Resolution SENASA-DMV-002-2019. Guide to good practices for the storage, transportation and distribution of products for veterinary use

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Distribution date: 29 August 2019 | Final date for Comment: 07 May 2025

Costa Rica hereby notifies the entry into force of the sanitary measures established in Resolution SENASA-DMV-002-2019. Text available at: https://members.wto.org/crnattachments/2019/SPS/CRI/19_4720_00_s.pdf

Products Covered:

Regulation Type: Addendum to Regular Notification

Proyecto de Reglamento para el Registro Sanitario de Productos Sanitarios: Artículos para Bebés (Draft regulation on sanitary registration of sanitary products: Articles for babies). (10 pages, in Spanish)

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Distribution date: 29 August 2019 | Final date for Comment: 27 October 2019

The purpose of the notified regulation is to set forth the regulatory provisions for Law No. 29459, Law on pharmaceutical products, medical devices and sanitary products: Articles for babies.

Products Covered: Articles for babies; Pharmaceutical goods specified in Note 4 to this Chapter (HS 3006)

Regulation Type: Regular notification

Notice of Consultation on the Prescription Drug List (PDL): Epinephrine (2 pages, in English and French)

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Distribution date: 29 August 2019 | Final date for Comment: 26 October 2019

This Notice of Consultation provides an opportunity to comment on the proposal to add epinephrine or its salts topical solution for hemostasis when sold at a concentration equal to or greater than 1 mg/ ml (1:1000) to the Prescription Drug List (PDL).  Only the Human part of the PDL is proposed to be revised.  

Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)

Regulation Type: Regular notification

Imports of gelatine, flavouring innards and rendered fatsImports of gelatine, flavouring innards and rendered fats

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Distribution date: 03 September 2019 | Final date for Comment: 07 May 2025

The proposal notified in G/SPS/N/EU/321 (6 May 2019) was adopted as Commission Implementing Regulation (EU) 2019/1177 of 10 July 2019 amending Regulation (EU) No 142/2011 as regards imports of gelatine, flavouring innards and rendered fats [OJ L 185, 11 July 2019, p.26].   This Regulation shall apply from 31 July 2019.

Products Covered:

Regulation Type: Addendum to Regular Notification

Draft resolution number 703, August 23rd, 2019. Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=49636

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Distribution date: 04 September 2019 | Final date for Comment: 18 October 2019

This draft resolution proposes the revision of the Resolution – RDC 64, 18 December 2009, which establishes the market authorization for radiopharmaceuticals.

Products Covered: HS CODE: 3006 (radiopharmaceuticals)

Regulation Type: Regular notification

DUS 2159-2:2019 Hydraulic fluid — Performance Classifications — Part 2: Specifications for categories HH, HL, HM, HV and HG, First Edition

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Distribution date: 04 September 2019 | Final date for Comment: 03 November 2019

This Draft Uganda Standard specifies performance requirements, sampling and test methods for new mineral oil hydraulic fluids of categories classified as HH, HL, HM, HV and HG, and intended for hydraulic systems, particularly for hydrostatic hydraulic fluid power application.

Products Covered: Hydraulic fluids

Regulation Type: Regular notification

DUS 2159-1:2019 Hydraulic fluid — Performance Classifications —Part 1: General, First Edition

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Distribution date: 04 September 2019 | Final date for Comment: 03 November 2019

This Draft Uganda Standard covers classification of hydraulic fluids used in hydraulic systems. This classification system does not include automotive brake fluids or aircraft hydraulic fluids. This specification defines only new hydraulic fluids before they are installed in the hydraulic system.This specification defines specific types of hydraulic fluids. It does not include all hydraulic fluids. Some oils that are not included may be satisfactory for certain hydraulic applications.

Products Covered: Hydraulic fluid

Regulation Type: Regular notification

Steel products for concrete reinforcement By means of this Addendum No. 1, the Republic of Ecuador hereby advises that the fifth revision (5R) of Ecuadorian Technical Regulation RTE INEN No. 016 "Steel products for concrete reinforcement", notified in document G/TBT/N/ECU/350 on 8 April 2019, has been issued pursuant to Resolution No. 19 051 of 1 August 2019 by the Under-Secretariat for Quality of the Ministry of Production, Foreign Trade, Investment and Fisheries, published in Official Journal No. 27 of 28 August 2019. Ecuadorian Technical Regulation No. 016 (5R) replaces RTE INEN No. 016:2018 (4R) and will enter into force six months after its publication in the Official Journal. Text available from the Ministry of Production, Foreign Trade, Investment and Fisheries, Under-Secretariat for Quality, National Notification Authority: TBT enquiry point: Andrés Ramón Plataforma Gubernamental de Gestión Financiera - Piso 8, Bloque amarillo, Av. Amazonas entre Unión Nacional de Periodistas y Alfonso Pereira Quito - Ecuador Tel.: (+593-2) 3948760, Ext. 2252/2254 Email: [email protected] [email protected] [email protected] [email protected] www.normalizacion.gob.ec

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Distribution date: 09 September 2019 | Final date for Comment: 07 May 2025

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Regulation Type: Addendum to Regular Notification

Draft resolution number 704, August 23rd, 2019. Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=49635

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Distribution date: 09 September 2019 | Final date for Comment: 04 November 2019

This draft resolution is a complement for the revision of the Resolution – RDC 64,18 December 2009, which establishes the market authorization for radiopharmaceuticals, and proposes the documenting necessary for the protocol of market authorization for radiopharmaceuticals.

Products Covered: HS CODE: 3006 (radiopharmaceuticals)

Regulation Type: Regular notification

Draft normative instruction number 705, August 23rd, 2019. Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=49634

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Distribution date: 09 September 2019 | Final date for Comment: 04 November 2019

This draft normative instruction is a complement for the revision of the Resolution – RDC number 64, December 18th, 2009, and establishes the list of radiopharmaceuticals that can present the literature for security and efficacy demonstration.

Products Covered: HS CODE: 3006 (radiopharmaceuticals)

Regulation Type: Regular notification

Human health

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