Regulatory Updates

Distribution date: 08 January 2020 | Final date for Comment: 02 March 2020

This Draft Resolution proposes the updating of the technical requirements for the labelling of personal hygiene products, cosmetics, and perfumes.

Products Covered: HS Codes: 3303; 3304; 3305; 3306;3307; 340111; 340130; 9616; 9619 (personal hygiene products, cosmetics, and perfumes)

Regulation Type: Regular notification

Distribution date: 07 January 2020 | Final date for Comment: 07 March 2020

This Draft East African Standard specifies the requirements, sampling and test methods for non-absorbable surgical sutures.

Products Covered: (HS code(s): 300610); Surgical instruments and materials (ICS code(s): 11.040.30)

Regulation Type: Regular notification

Distribution date: 07 January 2020 | Final date for Comment: 07 March 2020

These drafts technical regulations stipulate technical requirements and the management on quality, hygiene and safety of calcium cyclamate, sodium cyclamate, calcium saccharin, potassium saccharin, sodium saccharin, sucralose, alitame, aspartame-acesulfame, polyglycitol syrup, sorbitol syrup. These drafts technical regulations applies to organizations and individuals who produce, trade and import these sweeteners for circulation in Vietnam and relevant agencies, organizations and individuals. These drafts technical regulations include: National technical regulation of Alitame National technical regulation of Aspartame-Acesulfame National technical regulation of Calcium cyclamate National technical regulation of Calcium saccharin National technical regulation of Potassium saccharin National technical regulation of Sodium cyclamate National technical regulation of Sodium saccharin National technical regulation of Polyglycitol syrup National technical regulation of Sorbitol syrup National technical regulation of Sucralose

Products Covered: Calcium cyclamate (HS code 2933.59.90), sodium cyclamate (HS code 2929.90.10), calcium saccharin (HS code 2925.11.00), potassium saccharin (HS code 2925.11.00), sodium saccharin (HS code 2925.11.00), sucralose (HS code 2940.00.00), alitame (HS code 2934), aspartame-acesulfame (HS code 2934.99.90), polyglycitol syrup (HS code 1702.20.00), sorbitol syrup (HS code 2905.44.00)

Regulation Type: Regular notification

Distribution date: 07 January 2020 | Final date for Comment: 25 January 2020

The draft amendments to the Requirements for stability testing of drugs and pharmaceutical substances applies to put into circulation on the territory of the Eurasian economic Union drugs and calls for the unified approach to the definition of "production date of the series" in order to exclude the possibility of automatic updates of the shelf life of the pharmaceutical substance by a simple repackaging, and the calculation of the shelf life of finished drugs, issued in circulation in the customs territory of the Eurasian economic Union for the purpose of elimination of the possibility of automatic renewal of the shelf life of the pharmaceutical substance by its simple repackaging, as well as the use in the production of substances with an expiration date not corresponding to the shelf life of finished drugs, which may lead to inconsistencies of expert reports and recognition.  The draft guide has been prepared in order to: - protection of life and health of the patient (as the final consumer of medicines); - protection of the interests of the health care system as a whole (as the primary consumer of medicines)  - protection of the interests of the authorized bodies (expert organizations) that perform the procedure of evaluation of the registration dossier of the drug from the position of proof of its compliance with the specified quality standard.

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

Regulation Type: Regular notification

Distribution date: 07 January 2020 | Final date for Comment: 07 March 2020

This Draft East African Standard specifies the requirements, sampling and test methods for absorbable surgical sutures.

Products Covered: (HS code(s): 300610); Surgical instruments and materials (ICS code(s): 11.040.30)

Regulation Type: Regular notification

Distribution date: 07 January 2020 | Final date for Comment: 15 February 2020

This Draft resolution incorporates the following changes for the active ingredient N08 - NICOSSULFUROM (nicosulfuron) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of pre-emergence use (application):- includes the soya culture with MRL of 0.01 mg/kg and safety security period "Not-determined due to the modality of use".

Products Covered: HS Code(s): 1201; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 07 January 2020 | Final date for Comment: 15 February 2020

This Draft resolution incorporates the following changes for the active ingredient F66 - FLUBENDIAMIDA (flubendiamide) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application):- includes the millet and sorghum cultures with MRL of 0.1 mg/kg and safety security period of 20 days.

Products Covered: HS Code(s): 1007, 100820; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 07 January 2020 | Final date for Comment: 15 February 2020

This Draft resolution incorporates the following changes for the active ingredient H07.1 - HALOXIFOPE-P-METÍLICO (haloxyfop-P) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of post-emergence use (application):- includes the coffee culture with MRL of 0.01 mg/kg and safety security period of 20 days.

Products Covered: HS Code(s): 09; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 07 January 2020 | Final date for Comment: 15 February 2020

This Draft resolution incorporates the following changes for the active ingredient F32 - FENOXAPROPE-P (fenoxaprop-P) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers:- includes the cotton culture with MRL of 0.01 mg/kg and safety security period of 110 days in the modality of post-emergence use (application);- includes the wheat culture with MRL of 0.01 mg/kg and safety security period Not-determined due to the modality of pre-emergence use (application).

Products Covered: HS Code(s): 52, 1001; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 07 January 2020 | Final date for Comment: 15 February 2020

This Draft resolution incorporates the following changes for the active ingredient F47 - FLUAZINAM (fluazinam) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application):- changes the MRL of the cotton culture from 0.02 to 0.04 mg/kg and mantains the safety security period of 30 days;- changes the MRL of the onion culture from 0.05 to 0.15 mg/kg and mantains the safety security period of 14 days.

Products Covered: HS Code(s): 52, 071220; ICS Code(s): 13, 65

Regulation Type: Regular notification