DEAS 1019-1: 2019 Surgical sutures — Specification — Part 1: Absorbable
Distribution date: 07 January 2020 | Final date for Comment: 07 March 2020
This Draft East African Standard specifies the requirements, sampling and test methods for absorbable surgical sutures.
Products Covered: (HS code(s): 300610); Surgical instruments and materials (ICS code(s): 11.040.30)
Regulation Type: Regular notification
Draft amendments to Requirements for stability testing of drugs and pharmaceutical substances.
Distribution date: 07 January 2020 | Final date for Comment: 25 January 2020
The draft amendments to the Requirements for stability testing of drugs and pharmaceutical substances applies to put into circulation on the territory of the Eurasian economic Union drugs and calls for the unified approach to the definition of "production date of the series" in order to exclude the possibility of automatic updates of the shelf life of the pharmaceutical substance by a simple repackaging, and the calculation of the shelf life of finished drugs, issued in circulation in the customs territory of the Eurasian economic Union for the purpose of elimination of the possibility of automatic renewal of the shelf life of the pharmaceutical substance by its simple repackaging, as well as the use in the production of substances with an expiration date not corresponding to the shelf life of finished drugs, which may lead to inconsistencies of expert reports and recognition. The draft guide has been prepared in order to: - protection of life and health of the patient (as the final consumer of medicines); - protection of the interests of the health care system as a whole (as the primary consumer of medicines) - protection of the interests of the authorized bodies (expert organizations) that perform the procedure of evaluation of the registration dossier of the drug from the position of proof of its compliance with the specified quality standard.
Products Covered: 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); Medicaments (ICS code(s): 11.120.10)
Regulation Type: Regular notification
Draft national technical regulations on sweeteners
Distribution date: 07 January 2020 | Final date for Comment: 07 March 2020
These drafts technical regulations stipulate technical requirements and the management on quality, hygiene and safety of calcium cyclamate, sodium cyclamate, calcium saccharin, potassium saccharin, sodium saccharin, sucralose, alitame, aspartame-acesulfame, polyglycitol syrup, sorbitol syrup. These drafts technical regulations applies to organizations and individuals who produce, trade and import these sweeteners for circulation in Vietnam and relevant agencies, organizations and individuals. These drafts technical regulations include: National technical regulation of Alitame National technical regulation of Aspartame-Acesulfame National technical regulation of Calcium cyclamate National technical regulation of Calcium saccharin National technical regulation of Potassium saccharin National technical regulation of Sodium cyclamate National technical regulation of Sodium saccharin National technical regulation of Polyglycitol syrup National technical regulation of Sorbitol syrup National technical regulation of Sucralose
Products Covered: Calcium cyclamate (HS code 2933.59.90), sodium cyclamate (HS code 2929.90.10), calcium saccharin (HS code 2925.11.00), potassium saccharin (HS code 2925.11.00), sodium saccharin (HS code 2925.11.00), sucralose (HS code 2940.00.00), alitame (HS code 2934), aspartame-acesulfame (HS code 2934.99.90), polyglycitol syrup (HS code 1702.20.00), sorbitol syrup (HS code 2905.44.00)
Regulation Type: Regular notification
DEAS 1019-2: 2019 Surgical sutures — Specification — Part 2: Non-absorbable
Distribution date: 07 January 2020 | Final date for Comment: 07 March 2020
This Draft East African Standard specifies the requirements, sampling and test methods for non-absorbable surgical sutures.
Products Covered: (HS code(s): 300610); Surgical instruments and materials (ICS code(s): 11.040.30)
Regulation Type: Regular notification
Draft Resolution 758, 19 December 2019. Number of pages: 7; Language(s): Portuguese Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=52832
Distribution date: 08 January 2020 | Final date for Comment: 02 March 2020
This Draft Resolution proposes the updating of the technical requirements for the labelling of personal hygiene products, cosmetics, and perfumes.
Products Covered: HS Codes: 3303; 3304; 3305; 3306;3307; 340111; 340130; 9616; 9619 (personal hygiene products, cosmetics, and perfumes)
Regulation Type: Regular notification
Medical devices for in vitro diagnosis The final date for comments (30 December 2019) of the Draft Resolution 734, 22 October 2019 – previously notified through G/TBT/N/BRA/929 – which proposes the updating of the Resolution – RDC 36, 26 August 2015, which establishes the risk classification, control scheme of notification, registration, market authorization and technical requirements for labelling and usage instructions of medical devices for in vitro diagnosis, was extended for 30 days. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 08 January 2020 | Final date for Comment: 09 May 2025
Products Covered: HS Code(s): 3002300, 3822 (In vitro diagnosis products)
Regulation Type: Addendum to Regular Notification
Medical devices The final date for comments (30 December 2019) of the Draft Resolution 730, 14 October 2019 – previously notified through G/TBT/N/BRA/928 – which proposes the updating of the Resolution – RDC 185, 22 October 2001, which establishes the risk classification, market authorization and technical requirements for labelling and usage instructions of medical devices, was extended for 30 days. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 08 January 2020 | Final date for Comment: 09 May 2025
Products Covered: HS Code(s): 2936, 2937, 3001, 3002, 3003, 3004, 3006 (medical devices)
Regulation Type: Addendum to Regular Notification
DUS DEAS 849:2019, Silk (sheen) emulsion paint for interior use — Specification, Second Edition
Distribution date: 08 January 2020 | Final date for Comment: 08 March 2020
This Draft Uganda Standard specifies requirements, sampling and test methods for silk (sheen) emulsion paint for interior use.
Products Covered: Silk (sheen) emulsion paint
Regulation Type: Regular notification
DUS DEAS 998:2019,Textured paints — Specification, First Edition
Distribution date: 08 January 2020 | Final date for Comment: 08 March 2020
This Draft Uganda Standard specifies requirements, sampling and test methods for water based textured paints suitable for exterior and Interior use on concrete surfaces, boards, primed wood, primed metal to give a protective and decorative coating.
Products Covered: Textured paints
Regulation Type: Regular notification
DUS DEAS 937:2019, Semi-gloss (egg shell) solvent borne paints for interior and exterior use — Specification, First Edition
Distribution date: 08 January 2020 | Final date for Comment: 08 March 2020
This Draft Uganda Standard specifies requirements, methods of sampling and test for semi-gloss (egg-shell) solvent borne paints for interior and exterior use. This standard does not apply to automotive, road marking and Industrial applications.
Products Covered: Semi-gloss (egg shell) solvent borne paints
Regulation Type: Regular notification
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