Distribution date: 08 June 2021

ANVISA Resolution number 483, 19 March 2021- previously notified through  G/TBT/N/BRA/1154 - which establishes exceptional and temporary technical requirements for the import of new medical devices and medicines identified as indispensable for the use in healthcare services due to the international public health emergency related to the SARS-CoV-2, was amended by Resolution – RDC  number 516, 2 June 2021.  

Products Covered: Provitamins and vitamins, natural or reproduced by synthesis, incl. natural concentrates, derivatives thereof used primarily as vitamins, and intermixtures of the foregoing, whether or not in any solvent (HS code(s): 2936); Hormones, prostaglandins, thromboxanes and leukotrienes, natural or reproduced by synthesis; derivatives and structural analogues thereof "incl. chain modified polypeptides", used primarily as hormones (HS code(s): 2937); Antibiotics (HS code(s): 2941); PHARMACEUTICAL PRODUCTS (HS code(s): 30); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification

Distribution date: 08 June 2021 | Final date for Comment: 07 August 2021

This Draft Uganda Standard specifies the requirements, sampling and test methods for bath oils based on refined vegetable oils or vegetable oils blends, mineral oils or mixture of the vegetable oils and mineral oils meant for application on the skin.

Products Covered: Bath oil

Regulation Type: Regular notification

Distribution date: 08 June 2021 | Final date for Comment: 07 August 2021

This Draft Uganda Standard specifies the requirements and methods of sampling and test for sodium hypochlorite solution used for disinfection of water intended for human use.

Products Covered: Sodium hypochlorite for water treatment

Regulation Type: Regular notification

Distribution date: 08 June 2021 | Final date for Comment: 07 August 2021

This Draft Uganda Standard specifies the requirements and methods of sampling and test for polyamines used for water treatment intended for human use.

Products Covered: Polyamines

Regulation Type: Regular notification

Distribution date: 07 June 2021

The purpose of this Notice of Intent to Amend is to announce that Health Canada will add Epinephrine 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). Both the Human and the Veterinary parts of the List will be updated.

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

Regulation Type: Addendum to Regular Notification

Distribution date: 03 June 2021 | Final date for Comment: 24 June 2021

ANVISA Public Consultation No. 1043, 8 April 2021 - previously notified through G/TBT/N/BRA/1166 - which establishes technical requirements for the import, commercialization, and donation of used reprocessed medical devices, was extended for 30 days. The extension text is available only in Portuguese and can be downloaded at:https://www.in.gov.br/web/dou/-/despacho-n-59-de-20-de-maio-de-2021-321789910

Products Covered: HS Code(s): 2936, 2937, 3001, 3002, 3003, 3004, 3006 (medical devices)

Regulation Type: Addendum to Regular Notification

Distribution date: 03 June 2021 | Final date for Comment: 11 June 2021

Following consultation, the United Kingdom Government has now developed a draft of the regulation for Mandatory Validation of Covid 19 In vitro Diagnostic antigen and Molecular tests. This text will amend the Medical Device Regulations 2002, using powers provided in the Medicines and medical Devices Act 2021. The legal text is available on request. 

Products Covered: HS3822

Regulation Type: Addendum to Regular Notification

Distribution date: 01 June 2021 | Final date for Comment: 31 July 2021

This draft Commission Decision aims at identifying resorcinol as a substance of very high concern due to its endocrine disrupting properties whose effects to human health give rise to an equivalent level of concern according to Article 57(f) of Regulation (EC) No 1907/2006 (REACH).

Products Covered: Chemical substance Resorcinol

Regulation Type: Regular notification

Distribution date: 31 May 2021

Products Covered: Pressure vessels

Regulation Type: Addendum to Regular Notification

Distribution date: 31 May 2021

ANVISA Draft Resolution number 805, 27 March 2020 – previously notified through G/TBT/N/BRA/997 – which establishes administrative procedure for the concession of Good Manufacturing Practices Certification for medicines, medical devices, personal hygiene products, cosmetics, perfumes, sanitizers, active pharmaceutical ingredients, and food; and Good Practices of Storage and Distribution Certification for medicines, medical devices, and active pharmaceutical ingredients, was adopted as Resolution – RDC number 497, 20 May 2021. The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/5833170/RDC_497_2021_.pdf/28c1740f-a816-4e86-92f7-fd64f3ac90fb

Products Covered: HS Code(s): 2106, 29, 2936, 2937, 2941, 3303, 3304, 3305, 3306, 3307, 340111, 340130, 3402, 340119, 340120, 330290, 9616, 9619.

Regulation Type: Addendum to Regular Notification