Regulatory Updates

Distribution date: 28 June 2021

The Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor) introduced a temporary restriction on imports of feed and feed additives used for animal feeding, including feed of plant origin, or containing products of chemical and microbiological synthesis from Lithuania to the Russian Federation due to detection of numerous violations of EAEU SPS requirements.

Products Covered: Feed and feed additives used for animal feeding, including feed of plant origin, or containing products of chemical and microbiological synthesis (HS Codes: 0106, 0307, 0505, 0511, 1001, 1002, 1003, 1004, 1005, 1103, 1201, 1208, 1211, 1213, 1214, 1501, 1502, 1504, 1505, 1506, 1516, 1518, 2102, 2301, 2302, 2303, 2304, 2306, 2308, 2309)

Regulation Type: Emergency notifications (SPS)

Distribution date: 25 June 2021 | Final date for Comment: 24 August 2021

Among the already designated products, the Minister newly proposes the standard of judgement for part of multi-air conditioners for buildings. In order to do it, the “Ministerial order of the Ministry of Economy, Trade and Industry”, which stipulates the scope for manufactures or importers who are designated to receive the recommendation by the Minister of Economy, Trade and Industry, is revised and the standards of judgement and labeling requirement are newly stipulated in the “Notifications of the Ministry of Economy, Trade and Industry”.

Products Covered: Among multi-air conditioners for buildings (separate type with a structure in which two or more indoor units are connected to one outdoor unit, and the air temperature or humidity can be adjusted for each indoor unit), other than the following. 1) Shipped on the premise of using the existing refrigerant piping 2) Equipped with the structure required for refrigerant diversion in order to use cooling and heating at the same time. 3) Equipped with a function to suppress a decrease in heating capacity when the outside air temperature is low 4) A structure that uses water as a heat source 5) A structure with a dedicated heat storage tank for storing heat for cooling or cooling/heating HS:8415.10

Regulation Type: Regular notification

Distribution date: 25 June 2021

The Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor) introduced a temporary restriction on imports from 24 June 2021 of feed and feed additives used for animal feeding, including feed of plant origin, or containing products of chemical and microbiological synthesis from Latvia to the Russian Federation due to detection of numerous violations of EAEU SPS requirements.

Products Covered: Feed and feed additives used for animal feeding, including feed of plant origin, or containing products of chemical and microbiological synthesis (HS Codes: 0106, 0307, 0505, 0511, 1001, 1002, 1003, 1004, 1005, 1103, 1201, 1208, 1211, 1213, 1214, 1501, 1502, 1504, 1505, 1506, 1516, 1518, 2102, 2301, 2302, 2303, 2304, 2306, 2308, 2309)

Regulation Type: Emergency notifications (SPS)

Distribution date: 25 June 2021

The Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor) introduced a temporary restriction on imports from 25 June 2021 of feed and feed additives used for animal feeding, including feed of plant origin, or containing products of chemical and microbiological synthesis from Poland to the Russian Federation due to detection of numerous violations of EAEU SPS requirements.

Products Covered: Feed and feed additives used for animal feeding, including feed of plant origin, or containing products of chemical and microbiological synthesis (HS Codes: 0106, 0307, 0505, 0511, 1001, 1002, 1003, 1004, 1005, 1103, 1201, 1208, 1211, 1213, 1214, 1501, 1502, 1504, 1505, 1506, 1516, 1518, 2102, 2301, 2302, 2303, 2304, 2306, 2308, 2309)

Regulation Type: Emergency notifications (SPS)

Distribution date: 25 June 2021

The Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor) introduced a temporary restriction on imports from 21 June 2021 of feed and feed additives used for animal feeding, including feed of plant origin, or containing products of chemical and microbiological synthesis from the Czech Repuplic to the Russian Federation due to detection of numerous violations of EAEU SPS requirements.

Products Covered: Feed and feed additives used for animal feeding, including feed of plant origin, or containing products of chemical and microbiological synthesis (HS Codes: 0106, 0307, 0505, 0511, 1001, 1002, 1003, 1004, 1005, 1103, 1201, 1208, 1211, 1213, 1214, 1501, 1502, 1504, 1505, 1506, 1516, 1518, 2102, 2301, 2302, 2303, 2304, 2306, 2308, 2309)

Regulation Type: Emergency notifications (SPS)

Distribution date: 23 June 2021

Due to the international public health emergency resulting from the new Coronavirus, this resolution establishes exceptional and temporary criteria and requirements for exemption from package inserts and labeling information for the presentation of medicines for use restricted to hospitals, clinics and services of home care, except pharmacies and drugstores.

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 for transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3004); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 23 June 2021

RDC No. 519 amends the Resolution 56, 8 October 2014, which provides for the Certification of Good Practices for conducting Bioavailability/Bioequivalence studies of medicines and other measures.

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 for 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: 23 June 2021

The Resolution amends the Resolution number 67, 23 March 2016, which disposes of applications for qualification requests, license renewals, post-qualification modifications, trial outsourcing, suspensions, and cancellations of Pharmaceutical Equivalence Centers, and gives other arrangements.

Products Covered: Pharmaceutical preparations and products of subheadings 3006.10.10 to 3006.60.90 (HS code(s): 3006); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 22 June 2021 | Final date for Comment: 16 July 2021

ANVISA issued Dispatch 85, which extends the comment periodor 30 days of the Public Consultation No. 1037, 8 April 2021, previously notified G/TBT/N/BRA/1171 - which establishes technical requirements for research on pesticide residues and establishment of Maximum Residue Limits (MRL) for the purpose of market authorization for pesticides in Brazil. The extension text is available only in Portuguese and can be downloaded at:  https://www.in.gov.br/en/web/dou/-/despacho-n-85-de-14-de-junho-de-2021-326195155 This regulation will be also notified to the SPS Committee

Products Covered: HS Code(s): 38089910 (pesticides)

Regulation Type: Addendum to Regular Notification

Distribution date: 17 June 2021

The general objective of this Order is to rationalize the requirements and procedures of the importation of wood products into the country.

Products Covered: Fuel wood, in logs, billets, twigs, faggots or similar forms; wood in chips or particles; sawdust and wood waste and scrap, whether or not agglomerated in logs, briquettes, pellets or similar forms (HS code(s): 4401); Wood charcoal, incl. shell or nut charcoal, whether or not agglomerated (excl. wood charcoal used as a medicament, charcoal mixed with incense, activated charcoal and charcoal in the form of crayons) (HS code(s): 4402); Wood in the rough, whether or not stripped of bark or sapwood, or roughly squared (excl. rough-cut wood for walking sticks, umbrellas, tool shafts and the like; wood in the form of railway sleepers; wood cut into boards or beams, etc.) (HS code(s): 4403); Hoopwood; split poles; piles, pickets and stakes of wood, pointed but not sawn lengthwise; wooden sticks, roughly trimmed but not turned, bent or otherwise worked, for the manufacture of walking sticks, umbrellas, tool handles or the like; chipwood, wooden slats and strips and the like (excl. hoopwood cut to length and chamfered; brush surrounds and shoe trees) (HS code(s): 4404); Wood wool; wood flour "wood powder able to pass through a fine", 0,63 mm mesh, sieve with a residue of 6 mm (HS code(s): 4407); Sheets for veneering, incl. those obtained by slicing laminated wood, for plywood or for other similar laminated wood and other wood, sawn lengthwise, sliced or peeled, whether or not planed, sanded, spliced or end-jointed, of a thickness of

Regulation Type: Regular notification