Regulatory Updates
Resolución Ejecutiva No. 001-2018 Regulación de ciertas sustancias prohibidas y restringidas de uso veterinario en la República de Nicaragua (Executive Resolution No. 001-2018 regulating certain prohibited and restricted substances for veterinary use in the Republic of Nicaragua)
Distribution date: 03 May 2018
The notified Executive Resolution contains a list of substances for veterinary use and provisions regulating and controlling the use and marketing of such substances, based on their prohibited or restricted status. It contains provisions prohibiting, on national territory, the manufacturing, registration, importation, sale, marketing, transport, storage, handling, possession and use of the following substances, whether alone or combined, as raw materials or in finished veterinary drugs, and intended for any animal species and using any route of administration: Thyrostatics, carbadox, malachite green, olaquindox, nitrofurans, sulfathiazole, vancomycin, strychnine, organochlorides (chlorinated compounds), stilbenes, chloramphenicol and any of its salts, ethion, clenbuterol, gentian violet, dimetridazole, chlorpyrifos, avermectins, sulphonamides (sulpha drugs), antimicrobials to promote growth or improve yields, anabolics, beta-agonists, coccidiostats and coccidiocides.
Products Covered: Substances for veterinary use: Thyrostatics, carbadox, malachite green, olaquindox, nitrofurans, sulfathiazole, vancomycin, strychnine, organochlorides (chlorinated compounds), stilbenes, chloramphenicol and any of its salts, ethion, clenbuterol, gentian violet, dimetridazole, chlorpyrifos, avermectins, sulphonamides (sulpha drugs), antimicrobials to promote growth or improve yields, anabolics, beta-agonists, coccidiostats and coccidiocides.
Regulation Type: Regular notification
Reglamento de la Ley General de Salud en materia de Control Sanitario de la Cannabis y derivados de la misma (Implementing Regulations to the General Law on Health with respect to the sanitary control of cannabis and derivatives thereof)
Distribution date: 03 May 2018 | Final date for Comment: 02 July 2018
The notified document contains regulations describing the pharmacological derivatives of cannabis and setting out the requirements governing their marketing for industrial use. It covers the following: sowing, cultivation, harvesting, preparation, consolidation, acquisition, possession, trade, any form of transportation, supply, employment, use, consumption, and in general, any activity relating to cannabis conducted for medical and scientific research purposes. The Regulations are binding throughout national territory.
Products Covered: Cannabis sativa, indica and americana or marijuana, resin, preparations, seed, pharmacological derivatives and products for extensive industrial use containing cannabis derivatives in a concentration equal to or less than 1% of Tetrahydrocannabinol (THC) (Tariff headings concerned: 13021902, 12099907, 12119002, 30034001, 30049033, 30039005, 30044002)
Regulation Type: Regular notification
Draft revision of the Ordinance on Licensing in the Medicinal Products Sector, 41 pages, available in German, French and Italian.
Distribution date: 02 May 2018 | Final date for Comment: 01 July 2018
The Ordinance on Licensing in the Medicinal Products Sector (SR 812.212.1) is being currently revised due to numerous amendments relating to the ordinary revision of the Therapeutic Products Act (TPA) adopted by Parliament on 18 March 2016 as well as to the approval and implementation of the Medicrime Convention adopted by Parliament on 29 September 2017. The following amendments of the abovementioned ordinance may be relevant for international trade: more detailed specifications with regard to the licence for the import, export and foreign trade of medicinal products new licence for the activities of brokers simplifications with regard to the individual import of immunological medicinal products or blood/blood products new regulation concerning the import of unauthorised medicinal products in small quantities by private individuals and by health professionals
Products Covered: Medicinal products: products of chemical or biological origin which are intended to have or are presented as having a medicinal effect on the human or animal organism, in particular in the diagnosis, prevention or treatment of diseases, injuries and handicaps; blood and blood products are also considered to be medicinal products (relevant tariff items: 3002, 3003, 3004).
Regulation Type: Regular notification
Reglamento de la Ley General de Salud en materia de Control Sanitario de la Cannabis y derivados de la misma (Implementing Regulations to the General Law on Health with respect to the sanitary control of cannabis and derivatives thereof), 15 pages, in Spanish
Distribution date: 01 May 2018
The notified document contains regulations describing the pharmacological derivatives of cannabis and setting out the requirements governing the marketing of cannabis for industrial use. It covers the following: sowing, cultivation, harvesting, preparation, consolidation, acquisition, possession, trade, any form of transportation, supply, employment, use, consumption, and in general, any cannabis-related activity conducted for medical and scientific research purposes. The Regulations are binding throughout national territory.
Products Covered: Cannabis sativa, indica and americana or marijuana, resin, preparations, seeds, pharmacological derivatives and products for extensive industrial use containing cannabis derivatives in a concentration equal to or less than 1% of Tetrahydrocannabinol (THC). (Tariff headings concerned: 13021902, 12099907, 12119002, 30034001, 30049033, 30039005, 30044002).
Regulation Type: Regular notification
Health measure on polymyxin E (colistin) and polymyxin B
Distribution date: 30 April 2018
The Republic of Colombia hereby notifies that draft Colombian Agricultural Institute (ICA) Resolution "Prohibiting the importation, manufacturing, registration, marketing and use of additives containing polymyxin E (colistin) and polymyxin B as growth promoters for animals producing food for human consumption", notified on 20 November 2017 by the World Trade Organization in document G/SPS/N/COL/275, has been issued pursuant to ICA Resolution No. 00022747 of 9 April 2018, which will enter into force upon its publication in the Official Journal. Text available at: https://members.wto.org/crnattachments/2018/SPS/COL/18_2294_00_s.pdf
Products Covered:
Regulation Type: Addendum to Regular Notification
TITLE: Labeling of Certain Household Products Containing Methylene Chloride; Supplemental Guidance; Correction AGENCY: Consumer Product Safety Commission ACTION: Guidance; correction SUMMARY: The Consumer Product Safety Commission is correcting supplemental guidance on the Labeling of Certain Household Products Containing Methylene Chloride, which appeared in the Federal Register of 21 March 2018. The document provides guidance regarding labeling to warn of acute hazards associated with paint strippers containing methylene chloride. This correction provides the appropriate link to the petition briefing package and the format of a warning label. DATES: This correction is effective 26 April 2018. As established in the supplemental guidance, the guidance document became applicable on the date of its publication in the Federal Register, 21 March 2018.
Distribution date: 30 April 2018
Products Covered: Household products containing Methylene Chloride
Regulation Type: Corrigendum to Regular Notification
Revocation of designation of Efrotomycin as feed additives
Distribution date: 27 April 2018 | Final date for Comment: 26 June 2018
The Ministry of Agriculture, Forestry and Fisheries (MAFF) will revoke designation of efrotomycin as feed additive since efrotomycin is no longer used, produced, imported or expected to be used in the future in/into Japan.
Products Covered: Efrotomycin as a feed additive
Regulation Type: Regular notification
Importation of egg products and dairy products for food purposes classified under specific HS codes shall be accompanied with official certificates noted for food purpose and to attest that the products are in compliance with relevant food safety and sanitary regulations, and certificates shall be issued by the competent authority of the exporting country
Distribution date: 26 April 2018 | Final date for Comment: 30 June 2018
The Taiwan Food and Drug Administration (TFDA) is proposing an imported inspection requirement on egg products and dairy products importation. Importation of egg products for food purposes classified under four specific HS codes including 0407, 0408, 350211 and 350219, and dairy products for food purposes classified under seven specific HS codes including 0401, 0402, 0403, 0404, 0405, 0406 and 9806, shall be accompanied with official certificates individually noted for food purpose and in compliance with relevant food safety and sanitary regulations, and certificates shall be issued by the competent authority of the exporting country.
Products Covered: Egg products (HS Codes: 0407, 0408, 350211 and 350219) and dairy products (HS Codes: 0401, 0402, 0403, 0404, 0405, 0406 and 9806) for food purposes
Regulation Type: Regular notification
Technical Regulation No. 01, 16 April 2018 (Instrução Normativa Conjunta SDA/SMC N° 01, de 16 de Abril de 2018)
Distribution date: 26 April 2018
Technical Regulation amending Annex II of the SDA/SDC N° 02, 12 July 2013, that establishes the reference specifications for plant protection products approved for organic agriculture.
Products Covered: HS 38.08
Regulation Type: Regular notification
Proyecto de Resolución del Instituto Colombiano Agropecuario - ICA "Por medio de la cual se establecen los requisitos y el procedimiento para el registro ante el ICA de los cosméticos de uso veterinario y se dictan otras disposiciones" (Draft Colombian Agricultural Institute (ICA) Resolution "Establishing the requirements and procedure for the registration with the ICA of cosmetics for veterinary use and adopting other provisions")
Distribution date: 23 April 2018 | Final date for Comment: 22 June 2018
The notified draft Resolution establishes the requirements and procedure for the registration with the ICA of cosmetics for veterinary use. The draft text covers the following: Purpose; Scope; Definitions; Registration of cosmetics for veterinary use; Requirements for the registration of cosmetics for veterinary use; Labelling; Review of registration requests; Procedures for issuing registration certificates; Issue of registration certificates; Amendments to registration; Obligations; Cancellation of registration; Authorization to import raw materials for the manufacturing of products exclusively for exportation; Other provisions; Advertising; Official control; Penalties; Transitional provision; and Period of validity.
Products Covered: Cosmetics for veterinary use
Regulation Type: Regular notification
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