62 Notificaciones OMC Organización Mundial del Comercio SEPTIEMBRE ARGENTINA Notificación: G/TBT/N/ARG/291 Sustancias químicas: gamma butirolactona (GBL) y cloruro de etilo (Chemical substances: gamma-butyrolactone (GBL) and ethyl chloride) (2 pages, in Spanish). The substances gamma-butyrolactone (GBL) and ethyl chloride have been included in the latest update of the “Lists of narcotic drugs, psychotropic substances and other substances that may cause physical or psychological dependence”. The National Drugs, Food and Medical Technology Administration (ANMAT) has established an authorization system for the importation of gamma-butyrolactone (GBL) and ethyl chloride intended for the production of medicines, food or cosmetics. The sectors of the pharmacy, food and cosmetics industries, which are regulated by National Drugs, Food and Medical Technology Administration (ANMAT), will be able to obtain authorization justifying their lawful use of these substances. The authorization procedure for the importation of gammabutyrolactone (GLB) will be initiated by the National Food Institute (INAL) or by the National Institute of Medicines (INAME), depending on whether it applies to the food or cosmetics industry. The authorization procedure for the importation of ethyl chloride will be initiated by the National Institute of Medicines (INAME). Both institutes are attached to the National Drugs, Food and Medical Technology Administration (ANMAT). For all cases, the administrative procedures will be dealt with by the Directorate for the Surveillance of Substances Subject to Special Control, attached to the National Institute of Medicines (INAME) which issues the import authorization. Objeto y razón de ser: Protection of public health. CANADÁ Notificación: G/TBT/N/CAN/463 Notice to interested parties – Proposal regarding an order amending the schedules to the Controlled Drugs and Substances Act (CDSA) and regulations amending the regulations to the CDSA to facilitate legitimate access to certain substances (2 pages, available in English and French). This notice provides interested stakeholders with the opportunity to provide comments on Health Canada’s proposal for the exclusion of barbituric acid, naloxegol and its salts, methylnaltrexone and its salts, as well as the salts of nalmefene, naloxone and naltrexone from the schedules to the CDSA and its regulations. This proposal also includes amendments to Part J of the Food and Drug Regulations (FDR) in order to add Catha edulis Forsk, cathine and cathinone in its schedule. The CDSA and its regulations provide a framework for the control of substances that can alter mental processes and that may cause harm to health or to society when diverted to an illicit market or use. It has come to the attention of Health Canada that several substances that do not pose risks to public health and safety are captured under the schedules to the CDSA. In addition, certain substances scheduled under the Act are not listed under any of its regulations, thereby hampering access to these substances for legitimate purposes. Amendments to the schedules to the CDSA and its regulations are therefore being proposed to address these issues. Objeto y razón de ser: The purpose of these amendments are to exclude specific substances that do not pose a threat to public health or public safety from the schedules of the CDSA and its regulations and to facilitate legitimate access to specific substances that are currently controlled under the CDSA. Notificación: G/TBT/N/CAN/464 Notice to interested parties – Proposal regarding an order amending the schedules to the Controlled Drugs and Substances Act (CDSA) and regulations amending the regulations under the CDSA to exclude the salts of 14 substances that are currently excluded from the CDSA (2 pages, available in English and French). This notice provides interested stakeholders with the opportunity to provide comments on Health Canada’s proposal for the exclusion of the salts of the following 14 substances from the Controlled Drugs and Substances Act (CDSA) and its regulations: apomorphine, cyprenorphine, narcotine, papaverine, carbamethidine, oxpheneridine, ethoheptazine, metethoheptazine, metheptazine, dextromethorphan, dextrorphan, levallorphan, levargorphan, and cyclazocine. The salts of these 14 substances are not captured within the current exclusions, which explicitly capture only the parent substances. Under this regulatory proposal, the scope of the exclusions for these 14 substances would be extended to include their salts. The salts of these substances are used for a wide variety of purposes and do not pose a threat to public health or public safety. For most of these substances, the salt form is the most common commercially available form of the substance. Salt forms can often have improved chemical and physical stability (e.g. for storage and transport) and can be easier to process (e.g. forming a salt can turn a viscous oil into a free-flowing powder). They are thus used in lieu of the parent substance. The salts of these substances are contained in a variety of products currently sold in Canada (e.g. cough syrups commonly contain the salt of dextromethorphan). Objeto y razón de ser: The purpose of these amendments are to exclude specific substances that do not pose a threat to public health or public safety from the schedules of the CDSA and its regulations and to facilitate legitimate access
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