PART CDrugs (continued)
DIVISION 1 (continued)
Annual Summary Report and Case Reports
C.01.018 (1) The manufacturer shall prepare an annual summary report of all information relating to adverse drug reactions and serious adverse drug reactions to the drug that it received or became aware of during the previous 12 months.
(2) The annual summary report shall contain a concise, critical analysis of the adverse drug reactions and serious adverse drug reactions to the drug.
(3) In preparing the annual summary report, the manufacturer shall determine, on the basis of the analysis referred to in subsection (2), whether there has been a significant change in what is known about the risks and benefits of the drug during the period covered by the report and shall include its conclusions in this regard in the summary report.
(4) If, in preparing the annual summary report, the manufacturer concludes that there has been a significant change, it shall notify the Minister without delay, in writing, unless this has already been done.
(5) The Minister may, for the purposes of assessing the safety and effectiveness of the drug, request in writing that the manufacturer submit to the Minister one or both of the following:
(a) the annual summary reports;
(b) the case reports relating to the adverse drug reactions and serious adverse drug reactions to the drug that are known to the manufacturer.
(6) The Minister shall, after giving the manufacturer an opportunity to be heard, specify a period for the submission of the annual summary reports or case reports, or both, that is reasonable in the circumstances, and the manufacturer shall submit the reports within that period.
- SOR/2011-31, s. 1
C.01.018.1 Section C.01.018 does not apply in respect of a veterinary health product.
- SOR/2017-76, s. 4
Issue-Related Summary Report
C.01.019 (1) The Minister may, for the purposes of assessing the safety and effectiveness of the drug, request in writing that the manufacturer submit to the Minister an issue-related summary report.
(2) The report shall contain a concise, critical analysis of the adverse drug reactions and serious adverse drug reactions to the drug, as well as case reports of all or specified adverse drug reactions and serious adverse drug reactions to the drug that are known to the manufacturer in respect of the issue that the Minister directs the manufacturer to analyze in the report.
(3) The Minister shall, after giving the manufacturer an opportunity to be heard, specify a period for the submission of the report that is reasonable in the circumstances. The Minister may only specify a period that is less than 30 days if the Minister needs the information in the report to determine whether the drug poses a serious and imminent risk to human health.
(4) The manufacturer shall submit the report within the specified period.
- SOR/2011-31, s. 1
- SOR/2017-18, s. 14
C.01.019.1 Section C.01.019 does not apply in respect of a veterinary health product.
- SOR/2017-76, s. 5
Maintenance of Records
C.01.020 (1) The manufacturer shall maintain records of the reports and case reports referred to in sections C.01.017 to C.01.019.
(2) The manufacturer shall retain the records for 25 years after the day on which they were created.
- SOR/2011-31, s. 1
Provision of Information Under Section 21.8 of Act
C.01.020.1 (1) For the purposes of section 21.8 of the Act, hospitals are the prescribed health care institutions that shall provide information that is in their control to the Minister about a serious adverse drug reaction.
(2) The following prescribed information about a serious adverse drug reaction that is in a hospital’s control shall be provided to the Minister in writing within 30 days after the day on which the serious adverse drug reaction is first documented within the hospital:
(a) the name of the hospital and the contact information of a representative of that hospital;
(b) the drug’s brand name, proper name or common name;
(c) in the case of a drug imported under subsection C.10.001(2) or section C.10.006, the identifying code or number of the drug, if any, assigned in the country in which the drug was authorized for sale;
(d) the drug identification number assigned for the drug, if applicable;
(e) the patient’s age and sex;
(f) a description of the serious adverse drug reaction;
(g) the date on which the serious adverse drug reaction was first documented;
(h) the date on which the patient first used the drug and, if applicable, the date on which the patient stopped using the drug;
(i) the date on which the serious adverse drug reaction first occurred and, if applicable, the date on which the patient’s health was restored to its state prior to the reaction;
(j) any medical condition of the patient that directly relates to the serious adverse drug reaction;
(k) any concomitant therapeutic products used by the patient; and
(l) the effect of the serious adverse drug reaction on the patient’s health.
(3) A hospital is exempt from section 21.8 of the Act in respect of the reporting of information referred to in subsection (2) if
(a) the hospital does not have in its control all of the information referred to in paragraphs (2)(b), (c), (e) and (f) in respect of the serious adverse drug reaction; or
(b) the serious adverse drug reaction relates only to any of the following drugs:
(i) a vaccine that was administered under a routine immunization program of a province,
(ii) a drug that is authorized for sale under Division 5 of this Part, or
(iii) a drug that was sold under subsection C.08.011(1).
(4) In this section, hospital means a facility
(a) that is licensed, approved or designated as a hospital by a province in accordance with the laws of the province to provide care or treatment to persons suffering from any form of disease or illness; or
(b) that is operated by the Government of Canada and that provides health services to in-patients.
Limits of Drug Dosage
C.01.021 Except as provided in these Regulations, no person shall sell a drug for human use listed in the following table unless both the inner and the outer labels other than the inner label of a single dose container carry a statement of
(a) the quantitative content of the drug,
(b) the recommended single and daily adult dose designated as such, except for
(i) preparations solely for external use, or
(ii) preparations solely for children’s use; and
(c) adequate directions for use when the drug is recommended for children which shall be either
(i) the statement “CHILDREN: As directed by the physician”, or
(ii) a suitable reduced maximum single and daily dose which shall not exceed the following:
Age in years Proportion of adult dose 10 - 14 one-half 5 - 9 one-fourth 2 - 4 one-sixth under 2 years as directed by physician
Table of Limits of Drug Dosage for Adults
Item External Use Internal Use — — Maximum Limit Maximum Dosage Unless otherwise stated, doses are in milligrams Per cent Single Daily Acetaminophen — 650 4.0 g Acetanilide and derivatives (except N-Acetyl-ρ-amino phenol) — 65 195 Acetylsalicylic Acid — 650 4.0 g Aconitine, its preparations and derivatives 0.2 0.1 0.1 Adonis vernalis — 65 195 Amylocaine, its salts and derivatives when sold or recommended for opthalmic use 0.0 0.0 0.0 Amylocaine Hydrochloride, except when sold or recommended for ophthalmic use 1.0 0.0 0.0 Antimony, compounds of — 3.3 13 Atropine, Methylatropine, and their salts 1.0 0.13 0.44 Belladonna and its preparations, on the basis of belladonna alkaloids 0.375 0.13 0.44 Benzene (Benzol) — — — Benzocaine 8.0 195 585 Beta-Naphthol — 195 585 Butacaine, its salts and derivatives when sold or recommended for ophthalmic use 0.0 0.0 0.0 Butacaine Sulphate, except when sold or recommended for opthalmic use 1.0 0.0 0.0 Cadexomer Iodine 0.0 0.0 0.0 Cantharides, cantharidin, and their preparations, on the basis of cantharidin, except blisters 0.03 0.0 0.0 Cantharides, blisters only 0.2 0.0 0.0 Cedar Oil 25.0 0.0 0.0 Chlorbutol (not more often than every 4 hours) — 325 975 Choline Salicylate — 870 5.22 g Cinchocaine Hydrochloride, except suppositories 1.0 0.0 0.0 Cinchocaine Hydrochloride, suppositories only — 11 11 Colchicine and its salts — 0.55 1.65 Colchicum and its preparations, on the basis of colchicine — 0.27 0.81 Croton Oil 10.0 0.0 0.0 Cyproheptadine and its salts — when sold or recommended for the promotion of weight gain — 0.0 0.0 Ephedrine and its salts — 11 32.5 Ephedrine and its salts, sprays 1.0 — — Epinephrine and its salts, sprays 1.0 — — Gelseminine (Gelsemine) and its salts (not to be repeated within 4 hours) — 0.55 1.65 Gelsemium and its preparations, on the basis of the crude drug — 16.2 48.6 Hydrocyanic (Prussic) Acid as 2 per cent solution — 0.062 ml 0.31 ml Hydroquinone 2.0 — — Hyoscine (Scopolamine) and its salts 0.5 0.325 0.975 Hyoscine aminoxide hydrobromide 0.5 0.325 0.975 Hyoscyamine and its salts — 0.325 0.975 Hyoscyamus and its preparations, on the basis of hyoscyamus alkaloids — 0.073 0.22 Lobelia and its preparations, on the basis of the crude drug — 130 390 Lobeline and its salts — 2.0 6.0 Magnesium Salicylate — 650 4.0 g Methyl Salicylate 30 — — Methylene Blue — 130 390 Phenacetin — 650 1.95 g Phenazone and compounds thereof — 325 975 Phenol 2.0 32.5 260 Phenylpropanolamine when sold or recommended as an appetite depressent — 0.0 0.0 Phosphorus — 0.0 0.0 Podophyllin 0.0 0.0 0.0 Potassium Chlorate — 325 975 Potassium Chlorate, gargle 2.5 — — Procaine and its salts — — — Proxymetacaine, its salts and derivatives when sold or recommended for ophthalmic use 0.0 0.0 0.0 Salicylamide — 975 2.925 g Santonin — 65 130 Selenium and its compounds 2.5 0.0 0.0 Sodium Chlorate — 325 975 Sodium Fluoride — 0.1 0.1 Sodium Salicylate — 650 4.0 g Squill and its preparations, on the basis of crude drug — 32.5 97.5 Stramonium and its preparations, on the basis of stramonium alkaloids — 0.16 0.65 Strychnine and its salts — 0.0 0.0 Tannic Acid — 150 1 000 Tetracaine, its salts and derivatives when sold or recommended for ophthalmic use 0.0 0.0 0.0 Thiocyanates 0.0 0.0 0.0 Urethane 0.0 0.0 0.0
Where drugs having similar physiological actions occur in combination, the dosage of each shall be proportionately reduced.
Accurate dosagesmay be expressed in either metric units or imperial units. If the dosage is expressed in both systems, then an approximation may be used for one expression, but such approximation must precede or follow the accurate statement by which the product will be judged and must be in brackets.
- SOR/78-422, s. 1
- SOR/80-544, s. 3
- SOR/84-145, s. 1
- SOR/85-715, s. 3
- SOR/85-966, s. 2
- SOR/88-94, s. 1
- SOR/89-229, s. 2
- SOR/89-548, s. 1
- Date modified: