Distribution date: 08 March 2018

This Resolution applies to requests for post-registration alteration of medicines and biological products filed with Anvisa before and after Law 13.411 of 28 December 2016. Art. 2. The maximum period for the final decision in the post-registration change processes of medicines and biological products will be, respectively: I - for the priority category, of sixty days, counted from the date of the respective prioritization protocol; II - for the ordinary category, one hundred and eighty days, counted from the date of the respective post-registration change protocol. Paragraph 1. The aforementioned period may be extended by up to one-third of the original term, once, by means of a reasoned decision of Anvisa issued at least fifteen business days before the end of the original term. Paragraph 2. The aforementioned period will have their countdown suspended when they request information or requirements, until they are attended to. Art. 6. Petitions for post-registration changes petitioned before the enactment of Law nº 13.411, of 2016, for which a safety and efficacy report is required, will have its analysis procedures maintained and can only be implemented after approval by Anvisa. Art. 8. The Anvisa areas responsible for medicine registration, inspection, monitoring and monitoring will establish a program to monitor post-registration changes implemented in accordance with the conditional approval set forth in this Resolution. Art. 9. During follow-up inspections or inspection actions, the company must provide all documentation related to the complete technical dossier, required by the health regulations in force at the time of the petition, which deals with post-registration changes. Art. 17. This Resolution comes into force on the date of its publication.

Products Covered: Chapter 30 - Pharmaceutical products

Regulation Type: Regular notification

Distribution date: 06 March 2018 | Final date for Comment: 27 May 2018

Este Proyecto revisión de Reglamento Técnico establece el Objeto; campo de aplicación; definiciones; requisitos; muestreo; ensayos para evaluar la conformidad; documentos de referencia; procedimiento para la evaluación de la conformidad; autoridad de vigilancia y control; régimen de sanciones; responsabilidad de los organismos de evaluación de la conformidad y revisión y actualización del Reglamento Técnico Ecuatoriano RTE INEN 088 (1R) "Agentes de tensión superficial".

Products Covered: (HS code(s): 340119, 340130, 340220, 340290, 340540); (ICS code(s): 71.100.40)

Regulation Type: Revision to Regular Notification

Distribution date: 06 March 2018 | Final date for Comment: 05 May 2018

The notified text establishes the health and safety requirements to be met by apiaries and by establishments where honey and apiculture products are processed for direct human consumption. Its aim is to protect consumer health via the inspection, approval and health certification of these products. Its provisions cover the health and safety requirements applicable to apiaries and beekeeping establishments, and touch upon inspection, approval, safety management system certification, traceability, and the national programme for the monitoring and control of chemical residues.

Products Covered: ICS number: 67.180.10 Honey and apiculture products

Regulation Type: Regular notification

Distribution date: 05 March 2018 | Final date for Comment: 02 April 2018

Draft Mercosur Technical Regulation establishing provisions for the net content of frozen fish fillets, toothpaste, soap bars and solid bleach (quantity of the consumable item contained in a package, as stated on the label), in order to repeal "GMC Resolution 31/07” and shall apply to trade in such goods.

Products Covered: Net content of frozen fish fillet, toothpaste, bar wash soap and solid bleach – HS: 0304 Fish fillets frozen (whether or not minced); 3306 Preparations for oral or dental hygiene toothpaste 340211 Soap bars; 2828 Hypochlorites; commercial calcium hypochlorite; chlorites; hypobromites.

Regulation Type: Regular notification

Distribution date: 02 March 2018

Products Covered: Environmental protection (ICS: 13.020), Fuels (ICS:75.160), Biological sources and alternative sources of energy (ICS: 27.190) ; HS codes ; For the two fuels regulations: 2207.20; 2710; 2710.12; 2710.19;2710.91;2710.99; 3826. ; For Tetrachloroethylene (Use in Dry Cleaning and Reporting Requirements) Regulations ; and Solvent Degreasing Regulations: 2903.23.00.00 ; For Solvent Degreasing Regulations: 2903.22.00.00 ; For Volatile Organic Compound (VOC) Concentration Limits for Automotive Refinishing Products Regulations: 2710.12.90 31;3208.90.90 10; 3208.90.90 20; 3209.10.00 10; 3209.10.00 20; 3209.90.00 10; 3209.90.00 20; 3210.00.00 10; 3210.00.00 20; 3210.00.00 90; 32.12; 3814.00.00 10; 3814.00.00 20; 3814.00.00 30; 3814.00.00 90. ; For Volatile Organic Compound (VOC) Concentration Limits for Architectural Coatings Regulations: 3208.90.90 10; 3208.90.90 20; 3209.10.00 10; 3209.10.00 20; 3209.90.00 10; 3209.90.00 20; 3210.00.00 10; 3210.00.00 20; 3210.00.00 90; 32.12; 3214.10.90 10; 3214.10.90 20; 3214.10.90 90; 3214.90.00 10; 3214.90.00 90; 3814.00.00 10; 3814.00.00 20; 3814.00.00 30; 3814.00.00 90; 3824.40.00 00.

Regulation Type: Addendum to Regular Notification

Distribution date: 23 February 2018

Products Covered: Fire-retardant paints for buildings

Regulation Type: Addendum to Regular Notification

Distribution date: 22 February 2018 | Final date for Comment: 22 March 2018

The Minimum Requirements for Biological Products shall be partially amended to add the standard for a vaccine product to be newly approved.

Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30); (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 20 February 2018 | Final date for Comment: 21 April 2018

Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Propiconazole. Propiconazole is used as a fungicide during production of crops, and it is also used for post-harvest treatment on citrus fruits and stone fruits. Post-harvest pesticides, which are used to prevent mold from getting on harvested crops, are regulated as food additives in Japan. The Food Sanitation Act defines food additives as substances which are used by being added, mixed or infiltrated into food or by other methods in the process of producing food or for the purpose of processing or preserving food. Propiconazole is not currently permitted to use for post-harvest treatment. The Ministry of Health, Labour and Welfare of Japan (MHLW) has decided to newly designate Propiconazole as a food additive, and to set the use standard for citrus fruits (excluding unshu orange), peach, nectarine, apricot, Japanese plum and cherry on the basis of scientific data provided by an applicant. Along with this, the MHLW has decided to establish maximum residue limits (MRLs) for Propiconazole on these commodities so that their Propiconazole residue concentrations will not exceed the MRLs if the pesticide is used properly according to the use standards. The MHLW is also going to revise MRLs in several commodities on the basis of the scientific data such as supervised residue trials conducted by Good Agricultural Practices (GAPs). When setting the MRLs, the MHLW confirmed that the estimated long-term and short-term dietary exposures to Propiconazole do not exceed an ADI of 0.019 mg/kg bw and an ARfD of 0.3 mg/kg bw, respectively, which were set by the Food Safety Commission of Japan.

Products Covered: Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) Dairy produce and birds' eggs (HS Codes: 04.01, 04.07 and 04.08) Products of animal origin (HS Code: 05.04) Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14) Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10 and 08.11) Coffee, tea, mate and spices (HS Codes: 09.01, 09.02 and 09.03) Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.02, 12.04, 12.05, 12.06, 12.07, 12.10 and 12.12)Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06)                           

Regulation Type: Regular notification

Distribution date: 19 February 2018

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

Regulation Type: Addendum to Regular Notification

Distribution date: 19 February 2018 | Final date for Comment: 17 May 2018

The notified draft Technical Regulation on the labelling of cosmetic products covers the following: Purpose; Scope; Definitions; Labelling requirements; Conformity assessment; Inspection and monitoring; Supplementary and transitional provisions; Annex 1.

Products Covered: Cosmetic products in HS Chapters 33 and 34

Regulation Type: Regular notification