Vol. 141, No. 24 — June 16, 2007

Regulations Amending Schedule A to the Food and Drugs Act and the Medical Devices Regulations (Project 1539)

Statutory authority

Food and Drugs Act

Sponsoring department

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

For the Regulatory Impact Analysis Statement, see the Regulations Amending Certain Regulations Made under the Food and Drugs Act (Project 1539).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to subsection 30(1) (see footnote a) of the Food and Drugs Act, proposes to make the annexed Regulations Amending Schedule A to the Food and Drugs Act and the Medical Devices Regulations (Project 1539).

Interested persons may make representations concerning the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Project #1539, Policy Division, Bureau of Policy, Science, and International Programs, Therapeutic Products Directorate, 1600 Scott Street, Holland Cross, Tower B, 2nd floor, Address Locator 3102C5, Ottawa, Ontario K1A 0K9 (tel.: 613-948-4623; fax: 613-941-6458; e-mail: regaff-affreg@hc-sc.gc.ca), with a reference to Project #1539.

Ottawa, June 7, 2007

MARY O'NEILL
Assistant Clerk of the Privy Council

REGULATIONS AMENDING SCHEDULE A TO THE FOOD AND DRUGS ACT AND THE MEDICAL DEVICES REGULATIONS (PROJECT 1539)

FOOD AND DRUGS ACT

1. The references to

Alcoholism
Alcoolisme

Alopecia (except hereditary androgenetic alopecia)
Alopécie (sauf l'alopécie androgénogénétique)

Anxiety state
États d'angoisse

Arthritis
Arthrite

Bladder disease
Vessie (maladies)

Disease of the prostate
Prostate (maladies)

Disorder of menstrual flow
Troubles du flot menstruel

Dysentery
Dysenterie

Edematous state
Œdème

Epilepsy
Épilepsie

Gall bladder disease
Vésicule biliaire (maladies)

Gout
Goutte

Heart disease
Cœur (maladies)

Hernia
Hernie

Hypotension
Hypotension

Impetigo
Impétigo

Kidney disease
Reins (maladies)

Leukemia
Leucémie

Liver disease (except hepatitis)
Foie (maladies sauf l'hépatite)

Pleurisy
Pleurésie

Sexual impotence
Impuissance sexuelle

Tumor
Tumeurs

Venereal disease
Maladies vénériennes

in Schedule A to the Food and Drugs Act (see footnote 1) are repealed.

2. Schedule A to the Act is amended by adding the following in alphabetical order:

Acute alcoholism
Alcoolisme aigu

Acute anxiety state
État anxieux aigu

Acute infectious respiratory syndromes
Syndromes respiratoires infectieux aigus

Acute, inflammatory and debilitating arthritis
Arthrite aiguë, inflammatoire et débilitante

Acute psychotic conditions
Troubles psychotiques aigus

Addiction
Dépendance

Congestive heart failure
Insuffisance cardiaque congestive

Dementia
Démence

Haematologic bleeding disorders
Affections hématologiques hémorragiques

Hepatitis
Hépatite

Sexually transmitted diseases
Maladies transmises sexuellement

Strangulated hernia
Hernie étranglée

MEDICAL DEVICES REGULATIONS

3. Subsection 24(1) of the Medical Devices Regulations (see footnote 2) is replaced by the following:

24. (1) For the purposes of subsections 3(1) and (2) of the Act and subject to section 27, a condom may be advertised and sold to the general public for the purpose of preventing the transmission of sexually transmitted diseases if the advertisement and the label of the condom claim only that the condom reduces the risk of transmitting sexually transmitted diseases.

COMING INTO FORCE

4. These Regulations come into force on the day on which they are registered.

[24-1-o]

Footnote a

S.C. 1999, c. 33, s. 347

Footnote 1

R.S., c. F-27

Footnote 2

SOR/98-282

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