Draft Resolution no. 815, 01 June 2020

Distribution date: 26 June 2020 | Final date for Comment: 07 September 2020
This draft resolution establishes technical requirements for the labelling of medicines.
Products Covered: Antibiotics (HS code(s): 2941); Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3003); Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses "incl. those in the form of transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3004); Wadding, gauze, bandages and the like, e.g. dressings, adhesive plasters, poultices, impregnated or covered with pharmaceutical substances or put up for retail sale for medical, surgical, dental or veterinary purposes (HS code(s): 3005); Pharmaceutics (ICS code(s): 11.120)
Regulation Type: Regular notification
Draft Resolution no. 815, 01 June 2020

Distribution date: 26 June 2020 | Final date for Comment: 07 September 2020
This draft resolution establishes technical requirements for the labelling of medicines.
Products Covered: Antibiotics (HS code(s): 2941); Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3003); Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses "incl. those in the form of transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3004); Wadding, gauze, bandages and the like, e.g. dressings, adhesive plasters, poultices, impregnated or covered with pharmaceutical substances or put up for retail sale for medical, surgical, dental or veterinary purposes (HS code(s): 3005); Pharmaceutics (ICS code(s): 11.120)
Regulation Type: Regular notification
DUS 624:2020, Chrome-tanned bend outer sole leather — Specification, Second Edition.

Distribution date: 29 June 2020 | Final date for Comment: 28 August 2020
This draft Uganda standard specifies requirements, sampling and test methods for chrome tanned, wax impregnated bend outer sole leather.
Products Covered: Sole leather
Regulation Type: Regular notification
DUS 630:2020, Vegetable-tanned bend outer sole leather — Specification, Second Edition.

Distribution date: 29 June 2020 | Final date for Comment: 28 August 2020
This draft Uganda standard specifies requirements, sampling and methods of test for vegetable-tanned bend outer sole leather.
Products Covered: Sole leather
Regulation Type: Regular notification
DUS 624:2020, Chrome-tanned bend outer sole leather — Specification, Second Edition.

Distribution date: 29 June 2020 | Final date for Comment: 28 August 2020
This draft Uganda standard specifies requirements, sampling and test methods for chrome tanned, wax impregnated bend outer sole leather.
Products Covered: Sole leather
Regulation Type: Regular notification
Draft Normative Instruction no. 816, 01 June 2020

Distribution date: 29 June 2020 | Final date for Comment: 07 September 2020
This draft resolution establishes technical requirements for labelling of large-volume parenteral solutions, solutions for irrigation, dialysis, plasma expanders and small-volume parenteral solutions.
Products Covered: HS Code(s): 3003; 3004; 3005; 2941 (pharmaceutical products).
Regulation Type: Regular notification
Draft Normative Instruction no. 816, 01 June 2020

Distribution date: 29 June 2020 | Final date for Comment: 07 September 2020
This draft resolution establishes technical requirements for labelling of large-volume parenteral solutions, solutions for irrigation, dialysis, plasma expanders and small-volume parenteral solutions.
Products Covered: HS Code(s): 3003; 3004; 3005; 2941 (pharmaceutical products).
Regulation Type: Regular notification
Decreto Ejecutivo No. 490 de 4 de octubre de 2019, que reglamenta la Ley 90 de 26 de diciembre de 2017 sobre dispositivos médicos y productos afines, conforme fue modificada por la ley 92 de 12 de septiembre de 2019 (Executive Decree No. 490 of 4 October 2019 laying down regulations for Law No. 90 of 26 December 2017 on medical devices and related products, as amended by Law No. 92 of 12 September 2019) (27 pages, in Spanish)

Distribution date: 29 June 2020 | Final date for Comment: 13 May 2025
The notified Executive Decree lays down regulations for Law No. 90 of 2017, amended by Law No. 92 of 2019, which governs all aspects relating to the manufacturing, packaging, importation, exportation, re-exportation, information, advertising, labelling, distribution, marketing, storage, use and final disposal of medical devices and related products in Panama, including in vitro medical devices. In addition, it establishes the National Directorate for Medical Devices, which will be the authority responsible for regulating and monitoring medical devices and related products in Panama. It also regulates all aspects relating to operating licences; requirements for issuing, renewing, updating and correcting technical criteria certificates; the monitoring of medical devices; and fees and penalties.
Products Covered: Chapter 90, headings: 90.02; 90.03; 90.04; 90.10; 90.11; 90.12; 90.18; 90.19; 90.20; 90.21 and 90.22. Chapter 94, heading 94.02: Medical, surgical or dental furniture. Other headings: 94.02.10; 94.03.10; 25.20; 35.02; 34.07 and 30.06.
Regulation Type: Regular notification
Decreto Ejecutivo No. 490 de 4 de octubre de 2019, que reglamenta la Ley 90 de 26 de diciembre de 2017 sobre dispositivos médicos y productos afines, conforme fue modificada por la ley 92 de 12 de septiembre de 2019 (Executive Decree No. 490 of 4 October 2019 laying down regulations for Law No. 90 of 26 December 2017 on medical devices and related products, as amended by Law No. 92 of 12 September 2019) (27 pages, in Spanish)

Distribution date: 29 June 2020 | Final date for Comment: 13 May 2025
The notified Executive Decree lays down regulations for Law No. 90 of 2017, amended by Law No. 92 of 2019, which governs all aspects relating to the manufacturing, packaging, importation, exportation, re-exportation, information, advertising, labelling, distribution, marketing, storage, use and final disposal of medical devices and related products in Panama, including in vitro medical devices. In addition, it establishes the National Directorate for Medical Devices, which will be the authority responsible for regulating and monitoring medical devices and related products in Panama. It also regulates all aspects relating to operating licences; requirements for issuing, renewing, updating and correcting technical criteria certificates; the monitoring of medical devices; and fees and penalties.
Products Covered: Chapter 90, headings: 90.02; 90.03; 90.04; 90.10; 90.11; 90.12; 90.18; 90.19; 90.20; 90.21 and 90.22. Chapter 94, heading 94.02: Medical, surgical or dental furniture. Other headings: 94.02.10; 94.03.10; 25.20; 35.02; 34.07 and 30.06.
Regulation Type: Regular notification
Draft Resolution no. 817, 01 June 2020

Distribution date: 29 June 2020 | Final date for Comment: 07 September 2020
This draft resolution establishes warning phrases for substances and or therapeutic classes in leaflets and packaging of medicines.
Products Covered: HS Code(s): 3003; 3004; 3005; 2941 (pharmaceutical products).
Regulation Type: Regular notification
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