Two - Way Alert Programme

Administrative Arrangement under Article 15.3(b) of the Protocolon the Mutual Recognition of the Compliance and Enforcement Programme regarding Good Manufacturing Practices for Pharmaceutical Products

This administrative arrangement is not intended to create rights or obligations under international or domestic law and, in line with Article 15(7) of the Protocol, is not subject of the provision of Chapter 29 of the CETA Agreement.

Between DG SANTE and Health Canada

Friday, November 16, 2018

DG Santé is a Directorate General of the European Commission.
Health Canada is a Federal department of the Government of Canada.

This administrative arrangement has been approved by the European Medicines Agency (EMA) and the competent authorities of the EU Member States.

1. Introduction

This Administrative Arrangement sets out the Two-Way Alert Programme which is one of the main elements of the Protocol to the Canada – European Union Comprehensive Economic and Trade Agreement between the European Union and Canada on the Mutual Recognition of the Compliance and Enforcement Programme Regarding Good Manufacturing Practices for Pharmaceutical Products (CETA GMP Protocol) that the Parties are required to establish for the purposes of complying with the requirements under Article 11.1 of the CETA GMP Protocol.

Article 11.1.

A Party shall, pursuant to the two-way alert programme under the GMP Administrative Arrangement referred to in Article 15.3:

2.   Purpose

In order to protect Canadian and European Union (EU) consumers from potential health risks, the purpose of this Administrative Arrangement is to clarify the practical arrangements under which the Canadian and EU Regulatory Authorities (RAs), recognized in Annex 2 to the CETA GMP Protocol:

3. Scope

The Two-Way Alert Programme appliesto the human and veterinary medicinal products/ drugs covered in Annex 1 to the CETA GMP Protocol.

The Two-Way Alert Programme applies to the following situations that negatively affect or may negatively affect the quality of the products specified in Annex I to the CETA GMP Protocol:

The Two-Way Alert Programme does not apply to pharmacovigilance or medical device alerts.

4.   Confidentiality

Article 14 of the CETA GMP Protocol outlines the confidentiality obligations regarding the sharing of information.

The RA of one Participant will inform the RA of the other Participant within two working days of any effort made to obtain non-public information in cases when a judicial or legislative mandate orders disclosure of non-public information. 

5.   Mutual Notification

5.1 Procedure for the rapid exchange of information and data aboutlife-threatening or serious medicinal product recalls (Rapid Alert Notification)

5.2 Procedure for the notification of confirmed defective product reports

5.3 Procedures for the notification of suspension or revocation of a manufacturing authorisation / establishment license, restriction/withdrawal of a GMP certificate and notification of non-compliance with GMP.

5.4 Fraud and Counterfeit Products / Falsification:

6. Roles

 6.1 General

 6.2 Product specific actions / recalls

 6.3 All other notifications

7.   Language of Communication

RA(s) should notify the other Participant as required under this Administrative Arrangement in the English language.

8.   Mode of Transmission

RA(s) will transmit information by e-mail or fax to the contact points, or through entry into the EudraGMDP database.

9.   Effective date

This Administrative Arrangement is to come into operation on the date of the coming into force of the CETA.

Attachment 1

Rapid Alert System: Classification of Urgency of Defective Medicinal Product Alerts

CLASS I

Class I defects are potentially life threatening or could cause a serious risk to health and are notified through the Rapid Alert System in all cases.

Examples:

CLASS II

Class II defects could cause illness or mistreatment, but are not Class I. A rapid alert notification should be sent to all contacts on the rapid alert notification list as it might be difficult to know where a batch has been distributed. If the product distribution is known, the notification should be only sent to the contacts concerned.

Examples:

CLASS III

Class III defects may not pose a significant hazard to health, but withdrawal of the products may have been initiated for other reasons. If deemed relevant by the issuing authority, the rapid alert system may be used.

Examples:

Attachment 2

Contact points pursuant to article 11(3) of the GMP Protocol

For Canada:

Manager, Health Product Compliance & Enforcement Unit

Regulatory Operations and Enforcement Branch (ROEB) Health Canada
14th floor, room 319, Jeanne Mance Building
200 Eglantine Driveway
Ottawa, Canada
K1A 0K9
Phone: (001) 613 954 0513
Fax: (001) 613 946 5636
Email : RapidAlert@hc-sc.gc.ca

For European Union:

The list of EU contact points for Rapid Alerts is updated and provided to Health Canada by the European Medicines Agency whenever it is updated.

Attachment 3

Minimum Contents of a Rapid Alert Notification of a Quality Defect or Recall

A Participant will endeavour to use internationally harmonised templates for the transmission of Rapid Alerts

The Participants should consider including in the rapid alert notification the elements listed below, as appropriate:

  1. Reference Number
  2. Addressee (To:)
  3. Product Recall Class of Defect:  I  or  II (to be specified)
  4. Falsification / Fraud (to be specified)
  5. Product(s) affected
  6. Marketing Authorisation Number and Use in humans or animals (to be specified)
  7. Brand/Trade Name
  8. INN or Generic Name
  9. Dosage Form
  10. Strength
  11. Batch/Lot Number (and bulk, if different)
  12. Expiry Date
  13. Pack size and Presentation
  14. Date Manufactured
  15. Marketing Authorisation Holder (in the reporting Participant)
  16. Manufacturer (name and address), Contact Person and Telephone
  17. Site where the defect occurred (in case the defect is attributed to a manufacturing site)
  18. Recalling firm (if different from manufacturer), Contact Person and Telephone
  19. Recall Number Assigned
  20. Details of Defect/Reason for Recall
  21. Information on distribution including exports (type of customer, e.g. hospitals)
  22. Action taken by Issuing Authority and/or Proposed Action
  23. Issuing Authority name (From:)
  24. Contact Person at the issuing authority and telephone
  25. Signature
  26. Date
  27. Time

Attachment 4

Minimum Contents of Follow-up and Non-urgent Information for Quality Defects

Each Participant will endeavour to use internationally harmonised templates for the transmission of Follow-up and Non-urgent information

The Participants should consider including the elements listed below, as appropriate in the notification:

  1. Addressee (To:)
  2. Recall Number Assigned and national reference number (if applicable):
  3. Product
  4. Marketing Authorisation Number
  5. Brand/Trade name
  6. INN or Generic Name
  7. Dosage form
  8. Strength
  9. Batch number (and bulk, if different)
  10. Marketing Authorisation holder
  11. Manufacturer and contact person
  12. Subject title and description of the issue
  13. Issuing Authority (From:)
  14. Issuing Authority Contact Person
  15. Signature
  16. Date
  17. Time
Date Modified: