Drug and natural health products recall guide consultation

From Health Canada

Health Canada is pleased to announce the release of the draft Drug and natural health products recall guide (GUI-0039) for a sixty day public consultation from November 15, 2018 to January 14, 2019. This document, Draft – Drug and natural health products recall guide, interprets sections of the Food and Drugs Act and Regulations that pertain to the recall of drugs and natural health products. Guidance documents like this one are meant to help industry and health care professionals understand how to comply with regulations. They also provide guidance to Health Canada staff for fair and consistent compliance and enforcement across Canada.

Why

The information in the guidance document, Draft - Drug and natural health products recall guide, states acceptable practices to facilitate compliance with the Food and Drugs Act, the Food and Drug Regulations and the Natural Health Products Regulations in the context of a recall of drugs or natural health products. This includes roles and responsibilities and guidance around the recall process.

This guidance document is intended to replace an existing Health Canada webpage, Product Recall Procedures that was issued in 1993. It complements the Recall Policy POL-0016, issued March 5, 2015.The document was previously published for consultation in 2008; stakeholders are being consulted now due to changes in format and content as well as the length of time since the previous consultation.

Who

We are consulting with industry members, associations and the general Canadian public.

What

Health Canada invites stakeholder's comments on the draft guidance document: Drug and natural health products recall guide.

Public consultation on draft guidance document

Request a copy of the draft guidance: Interested stakeholders who wish to provide comments may send a request for an electronic copy or alternate format of the document to hc.hpce-cpsal.sc@Ca-ciconline.com.

Please include in the subject line, the title and the preferred language of the consultation document you wish to receive.

Provide comments: Interested stakeholders may provide comments by email to hc.hpce-cpsal.sc@Ca-ciconline.com.

Please include in the subject line, the title of the consultation document for which you are providing comments.

When

Feedback on the public consultation will be collected between November 15, 2018 and January 14, 2019.

Comments received from stakeholders will be reviewed after the 60 day consultation period. Health Canada will review and consider all comments received from the consultation. The final version of the Drug and natural health products recall guide will be published online.

How to participate

Read our draft guidance document and provide your comments by email to: hc.hpce-cpsal.sc@Ca-ciconline.com.

Related information

Product Recall Procedures
Recall Policy

Contact us

Any questions or comments should be addressed to hc.hpce-cpsal.sc@Ca-ciconline.com.