Regulatory Updates

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: 11 January 2018

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 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: 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: 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: 10 January 2018

The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu notified to the Draft of using restrictions and labelling requirements of senna dated 26 July 2016 (G/SPS/N/TPKM/405). The final regulation of the use restriction and labelling requirements of senna was promulgated on 9 January 2018 and will enter into force on 1 July 2018

Products Covered:

Regulation Type: Addendum to Regular Notification

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

This Draft Uganda Standard prescribes the hygienic conditions and practices for production, handling, processing, storage, transportation, marketing, distribution and sale of milk and milk products.

Products Covered: Milk and cream, not concentrated nor containing added sugar or other sweetening matter (HS code(s): 0401); Milk and cream, concentrated or containing added sugar or other sweetening matter (HS code(s): 0402); Buttermilk, curdled milk and cream, yogurt, képhir and other fermented or acidified milk and cream, whether or not concentrated or flavoured or containing added sugar or other sweetening matter, fruits, nuts or cocoa (HS code(s): 0403); Whey, whether or not concentrated or containing added sugar or other sweetening matter; products consisting of natural milk constituents, whether or not containing added sugar or other sweetening matter, n.e.s. (HS code(s): 0404); Butter, incl. dehydrated butter and ghee, and other fats and oils derived from milk; dairy spreads (HS code(s): 0405); Milk albumin "lactalbumin", incl. concentrates of two or more whey proteins containing by weight > 80% whey proteins, calculated on the dry matter (HS code(s): 350220); Milk and milk products (ICS code(s): 67.100)

Regulation Type: Regular notification

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 enterprises that store raw materials, bulk materials and finished products (pharmaceutical products, cosmetics, disinfectants, ectoparasiticides and other products for veterinary use). It contains articles on: Purpose; Scope; Definitions; Registration of warehousing enterprises; Requirements; Registration of technical officers; Review of registration requests; Audit visits; Issue of registration certificates, amendments to registration and cancellation of registration; Good warehousing practices (GWP); Prohibitions; Other provisions; Penalties; Transitional provision; and Period of validity.

Products Covered: Raw materials and pharmaceutical products for veterinary use

Regulation Type: Regular notification

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 producers, contracted producers, semi-processors and importers of pharmaceutical products, cosmetics, disinfectants, ectoparasiticides and various products for veterinary use. It contains articles on: Purpose; Scope; Definitions; Registration of enterprises; General requirements; Specific requirements; Registration of enterprises located overseas; Technical officers; Registration of technical officers; Procedure for the registration of enterprises; Document review; Audit visits; Issue of registration certificates, amendments to registration and cancellation of registration; Prohibitions; Other provisions; Official control; Penalties; Transitional provision; and Period of validity.

Products Covered: Pharmaceutical products for veterinary use

Regulation Type: Regular notification

Distribution date: 09 January 2018

Products Covered: HS-Chapter 32 - paints

Regulation Type: Corrigendum to Regular Notification