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Applied by Malawi on the entire world
The measure came into effect on 26 August 2016
Non-Tariff Measure
- NTM classification
- B83: Certification requirement
- Date when the measure came into force
- 26 August 2016
- Publication where the measure is specified
- The Malawi Gazette Supplement, dated 26th August, 2016 containing Regulations, Rules, etc
- Regulation where the measure is specified
- MS 49:2006 Toilet soap-Specification
- Country/Region applying the measure
- Malawi
- The rationale of the measure
- Protection of human safety
- Coded list of objectives
- A: Protection of human life and health
- Description of the measure
- Conformity requirements
- Reference of the measure
- MS 49 clause 6.4
- Measure also domestic
- Yes
Products affected by the measure.
- Description
- Toilet soaps
Countries/Regions affected by the measure.
Inclusion/Exclusion Country Date in Date out Inclusion Entire world -
Non-Tariff Measure
- NTM classification
- B83: Certification requirement
- Date when the measure came into force
- 18 July 2016
- Publication where the measure is specified
- Regulation on Production, Transportation, Marketing and Quality Assurance of Common Cement
- Regulation where the measure is specified
- Regulation on Production, Transportation, Marketing and Quality Assurance of Common Cement
- Country/Region applying the measure
- Mozambique
- Coded list of objectives
- X: For purposes n.e.s.
- Description of the measure
- (1) The sale of common cements in the domestic market can only be held after being certified by Mozambique Engineering Laboratory, as the certifying body.
(2) Current cement imported must be accompanied by a quality certificate issued by a competent authority recognized by INNOQ, before entering the country. - Reference of the measure
- Article 12(1)(2)
- Measure also domestic
- Yes
Products affected by the measure.
- Description
- Common cement
Countries/Regions affected by the measure.
-
Non-Tariff Measure
- NTM classification
- B83: Certification requirement
- Date when the measure came into force
- 05 August 2015
- Publication where the measure is specified
- Decreto n.º 16/2015, de 5 de Agosto
- Regulation where the measure is specified
- Rules on the Management and Control of Plastic Bags
- Country/Region applying the measure
- Mozambique
- The rationale of the measure
- To reduce negative impacts on human health, infrastructure, biodiversity and environment in general mainly due to its non-biodegradability characteristic
- Description of the measure
- Imports of plastic bags should comply with the Mozambican standard NM 596
- Reference of the measure
- Article 5(1)
- Measure also domestic
- Yes
Products affected by the measure.
- Description
- Plastic bags
Countries/Regions affected by the measure.
-
Applied by Rwanda on the entire world for
The measure came into effect on 18 November 2010
Non-Tariff Measure
- NTM classification
- B83: Certification requirement
- Date when the measure came into force
- 18 November 2010
- Publication where the measure is specified
- Official Gazette n° 50 of 13/12/2010
- Regulation where the measure is specified
- Ministerial Order N°008/11.30 Of 18/11/2010 Determining The Organization Of Veterinary Pharmacy Practice
- Country/Region applying the measure
- Rwanda
- The rationale of the measure
- This Order organises the veterinary pharmacy practice in Rwanda
- Coded list of objectives
- X: For purposes n.e.s.
- Description of the measure
- Import of veterinary medicines and pharmaceutical products is subject to verification of the license issued by the
Minister or his/her representative upon presentation of the certificate of origin issued by the manufacturer and attesting of quality of the products. - Reference of the measure
- Art 12 paragraph 2
- Measure also domestic
- No
Products affected by the measure.
Code Product Partial coverage Partial coverage indication Date in Date out PG: 25 Medicines for animal use No - Description
- Veterinary medicines and pharmaceutical products
Veterinary medicines: substance or preparation presented as having preventive or curative properties
against animal diseases, and any product that can be administered to animals in order to restore, correct or
modify functions of their organs. Are also considered as veterinary medicines, products used to diagnose
animal diseases.
Pharmaceutical products (for veterinary use)
Countries/Regions affected by the measure.
Inclusion/Exclusion Country Date in Date out Inclusion Entire world - Description
- All countries
-
Applied by Rwanda on the entire world for
The measure came into effect on 15 August 2008
Non-Tariff Measure
- NTM classification
- B83: Certification requirement
- Date when the measure came into force
- 15 August 2008
- Publication where the measure is specified
- Ministerial Order Nº006/2008 Of 15/08/2008
- Regulation where the measure is specified
- Ministerial Order Nº006/2008 Of 15/08/2008 Regulating The Importation And Exportation Of Ozone Layer Depleting Substances Products And Equipment Containing Such Substances
- Country/Region applying the measure
- Rwanda
- The rationale of the measure
- The present Order shall regulate imports, exports and reexports of substances that deplete the Ozone Layer abbreviated as ODS, products and equipment containing such substances.
- Coded list of objectives
- X: For purposes n.e.s.
- Description of the measure
- The Ozone depleting substances should be accompanied with a certificate of origin
- Reference of the measure
- Art 11
- Measure also domestic
- No
Products affected by the measure.
Code Product Partial coverage Partial coverage indication Date in Date out PG: 36 Ozone-depleting substances Yes Annex 1 CFC-11 CFC-12 CFC-113 CFC-115 CFC-114 Halon-1211 Halon-1301 Halon-2402 Annex 2 CFC-13 CFC-111 CFC-112 CFC-211 CFC-212 CFC-213 CFC- 214 CFC-215 CFC-216 CFC-217 Carbon tetra chloride methyl chloroform or 1,1,1-trichloroethane Annex III HCFC-21 (3) HCFC-22 (3) HCFC-31 HCFC-121 HCFC-122 HCFC-123 (3) HCFC-124 (3) HCFC-131 HCFC-132 HCFC-133 HCFC-141 HCFC-141b (3) HCFC-142 HCFC-142b (3) HCFC-151 HCFC-221 HCFC-222 HCFC-223 HCFC-224 HCFC-225 HCFC-225ca (3) HCFC-225cb HCFC-226 HCFC-231 HCFC-232 HCFC-233 HCFC-234 HCFC-235 HCFC-241 HCFC-242 HCFC-243 HCFC-244 HCFC-251 HCFC-252 HCFC-253 HCFC-261 HCFC-262 HCFC-271 HBFC – 22B1 - Description
- Annex 1
CFC-11
CFC-12
CFC-113
CFC-115
CFC-114
Halon-1211
Halon-1301
Halon-2402
Annex 2
CFC-13
CFC-111
CFC-112
CFC-211
CFC-212
CFC-213
CFC- 214
CFC-215
CFC-216
CFC-217
Carbon tetra chloride
methyl chloroform or 1,1,1-trichloroethane
Annex III
HCFC-21 (3)
HCFC-22 (3)
HCFC-31
HCFC-121
HCFC-122
HCFC-123 (3)
HCFC-124 (3)
HCFC-131
HCFC-132
HCFC-133
HCFC-141
HCFC-141b (3)
HCFC-142
HCFC-142b (3)
HCFC-151
HCFC-221
HCFC-222
HCFC-223
HCFC-224
HCFC-225
HCFC-225ca (3)
HCFC-225cb
HCFC-226
HCFC-231
HCFC-232
HCFC-233
HCFC-234
HCFC-235
HCFC-241
HCFC-242
HCFC-243
HCFC-244
HCFC-251
HCFC-252
HCFC-253
HCFC-261
HCFC-262
HCFC-271
HBFC – 22B1
Countries/Regions affected by the measure.
Inclusion/Exclusion Country Date in Date out Inclusion Entire world - Description
- All countries
-
Applied by Rwanda on the entire world for
The measure came into effect on 15 February 2012
Non-Tariff Measure
- NTM classification
- B83: Certification requirement
- Date when the measure came into force
- 15 February 2012
- Publication where the measure is specified
- Official Gazette n° 15 0f 09/04/2012
- Regulation where the measure is specified
- Law N°03/2012 Of 15/02/2012 Governing Narcotic Drugs, Psychotropic Substances And Precursors In Rwanda
- Country/Region applying the measure
- Rwanda
- The rationale of the measure
- This Law regulates the production, processing, distribution and use of narcotic drugs, psychotropic substances and precursors in Rwanda.
- Coded list of objectives
- X: For purposes n.e.s.
- Description of the measure
- Import and export shall be subjected to the acquisition of a certificate issued by the Minister in charge of health. The certificate shall not be necessary in case of disaster.
The certificate shall indicate:
1º the names and addresses of the importer, the exporter and the recipient if he/she is
known;
2º the common international denomination (CID) of each substance and in case of
absence of such a denomination, the determination of the substance in the international convention tables;
3º its pharmaceutical form and, if it is a preparation, its trade mark if any;
4º the quantity of each substance and preparation concerned by the transaction;
5º the period during which this operation must take place;
6º the transport or shipping means;
7º the place of entry at the border on the national territory.
The import certificate for narcotic drugs and psychotropic substances shall specify if the import
is being done once or many times.
The export certificate for narcotic drugs and psychotropic substances shall indicate the number and the date of the import certificate issued by the country or the region that imported them. - Reference of the measure
- Art 10
- Measure also domestic
- No
Products affected by the measure.
Code Product Partial coverage Partial coverage indication Date in Date out PG: 37 Narcotic drugs and psychotropic substances No - Description
- Narcotic drugs and psychotropic substances
Narcotic drugs
a. Table I: includes the chemicals that result into a heavy addiction and lead to abuse.
b. Table II: includes chemicals that cause less addiction and result into less abuse than that of table I.
c. Table III: includes the preparation containing narcotics made for medical legitimate purposes and composed in such a manner that they are less susceptible to be an object of abuse and cannot easily produce a narcotic drug.
d. Table IV: includes certain narcotic drugs named in table I that are considered as particularly harmful due to their properties and their use.
Psychotropic substances
a. Table I: includes prohibited chemicals that are of no medical interest.
b. Table II: includes chemicals that are of medical interest subjected to strictness.
c. Table III: includes the chemicals that are of medical interest, subjected to normal control.
d. Table IV: includes some of narcotic drugs named in table I that are considered as particularly
harmful due to their properties and their use.
Countries/Regions affected by the measure.
Inclusion/Exclusion Country Date in Date out Inclusion Entire world - Description
- All countries
-
Applied by Rwanda on the entire world for
The measure came into effect on 14 January 2013
Non-Tariff Measure
- NTM classification
- B83: Certification requirement
- Date when the measure came into force
- 14 January 2013
- Publication where the measure is specified
- Official Gazette n° Special of 17/01/2013
- Regulation where the measure is specified
- Law No47/2012 Of 14/01/2013 Relating To The Regulation And Inspection Of Food And Pharmaceutical Products
- Country/Region applying the measure
- Rwanda
- The rationale of the measure
- This Law relates to the regulation and inspection of food and pharmaceutical products.
- Coded list of objectives
- X: For purposes n.e.s.
- Description of the measure
- The registration of activities and premises shall be proven by a certificate issued by a competent organ. An Order of the Minister shall determine modalities for registration of premises.
- Reference of the measure
- Art 3 paragraph 2
- Measure also domestic
- No
Products affected by the measure.
Code Product Partial coverage Partial coverage indication Date in Date out PG: 7 Food products No PG: 22 Cosmetics No PG: 23 Medicines No PG: 24 Medicines for human use No PG: 26 Medical devices No PG: 1 All products Yes Poisonous product - Description
- Food, pharmaceutical products, medical devices, poisonous product, cosmetics, herbal medicines and any other health commodities.
Countries/Regions affected by the measure.
Inclusion/Exclusion Country Date in Date out Inclusion Entire world - Description
- All countries
-
Applied by Tanzania on the entire world
The measure came into effect on 31 July 2015
Non-Tariff Measure
- NTM classification
- B83: Certification requirement
- Date when the measure came into force
- 31 July 2015
- Publication where the measure is specified
- The Tanzania Food, Drugs and Cosmetics (Registration of Premises, Importation and Exportation of Pharmaceutical Products and Raw Materials) Regulations, 2015 GN. No. 312
- Regulation where the measure is specified
- Tanzania Food, Drugs and Cosmetics (Importation and Exportation of Pharmaceutical Products and Raw materials) Regulations, 2015.
- Country/Region applying the measure
- Tanzania
- Coded list of objectives
- A: Protection of human life and health
- Description of the measure
- 18.-(1) Subject to other conditions relating to import permit set in these Regulations, import permit for controlled drugs shall be issued together with the controlled drugs import certificate.
(2) The certificate referred to in sub regulation (1) shall be valid for nine (9) months. - Reference of the measure
- Part III Regulation 18
- Measure also domestic
- No
Products affected by the measure.
- Description
- Narcotic drugs
Countries/Regions affected by the measure.
Inclusion/Exclusion Country Date in Date out Inclusion Entire world -
Applied by Tanzania on the entire world
The measure came into effect on 31 July 2015
Non-Tariff Measure
- NTM classification
- B83: Certification requirement
- Date when the measure came into force
- 31 July 2015
- Publication where the measure is specified
- The Tanzania Food, Drugs and Cosmetics (Registration of Premises, Importation and Exportation of Pharmaceutical Products and Raw Materials) Regulations, 2015 GN. No. 312
- Regulation where the measure is specified
- Tanzania Food, Drugs and Cosmetics (Importation and Exportation of Pharmaceutical Products and Raw materials) Regulations, 2015.
- Country/Region applying the measure
- Tanzania
- Coded list of objectives
- A: Protection of human life and health
- Description of the measure
- 18.-(1) Subject to other conditions relating to import permit set in these Regulations, import permit for controlled drugs shall be issued together with the controlled drugs import certificate.
(2) The certificate referred to in sub regulation (1) shall be valid for nine (9) months. - Reference of the measure
- Part III Regulation 18
- Measure also domestic
- No
Products affected by the measure.
- Description
- Psychotropic substances or precursors
Countries/Regions affected by the measure.
Inclusion/Exclusion Country Date in Date out Inclusion Entire world -
Applied by Tanzania on the entire world
The measure came into effect on 31 July 2015
Non-Tariff Measure
- NTM classification
- B83: Certification requirement
- Date when the measure came into force
- 31 July 2015
- Publication where the measure is specified
- The Tanzania Food, Drugs and Cosmetics (Registration of Premises, Importation and Exportation of Pharmaceutical Products and Raw Materials) Regulations, 2015 GN. No. 312
- Regulation where the measure is specified
- Tanzania Food, Drugs and Cosmetics (Importation and Exportation of Pharmaceutical Products and Raw materials) Regulations, 2015.
- Country/Region applying the measure
- Tanzania
- Coded list of objectives
- A: Protection of human life and health and B: Protection of life and health of animals
- Description of the measure
- 24.- (1) An application for importation of investigational medicinal products shall be made by a clinical trial sponsor or Principal investigator for a study approved to be conducted in Tanzania.
(2) Subject to sub regulation (1), the application shall be accompanied by Clinical Trial Approval Letter issued by the Authority. - Reference of the measure
- Part III Regulation 24 (2)
- Measure also domestic
- No
Products affected by the measure.
- Description
- Medicinal products
Countries/Regions affected by the measure.
Inclusion/Exclusion Country Date in Date out Inclusion Entire world -
Applied by Tanzania on the entire world
The measure came into effect on 31 July 2015
Non-Tariff Measure
- NTM classification
- B83: Certification requirement
- Date when the measure came into force
- 31 July 2015
- Publication where the measure is specified
- The Tanzania Food, Drugs and Cosmetics (Registration of Medicinal Products) Regulations, 2015 ; GN. No. 314
- Regulation where the measure is specified
- The Tanzania Food, Drugs and Cosmetics (Registration of Medicinal Products) Regulations, 2015
- Country/Region applying the measure
- Tanzania
- Coded list of objectives
- A: Protection of human life and health
- Description of the measure
- 5.-(1) Every application for registration of a medicinal product shall be made in hard and electronic copies and shall be accompanied by the following:
(e) an original Certificate of Pharmaceutical Product (WHO Format) on official papers of the issuing competent authority; - Reference of the measure
- Regulation 5 (1)(e)
- Measure also domestic
- No
Products affected by the measure.
- Description
- Medicinal products
Countries/Regions affected by the measure.
Inclusion/Exclusion Country Date in Date out Inclusion Entire world -
Applied by Tanzania on the entire world
The measure came into effect on 26 January 2007
Non-Tariff Measure
- NTM classification
- B83: Certification requirement
- Date when the measure came into force
- 26 January 2007
- Publication where the measure is specified
- The Zanzibar Food, Drugs and Cosmetics ACT, NO.2 OF 2006
- Regulation where the measure is specified
- The Zanzibar Food, Drugs and Cosmetics Act 2006
- Country/Region applying the measure
- Tanzania
- Coded list of objectives
- A: Protection of human life and health
- Description of the measure
- 62 (2) Subject to the provisions of this Part, no person shall, in the course of a business carried on by him:
(b) procure, import, manufacture or assemble any drugs, medical devices or herbal drugs for sale or supply for the purpose of clinical trial unless:ii) a ''Certificate'' for the purpose of this section (in this Act referred to as a ''Clinical Trial
Certificate'') has been issued in writing to him certifying that, subject to the conditions of the certificate, the Board authorized the clinical trial in question and that a certificate is for the time being valid and the trial is to be carried out in accordance with that certificate or instruction issued in writing by the Registrar. - Reference of the measure
- Part IV Regulation 62 (2) (b) (ii)
- Measure also domestic
- Yes
Products affected by the measure.
- Description
- Drugs
Countries/Regions affected by the measure.
Inclusion/Exclusion Country Date in Date out Inclusion Entire world -
Applied by Tanzania on the entire world
The measure came into effect on 26 January 2007
Non-Tariff Measure
- NTM classification
- B83: Certification requirement
- Date when the measure came into force
- 26 January 2007
- Publication where the measure is specified
- The Zanzibar Food, Drugs and Cosmetics ACT, NO.2 OF 2006
- Regulation where the measure is specified
- The Zanzibar Food, Drugs and Cosmetics Act 2006
- Country/Region applying the measure
- Tanzania
- Coded list of objectives
- A: Protection of human life and health
- Description of the measure
- 62 (2) Subject to the provisions of this Part, no person shall, in the course of a business carried on by him:
(b) procure, import, manufacture or assemble any drugs, medical devices or herbal drugs for sale or supply for the purpose of clinical trial unless:ii) a ''Certificate'' for the purpose of this section (in this Act referred to as a ''Clinical Trial
Certificate'') has been issued in writing to him certifying that, subject to the conditions of the certificate, the Board authorized the clinical trial in question and that a certificate is for the time being valid and the trial is to be carried out in accordance with that certificate or instruction issued in writing by the Registrar. - Reference of the measure
- Part IV Regulation 62 (2) (b) (ii)
- Measure also domestic
- Yes
Products affected by the measure.
- Description
- Medical devices
Countries/Regions affected by the measure.
Inclusion/Exclusion Country Date in Date out Inclusion Entire world -
Applied by Tanzania on the entire world
The measure came into effect on 26 January 2007
Non-Tariff Measure
- NTM classification
- B83: Certification requirement
- Date when the measure came into force
- 26 January 2007
- Publication where the measure is specified
- The Zanzibar Food, Drugs and Cosmetics ACT, NO.2 OF 2006
- Regulation where the measure is specified
- The Zanzibar Food, Drugs and Cosmetics Act 2006
- Country/Region applying the measure
- Tanzania
- Coded list of objectives
- A: Protection of human life and health
- Description of the measure
- 62 (2) Subject to the provisions of this Part, no person shall, in the course of a business carried on by him:
(b) procure, import, manufacture or assemble any drugs, medical devices or herbal drugs for sale or supply for the purpose of clinical trial unless:ii) a ''Certificate'' for the purpose of this section (in this Act referred to as a ''Clinical Trial
Certificate'') has been issued in writing to him certifying that, subject to the conditions of the certificate, the Board authorized the clinical trial in question and that a certificate is for the time being valid and the trial is to be carried out in accordance with that certificate or instruction issued in writing by the Registrar. - Reference of the measure
- Part IV Regulation 62 (2) (b) (ii)
- Measure also domestic
- Yes
Products affected by the measure.
- Description
- Herbal drugs
Countries/Regions affected by the measure.
Inclusion/Exclusion Country Date in Date out Inclusion Entire world -
Applied by Tanzania on the entire world for 3808: Insecticides, rodenticides, fungicides, herbicides, anti-sprouting products and plant-growth regulators, disinfectants and similar products, put up in forms or packings for retail sale or as preparations or articles (for example, sulphur-treated bands, wi
The measure came into effect on 01 January 1984
Non-Tariff Measure
- NTM classification
- B83: Certification requirement
- Date when the measure came into force
- 01 January 1984
- Publication where the measure is specified
- Pestcides control regulations. The united republic of Tanzania, The pestcides control regulations . 1984
- Regulation where the measure is specified
- The pesticides control regulations, 1984
- Country/Region applying the measure
- Tanzania
- Coded list of objectives
- B: Protection of life and health of animals
- Description of the measure
- 22. Licensing authorities shall only issue trading licences to persons intending to carry out pesticide business including manufactures, distributors, formulators, fumigators, and other pest controllers, etc after such persons have produced a written approval or registration certificate from the Registrar
- Reference of the measure
- Section 22
- Measure also domestic
- Yes
Products affected by the measure.
Code Product Partial coverage Partial coverage indication Date in Date out 3808 Insecticides, rodenticides, fungicides, herbicides, anti-sprouting products and plant-growth regulators, disinfectants and similar products, put up in forms or packings for retail sale or as preparations or articles (for example, sulphur-treated bands, wi Yes pesticide - Description
- pesticide
Countries/Regions affected by the measure.
Inclusion/Exclusion Country Date in Date out Inclusion Entire world 01 January 1984 - Description
- All countries
-
Applied by Tanzania on the entire world
The measure came into effect on 05 April 2003
Non-Tariff Measure
- NTM classification
- B83: Certification requirement
- Date when the measure came into force
- 05 April 2003
- Publication where the measure is specified
- Industrial and Consumer ( Chemicals Management and Control ) Act , 2003
- Regulation where the measure is specified
- Industrial and Consumer Chemicals Short (Management and Control) Act, 2003,
- Country/Region applying the measure
- Tanzania
- Coded list of objectives
- A: Protection of human life and health and E: Protection of the environment
- Description of the measure
- 29.-(I) No person shall produce, import, export, store, transport or deal in chemicals without a certificate and subject to such conditions as may be prescribed.
32.-(I) No person shall use or shall be found in Possession of a chemical, which has been registered under section 29 without a certificate Use of restricted chemicals issued by the Registrar. - Reference of the measure
- Part III Regulations 29 (1); 32(1)
- Measure also domestic
- Yes
Products affected by the measure.
- Description
- Chemicals
Countries/Regions affected by the measure.
Inclusion/Exclusion Country Date in Date out Inclusion Entire world -
Applied by Tanzania on the entire world
The measure came into effect on 21 October 2011
Non-Tariff Measure
- NTM classification
- B83: Certification requirement
- Date when the measure came into force
- 21 October 2011
- Publication where the measure is specified
- GOVERNMENT NOTICE NO. 350 , The Fertiliser Act CAP 378
- Regulation where the measure is specified
- Fertiliser Regulations , 2011
- Country/Region applying the measure
- Tanzania
- Coded list of objectives
- X: For purposes n.e.s.
- Description of the measure
- 48 (7)Any imported fertilizer or fertilizer supplement shall be accompanied by certificate of quality issued by a
Recognized Certification Authority of country of origin of the exporter of fertilizer or fertilizer supplement.
(8) Where an import consignment of risk materials of animal origin is to be imported, an additional Quality Assurance Certificate from relevant authority of exporting country shall accompany the application form and approved by the Director of Veterinary Services. - Reference of the measure
- Part VIII Regulation 48( 7; 8)
- Measure also domestic
- No
Products affected by the measure.
- Description
- Fertilizer
Countries/Regions affected by the measure.
Inclusion/Exclusion Country Date in Date out Inclusion Entire world -
Applied by Tanzania on the entire world
The measure came into effect on 21 October 2011
Non-Tariff Measure
- NTM classification
- B83: Certification requirement
- Date when the measure came into force
- 21 October 2011
- Publication where the measure is specified
- GOVERNMENT NOTICE NO. 350 , The Fertiliser Act CAP 378
- Regulation where the measure is specified
- Fertiliser Regulations , 2011
- Country/Region applying the measure
- Tanzania
- Coded list of objectives
- X: For purposes n.e.s.
- Description of the measure
- 48 (7)Any imported fertilizer or fertilizer supplement shall be accompanied by certificate of quality issued by a
Recognized Certification Authority of country of origin of the exporter of fertilizer or fertilizer supplement.
(8) Where an import consignment of risk materials of animal origin is to be imported, an additional Quality Assurance Certificate from relevant authority of exporting country shall accompany the application form and approved by the Director of Veterinary Services. - Reference of the measure
- Part VIII Regulation 48( 7; 8)
- Measure also domestic
- No
Products affected by the measure.
- Description
- Fertilizer supplement
Countries/Regions affected by the measure.
Inclusion/Exclusion Country Date in Date out Inclusion Entire world -
Applied by Tanzania on the entire world
The measure came into effect on 03 July 2015
Non-Tariff Measure
- NTM classification
- B83: Certification requirement
- Date when the measure came into force
- 03 July 2015
- Publication where the measure is specified
- The Tanzania Food, Drugs and Cosmetics ACT, 2003
- Regulation where the measure is specified
- Tanzania, Food, Drugs and Cosmetics (Control of Medical Devices) Regulations, 2015
- Country/Region applying the measure
- Tanzania
- Coded list of objectives
- A: Protection of human life and health
- Description of the measure
- 54 (2) Subject to sub regulation (1), applications shall be accompanied by Clinical Trial Approval Letter issued by the Authority.
- Reference of the measure
- Part V Regulation 54 (2)
- Measure also domestic
- No
Products affected by the measure.
- Description
- Medical devices
Countries/Regions affected by the measure.
Inclusion/Exclusion Country Date in Date out Inclusion Entire world -
Applied by Uganda on the entire world for 8517: Telephone sets, including telephones for cellular networks or for other wireless networks; other apparatus for the transmission or reception of voice, images or other data, including apparatus for communication in a wired or wireless network (such as a lo
The measure came into effect on 01 January 2005
Non-Tariff Measure
- NTM classification
- B83: Certification requirement
- Date when the measure came into force
- 01 January 2005
- Publication where the measure is specified
- STATUTORY INSTRUMENTSSTATUTORY INSTRUMENTS SUPPLEMENT No. 10 11th March, 2005 STATUTORY INSTRUMENTS SUPPLEMENT to The Uganda Gazette No. 14 Volume XCVIII dated 11th March, 2005 Printed by UPPC, Entebbe, by Order of the Government
- Regulation where the measure is specified
- The Communications (Telecommunications and radio communicatons equipmnt type approval)Regulations 2005 ( Under section 94 of the Uganda communications Act,cap 106
- Country/Region applying the measure
- Uganda
- The rationale of the measure
- to set technical standards of telecommunications and radio communications equipment;
- Coded list of objectives
- X: For purposes n.e.s.
- Description of the measure
- 12.Certification of equipment
(1) A telecommunications or radio communications equipment may receive a certification or equipment authorisation issued by the Commission, based on representations and test data submitted by an applicant.
(2) A grantee of an equipment authorisation shall guarantee and give a warrant that each unit of equipment marketed under the grant and bearing the identification specified in the grant shall, conform to the unit that was measured and that the data, including the design and rated operational characteristics, filed with the application for certification, continues to be representative of the equipment produced under the grant within a variation that can be expected due to quantity production and testing on a statistical basis.
(3) The Commission may require an applicant to submit a sample unit for measurement at the Commission’s laboratory or at any other place as the Commission may specify.
(4) Where the applicant believes that shipment of a sample to the Commission’s laboratory is impractical because of the size or weight of the equipment, the power requirement or for any other reason, the applicant may submit a written statement explaining why the shipment is impractical and should not be required.
(5) The Commission may from time to time request a party responsible for any equipment, to submit the equipment to determine the extent to which subsequent production of the equipment continues to comply with the data filed by an applicant or data kept on file with that party, subject to a declaration of conformity.
(6) Any measurement procedure acceptable to the Commission may be used to prepare data demonstrating compliance.
(7) Information on measurement submitted to the Commission shall identify the specific standard or measurement procedure used.
(8) A party making measurements of equipment that is subject to equipment authorization, whether the measurements are filed with the Commission or kept on file by the party responsible for the compliance of the equipment, shall compile a description of the measurement facilities employed.
(9) A description of measurement facilities shall contain—
(a)the location of a test site;
(b)physical description of a test site, accompanied by photographs;
(c)a drawing showing the dimensions of a test site, the physical layout of all supporting structures and all structures within five times the distance between a measuring antenna and a device which is measured;
(d) a description of structures used to support a device which is measured and the test instrumentation;
(e) a list of measuring equipment used;
(f) information concerning the calibration of the measuring equipment, including the date the equipment was last calibrated and how often the equipment is calibrated;
(g)where desired, a statement on whether a test site is available to do measurement services for the public at a fee.
(10) Each equipment covered in an application for equipment authorisation shall bear a name plate or label with a Commission identifier.
(11) A name-plate or label shall be permanently affixed to an equipment and shall be readily visible to a purchaser at the time of purchase.
(12) A grant of equipment authorisation is valid only where the Commission identifier is permanently affixed to the device and remains effective until it is revoked, withdrawn, rescinded, surrendered, or where a termination date is specified by the Commission.
(13) A grantee of equipment authorisation shall be responsible to the Commission, for any equipment produced using the authorisation.
(14) Certification attaches to any equipment subsequently marketed by an authorised person, which is identical to the tested sample
18.Labelling requirements
(1) A manufacturer or importer of specified customer equipment or specified customer cabling shall apply on the equipment or cabling, a label that indicates that the equipment or cabling meets the prescribed standards.
(2) Before a label is applied on any equipment or cabling, the following requirements shall be complied with—
(a)the manufacturer or importer shall obtain certification from the Commission, that the equipment or cabling complies with the prescribed standard;
(b)the equipment or cabling shall be tested by a recognised testing authority, for compliance with the prescribed standards;
(c)a manufacturer or importer shall—
(i) conduct quality assurance programs;
(ii) be satisfied that quality assurance programs are conducted; and
(iii) have regard to the results of quality assurance programs;
(d) a manufacturer or importer shall obtain certification from the Commission that reasonable efforts have been made to comply with the specified standards; and
(e)a manufacturer or importer shall make a written declaration in relation to the equipment or cabling - Reference of the measure
- Section 12(14), 18(2)a,d
- Measure also domestic
- Yes
Products affected by the measure.
Code Product Partial coverage Partial coverage indication Date in Date out 8517 Telephone sets, including telephones for cellular networks or for other wireless networks; other apparatus for the transmission or reception of voice, images or other data, including apparatus for communication in a wired or wireless network (such as a lo No - Description
- A telecommunications or radio communications equipment
Countries/Regions affected by the measure.
Inclusion/Exclusion Country Date in Date out Inclusion Entire world 01 January 2005 - Description
- All countries
B83: Certification requirement
