Regulatory Updates

Distribution date: 05 January 2023 | Final date for Comment: 06 March 2023

This Draft Resolution is regarded to a proposal to define the general guidelines for the pilot implementation of the optimized analysis procedure, based on risk criteria, to confirm the suitability of the documentation submitted to Anvisa for marketing authorization and post-marketing authorization changes to medicines.

Products Covered: Medicaments (ICS code(s): 11.120.10)

Regulation Type: Regular notification

Distribution date: 05 January 2023

The aim of this addendum is to inform WTO Members that the Draft Tanzania Standard; DEAS 960: 2019 Deodorants and antiperspirants — Specification notified in G/TBT/N/TZA/289 entered into force on 01 April 2022 as Tanzania Standard, TZS 919:2021/EAS 960:2020Deodorants and antiperspirants - Specification. This specification can be purchased by contacting the TBT NEP through nep@tbs.go.tz

Products Covered: Personal deodorants and antiperspirants (HS code(s): 330720); Cosmetics. Toiletries (ICS code(s): 71.100.70)

Regulation Type: Addendum to Regular Notification

Distribution date: 05 January 2023

The aim of this addendum is to inform WTO Members that the Draft East Africa Standard; DEAS 957: 2019 Aftershave — Specification notified in G/TBT/N/TZA/281 entered into force on 01 April 2022 as Tanzania Standard, TZS 2850:2021/EAS 957:2020 Aftershave – Specification. This specification can be purchased by contacting the TBT NEP through nep@tbs.go.tz

Products Covered: Shaving preparations, incl. pre-shave and after-shave products (HS code(s): 330710); Cosmetics. Toiletries (ICS code(s): 71.100.70)

Regulation Type: Addendum to Regular Notification

Distribution date: 05 January 2023

The Resolution - RDC number 768, 12 December 2022 - previously notified through G/TBT/N/BRA/1024/Add.1 - which establishes the rules for drug labeling, was updated by Normative Instruction 199, 12 December 2022. The final text is available only in Portuguese and can be downloaded at:  http://antigo.anvisa.gov.br/documents/10181/3426875/IN_199_2022_.pdf/e8304a48-03a2-444d-a1fb-29d6367f1519 

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: Addendum to Regular Notification

Distribution date: 05 January 2023

The aim of this addendum is to inform WTO Members that the Draft Tanzania Standard; TDC 9(6784) P3 Textiles – Surgical face masks – Specification notified in G/TBT/N/TZA/473 entered into force on 01 April 2022 as Tanzania Standard, TZS 2871:2021 .Textiles – Surgical face masks –Specification. This specification can be purchased by contacting the TBT NEP through nep@tbs.go.tz

Products Covered: Surgical face masks

Regulation Type: Addendum to Regular Notification

Distribution date: 05 January 2023 | Final date for Comment: 06 March 2023

This Draft Resolution is regarded to a regulatory proposal for the establishment of specific criteria and procedures for defining the Equivalent Foreign Regulatory Authorities of the sanitary inspection process of manufacturers of active pharmaceutical ingredients, Cannabis products for medicinal purposes, medicines and biological products. And the optimized Good Manufacturing Practices (GMP) Certification review process. The Regulatory Trust Building Program for the recognition of the equivalence of the health inspection processes of an AREE is applicable exclusively to regulatory authorities or member entities of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

Products Covered: Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 05 January 2023

The aim of this addendum is to inform WTO Members that the Draft East Africa Standard; DEAS 964: 2019 Lip shine (gloss) — Specification notified in G/TBT/N/TZA/291 entered into force on 01 April 2022 as Tanzania Standard, TZS 2847:2021/EAS 964:2020Lip shine (lip gloss) – Specification. This specification can be purchased by contacting the TBT NEP through nep@tbs.go.tz

Products Covered: Lip make-up preparations (HS code(s): 330410); Cosmetics. Toiletries (ICS code(s): 71.100.70)

Regulation Type: Addendum to Regular Notification

Distribution date: 05 January 2023

The aim of this addendum is to inform WTO Members that the Draft East Africa Standard; DEAS 963: 2019 Lip balm (Lip salve) — Specification notified in G/TBT/N/TZA/285 entered into force on 01 April 2022 as Tanzania Standard, TZS 2848:2021/EAS 963:2020 Lip balm (lip salve) – Specification. This specification can be purchased by contacting the TBT NEP through nep@tbs.go.tz

Products Covered: Lip make-up preparations (HS code(s): 330410); Cosmetics. Toiletries (ICS code(s): 71.100.70)

Regulation Type: Addendum to Regular Notification

Distribution date: 05 January 2023 | Final date for Comment: 06 March 2023

The Therapeutic Goods Administration (TGA) is seeking comments on possible reforms to the regulation of ENDs. This includes vape liquids, e-liquids and e-juices that contain nicotine and/or nicotine salts. This does not include other nicotine replacement therapies (NRTs) containing nicotine, such as patches, gum, lozenges, mouth spray and inhalators nor nicotine-containing products that are not intended for use in ENDs, such as chewing tobacco and snuff. One of the possible reform options would also affect the importation of vaping devices that do not contain nicotine.  Since 1 October 2021, ENDs have been regulated as prescription medicines in Australia.  The aim of the 2021 reforms was to prevent children and adolescents from accessing ENDs, whilst allowing smokers to access these products for smoking cessation with a doctor’s prescription. However, evidence is emerging that the reforms are not meeting these aims. The TGA is considering whether refinements to the existing regulatory requirements for ENDs could be introduced to better support the intent of the 2021 reforms, namely preventing children and adolescents from accessing ENDs while supporting access to products of known composition and quality for smoking cessation with a doctor’s prescription. The TGA is seeking comment on potential reforms in 4 main areas:Changes to border controls for ENDs – to curb the unlawful supply of ENDs in Australia (one option includes to change the border controls for ENNDs to assist with the enforcement of the controls on ENDs (rather than with the aim of limiting access to ENNDs))Pre-market TGA assessment of ENDs against a product standard – to create a regulated source of quality ENDs to encourage doctors to prescribe, pharmacies to supply and vaping consumers to purchase ‘safer’ products lawfullyStrengthening the product standard regarding minimum quality and safety standards for ENDs – to make them less attractive to children and adolescents, for example by not permitting certain flavours or labellingClarifying the status of ENDs as ‘therapeutic goods’ – to ensure that any vaping product containing nicotine is captured by the regulatory framework.

Products Covered: Nicotine-containing products intended to be used in vaping devices such as e-cigarettes, e-cigars and other electronic nicotine delivery systems (ENDs). One of the possible reform options would also affect the importation of vaping devices that do not contain nicotine (ENNDs).  TOBACCO AND MANUFACTURED TOBACCO SUBSTITUTES (HS 24); PHARMACEUTICAL PRODUCTS (HS 30)

Regulation Type: Regular notification

Distribution date: 05 January 2023 | Final date for Comment: 06 March 2023

This Draft Resolution contains provisions on rules for preparing, harmonizing, updating, publishing and making available drug inserts for patients and health professionals.

Products Covered: Medicaments (ICS code(s): 11.120.10)

Regulation Type: Regular notification