical products have shown they respond quickly to demand, thoroughly
understanding the market and are fast to exploit opportunities. Most commonly, substandard and falsified medical products enter the legal supply chain at distribution
level through hospitals, clinics, pharmacies and wholesalers, who have obtained medical products from unknown sources and intermediaries without checking their
credentials or conducting any due diligence. For example, products whose price appears unusually low, or which are available in unusually large quantities should raise
suspicions and further checks should be conducted.
OTHER FACTORS:
 Did the patient (or did you) notice that the medical product looks, tastes, smells or feels different? Any irregularity in the uniformity of appearance (colour, shape,
texture, size, clarity), flavour, and odour should raise suspicion. For example, if the product is discoloured or degraded.
 Are there any empty or separated packaging components (bottle caps, spoons, bottles, flat packs, capsules)? Signs of empty or separated packaging components may
indicate signs of smuggling or tampering.
 Was the product properly stored? Storage conditions (temperature, humidity, etc.) should be stated on the label and maintained. Signs of degradation may include
leakage, discoloration, etc.

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 IDENTIFYING SUSPECT SUBSTANDARD AND FALSIFIED MEDICAL PRODUCTS
Some substandard and falsified medical products are almost visually identical Examples of Substandard Products
to the genuine product and very difficult to detect. The following signs should
raise your suspicion (please note that this guide is a non-exhaustive list):
THERAPEUTIC  Patients report that it is not working properly (unexpected lack of efficacy), 
EFFECT  Patients suffer unexpected adverse reaction(s)
 Packaging is not in good condition,
OUTER
(SECONDARY)
PACKAGING



Manufacturers details are not clearly stated,
Incorrect language, grammatical and spelling errors,
Batch numbers and expiry dates appear altered

INNER  Batch numbers, manufacturing and expiry dates on inner packaging (e.g.
(PRIMARY) blister) are different to outer packaging,
PACKAGING  Patient information leaflet is in the wrong language
Discolored
 Any suspicion on the source, price, accompanying documents authenticity,
SOURCE OF
SUPPLY
 Any suspicion on quantities available, for example products that are usually
in short supply are suddenly available very regularly or in large quantities
 Product does not look, smell, taste and feel correct,
OTHER
FACTORS
 Packaging components are empty or separated
 Product was not properly stored
If in doubt, REPORT IMMEDIATELY TO THE TFDA USING THE MPRO5 SMARTPHONE APP.
Retain the suspect medical product in a secure location in accordance with
temperature, humidity and storage requirements and await instructions from
the TFDA.

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 JANUARY 2017
Monday Tuesday Wednesday Thursday Friday Saturday Sunday
1
New Year’s Day

2 3 4 5 6 7 8

9 10 11 12 13 14 15
Zanzibar Revolution
Day

16 17 18 19 20 21 22

23 24 25 26 27 28 29

30 31

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 IDENTIFYING SUSPECT SUBSTANDARD AND FALSIFIED MEDICAL PRODUCTS
ss

Some substandard and falsified medical products are almost visually identical Examples of Substandard Products
to the genuine product and very difficult to detect. The following signs should
raise your suspicion (please note that this guide is a non-exhaustive list):
 
THERAPEUTIC  Patients report that it is not working properly (unexpected lack of efficacy),
EFFECT  Patients suffer unexpected adverse reaction(s)
 Packaging is not in good condition,
OUTER
 Manufacturers details are not clearly stated,
(SECONDARY)
PACKAGING
 Incorrect language, grammatical and spelling errors,
 Batch numbers and expiry dates appear altered
INNER  Batch numbers, manufacturing and expiry dates on inner packaging (e.g.
(PRIMARY) blister) are different to outer packaging,
Powdery
PACKAGING  Patient information leaflet is in the wrong language
 Any suspicion on the source, price, accompanying documents authenticity, Discolored and
SOURCE OF
SUPPLY
 Any suspicion on quantities available, for example products that are usually Crumbly
in short supply are suddenly available very regularly or in large quantities
 Product does not look, smell, taste and feel correct,
OTHER
FACTORS
 Packaging components are empty or separated
 Product was not properly stored
 
If in doubt, REPORT IMMEDIATELY TO THE TFDA USING THE MPRO5 SMARTPHONE APP.
Retain the suspect medical product in a secure location in accordance with
temperature, humidity and storage requirements and await instructions from
the TFDA.

WWW.TFDA.OR.TZ
 FEBRUARY 2017
Monday Tuesday Wednesday Thursday Friday Saturday Sunday
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27 28

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 IDENTIFYING SUSPECT SUBSTANDARD AND FALSIFIED MEDICAL PRODUCTS
Some substandard and falsified medical products are almost visually identical Example of Falsified Antimalarial
to the genuine product and very difficult to detect. The following signs should
raise your suspicion (please note that this guide is a non-exhaustive list):
THERAPEUTIC  Patients report that it is not working properly (unexpected lack of efficacy),
EFFECT  Patients suffer unexpected adverse reaction(s)
 Packaging is not in good condition,
OUTER
 Manufacturers details are not clearly stated,
(SECONDARY)
 Incorrect language, grammatical and spelling errors,


PACKAGING
 Batch numbers and expiry dates appear altered
INNER  Batch numbers, manufacturing and expiry dates on inner packaging (e.g.
(PRIMARY) blister) are different to outer packaging,
PACKAGING  Patient information leaflet is in the wrong language
 Any suspicion on the source, price, accompanying documents authenticity, Spelling Errors
SOURCE OF
SUPPLY
 Any suspicion on quantities available, for example products that are usually
in short supply are suddenly available very regularly or in large quantities
 Product does not look, smell, taste and feel correct,
OTHER
FACTORS
 Packaging components are empty or separated
 Product was not properly stored
If in doubt, REPORT IMMEDIATELY TO THE TFDA USING THE MPRO5 SMARTPHONE APP.
Retain the suspect medical product in a secure location in accordance with
temperature, humidity and storage requirements and await instructions from
the TFDA. 
Genuine Product

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 MARCH 2017
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WWW.TFDA.OR.TZ
 IDENTIFYING SUSPECT SUBSTANDARD AND FALSIFIED MEDICAL PRODUCTS
Some substandard and falsified medical products are almost visually identical Examples of Falsified Products
to the genuine product and very difficult to detect. The following signs should
raise your suspicion (please note that this guide is a non-exhaustive list):
THERAPEUTIC  Patients report that it is not working properly (unexpected lack of efficacy),
EFFECT  Patients suffer unexpected adverse reaction(s)
 Packaging is not in good condition,
OUTER
 Manufacturers details are not clearly stated,
(SECONDARY)
PACKAGING
 Incorrect language, grammatical and spelling errors,
 Batch numbers and expiry dates appear altered
INNER  Batch numbers, manufacturing and expiry dates on inner packaging (e.g.
(PRIMARY) blister) are different to outer packaging, White, Non-useable
PACKAGING  Patient information leaflet is in the wrong language “Scratch” Area

 Any suspicion on the source, price, accompanying documents authenticity,

SOURCE OF
SUPPLY
 Any suspicion on quantities available, for example products that are usually Altered Manufacturing
in short supply are suddenly available very regularly or in large quantities and Expiry Dates
 Product does not look, smell, taste and feel correct,
OTHER
FACTORS
 Packaging components are empty or separated
 Product was not properly stored
If in doubt, REPORT IMMEDIATELY TO THE TFDA USING THE MPRO5 SMARTPHONE APP.
Retain the suspect medical product in a secure location in accordance with
temperature, humidity and storage requirements and await instructions from
the TFDA.

WWW.TFDA.OR.TZ
 APRIL 2017
Monday Tuesday Wednesday Thursday Friday Saturday Sunday
1 2

3 4 5 6 7 8 9
Karume Day

10 11 12 13 14 15 16
Good Friday Easter Sunday

17 18 19 20 21 22 23
Easter Monday

24 25 26 27 28 29 30
Union Day

WWW.TFDA.OR.TZ
 IDENTIFYING SUSPECT SUBSTANDARD AND FALSIFIED MEDICAL PRODUCTS
Some substandard and falsified medical products are almost visually identical Example of Falsified Product
to the genuine product and very difficult to detect. The following signs should
raise your suspicion (please note that this guide is a non-exhaustive list):
THERAPEUTIC  Patients report that it is not working properly (unexpected lack of efficacy),
EFFECT  Patients suffer unexpected adverse reaction(s)
 Packaging is not in good condition,
OUTER
 Manufacturers details are not clearly stated,
(SECONDARY)
PACKAGING
 Incorrect language, grammatical and spelling errors,
 Batch numbers and expiry dates appear altered
INNER  Batch numbers, manufacturing and expiry dates on inner packaging (e.g.
(PRIMARY) blister) are different to outer packaging,
PACKAGING  Patient information leaflet is in the wrong language Country Doesn’t
Spelling Errors
Exist
 Any suspicion on the source, price, accompanying documents authenticity,
SOURCE OF
SUPPLY
 Any suspicion on quantities available, for example products that are usually
in short supply are suddenly available very regularly or in large quantities Grammatical Errors

 Product does not look, smell, taste and feel correct,

OTHER
FACTORS
 Packaging components are empty or separated
 Product was not properly stored
If in doubt, REPORT IMMEDIATELY TO THE TFDA USING THE MPRO5 SMARTPHONE APP.
Retain the suspect medical product in a secure location in accordance with
temperature, humidity and storage requirements and await instructions from
the TFDA.

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 MAY 2017
Monday Tuesday Wednesday Thursday Friday Saturday Sunday
1 2 3 4 5 6 7
Labour Day

8 9 10 11 12 13 14

15 16 17 18 19 20 21

22 23 24 25 26 27 28

29 30 31

WWW.TFDA.OR.TZ
 IDENTIFYING SUSPECT SUBSTANDARD AND FALSIFIED MEDICAL PRODUCTS
Some substandard and falsified medical products are almost visually identical Example of Falsified Product
to the genuine product and very difficult to detect. The following signs should
raise your suspicion (please note that this guide is a non-exhaustive list):
THERAPEUTIC  Patients report that it is not working properly (unexpected lack of efficacy),
EFFECT  Patients suffer unexpected adverse reaction(s)
 Packaging is not in good condition,
OUTER
 Manufacturers details are not clearly stated,
(SECONDARY)
PACKAGING
 Incorrect language, grammatical and spelling errors,
 Batch numbers and expiry dates appear altered
INNER  Batch numbers, manufacturing and expiry dates on inner packaging (e.g.
(PRIMARY) blister) are different to outer packaging,
PACKAGING  Patient information leaflet is in the wrong language
 Any suspicion on the source, price, accompanying documents authenticity,
SOURCE OF
SUPPLY
 Any suspicion on quantities available, for example products that are usually
in short supply are suddenly available very regularly or in large quantities
 Product does not look, smell, taste and feel correct, Altered Manufacturing
OTHER
FACTORS
 Packaging components are empty or separated and Expiry Dates
 Product was not properly stored (Relabeling)
If in doubt, REPORT IMMEDIATELY TO THE TFDA USING THE MPRO5 SMARTPHONE APP.
Retain the suspect medical product in a secure location in accordance with
temperature, humidity and storage requirements and await instructions from
the TFDA.

WWW.TFDA.OR.TZ
 JUNE 2017
Monday Tuesday Wednesday Thursday Friday Saturday Sunday
1 2 3 4

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26 27 28 29 30
Eid ul-Fitr

WWW.TFDA.OR.TZ
 IDENTIFYING SUSPECT SUBSTANDARD AND FALSIFIED MEDICAL PRODUCTS
Some substandard and falsified medical products are almost visually identical Example of Falsified Product
to the genuine product and very difficult to detect. The following signs should
raise your suspicion (please note that this guide is a non-exhaustive list):   Genuine
Product
THERAPEUTIC  Patients report that it is not working properly (unexpected lack of efficacy),
EFFECT  Patients suffer unexpected adverse reaction(s)
 Packaging is not in good condition,
OUTER
 Manufacturers details are not clearly stated,
(SECONDARY)
PACKAGING
 Incorrect language, grammatical and spelling errors,
 Batch numbers and expiry dates appear altered
INNER  Batch numbers, manufacturing and expiry dates on inner packaging (e.g.
(PRIMARY) blister) are different to outer packaging,
PACKAGING  Patient information leaflet is in the wrong language
 Any suspicion on the source, price, accompanying documents authenticity,
SOURCE OF Paler Label
SUPPLY
 Any suspicion on quantities available, for example products that are usually Smaller Size and
in short supply are suddenly available very regularly or in large quantities Lighter Color
 Product does not look, smell, taste and feel correct,
OTHER
FACTORS
 Packaging components are empty or separated
 Product was not properly stored Incorrect Logo

If in doubt, REPORT IMMEDIATELY TO THE TFDA USING THE MPRO5 SMARTPHONE APP.
Retain the suspect medical product in a secure location in accordance with
temperature, humidity and storage requirements and await instructions from
the TFDA.

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 JULY 2017
Monday Tuesday Wednesday Thursday Friday Saturday Sunday
1 2

3 4 5 6 7 8 9
Saba Saba

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24 25 26 27 28 29 30

31

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 IDENTIFYING SUSPECT SUBSTANDARD AND FALSIFIED MEDICAL PRODUCTS
Some substandard and falsified medical products are almost visually identical Example of Falsified Product
to the genuine product and very difficult to detect. The following signs should
raise your suspicion (please note that this guide is a non-exhaustive list):
THERAPEUTIC  Patients report that it is not working properly (unexpected lack of efficacy),
EFFECT  Patients suffer unexpected adverse reaction(s)
 Packaging is not in good condition,
OUTER
 Manufacturers details are not clearly stated,
(SECONDARY)
PACKAGING
 Incorrect language, grammatical and spelling errors,
 Batch numbers and expiry dates appear altered
INNER  Batch numbers, manufacturing and expiry dates on inner packaging (e.g.
(PRIMARY) blister) are different to outer packaging,
PACKAGING  Patient information leaflet is in the wrong language Grammatical
 Any suspicion on the source, price, accompanying documents authenticity, Errors (should be
SOURCE OF Spelling
SUPPLY
 Any suspicion on quantities available, for example products that are usually ‘Tablets’)
in short supply are suddenly available very regularly or in large quantities Errors
(should be
 Product does not look, smell, taste and feel correct, ‘Batch’)
OTHER
FACTORS
 Packaging components are empty or separated
 Product was not properly stored
If in doubt, REPORT IMMEDIATELY TO THE TFDA USING THE MPRO5 SMARTPHONE APP.
Retain the suspect medical product in a secure location in accordance with
temperature, humidity and storage requirements and await instructions from
the TFDA.

WWW.TFDA.OR.TZ
 AUGUST 2017
Monday Tuesday Wednesday Thursday Friday Saturday Sunday
1 2 3 4 5 6

7 8 9 10 11 12 13
Nane Nane (Farmer’s
Day)

14 15 16 17 18 19 20

21 22 23 24 25 26 27

28 29 30 31

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 IDENTIFYING SUSPECT SUBSTANDARD AND FALSIFIED MEDICAL PRODUCTS
Some substandard and falsified medical products are almost visually identical Empty or Separated Packaging
to the genuine product and very difficult to detect. The following signs should Components
raise your suspicion (please note that this guide is a non-exhaustive list):
THERAPEUTIC  Patients report that it is not working properly (unexpected lack of efficacy),
EFFECT  Patients suffer unexpected adverse reaction(s)
 Packaging is not in good condition,
OUTER
 Manufacturers details are not clearly stated,
(SECONDARY)
PACKAGING
 Incorrect language, grammatical and spelling errors,
 Batch numbers and expiry dates appear altered
INNER  Batch numbers, manufacturing and expiry dates on inner packaging (e.g.
(PRIMARY) blister) are different to outer packaging,
PACKAGING  Patient information leaflet is in the wrong language
 Any suspicion on the source, price, accompanying documents authenticity,
SOURCE OF
SUPPLY
 Any suspicion on quantities available, for example products that are usually
in short supply are suddenly available very regularly or in large quantities
 Product does not look, smell, taste and feel correct,
OTHER
FACTORS
 Packaging components are empty or separated
 Product was not properly stored
If in doubt, REPORT IMMEDIATELY TO THE TFDA USING THE MPRO5 SMARTPHONE APP.
Retain the suspect medical product in a secure location in accordance with
temperature, humidity and storage requirements and await instructions from
the TFDA. Signs of Smuggling or Tampering

WWW.TFDA.OR.TZ
 SEPTEMBER 2017
Monday Tuesday Wednesday Thursday Friday Saturday Sunday
1 2 3
Eid El-Hajj

4 5 6 7 8 9 10

11 12 13 14 15 16 17

18 19 20 21 22 23 24

25 26 27 28 29 30

WWW.TFDA.OR.TZ
 IDENTIFYING SUSPECT SUBSTANDARD AND FALSIFIED MEDICAL PRODUCTS
Some substandard and falsified medical products are almost visually identical Suspicious Documents
to the genuine product and very difficult to detect. The following signs should
raise your suspicion (please note that this guide is a non-exhaustive list):
THERAPEUTIC  Patients report that it is not working properly (unexpected lack of efficacy),
EFFECT  Patients suffer unexpected adverse reaction(s)
 Packaging is not in good condition,
OUTER
 Manufacturers details are not clearly stated,
(SECONDARY)
PACKAGING
 Incorrect language, grammatical and spelling errors,
 Batch numbers and expiry dates appear altered
INNER  Batch numbers, manufacturing and expiry dates on inner packaging (e.g.
(PRIMARY) blister) are different to outer packaging,
PACKAGING  Patient information leaflet is in the wrong language
 Any suspicion on the source, price, accompanying documents authenticity,
SOURCE OF
SUPPLY
 Any suspicion on quantities available, for example products that are usually
in short supply are suddenly available very regularly or in large quantities
 Product does not look, smell, taste and feel correct,
OTHER
FACTORS
 Packaging components are empty or separated
 Product was not properly stored
If in doubt, REPORT IMMEDIATELY TO THE TFDA USING THE MPRO5 SMARTPHONE APP. Packaging Catalogues for Falsified
Retain the suspect medical product in a secure location in accordance with Medical Products
temperature, humidity and storage requirements and await instructions from
the TFDA. Signs of Smuggling or Tampering

WWW.TFDA.OR.TZ
 OCTOBER 2017
Monday Tuesday Wednesday Thursday Friday Saturday Sunday
1

2 3 4 5 6 7 8

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Nyerere Day

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23 24 25 26 27 28 29

30 31

WWW.TFDA.OR.TZ
 IDENTIFYING SUSPECT SUBSTANDARD AND FALSIFIED MEDICAL PRODUCTS
Some substandard and falsified medical products are almost visually identical Altered Dates
to the genuine product and very difficult to detect. The following signs should
raise your suspicion (please note that this guide is a non-exhaustive list):
THERAPEUTIC  Patients report that it is not working properly (unexpected lack of efficacy),
EFFECT  Patients suffer unexpected adverse reaction(s)
 Packaging is not in good condition,
OUTER
 Manufacturers details are not clearly stated,
(SECONDARY)
PACKAGING
 Incorrect language, grammatical and spelling errors,
 Batch numbers and expiry dates appear altered
INNER  Batch numbers, manufacturing and expiry dates on inner packaging (e.g.
(PRIMARY) blister) are different to outer packaging,
PACKAGING  Patient information leaflet is in the wrong language
 Any suspicion on the source, price, accompanying documents authenticity,
SOURCE OF
SUPPLY
 Any suspicion on quantities available, for example products that are usually
in short supply are suddenly available very regularly or in large quantities
 Product does not look, smell, taste and feel correct,
OTHER
FACTORS
 Packaging components are empty or separated
 Product was not properly stored
If in doubt, REPORT IMMEDIATELY TO THE TFDA USING THE MPRO5 SMARTPHONE APP.
Retain the suspect medical product in a secure location in accordance with
temperature, humidity and storage requirements and await instructions from
the TFDA.

WWW.TFDA.OR.TZ
 NOVEMBER 2017
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27 28 29 30

WWW.TFDA.OR.TZ
 IDENTIFYING SUSPECT SUBSTANDARD AND FALSIFIED MEDICAL PRODUCTS
Some substandard and falsified medical products are almost visually identical Example of Falsified Medical Product
to the genuine product and very difficult to detect. The following signs should
raise your suspicion (please note that this guide is a non-exhaustive list):
THERAPEUTIC  Patients report that it is not working properly (unexpected lack of efficacy),
EFFECT  Patients suffer unexpected adverse reaction(s)
 Packaging is not in good condition,
OUTER
 Manufacturers details are not clearly stated,
(SECONDARY)
PACKAGING
 Incorrect language, grammatical and spelling errors,
 Batch numbers and expiry dates appear altered
INNER  Batch numbers, manufacturing and expiry dates on inner packaging (e.g.
(PRIMARY) blister) are different to outer packaging,
PACKAGING  Patient information leaflet is in the wrong language
 Any suspicion on the source, price, accompanying documents authenticity,
SOURCE OF
SUPPLY
 Any suspicion on quantities available, for example products that are usually
in short supply are suddenly available very regularly or in large quantities
 Product does not look, smell, taste and feel correct,
OTHER
FACTORS
 Packaging components are empty or separated
 Product was not properly stored Staples to attach packaging

If in doubt, REPORT IMMEDIATELY TO THE TFDA USING THE MPRO5 SMARTPHONE APP. Signs of Tampering
Retain the suspect medical product in a secure location in accordance with
temperature, humidity and storage requirements and await instructions from
the TFDA.

WWW.TFDA.OR.TZ
 DECEMBER 2017
Monday Tuesday Wednesday Thursday Friday Saturday Sunday
1 2 3
Maulid Day

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Independence Day

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18 19 20 21 22 23 24
Christmas Eve

25 26 27 28 29 30 31
Christmas Day Boxing Day New Year’s Eve

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WWW.TFDA.OR.TZ