Traduction de «Direction des médicaments » (Français → Anglais) :

Therapeutic Products Directorate [ TPD | Therapeutic Products Programme | Drugs and Medical Devices Directorate | Drugs and Medical Devices Programme | Drugs Directorate ]

Medication set-up teaching, guidance, and counseling

Medication prescription teaching, guidance and counseling

Warning. Follow the printed instructions you have been given with this medicine

Committee for the adaption to technical progress of the directives on the removal of technical barriers to trade in colouring matters which may be added to medicinal products

Advisory Committee on the Implementation of Directive 89/105/EEC relating to the Transparency of Measures Regulating the Pricing of Medicinal Products for Human Use and their Inclusion in the Scope of National Health Insurance Systems

Committee for Adaptation to Technical Progress of the Directives on Veterinary Medicinal Products

Direct to Consumer Advertising for Prescription Drugs

over-the-counter drug [ non-prescription drug | non-prescription medicinal product | OTC drug | OTC medicine | over-the-counter medicine ]

With reference to the neuro-psychiatric side-effects experienced by those taking the anti-malarial drug mefloquine (Lariam): (a) Of those Canadians administered mefloquine prior to the date of its licensing for general use by the Health Protection Branch in 1993, how many persons committed suicide or attempted to commit suicide and how many of these incidents were associated with alcohol use; (b) Of those Canadians administered mefloquine after the date of its licensing for general use by the Health Protection Branch in 1993, how many persons committed suicide or attempted to commit suicide and how many of these incidents were associated with alcohol use; (c) Of those members of the Canadian forces who were administered mefloquine since 1 ...[+++]992, how many have attempted suicide or committed suicide; in what year; in Canada or abroad and if abroad name the country; (d) Of those members of the Canadian forces who were administered mefloquine since 1992 and attempted suicide or committed suicide, how many of these incidents were associated with alcohol use; (e) Has the Health Protection Branch reviewed the international experience concerning suicides, suicide attempts, and suicidal ideation associated with mefloquine use, and if so when, and what were the results and recommendations of the review, and what steps have been taken to implement the recommendations; (f) Has the Health Protection Branch reviewed the scientific literature with regard suicides, suicide attempts and suicidal ideation associated with mefloquine use and if so when, and what were the results and recommendations of the review and what steps have been taken to implement the recommendations; (g) Has the Health Protection Branch revised the administering instructions for mefloquine to include warnings regarding suicides, attempted suicides, suicidal ideation, or the combination of mefloquine and alcohol and if so when, and what action taken, and if not does it plan to do so and if so when; (h) Ha ...

(9) In accordance with the principle of proportionality, it is appropriate to limit the scope of this Directive to prescription-only medicinal products, as current Community rules allow the advertising to the general public of medicinal products not subject to prescription, under certain conditions.

Question No. 609 Ms. Anne Minh-Thu Quach: With respect to drug regulation and approval: (a) does the 2012 Economic Action Plan provide for decreases or increases in the financial and human resources allocated to (i) drug approval services, (ii) regulatory activities to evaluate and monitor the safety, efficacy and quality of drugs before and after they enter the marketplace, (iii) activities related to the review of submissions by drug manufacturers for market authorization and post-market changes, (iv) activities related to enforcing compliance with existing regulations, inc ...[+++]luding those concerning clinical trials, drug manufacturing and the reporting of adverse drug reactions, (v) activities of the Patented Medicine Prices Review Board, (vi) services such as the Patent Register, Drug Product Database, Notice of Compliance, and Progressive Licensing Project, (vii) various areas of Health Canada such as the Marketed Health Products Directorate, Therapeutic Products Directorate, Biologics and Genetic Therapies Directorate, and the Veterinary Drugs Directorate; (b) for each of the programs and directorates listed in (a), (i) what is the estimated extent of the decreases or increases in human or financial resources, (ii) are positions expected to be cut and, if so, how many will be eliminated; (c) was a value-for-money assessment conducted for the drug approval process; and (d) what is the government’s financial allocation plan regarding drug regulation?

1. Without prejudice to Regulation [(EEC) No 2309/93], a Member State may, in accordance with legislation in force and to fulfil special needs, exclude from the provisions of this Directive medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorised health care professional and for use by an individual patient under his direct personal responsibility