Distribution date: 07 October 2022

The Draft Resolution number 932, 13 October 2020 - previously notified through G/TBT/N/BRA/1095 - which establishes criteria for the concession of market authorization for medicines with synthetic and semisynthetic active principles for human use categorized as new, innovative, generic, and similar, was adopted as Resolution - RDC number 753, 28 September 2022  The final text is available only in Portuguese and can be downloaded at:  http://antigo.anvisa.gov.br/documents/10181/5457402/RDC_753_2022_.pdf/366cc4a2-4857-4902-b4a1-07769cf962c8 

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 for 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); Pharmaceutical preparations and products of subheadings 3006.10.10 to 3006.60.90 (HS code(s): 3006); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification

Distribution date: 07 October 2022

The Draft Normative Instruction number 931, 13 October 2020 - previously notified through G/TBT/N/BRA/1094 - which establishes new codes for the administrative request of market authorization for new and innovative synthetic and semisynthetic medicines, was adopted as  Normative Instruction number 184, 28 September 2022. The final text is available only in Portuguese and can be downloaded at:  http://antigo.anvisa.gov.br/documents/10181/5457402/IN_184_2022_.pdf/ad7438ee-2b82-47df-bc21-23c1f6e94739 

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 for 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); Pharmaceutical preparations and products of subheadings 3006.10.10 to 3006.60.90 (HS code(s): 3006); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification

Distribution date: 07 October 2022

The Resolution - RDC number 721, 01 July 2022 - previously notified through   G/TBT/N/BRA/1412   - contains provisions on marketing authorization, renewal of marketing authorization, post-marketing authorization changes and notification of industrialized dynamized drugs., was republished.   The republished text is available only in Portuguese and can be downloaded at:  https://www.in.gov.br/en/web/dou/-/resolucao-rdc-n-721-de-1-de-julho-de-2022-*-429194963

Products Covered: Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale. (HS code(s): 3003); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale. (HS code(s): 3004)

Regulation Type: Corrigendum to Regular Notification

Distribution date: 06 October 2022 | Final date for Comment: 05 December 2022

To organize the matters entrusted by the Act, such as the GMP compliance determination subject, documents for GMP compliance determination application, GMP inspection procedure and GMP training, requirements for designation of training institutions, and designation application document and designation procedure, and matters necessary for its implementation, as the Pharmaceutical Affairs Act was revised (Act No. 18970, Notification Date June 10, 2022, Enforcement Date December 11, 2022), which intends to provide a basis for taking measures such as GMP compliance determination, GMP inspection and cancellation of the determination in case of violation and for implementing training for GMP inspectors.

Products Covered: Pharmaceuticals

Regulation Type: Regular notification

Distribution date: 04 October 2022 | Final date for Comment: 03 December 2022

This Draft Uganda Standard specifies requirements, sampling and test methods for travel bags (including suitcases).

Products Covered: Trunks, suit-cases, vanity-cases, executive-cases, brief-cases, school satchels, spectacle cases, binocular cases, camera cases, musical instrument cases, gun cases, holsters and similar containers; travelling-bags, insulated food or beverages bags, toilet bags, rucksacks, handbags, shopping-bags, wallets, purses, map-cases, cigarette-cases, tobacco-pouches, tool bags, sports bags, bottle-cases, jewellery boxes, powder-boxes, cutlery cases and similar containers, of leather or of composition leather, of sheeting of plastics, of textile materials, of vulcanised fibre or of paperboard, or wholly or mainly covered with such materials or with paper. (HS code(s): 4202); Other products of the textile industry (ICS code(s): 59.080.99); Leather products (ICS code(s): 59.140.35)

Regulation Type: Regular notification

Distribution date: 30 September 2022

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of calcium carbonate in dietary supplement tablets and capsules. We are taking this action in response to a color additive petition (CAP) submitted by Colorcon, Inc. (Colorcon or petitioner). This rule is effective 28 October 2022.

Products Covered: HS Code(s): 2936; ICS Code(s): 67

Regulation Type: Addendum to Regular Notification

Distribution date: 28 September 2022 | Final date for Comment: 27 November 2022

This Draft East African standard specifies the requirements, sampling and test methods for synthetic laundry detergent pastes based predominantly on alkyl aryl sulphonates for hand and machine wash.

Products Covered: - Soap and organic surface-active products and preparations, in the form of bars, cakes, moulded pieces or shapes, and paper, wadding, felt and nonwovens, impregnated, coated or covered with soap or detergent : (HS code(s): 34011); Surface active agents (ICS code(s): 71.100.40)

Regulation Type: Regular notification

Distribution date: 28 September 2022 | Final date for Comment: 27 November 2022

This Draft East African Standard specifies the requirements, sampling and test methods for a stain remover used in water to remove adsorbed food stains from plastic tableware, glass and China tableware and nonaluminium coffee urns

Products Covered: - Soap and organic surface-active products and preparations, in the form of bars, cakes, moulded pieces or shapes, and paper, wadding, felt and nonwovens, impregnated, coated or covered with soap or detergent : (HS code(s): 34011); Surface active agents (ICS code(s): 71.100.40)

Regulation Type: Regular notification

Distribution date: 28 September 2022 | Final date for Comment: 27 November 2022

This Draft East African Standard specifies the requirements, sampling and test methods for synthetic detergents powder for machine wash. It does not cover hand wash powders and industrial detergent powders.

Products Covered: - Soap and organic surface-active products and preparations, in the form of bars, cakes, moulded pieces or shapes, and paper, wadding, felt and nonwovens, impregnated, coated or covered with soap or detergent : (HS code(s): 34011); Surface active agents (ICS code(s): 71.100.40)

Regulation Type: Regular notification

Distribution date: 28 September 2022 | Final date for Comment: 27 November 2022

This Draft East African standard specifies the requirements, sampling and test methods for synthetic laundry detergent pastes based predominantly on alkyl aryl sulphonates for hand and machine wash.

Products Covered: - Soap and organic surface-active products and preparations, in the form of bars, cakes, moulded pieces or shapes, and paper, wadding, felt and nonwovens, impregnated, coated or covered with soap or detergent : (HS code(s): 34011); Surface active agents (ICS code(s): 71.100.40)

Regulation Type: Regular notification