Distribution date: 10 January 2018 | Final date for Comment: 11 March 2018

The notified draft Resolution establishes the requirements and procedure for the registration with the ICA of medicines for veterinary use. It contains articles on: Purpose; Scope; Definitions; Registration of medicines for veterinary use; Requirements for the registration of medicines for veterinary use; Labelling; Review of registration requests; Procedures for issuing registration certificates; Issue of registration certificates, amendments to registration and cancellation of registration; Prohibitions; Authorization to import raw materials for the manufacturing of products exclusively for exportation; Advertising; Other provisions; Official control; Penalties; Transitional provision; and Period of validity.

Products Covered: Medicines for veterinary use

Regulation Type: Regular notification

Distribution date: 11 January 2018 | Final date for Comment: 09 April 2018

This Resolution provides for food additives and technology adjuvants authorized for use in food supplements. Food additives authorized for use in food supplements, their respective functions, ceilings and conditions of use are listed in Annex I to this Resolution. Food additives and technology adjuvants shall meet the most current specifications set forth by the Joint FAO / WHO Expert Committee on Food Additives (JECFA) or Food Chemicals Codex (FCC) Food Chemicals. The period of 24 (twenty four) months is established for the adequacy of the products covered by this Resolution that, at the date of their publication, are regularized with the National Health Surveillance System.

Products Covered: HS Code: Food; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 11 January 2018 | Final date for Comment: 12 March 2018

This standard applies to food nutritional fortifier phytonadione (vitamin K1), which is obtained through chemical synthesis, using menadione and phytol (including natural plant alcohol and isophytol) as raw material. It specifies the technical requirements and test methods for food nutritional fortifier phytonadione.

Products Covered: Food nutritional fortifier phytonadione (HS Code: 293629)

Regulation Type: Regular notification

Distribution date: 11 January 2018 | Final date for Comment: 29 April 2025

This Resolution provides for the classification in the priority category, of registration petitions, post registration and prior consent in clinical trial of medicines. The criteria and procedures for framing on the priority category applications for registration, post-registration and prior consent in clinical trial for drugs are approved under the terms of this Resolution. In addition to the criteria established in arts. 3 and 4, Anvisa may classify as priority requests for registration and post-registration of medicines for sale under medical prescription, when the risk of market shortages that have an impact on public health is configured. The classification in the priority category should be made at the moment of the application of the petition regarding registration, post-registration alteration and prior consent in clinical trial. This resolution establishes the criteria for requests for registration of medicines and petitions for prior consent. The deadline for final decision regarding the analysis of petitions classified as priority will be: 120 (one hundred and twenty) days for drug registration applications and 60 (sixty) days for post-registration petitions. In order to be able to apply the criteria set forth in this resolution, the priority petition for registration, post-registration and prior consent in clinical trial must present all documentation required by the current resolution and current regulation, under penalty of rejection.

Products Covered: 3003 3004: Medicaments

Regulation Type: Regular notification

Distribution date: 11 January 2018 | Final date for Comment: 12 March 2018

This standard applies to food nutritional fortifier choline bitartrate, which is obtained by the reaction of trimethylamine, tartaric acid and ethylene oxide as the raw material, then through the process of concentration (or crystallizing), separating and drying. It specifies the technical requirements and detection methods for food nutritional fortifier choline bitartrate.

Products Covered: Food nutritional fortifier Choline bitartrate (HS Code: 292310)

Regulation Type: Regular notification

Distribution date: 12 January 2018 | Final date for Comment: 13 March 2018

Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Cadusafos

Products Covered: - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.06, 07.07, 07.08, 07.09, 07.10 and 07.14) - Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.03, 08.05, 08.07, 08.10 and 08.11) - Coffee, tea, mate and spices (HS Codes: 09.10) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01 and 12.12)

Regulation Type: Regular notification

Distribution date: 12 January 2018 | Final date for Comment: 13 March 2018

Proposed maximum residue limits (MRLs) for the following agricultural chemical. Pesticide: Chlorantraniliprole.

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) - Fish and crustaceans, molluscs and other aquatic invertebrates (HS Codes: 03.02, 03.03 and 03.04) - 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, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) - Coffee, tea, mate and spices (HS Codes: 09.01, 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - 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)- Cacao and cacao preparations (HS Code: 18.01)            

Regulation Type: Regular notification

Distribution date: 12 January 2018 | Final date for Comment: 13 March 2018

Proposed maximum residue limits (MRLs) for the following agricultural chemical - Pesticide: Desmedipham.

Products Covered: - Edible vegetables and certain roots and tubers (HS Codes: 07.09 and 07.10) - Edible fruits and nuts, peel of citrus/melons (HS Code: 08.14) - Coffee, tea, mate and spices (HS Codes: 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10)- Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Code: 12.12)              

Regulation Type: Regular notification

Distribution date: 12 January 2018 | Final date for Comment: 13 March 2018

Proposed maximum residue limits (MRLs) for the following agricultural chemical. Pesticide: Clethodim. Japan has received some comments and relevant data on document G/SPS/N/JPN/515 circulated on 16 May 2017. The MHLW has decided to modify the draft maximum residue limits (MRLs) for Clethodim in "Corn" based on the provided data.

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: 08.02, 08.07, 08.10, 08.11 and 08.14) - Coffee, tea, mate and spices (HS Codes: 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01, 10.03 and 10.05) - 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: Revision to Regular Notification

Distribution date: 12 January 2018 | Final date for Comment: 29 April 2025

This Resolution establishes special procedure for approval of clinical trials, good manufacturing practices certification and registration of new medicines for treatment, diagnosis or prevention of rare diseases. This resolution applies to new medicines for rare diseases.The special procedure applies to:I – clinical trials authorization to be performed in Brazil for the evaluation of medicines for rare diseases; II - certification of good manufacturing practices of medicines for rare diseases; III – market authorization of new medicines for rare diseases.A medicine for a rare disease shall be considered a medicine intended to treat, diagnose or prevent a rare disease and: I - is used in a serious debilitating condition; II - proposes to change in a clinically significant way the disease evolution or to make possible the remission of the disease.The request of approval for clinical trials and registration of a new medicine for rare diseases is established in this Resolution.If it is not confirmed during the technical analysis that the petitions for approval of clinical trials and registration of new medicine refers to rare disease, the petition will be rejected.Submission of clinical medicine development dossier, specific clinical trial dossier, substantial modification by inclusion of protocol should be performed according to specific legislation regarding clinical trials in Brazil, added by the documentation established in this Resolution.The request for registration of a new rare disease medicine must be carried out according to specific legislation for each regulatory category, added by the documentation described in this Resolution.Supplemental data and additional evidence may be allowed after the registration has been granted, by means of a signature of an agreement between Anvisa and the company requesting registration. Failure to comply with the agreement may lead to cancellation of the registration.Anvisa may permit the use of an international comparator medicine registered with another regulatory authority, under the terms set forth in this Resolution in the event of a request for registration of a rare disease medicine with the same registered medicine IFAs.Companies that submit a request for registration of new medicine in accordance with this resolution must present a maximum price definition dossier concomitantly with the registration requestFor applications for registration of new medicines for rare diseases, it does not apply the provisions of art. 2 of the Resolution of the Collegiate Board of Directors - RDC nº 20, of 10 April 2013.This resolution changes the text of §2 of art. 47 of the Resolution of the Collegiate Board of Directors - RDC nº 9 of 20 February 2015.

Products Covered: 3003 3004: Medicaments

Regulation Type: Regular notification