20.4 At the port of entry, consignments of pharmaceutical products should be stored under suitable conditions for as
short a time as possible.
20.5 All reasonable steps should be taken by importers to ensure that products are not mishandled or exposed to adverse storage conditions at wharves or airports.
This Uganda Standard specifies the Quality requirements, Labelling, transportation, packaging and storage methods of sampling and test for polyamines used for water treatment intended for human consumption.
This standard specifies the Quality requirements, Labelling, transportation, packaging and storage methods of sampling and test for sodium hypochlorite solution used for disinfection of water intended for human consumption.
Reference of the measure
US 925:2012
Measure also domestic
Yes
Products affected by the measure.
Description
sodium hypochlorite solution used for disinfection of water intended for human consumption.
A: Protection of human life and health and E: Protection of the environment
Description of the measure
91. Unpackaged shipments.
(1) An authorised person shall ensure that unpacked radioactive materials are transported under the following conditions—
(a) LSA-I and SCO-I may be transported unpackaged under exclusive use provided that all unpackaged material other than ores containing only naturally occurring radionuclides shall be transported in such a manner that under routine conditions of transport, there shall be no escape of the radioactive contents from the conveyance nor shall there be any loss of shielding;
(b) exclusive use is not required for SCO-I shipments where contamination on the accessible and the inaccessible surfaces is not greater than ten times the levels specified in regulation 94;
(c) for SCO-I shipments where it is suspected that non-fixed contamination exists on inaccessible surfaces in excess of ten times the levels specified in regulation 94, measures shall be taken to ensure that radioactive material is not released into the conveyance.
100. Loading and segregation.
(1) The following conditions for loading and segregation shall apply to all consignments—
(a) radioactive consignments shall be segregated from other dangerous goods during transport; and
(b) radioactive material shall be segregated from undeveloped photographic film so that the radiation exposure of film due to the transport of radioactive material is limited to 0.1mSv per consignment of such film.
(2) Where a consignment is to be transported, not under exclusive use, the following conditions shall apply—
(a) the consignment shall not include any package or overpack having a transport index greater than ten;
(b) the loading of freight containers and the accumulation of packages, overpacks and freight containers aboard a single conveyance shall be limited so that the total sum of the transport indexes aboard the conveyance does not exceed the values shown in the IAEA Safety Standards Series no. TS-R-1; and
(c) the loading of freight containers and the accumulation of packages, overpacks and freight containers aboard a single
conveyance shall be such that the radiation level under routine conditions of transport shall not exceed 2mSv/h at any point on, and 0.1 mSv/h at 2m from, the external surface of the conveyance.
(3) Where a consignment is to be transported under exclusive use there is no limit on the sum of transport indexes, but radiation levels shall be controlled as follows—
(a) for road and rail consignments under exclusive use the radiation level shall not exceed10mSv/h at any point on the
external surface of any package or overpack, and may only exceed 2mSv/h provided that—
(i) the vehicle is equipped with an enclosure which, during routine conditions of transport, prevents the access of unauthorized persons to the interior of the enclosure,
(ii) provisions are made to secure the package or overpack, so that its position within the vehicle remains fixed during routine conditions of transport, and
(iii) there is no loading or unloading during the shipment;
(b) 2mSv/h at any point on the outer surfaces of the vehicle, including the upper and lower surfaces, or, in the case of an open vehicle, at any point on the vertical planes projected from the outer edges of the vehicle, on the upper surface of the load, and on the lower external surface of the vehicle; or
(c) 0.1 mSv/h at any point 2m from the vertical planes represented by the outer lateral surfaces of the vehicle, or, if the load is transported in an open vehicle, at any point, 2m from the vertical planes projected from the outer edges of the vehicle.
103. Storage and dispatch.
Consignments of radioactive material shall be stored and dispatched as follows—
(a) segregation shall be required while in transit of dangerous goods from persons and undeveloped photographic films and plates;
(b) a package or overpack may be stored among packaged general cargo without any special storage provisions except as may be specifically required by the council provided the average surface heat flux does not exceed 15W/m2 and that the immediate surrounding cargo is not in sacks or bags; and
(c) any provisions in the certificates and any relevant perusal and preshipment requirements shall be observed.
This specification covers requirements for disinfectants and detergent-disinfectants intended for use on inanimate surfaces.
Coded list of objectives
X: For purposes n.e.s.
Description of the measure
3.2.6 Storage facilities for packaging materials
Containers, closures, cartons and labels for the packing and packaging of the disinfectant of detergent- disinfectant shall be stored in clean, reasonably dustproof, dry storage facilities.
3.2.7 Storage facilities for finished disinfectants or detergent-disinfectants
Finished disinfectants or detergent-disinfectants awaiting dispatch shall be stacked, but not direct upon the floor, in well-ventilated storage facilities. A separate quarantine area shall be provided for the storage of rejected materials.
Reference of the measure
Regulation 3.2.6 and 3.2.7
Measure also domestic
Yes
Products affected by the measure.
Code
Product
Partial coverage
Partial coverage indication
Date in
Date out
3808.94
-- Disinfectants
Yes
Disinfectants and detergent-disinfectants intended for use on inanimate surfaces.
Description
disinfectants and detergent-disinfectants intended for use on inanimate surfaces.
1.1 This specification covers requirements for the construction, fittings and pre-installation and post- installation performance of class I, class li and class III microbiological safety cabinets (also known as biological safety cabinets) intended to protect the operator and the environment from hazardous microbiological materials and (if so required by the customer or user or both), organic toxins and non-corrosive volatile organic agents.
NOTE - Microbiological safety cabinets are not intended to provide protection against corrosive chemical or radioactive materials.
1 .2 The specification does not cover the actual design of a safety cabinet and in no way restricts new design, provided that a microbiological safety cabinet of a new design complies with the requirements for materials, reliability, performance and safety given in this specification.
NOTE - Microbiological safety cabinets of class I, class II and class III should not be confused with laminar flow
clean workstations that usually discharge horizontally and vertically towards the operator and that do not provide
protection for an operator, but can even increase exposure to airborne hazards.
Coded list of objectives
X: For purposes n.e.s.
Description of the measure
5.1 Transport
The cabinet and its components shall be so transported and installed that damage to any part of the cabinet is prevented and the integrity of the cabinet is ensured.
Reference of the measure
Regulation 5.1
Measure also domestic
Yes
Products affected by the measure.
Code
Product
Partial coverage
Partial coverage indication
Date in
Date out
8414.80
- Other
Yes
Microbiological safety cabinets (classes I, II And II
Description
Microbiological safety cabinets (classes I, II And III)
12. (1) The Management Directorate shall grant an export permit if the following conditions are met:
(b) the Management Directorate is satisfied that any living specimen will be prepared and shipped in accordance with the most recent edition of the Live Animals Regulations of the International Air Transport Association, regardless of the mode of transport, so as to safeguard the general well-being of the specimen and minimize the risk of injury to the specimen;
A: Protection of human life and health and E: Protection of the environment
Description of the measure
After conventional storage under normal conditions for a period of 6 months after date of receipt, the petrol shall still comply with the requirements of this standard.
A: Protection of human life and health and E: Protection of the environment
Description of the measure
Filled containers shall always be handled, transported, used and stored in a secured, upright position except for containers that are designed to be handled, transported, used and stored in the horizontal position
Applied by Zimbabwe on the entire world for 2914.11.00: Acetone, 2915.24.00: Acetic anhydride, 2922.43.00: Anthranilic acid and its salts, 2939.41.00: Ephedrine and its salts, 2939.61.00: Ergometrine (inn) and its salts, 2806.10.00: Hydrogen chloride (hydrochloric acid), 2807.00.00: Sulphuric acid; oleu, 2932.94.00: Safrole, 2939.42.00: Pseudoephedrine (inn) and its salts and 2841.61.00: Potassium permanganate
Applied by Zimbabwe on the entire world for 2933.53.00: Allobarbital (inn),amobarbital (inn),barbital (inn), butalbital (inn), butobarbital, clobarbital (inn), methylphenobarbital (inn), pentobarbital (inn),phenobarbital (inn),secbutabarbital (inn), secobarbital (inn) and vinylbital (inn); salts there
72A. (1) Any person who wishes to
(a) import a psychotropic substance shall submit an application to the Director-General in Form M.C. 10A;
(b) export a psychotropic substance shall submit an application to the Director-General in Form M.C. 10B.
(2) Any person who imports or exports a psychotropic substance shall, for every import and export, as the case may be, whether such import or export consists of one or more substances, obtain a separate licence from the Authority for such importation or exportation.
(3) An import or export licence granted by the Authority shall state—
(a) the name and address of the importer or exporter, as the case may be;
(b) the international non-proprietary name of the psychotropic substance or if there is no such name, the appropriate name set out in Part I of the Eighth A Schedule;
(c) the quantity to be exported or imported;
(d) the pharmaceutical form;
(e) the period within which the import or export shall be effected;
(f) where the substance is imported or exported in the form of a preparation, the name of the preparation;
(4) An export licence shall state—
(a) the number and date of the import authorization; and
(b) the authority by whom it is issued.
(5) No export licence shall be granted in respect of a psychotropic substance by the Authority unless the exporter produces to the satisfaction of the Authority proof of an import authorization issued by a competent authority of the importing country confirming the approval of the proposed importation.
(6) A copy of the export licence shall accompany each consignment of a psychotropic substance, which is to be exported.
(7) Where any psychotropic substance is imported into Zimbabwe, the Director—General shall return authorization of the government of the exporting country and shall endorse on such authorization the amount of such substance, which has been actually imported.
(8) No psychotropic substance, which is in transit through Zimbabwe being exported from a destination outside Zimbabwe to another destination, shall be permitted to pass through Zimbabwe unless a copy of the export authorization is presented to and approved by the Director-General.
(9) Every consignment of a psychotropic substance whether imported or exported shall be accompanied by an export licence or similar authorization.
(10) Any consignment referred to in subsection (9) which is not accompanied by an export licence or similar authorization shall be detained by a customs officer until such licence or authorization is presented to and approved by the Director-General.
(11) No person shall mislabel any psychotropic substance intended for export.
(12) No psychotropic substance shall be imported or exported by ordinary or registered letter post.
(13) A licence granted by the Authority in term of subsection (1) shall –
(a) in the case of an import licence, be in Form M.C. 27;
(b) in the case of an export licence, be in Form M.C. 28.
A: Protection of human life and health and E: Protection of the environment
Description of the measure
The distances between an outside (open-air) storage area for containers and the nearest building, the boundary of the premises or other point of public gathering shall not be less than the appropriate minimum distances given in Table 7.
9. Deception
Any person who labels, packages, treats, processes, sells or advertises any drug in contravention of any regulations made under this Act, or in a manner that is false, misleading or deceptive as regards its character, constitution, value, potency, quality, composition, merit or safety, shall be guilty of an offence.
10. Standards of drugs
(1) Where a standard has been prescribed for a drug, any person who labels, packages, sells or advertises any substance in such a manner that it is likely to be mistaken for that drug shall be guilty of an offence unless the substance is the drug in question and complies with the prescribed standard.
(2) Where a standard has not been prescribed for a drug but a standard for the drug is contained in any of the publications specified in the Schedule, any person who labels, packages, sells or advertises any other substance or article in such a manner that it is likely to be mistaken for such drug shall be guilty of an offence.
(3) Any person who labels, packages, sells or advertises any drug for which no standard has been prescribed, or for which no standard is contained in any of the publications specified in the Schedule, shall be guilty of an offence unless such drug—
(a) is in accordance with the professed standard under which it is labelled, packaged, sold or advertised; and
(b) does not resemble, in a manner likely to deceive, any drug for which a standard has been prescribed or which is contained in any of the publications specified in the Schedule.
12. Preparation of drug under insanitary conditions
Any person who sells, prepares, preserves, packages, stores or conveys for sale any drug under insanitary conditions shall be guilty of an offence.
17. Deception
Any person who labels, packages, treats, processes, sells or advertises any device in contravention of any regulations made under this Act, or in a manner that is false, misleading or deceptive as regards its character, value, composition, merit or safety, shall be guilty of an offence.
Applied by Malawi on the entire world for 3003.10.00: Medicaments (excluding goods ofheading 30.02, 30.05 or 30.06)consisting of two or moreconstituents which have beenmixed together for therapeuticor prophylactic uses, not put upin measured doses or in forms orpackings for retail sale: Containing, 3003.20.00: Medicaments (excluding goods ofheading 30.02, 30.05 or 30.06)consisting of two or moreconstituents which have beenmixed together for therapeuticor prophylactic uses, not put upin measured doses or in forms orpackings for retail sale: Containing, 3003.31.00: Medicaments (excluding goods ofheading 30.02, 30.05 or 30.06)consisting of two or moreconstituents which have beenmixed together for therapeuticor prophylactic uses, not put upin measured doses or in forms orpackings for retail sale: Containing, 3003.39.00: Medicaments (excluding goods ofheading 30.02, 30.05 or 30.06)consisting of two or moreconstituents which have beenmixed together for therapeuticor prophylactic uses, not put upin measured doses or in forms orpackings for retail sale: Containing, 3003.40.00: Medicaments (excluding goods ofheading 30.02, 30.05 or 30.06)consisting of two or moreconstituents which have beenmixed together for therapeuticor prophylactic uses, not put upin measured doses or in forms orpackings for retail sale: Containing, 3003.90.00: Medicaments (excluding goods ofheading 30.02, 30.05 or 30.06)consisting of two or moreconstituents which have beenmixed together for therapeuticor prophylactic uses, not put upin measured doses or in forms orpackings for retail sale: Other, 3004.10.00: Medicaments (excluding goods ofheading 30.02, 30.05 or 30.06)consisting of mixed or unmixedproducts for therapeutic orprophylactic uses, put up inmeasured doses (including those inthe form of transdermaladministration systems) or in formsor pac, 3004.20.00: Medicaments (excluding goods ofheading 30.02, 30.05 or 30.06)consisting of mixed or unmixedproducts for therapeutic orprophylactic uses, put up inmeasured doses (including those inthe form of transdermaladministration systems) or in formsor pac, 3004.31.00: Medicaments (excluding goods ofheading 30.02, 30.05 or 30.06)consisting of mixed or unmixedproducts for therapeutic orprophylactic uses, put up inmeasured doses (including those inthe form of transdermaladministration systems) or in formsor pac, 3004.32.00: Medicaments (excluding goods ofheading 30.02, 30.05 or 30.06)consisting of mixed or unmixedproducts for therapeutic orprophylactic uses, put up inmeasured doses (including those inthe form of transdermaladministration systems) or in formsor pac, 3004.39.00: Medicaments (excluding goods ofheading 30.02, 30.05 or 30.06)consisting of mixed or unmixedproducts for therapeutic orprophylactic uses, put up inmeasured doses (including those inthe form of transdermaladministration systems) or in formsor pac, 3004.40.00: Medicaments (excluding goods ofheading 30.02, 30.05 or 30.06)consisting of mixed or unmixedproducts for therapeutic orprophylactic uses, put up inmeasured doses (including those inthe form of transdermaladministration systems) or in formsor pac, 3004.50.00: Medicaments (excluding goods ofheading 30.02, 30.05 or 30.06)consisting of mixed or unmixedproducts for therapeutic orprophylactic uses, put up inmeasured doses (including those inthe form of transdermaladministration systems) or in formsor pac, 3004.90.10: Medicaments (excluding goods ofheading 30.02, 30.05 or 30.06)consisting of mixed or unmixedproducts for therapeutic orprophylactic uses, put up inmeasured doses (including those inthe form of transdermaladministration systems) or in formsor pac, 3004.90.90: Medicaments (excluding goods ofheading 30.02, 30.05 or 30.06)consisting of mixed or unmixedproducts for therapeutic orprophylactic uses, put up inmeasured doses (including those inthe form of transdermaladministration systems) or in formsor pac, 3005.10.00: Wadding, gauze, bandages andsimilar articles (for example,dressings, adhesive plasters,poultices), impregnated or coatedwith pharmaceutical substances orput up in forms or packings forretail sale for medical, surgical,dental or veterinary purpo and 3005.90.00: Wadding, gauze, bandages andsimilar articles (for example,dressings, adhesive plasters,poultices), impregnated or coatedwith pharmaceutical substances orput up in forms or packings forretail sale for medical, surgical,dental or veterinary purpo
19. Importation of medicinal products with less than one-half of shelf-life
No person shall, without the prior written approval of the Board, import into Malawi any medicinal product which has less than one-half of its shelf-life remaining upon arrival in Malawi.
Reference of the measure
Article 19
Measure also domestic
No
Products affected by the measure.
Code
Product
Partial coverage
Partial coverage indication
Date in
Date out
3003.10.00
Medicaments (excluding goods ofheading 30.02, 30.05 or 30.06)consisting of two or moreconstituents which have beenmixed together for therapeuticor prophylactic uses, not put upin measured doses or in forms orpackings for retail sale: Containing
No
3003.20.00
Medicaments (excluding goods ofheading 30.02, 30.05 or 30.06)consisting of two or moreconstituents which have beenmixed together for therapeuticor prophylactic uses, not put upin measured doses or in forms orpackings for retail sale: Containing
No
3003.31.00
Medicaments (excluding goods ofheading 30.02, 30.05 or 30.06)consisting of two or moreconstituents which have beenmixed together for therapeuticor prophylactic uses, not put upin measured doses or in forms orpackings for retail sale: Containing
No
3003.39.00
Medicaments (excluding goods ofheading 30.02, 30.05 or 30.06)consisting of two or moreconstituents which have beenmixed together for therapeuticor prophylactic uses, not put upin measured doses or in forms orpackings for retail sale: Containing
No
3003.40.00
Medicaments (excluding goods ofheading 30.02, 30.05 or 30.06)consisting of two or moreconstituents which have beenmixed together for therapeuticor prophylactic uses, not put upin measured doses or in forms orpackings for retail sale: Containing
No
3003.90.00
Medicaments (excluding goods ofheading 30.02, 30.05 or 30.06)consisting of two or moreconstituents which have beenmixed together for therapeuticor prophylactic uses, not put upin measured doses or in forms orpackings for retail sale: Other
No
3004.10.00
Medicaments (excluding goods ofheading 30.02, 30.05 or 30.06)consisting of mixed or unmixedproducts for therapeutic orprophylactic uses, put up inmeasured doses (including those inthe form of transdermaladministration systems) or in formsor pac
No
3004.20.00
Medicaments (excluding goods ofheading 30.02, 30.05 or 30.06)consisting of mixed or unmixedproducts for therapeutic orprophylactic uses, put up inmeasured doses (including those inthe form of transdermaladministration systems) or in formsor pac
No
3004.31.00
Medicaments (excluding goods ofheading 30.02, 30.05 or 30.06)consisting of mixed or unmixedproducts for therapeutic orprophylactic uses, put up inmeasured doses (including those inthe form of transdermaladministration systems) or in formsor pac
No
3004.32.00
Medicaments (excluding goods ofheading 30.02, 30.05 or 30.06)consisting of mixed or unmixedproducts for therapeutic orprophylactic uses, put up inmeasured doses (including those inthe form of transdermaladministration systems) or in formsor pac
No
3004.39.00
Medicaments (excluding goods ofheading 30.02, 30.05 or 30.06)consisting of mixed or unmixedproducts for therapeutic orprophylactic uses, put up inmeasured doses (including those inthe form of transdermaladministration systems) or in formsor pac
No
3004.40.00
Medicaments (excluding goods ofheading 30.02, 30.05 or 30.06)consisting of mixed or unmixedproducts for therapeutic orprophylactic uses, put up inmeasured doses (including those inthe form of transdermaladministration systems) or in formsor pac
No
3004.50.00
Medicaments (excluding goods ofheading 30.02, 30.05 or 30.06)consisting of mixed or unmixedproducts for therapeutic orprophylactic uses, put up inmeasured doses (including those inthe form of transdermaladministration systems) or in formsor pac
No
3004.90.10
Medicaments (excluding goods ofheading 30.02, 30.05 or 30.06)consisting of mixed or unmixedproducts for therapeutic orprophylactic uses, put up inmeasured doses (including those inthe form of transdermaladministration systems) or in formsor pac
No
3004.90.90
Medicaments (excluding goods ofheading 30.02, 30.05 or 30.06)consisting of mixed or unmixedproducts for therapeutic orprophylactic uses, put up inmeasured doses (including those inthe form of transdermaladministration systems) or in formsor pac
No
3005.10.00
Wadding, gauze, bandages andsimilar articles (for example,dressings, adhesive plasters,poultices), impregnated or coatedwith pharmaceutical substances orput up in forms or packings forretail sale for medical, surgical,dental or veterinary purpo
No
3005.90.00
Wadding, gauze, bandages andsimilar articles (for example,dressings, adhesive plasters,poultices), impregnated or coatedwith pharmaceutical substances orput up in forms or packings forretail sale for medical, surgical,dental or veterinary purpo
This Law relates to the regulation and inspection of food and pharmaceutical products.
Coded list of objectives
A: Protection of human life and health
Description of the measure
No person shall manufacture, import, store, exhibit, sell or dispense cosmetics that:
1° contain or consist of substances likely to adversely affect health when used;
2° were manufactured, prepared, preserved or stored under unsanitary conditions.
Reference of the measure
Art 17 (2°)
Measure also domestic
No
Products affected by the measure.
Code
Product
Partial coverage
Partial coverage indication
Date in
Date out
PG: 22
Cosmetics
No
Description
Cosmetic products i.e any kind of products intended to be used by means of rubbing, pouring, steaming, sprinkling, spraying on or otherwise applied to the human body or any other part thereof for cleansing, beautifying, promoting attractiveness or altering the appearance. They also include any other product intended for use as a component of a product applied to the body with the exception of products intended for use in the diagnosis, treatment or prevention of diseases.
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