Distribution date: 14 August 2020 | Final date for Comment: 01 September 2020

New procedure announced by the Pharmaceutical Division at Israel's Ministry of Health called "Procedure for Packaging Labeling of Medical Preparations (PRA-043/03)". This procedure replaces a previous procedure from July 2007 (amended in July 2012) and is based on Regulation 20 of the "Pharmacists Regulations (Preparations) 5746-1986" and regulation 13 of the "Pharmacists Regulations (Sale of an over-the-counter preparation not in a pharmacy or not by a pharmacist) 5765-2004". The purpose of the procedure is to clarify the requirements of Regulation 20 and Regulation 13 and to ensure that all packaging requirements shall appear on the preparation packaging, listed in the Preparations Register, in order to provide patients with the essential information regarding the preparation and assist in providing safe and effective drug treatment. It collects all existing requirements into a unified list that contains also references to similar international requirements.

Products Covered: Pharmaceuticals

Regulation Type: Regular notification

Distribution date: 12 August 2020

This resolution establishes control measures for medicines that contain substances mentioned by the Annex I of this resolution, isolated or in association with other drugs, due to the international public health emergency of the new coronavirus (SARS-CoV-2).

Products Covered: Antibiotics. (HS code(s): 2941); Medicaments (excluding goods of heading No. 3002, 3005 or 3006) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or informs or packings for retail sale. (HS code(s): 3003); Medicaments (excluding goods of heading No. 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale. (HS code(s): 3004); Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes. (HS code(s): 3005); Pharmaceutical goods specified in Note 3 to this Chapter. (HS code(s): 3006)

Regulation Type: Regular notification

Distribution date: 12 August 2020

This resolution establishes control measures for medicines that contain substances mentioned by the Annex I of this resolution, isolated or in association with other drugs, due to the international public health emergency of the new coronavirus (SARS-CoV-2).

Products Covered: Antibiotics. (HS code(s): 2941); Medicaments (excluding goods of heading No. 3002, 3005 or 3006) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or informs or packings for retail sale. (HS code(s): 3003); Medicaments (excluding goods of heading No. 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale. (HS code(s): 3004); Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes. (HS code(s): 3005); Pharmaceutical goods specified in Note 3 to this Chapter. (HS code(s): 3006)

Regulation Type: Regular notification

Distribution date: 12 August 2020 | Final date for Comment: 11 October 2020

The Draft amendments to the Rules for conducting studies (tests) for evaluation of biological action of medical products to medical devices issued for circulation in the territory of the Eurasian Economic Union and provide for the following:- clarification of the concepts;- determining the grounds for excluding testing laboratories (centers) from the unified register of authorized organizations that have the right to conduct research (testing) of medical devices for the purpose of their registration;- clarification of the form of the Protocol of studies (tests) for evaluation of biological action of medical products.

Products Covered: Wadding, gauze, bandages and similar products (bandaging material, adhesive plasters,poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes (HS 3005); Instruments and appliances used in medical, surgical, dental or veterinary sciences,including scintigraphic apparatus, other electro-medical apparatus and sight testing instruments (HS 9018); X-ray, alpha, beta, gamma radiation apparatus; x-ray tubes, x-ray generators, high tension generators, control panels and desks, screens, examinationor treatment tables, chairs and the like (HS 9022); Furniture; medical, surgical, dental or veterinary (e.g. operating tables, hospital beds, dentists' chairs) barbers' chairs; parts (HS 9402).

Regulation Type: Regular notification

Distribution date: 12 August 2020 | Final date for Comment: 11 October 2020

The Draft amendments to the Rules for conducting studies (tests) for evaluation of biological action of medical products to medical devices issued for circulation in the territory of the Eurasian Economic Union and provide for the following:- clarification of the concepts;- determining the grounds for excluding testing laboratories (centers) from the unified register of authorized organizations that have the right to conduct research (testing) of medical devices for the purpose of their registration;- clarification of the form of the Protocol of studies (tests) for evaluation of biological action of medical products.

Products Covered: Wadding, gauze, bandages and similar products (bandaging material, adhesive plasters,poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes (HS 3005); Instruments and appliances used in medical, surgical, dental or veterinary sciences,including scintigraphic apparatus, other electro-medical apparatus and sight testing instruments (HS 9018); X-ray, alpha, beta, gamma radiation apparatus; x-ray tubes, x-ray generators, high tension generators, control panels and desks, screens, examinationor treatment tables, chairs and the like (HS 9022); Furniture; medical, surgical, dental or veterinary (e.g. operating tables, hospital beds, dentists' chairs) barbers' chairs; parts (HS 9402).

Regulation Type: Regular notification

Distribution date: 12 August 2020

The Draft Normative Instruction number 689, 12 August 2019 – previously notified through G/TBT/N/BRA/899 – which establishes guidelines for authorization of suppliers related to the Technical Regulation for Good Practice of Distribution and Fractioning of Active Pharmaceutical Ingredients (API), was adopted by the Normative Instruction 62, 16 June 2020. This regulation enters into force on 3 August 2020.  

Products Covered: HS CODE: 29; 30. (active pharmaceutical ingredients)

Regulation Type: Addendum to Regular Notification

Distribution date: 12 August 2020

The Draft Normative Instruction number 689, 12 August 2019 – previously notified through G/TBT/N/BRA/899 – which establishes guidelines for authorization of suppliers related to the Technical Regulation for Good Practice of Distribution and Fractioning of Active Pharmaceutical Ingredients (API), was adopted by the Normative Instruction 62, 16 June 2020. This regulation enters into force on 3 August 2020.  

Products Covered: HS CODE: 29; 30. (active pharmaceutical ingredients)

Regulation Type: Addendum to Regular Notification

Distribution date: 12 August 2020 | Final date for Comment: 06 October 2020

Proposed rule - The Environmental Protection Agency (EPA) is proposing to revise regulations governing the production and import of class I ozone-depleting substances in the United States to extend indefinitely the global essential laboratory and analytical use exemption. This exemption currently expires on 31 December 2021. This change would allow for continued production and import of class I substances in the United States solely for laboratory and analytical uses that have not been identified by the EPA as nonessential. This action is proposed under the Clean Air Act and is consistent with a decision by the Parties to the Montreal Protocol on Substances that Deplete the Ozone Layer to extend the global laboratory and analytical use exemption indefinitely beyond 2021.

Products Covered: Ozone-depleting substances

Regulation Type: Revision to Regular Notification

Distribution date: 12 August 2020 | Final date for Comment: 06 October 2020

Proposed rule - The Environmental Protection Agency (EPA) is proposing to revise regulations governing the production and import of class I ozone-depleting substances in the United States to extend indefinitely the global essential laboratory and analytical use exemption. This exemption currently expires on 31 December 2021. This change would allow for continued production and import of class I substances in the United States solely for laboratory and analytical uses that have not been identified by the EPA as nonessential. This action is proposed under the Clean Air Act and is consistent with a decision by the Parties to the Montreal Protocol on Substances that Deplete the Ozone Layer to extend the global laboratory and analytical use exemption indefinitely beyond 2021.

Products Covered: Ozone-depleting substances

Regulation Type: Revision to Regular Notification

Distribution date: 06 August 2020

This resolution establishes the temporary opening of entrance and exit points of substances subject to special control, due to the international public health emergency related to the new Coronavirus (SARS-CoV-2).

Products Covered: HS Code(s): 2941; 3003; 3004; 3005; 3006 (pharmaceutical products).

Regulation Type: Regular notification