Notice to Stakeholders - Good Manufacturing Practices for Active Pharmaceutical Ingredients - Implementation Pilot Project for Selected Consumer Health Products

November 2013

The Health Products and Food Branch Inspectorate is notifying stakeholders of a pilot project concerning the implementation of regulatory Good Manufacturing Practices (GMP) requirements for active pharmaceutical ingredients (API), which were published in Part II of the  Canada Gazette on May 8, 2013 and which will come into force on November 8, 2013.

This pilot affects importers of the following finished dosage-form products, and importers of API intended for use in the following finished dosage-form products:

• Products falling under the acne therapy monograph, Table 2
• Products falling under the anti-dandruff products monograph, Table 2
• Products falling under the antiseptic skin cleansers monograph, Table 2
• Products falling under the monograph for athletes foot treatments
• Products falling under the medicated skin care products monograph, Table 2
• Products falling under the diaper rash products monograph, Table 2
• Products falling under the sunscreen monograph, Table 2
• Products falling under the  monograph for throat lozenges
• Oral care (dentifrice/mouthwash) products containing triclosan or a combination of triclosan and fluoride (product must meet specifications set out in its market authorization)
• Oral care (dentifrice/mouthwash) products containing cetylpyridinium chloride (product must meet specifications set out in its market authorization)

The products selected for this pilot were chosen on the basis of their respective safety and efficacy profiles. This pilot project arises in part from Health Canada's commitment, set out in the  Regulatory Impact Analysis Statement accompanying the publication of the amended regulations in Part II of the Canada Gazette, to implement the new regulatory requirements in a manner which ensures that the administrative and compliance burden of the requirements is proportional to the quality risks presented by such products. It should be noted that importers of API who are unable to ascertain the intended use of that API (such that the API may end up being used in drugs other than the ones listed above) are not eligible to participate in this pilot project, as quality risk is predicated in part on the safety and efficacy profile of the finished dosage-form product.

For the duration of the pilot project, importers of the products listed above and importers of API intended for use in the products listed above will be required to complete only certain sections of the Foreign Building Information Table for the API used in the products they import, as follows:

Table A: Instructions specific to the Pilot for selected Consumer Health Products

Complete this Table for all Active Pharmaceutical Ingredients imported into Canada for use in pilot products and/or for all Active Pharmaceutical Ingredients used in the foreign fabrication, packaging/labelling, and/or testing of finished dosage forms part of the pilot products, intended for import into Canada.

Import Information refers to information related to the activity of import.

• [DEL #] (Column A) is completed by those who already possess a Drug Establishment Licence number. This number includes the letter suffix (10XXXX-X)
• [Imported As] (Column B) indicates whether the Active Pharmaceutical Ingredients at this foreign location are used for import into Canada and/or intended for the foreign fabrication, packaging/labelling, and/or testing of finished dosage forms intended for import into Canada. Select a type from the available predetermined list. API implies the imported product is an API. Dosage Form implies the API is imported via finished dosage form.
  • Note: If the [Dosage Form] option from column B is selected in Table A, then columns Q and R are not applicable at this time.
• [API Name] (Column C) is the name under which the API is sold. 

API Foreign Building Information refers to the name and address of the foreign API fabricator, packager/labeller, and/or tester from whom the product(s) will be imported into Canada or used by a foreign fabricator, packager/labeller, and/or tester of finished dosage forms who intends to import Finished Dosage Form products into Canada.

• [Foreign Building Name] (Column D) is the legal name of the foreign company that is engaged in a licensable activity related to APIs; not necessarily the DIN owner.
• [Foreign Building Address] (Columns E, F, G and H) is the physical location of the foreign building at which the licensable activity related to APIs is being conducted.

API Foreign Building GMP Status refers to the status of the Good Manufacturing of the building of the foreign source API fabricator, packager/labeller or tester.

• [Building complies with applicable GMP requirements set out in Part C Div. 2, FDR] (Column I) Select [Exception] as the API is used in a product part of the pilot for selected consumer health products.
  • Note: As the API is used in a product part of the pilot for selected consumer health products product and the [Exception] option from column I is selected in Table A, then columns J, K, L, M, N, O, P, Q, R, U, V, W and X are not applicable at this time.

API Product Information refers to information related to the API products handled at the foreign API source building.

• [DIN associated with API] (Column S) is the eight digit drug identification number issued to the Finished Dosage Form product intended to be sold in Canada, in which the API will be used to fabricate the Finished Dosage Form product (only if available).

API Activity Information refers to information regarding the activities conducted at the foreign building.

• [Activity] (Column T)activities are limited to fabricate, package/label and/or test. Multiple selections are possible
  • F = Fabricate
  • P/L = Package/Label
  • T = Test

In all other respects, for the time being, the general Notice to Stakeholders concerning the implementation of the new regulatory requirements applies.

Further initiatives are underway in consultation with affected stakeholders to determine with greater specificity the quality risks associated with API used in the products selected for this pilot, to evaluate current industry practice concerning the qualification of such API, and to develop, where appropriate, specialized GMP guidance pertaining to such API. Domestic manufacturers of the products listed above and domestic manufacturers of API intended for use in the products listed above will be included in these initiatives.

Questions and comments concerning the pilot project may be sent to

Drug Good Manufacturing Practices Inspection Unit
Health Products and Food Branch Inspectorate
Health Canada
250 Lanark Avenue
Ottawa, Ontario
K1A 0K9

E-mail: API_questions_IPA@hc-sc.gc.ca