Letter of the Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor) No.FS-KS-7/17439 of 21 June 2021

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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)

Feed additives Animal feed Animal health Pest- or Disease- free Regions / Regionalization

Letter of the Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor) No.FS-KS-7/17583 of 22 June 2021

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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)

Animal feed Animal health Pest- or Disease- free Regions / Regionalization Feed additives

Letter of the Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor) No. FS-YUSH-7/17140 of 17 June 2021

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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)

Animal feed Animal health Pest- or Disease- free Regions / Regionalization Feed additives

Resolution – RDC number 517, 10 June 2021.

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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

Labelling

Resolution – RDC number 519, 10 June 2021

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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

Resolution – RDC number 518, 10 June 2021.

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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

Public Consultation No. 1037 extension period

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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

DENR DAO 2021-06 “Revised Regulations Governing the Entry and Disposition of Imported Wood Products"

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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

Ordonnance sur les précurseurs de substances explosibles (Ordinance on precursors for explosive substances) (31 pages, in German; 31 pages, in French; 31 pages, in Italian)

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Distribution date: 17 June 2021 | Final date for Comment: 16 August 2021

In September 2020, the Parliament approved the new regulations on explosives precursors. Explosives precursors may be used to make homemade explosives. The regulations adopted by the Parliament cover a number of products mainly sold in pharmacies, drugstores and specialist shops. No restrictions are laid down for low concentrations. When concentrations are higher, an authorization issued by fedpol shall be required for purchase. The law also provides for the prohibition of access to substances, as well as exceptions to this. The regulations are not applicable to professionals, such as farmers. The notified Ordinance specifies the eight substances covered by the restrictions and their limit values for access, in addition to the role of specialist shops. These shops know their clients well and may therefore freely sell certain substances in small quantities. In contrast to European legislation, the new Ordinance does not for the time being restrict access to sulphuric acid, which is often used in car batteries.

Products Covered: INORGANIC CHEMICALS; ORGANIC OR INORGANIC COMPOUNDS OF PRECIOUS METALS, OF RARE-EARTH METALS, OF RADIOACTIVE ELEMENTS OR OF ISOTOPES (HS code(s): 28); ORGANIC CHEMICALS (HS code(s): 29); PHARMACEUTICAL PRODUCTS (HS code(s): 30); FERTILISERS (HS code(s): 31); TANNING OR DYEING EXTRACTS; TANNINS AND THEIR DERIVATIVES; DYES, PIGMENTS AND OTHER COLOURING MATTER; PAINTS AND VARNISHES; PUTTY AND OTHER MASTICS; INKS (HS code(s): 32); SOAP, ORGANIC SURFACE-ACTIVE AGENTS, WASHING PREPARATIONS, LUBRICATING PREPARATIONS, ARTIFICIAL WAXES, PREPARED WAXES, POLISHING OR SCOURING PREPARATIONS, CANDLES AND SIMILAR ARTICLES, MODELLING PASTES, ‘DENTAL WAXES’ AND DENTAL PREPARATIONS WITH A BASIS OF PLASTER (HS code(s): 34); Propellent powders (HS code(s): 3601); Prepared explosives (excl. propellent powders) (HS code(s): 3602); Ferro-cerium and other pyrophoric alloys in all forms; metaldehyde, hexamethylenetetramine and similar products in tablets, sticks or similar forms, for use as fuel; alcohol-based fuels and prepared fuels of a similar kind, solid or in paste form; liquid gases and liquid fuels for lighters or igniters, in containers of

Regulation Type: Regular notification

(1) Partial amendment to the Minimum Requirements for Biological Products (2) Partial amendment to the Public Notice on National Release Testing

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Distribution date: 16 June 2021

Amendment to establish, amend and delete articles under the Minimum Requirements for Biological Products and the Public Notice on National Release Testing was adopted and published on 22 January 2021. The outline of amendment is available as attached file.

Products Covered: Pharmaceutical Products (HS: 30)

Regulation Type: Addendum to Regular Notification

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