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Record 1,  Textual support,  English

Record number: 1, Textual support number: 1 CONT

Restricted drugs are a category of controlled substances listed in Schedule J of the FDR [Food and Drug Regulations] and are controlled under the CDSA [Controlled Drugs and Substances Act], meaning activities such as the sale, possession, production, etc. of these substances are illegal unless authorized.  2, record 1, English, - restricted%20drug

Record 1,  Textual support,  French

Record number: 1, Textual support number: 1 CONT

Les drogues d'usage restreint sont une catégorie de substances contrôlées énumérées à l'annexe J du RAD [Règlement sur les aliments et drogues] et sont contrôlées en vertu de la LRCDAS [Loi réglementant certaines drogues et autres substances], ce qui signifie que les activités telles que la vente, la possession, la production, etc. de ces substances sont illégales à moins d'être autorisées.  2, record 1, French, - drogue%20d%27usage%20restreint

Record number: 1, Textual support number: 1 OBS

drogue d'usage restreint : Le terme «drogue d'usage restreint» peut faire référence à un médicament d'usage restreint uniquement dans le contexte de la Loi sur les aliments et drogues et de son application.  3, record 1, French, - drogue%20d%27usage%20restreint

Record 1,  Textual support,  Spanish

Record 2,  Textual support,  English

Record number: 2, Textual support number: 1 CONT

In addition, regulatory initiatives of the U. S. [United States] Food and Drug Administration related to bioterrorism preparedness and implementing the provisions of the Bioterrorism Preparedness and Response Act of 2002 were highlighted, including Sections related to the Registration of Food Facilities, Establishment and Maintenance of Records, Prior Notice of Imported Food Shipments and Administrative Detention.  1, record 2, English, - bioterrorism%20preparedness

Record 2,  Textual support,  French

Record number: 2, Textual support number: 1 CONT

En outre, les initiatives de la Food and Drug Administration (FDA) liées à la préparation au bio-terrorisme et à la mise en œuvre des dispositions de la loi de préparation et de riposte au bio-terrorisme de 2002 ont été soulignées, notamment les sections concernant l'homologation des installations alimentaires, la création et la tenue à jour de fichiers, la notification préalable des cargaisons d'aliments importés et la détention administrative.  2, record 2, French, - pr%C3%A9paration%20au%20bioterrorisme

Record 2,  Textual support,  Spanish

Record 3,  Textual support,  English

Record number: 3, Textual support number: 1 OBS

The Food Safety Modernization Act(FSMA) was signed into law by President Barack Obama on January 4, 2011. The FSMA has given the Food and Drug Administration(FDA) new authorities to regulate the way foods are grown, harvested and processed.  1, record 3, English, - Food%20Safety%20Modernization%20Act

Record 3,  Textual support,  French

Record number: 3, Textual support number: 1 OBS

La règle de la loi FDA Food Safety Modernization Act (FSMA) [...] exige que les importateurs exécutent certaines activités [...] afin de vérifier que les denrées importées aux États-Unis ont été produites conformément aux normes américaines de sécurité applicables.  3, record 3, French, - Food%20Safety%20Modernization%20Act

Record 3,  Textual support,  Spanish

Record 4,  Textual support,  English

Record number: 4, Textual support number: 1 OBS

The Centre for Policy and Regulatory Affairs(CPRA) is responsible for regulatory policy development and evaluation, submission management, and health promotion support(including public involvement) to all areas of the Biologics and Genetic Therapies Directorate. Specifically, it is responsible for developing new and updating existing policies, standards, guidelines, directives and other legislative/regulatory instruments as it relates to biologics and genetic therapies. It also screens drug submissions and clinical trial applications(CTAs) for vaccines, biotherapeutics, radiopharmaceuticals and blood, tissues and organs(as outlined in Schedules C and D of the Food and Drugs Act), to ensure the completeness and accuracy of submissions received from the industry for review by BGTD, and that the final Notice of Compliance(NOC) package reflects the clinical, chemistry and manufacturing data that has been reviewed and found to be safe, efficacious and of good quality.  1, record 4, English, - Centre%20for%20Policy%20and%20Regulatory%20Affairs

Record 4,  Textual support,  French

Record number: 4, Textual support number: 1 OBS

Le Centre des politiques et des affaires réglementaires (CPAR) est chargé d'élaborer et d'évaluer les politiques réglementaires, de gérer les présentations et de fournir un soutien à la promotion de la santé (y compris la participation du public) dans tous les secteurs d'activités de la Direction des produits biologiques et des thérapies génétiques. En particulier, le Centre est responsable de l'élaboration de nouvelles politiques, normes, lignes directrices et directives ainsi que de nouveaux instruments législatifs et réglementaires, de même que de la mise à jour de ceux en vigueur, dans la mesure où ils traitent des produits biologiques et des thérapies génétiques. Il a également pour responsabilité de présélectionner les présentations de drogues et les demandes d'essais cliniques (DEC) pour les vaccins, les produits biothérapeutiques, les produits radiopharmaceutiques, le sang, les tissus et les organes (comme le stipulent brièvement les annexes C et D de la Loi sur les aliments et drogues ) afin d'assurer l'état complet et l'exactitude des présentations que soumet l'industrie à la DPBTG aux fins d'examen, et afin de s'assurer que l'avis de conformité (AC) final reflète les données cliniques chimiques et celles sur le processus de fabrication qui ont été examinées et déclarées sécuritaires, efficaces et de bonne qualité.  1, record 4, French, - Centre%20des%20politiques%20et%20des%20affaires%20r%C3%A9glementaires

Record 4,  Textual support,  Spanish

Record 5,  Textual support,  English

Record number: 5, Textual support number: 1 DEF

States associated with drug withdrawal ranging from severe, as specified for alcohol under 291.0 [of the DSM-III-R Manual] (delirium tremens) to less severe characterized by one or more symptoms such as convulsions, tremor, anxiety, restlessness, gastrointestinal and muscular complaints, and mild disorientation and memory disturbance.  1, record 5, English, - drug%20withdrawal%20syndrome

Record number: 5, Textual support number: 1 OBS

The English term "drug" has a less restrictive meaning than its French cognate "drogue". In English it not only conveys the meaning of any substance, whether legally available or not, which causes addiction, but also that of any substance intended for use in the treatment of a disease with or without a prescription. In French the primary meaning is that of an illicit substance, despite a more generic use found in legal contexts(Food and Drugs Act=Loi des aliments et drogues). Intrinsically more specific, the French favor the use of "produit pharmaceutique" and "médicament", as well as derivatives thereof, e. g. "pharmacodépendance, toxicomanie, etc. Consequently, in the case of "drug withdrawal syndrome", the use of "drogue"(i. e. substance that causes addiction) is not entirely inappropriate.  2, record 5, English, - drug%20withdrawal%20syndrome

Record 5,  Textual support,  French

Record number: 5, Textual support number: 1 DEF

États associés au sevrage de drogue, allant d'états graves, comme ceux décrits pour l'alcool sous [le code 291.0 du manuel DSM-III-R] (delirium tremens) à des états moins sévères caractérisés par un ou plusieurs symptômes tels que convulsions, tremblements, anxiété, agitation, douleurs gastro-intestinales et musculaires, troubles légers de l'orientation et de la mémoire.  1, record 5, French, - syndrome%20de%20sevrage%20de%20drogue

Record 5,  Textual support,  Spanish

Record 6,  Textual support,  English

Record number: 6, Textual support number: 1 CONT

[Under the Food and Drugs Act] "device" means any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or the symptoms thereof, in man or animal,(b) restoring, correcting or modifying a body function or the body structure of man or animal,(c) the diagnosis of pregnancy in humans or animals, or(d) the care of humans or animals during pregnancy and at and after birth of the offspring, including care of the offspring, and includes a contraceptive device but does not include a drug....  2, record 6, English, - device

Record 6,  Textual support,  French

Record number: 6, Textual support number: 1 CONT

[Dans la Loi sur les aliments et drogues] «instrument» signifie tout article, appareil ou dispositif, y compris tout composant, partie ou accessoire de ceux-ci, fabriqué ou vendu pour servir, ou présenté comme pouvant servir : a) au diagnostic, au traitement, à l'atténuation ou à la prévention d'une maladie, d'un désordre, d'un état physique anormal ou de leurs symptômes, chez l'homme ou les animaux; b) à la restauration, à la correction ou à la modification d'une fonction organique ou de la structure corporelle de l'homme ou des animaux; c) au diagnostic de la gestation chez l'homme ou les animaux; d) aux soins de l'homme ou des animaux pendant la gestation et aux soins prénatals et post-natals, notamment les soins de leur progéniture. Sont visés par la présente définition les moyens anticonceptionnels, tandis que les drogues en sont exclues.  2, record 6, French, - instrument

Record 6,  Textual support,  Spanish

Record number: 6, Textual support number: 1 DEF

Dispositivo diseñado para llevar a cabo cualquier tipo de observación u operación.  2, record 6, Spanish, - instrumento

Record 7,  Textual support,  English

Record number: 7, Textual support number: 1 OBS

The Center for Biologics Evaluation and Research(CBER) regulates biological products. Current authority for this responsibility resides in Section 351 of the Public Health Service Act and in specific sections of the Food Drug and Cosmetic Act [USA Administration].  1, record 7, English, - Center%20for%20Biologics%20Evaluation%20and%20Research

Record 7,  Textual support,  French

Record 7,  Textual support,  Spanish

Record 8,  Textual support,  English

Record number: 8, Textual support number: 1 OBS

Drug psychoses: syndromes that do not fit the descriptions given in [the DSM-III-R, codes] 295-298 (nonorganic psychoses) and which are due to consumption of drugs (notably amphetamines, barbiturates and the opiate and LSD groups) and solvents ....  1, record 8, English, - drug%20psychosis

Record number: 8, Textual support number: 2 OBS

The English term "drug" has a less restrictive meaning than its French cognate "drogue". In English it not only conveys the meaning of any substance, whether legally available or not, which causes addiction, but also that of any substance intended for use in the treatment of a disease with or without a prescription. In French the primary meaning is that of an illicit substance, despite a more generic use found in legal contexts(Food and Drugs Act=Loi des aliments et drogues). Intrinsically more specific, the French favor the use of "produit pharmaceutique" and "médicament", as well as derivatives thereof, e. g. "pharmacodépendance, toxicomanie, etc. Consequently, in the case of "drug psychosis", the use of "drogue"(i. e. substance that causes addiction) is not entirely inappropriate, although instances of the term "pharmacopsychose" do exist. As for the term "drug psychosis syndrome", this term cannot be substantiated in any reliable source. Do not use the term "syndrome" when it is not necessary.  2, record 8, English, - drug%20psychosis

Record 8,  Textual support,  French

Record number: 8, Textual support number: 1 DEF

Psychose chronique qui survient après des abus toxicomoniques de psychotropes.  3, record 8, French, - psychose%20due%20aux%20drogues

Record number: 8, Textual support number: 1 OBS

Psychoses dues aux drogues : syndromes ne correspondant pas aux descriptions données sous [les classifications, codes 295-298 du DSM-III-R] (psychoses non organiques) et dus à la consommation de médicaments (notamment d'amphétamines, de barbituriques, d'opiacés, de substances du type LSD et de solvants) [...]  1, record 8, French, - psychose%20due%20aux%20drogues

Record number: 8, Textual support number: 2 OBS

«Psychose due aux drogues» : terme employé dans le Manuel diagnostique et statistique des troubles mentaux (DSM-III-R), version française, ainsi que dans la Classification internationale des Maladies (CIM-9).  3, record 8, French, - psychose%20due%20aux%20drogues

Record 8,  Textual support,  Spanish

Record 9,  Textual support,  English

Record number: 9, Textual support number: 1 OBS

Food and Drug Act.  1, record 9, English, - Working%20Party%20on%20Drugs%20and%20Cosmetic%20Colours

Record 9,  Textual support,  French

Record number: 9, Textual support number: 1 OBS

Loi sur les aliments et drogues.  1, record 9, French, - Groupe%20de%20travail%20des%20colorants%20de%20m%C3%A9dicaments%20et%20de%20cosm%C3%A9tiques

Record 9,  Textual support,  Spanish

Record 10,  Textual support,  English

Record number: 10, Textual support number: 1 OBS

Food and Drug Act.  1, record 10, English, - New%20Drug%20Committee

Record 10,  Textual support,  French

Record number: 10, Textual support number: 1 OBS

Loi sur les aliments et drogues.  1, record 10, French, - Comit%C3%A9%20des%20drogues%20nouvelles

Record 10,  Textual support,  Spanish

Record 11,  Textual support,  English

Record number: 11, Textual support number: 1 DEF

Individual idiosyncratic reactions to comparatively small quantities of a drug, which take the form of acute, brief psychotic states of any type.  1, record 11, English, - pathological%20drug%20intoxication

Record number: 11, Textual support number: 1 OBS

Not to be confused with "physiological side-effects of drugs" or "expected brief psychotic reactions to hallucinogens (bad trips)" (305.3).  2, record 11, English, - pathological%20drug%20intoxication

Record number: 11, Textual support number: 2 OBS

The English term "drug" has a less restrictive meaning than its French cognate "drogue". In English it not only conveys the meaning of any substance, whether legally available or not, which causes addiction, but also that of any substance intended for use in the treatment of a disease with or without a prescription. In French the primary meaning is that of an illicit substance, despite a more generic use found in legal contexts(Food and Drugs Act=Loi des aliments et drogues). Intrinsically more specific, the French favor the use of "produit pharmaceutique" and "médicament", as well as derivatives thereof, e. g. "pharmacodépendance, toxicomanie, etc. Consequently, in the case of "pathological drug intoxication", the use of "drogue"(i. e. substance that causes addiction) is not entirely inappropriate.  2, record 11, English, - pathological%20drug%20intoxication

Record 11,  Textual support,  French

Record number: 11, Textual support number: 1 DEF

Réactions à des quantités de drogue relativement faibles liées à des prédispositions individuelles et qui peuvent prendre la forme de brefs états psychotiques aigus de n'importe quel type.  1, record 11, French, - forme%20pathologique%20d%27intoxication%20par%20les%20drogues

Record number: 11, Textual support number: 1 OBS

Ne pas confondre avec «brèves réactions psychotiques aux hallucinogènes (mauvais voyages)» (305.3) ou «effets physiologiques secondaires des drogues».  2, record 11, French, - forme%20pathologique%20d%27intoxication%20par%20les%20drogues

Record 11,  Textual support,  Spanish

Record 12,  Textual support,  English

Record number: 12, Textual support number: 1 OBS

Listed in a schedule of a legal act, as a drug in the Food and Drug Act or a disease in the Quarantine Act.  2, record 12, English, - scheduled

Record number: 12, Textual support number: 1 CONT

A quarantine officer may order the detention of a person arriving in Canada when the officer believes that the person may be the carrier of, or has been in close proximity to someone who has been exposed to or infected by, a scheduled disease....  1, record 12, English, - scheduled

Record 12,  Textual support,  French

Record 12,  Textual support,  Spanish