List of Contact Points responsible for matters arising under CETA Good Manufacturing Practices Protocol

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

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 Member States.

1.    Introduction

This Administrative Arrangement provides the List of contact points responsible for matters arising from the Administrative Arrangements set out in Article 15.3 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).

Article 15

3. The Joint Sectoral Group shall conclude a GMP Administrative Arrangement to facilitate the effective implementation of this Protocol. The GMP Administrative Arrangement shall include:

2.   Purpose

This Administrative Arrangement provides the contact points of both Participants and facilitates the application of the Administrative Arrangements referred to in Article 15.3 of the CETA GMP Protocol.

3.   Scope

This list of contact points responsible for matters arising under this Protocol applies to:

4.   Contact Points

Administrative ArrangementFor canadaFor european union
Terms of reference of the Joint Sectoral Group
– Article15.3 (a)
Co-chair
Director General, Health Product Compliance Directorate (HPCD)
Regulatory Operations and Enforcement Branch (ROEB)
Health Canada
Phone: (001) 613 957 6836
Email:
hc.drug.international.affairs-affaires.internationales.drogue.sc@canada.ca Director, Health Product  Inspection and Licensing (HPIL)
Regulatory Operations and Enforcement Branch (ROEB)
Health Canada
Phone: (001) 613 954 2996
Email:
hc.drug.international.affairs-affaires.internationales.drogue.sc@canada.ca
Co-chair
Head of Unit, Unit B 4. Medical products: Quality, Safety, Innovation
Directorate General for Health and Food safety
European Commission
Phone: +32 229 60541
Email:
SANTE-PHARMACEUTICALS-B4@ec.europa.eu
Contact Points
Manager, Mutual Recognition Agreement & International Affairs Unit (HPIL)
Regulatory Operations and Enforcement Branch (ROEB)
Health Canada
Phone: (001) 450 928 4209
Email:
hc.drug.international.affairs-affaires.internationales.drogue.sc@canada.ca
Contact Points
Policy Officer, Unit B 4. Medical products: Quality, Safety, Innovation
Directorate General for Health and Food safety
European Commission
Phone: +32 229 57667
Email:
SANTE-PHARMACEUTICALS-B4@ec.europa.eu DG Trade contact:
Assistant Policy Officer, Unit G3 - Market Access, Industry, Energy and Raw Materials, Directorate General for Trade, European Commission
Phone: +32 229 66925
Email: TRADE-G3-SEC@ec.europa.eu.
Two-Way Alert Programme – Article 15.3 (b)
  • Rapid Alert Notification
  • Notification of confirmed defective product reports
  • Notification of suspension, restriction or revocation of a manufacturing authorisation / establishment license, restriction/withdrawal of a GMP certificate and notification of non-compliance with GMP
  • Fraud and Counterfeit Products / Falsification
Manager, Health Product Compliance & Enforcement Unit
Regulatory Operations and Enforcement Branch (ROEB), Health Canada
Phone: (001) 613 954 0513
Fax: (001) 613 946 5636 ?
Email:
hc.rapid.alert-alerte.rapide.sc@canada.ca
The EU list of contact points for Rapid Alerts is maintained by European Medicines Agency (EMA) and provided to Health Canada at every update
Contact Points responsible for matters arising under CETA GMP Protocol
– Article 15.3 (c)
Manager, Mutual Recognition Agreement & International Affairs Unit (HPIL)
Regulatory Operations and Enforcement Branch (ROEB)
Health Canada
Telephone: (001) 450 928 4209
Email:
hc.drug.international.affairs-affaires.internationales.drogue.sc@canada.ca
Policy Officer, Unit B 4. Medical products: Quality, Safety, Innovation
Directorate General for Health and Food safety
European Commission
Phone: +32 229 57667
Email:
SANTE-PHARMACEUTICALS-B4@ec.europa.eu EMA: mra@ema.europa.eu DG Trade contact:
Assistant Policy Officer, Unit G3 - Market Access, Industry, Energy and Raw Materials, Directorate General for Trade, European Commission
Phone: +32 229 66925
Email: TRADE-G3-SEC@ec.europa.eu.
Components of the Information Sharing Process – Article 15.3 (d)Director, Health Product  Inspection and Licensing (HPIL)
Regulatory Operations and Enforcement Branch (ROEB)
Health Canada
Phone: (001) 613 954 2996
Email:
hc.drug.international.affairs-affaires.internationales.drogue.sc@canada.ca Manager, Mutual Recognition Agreement & International Affairs Unit (HPIL)
Regulatory Operations and Enforcement Branch (ROEB)
Health Canada
Telephone: (001) 450 928 4209
Email:
hc.drug.international.affairs-affaires.internationales.drogue.sc@canada.ca
Head of Unit, Unit B 4. Medical products: Quality, Safety, Innovation
Directorate General for Health and Food safety
European Commission
Phone: +32 229 60541
Email:
SANTE-PHARMACEUTICALS-B4@ec.europa.eu EMA: mra@ema.europa.eu EU National Competent Authorities:  as provided in the annual reports under the Equivalence Maintenance Programme (Appendix A to Adm. Arrangements Article 15.3(g) )
Components of a GMP Compliance Programme
– Article 15.3 (e)
Manager, Mutual Recognition Agreement & International Affairs Unit (HPIL)
Regulatory Operations and Enforcement Branch (ROEB)
Health Canada
Telephone: (001) 450 928 4209
Email:
hc.drug.international.affairs-affaires.internationales.drogue.sc@canada.ca
Policy Officer, Unit B 4. Medical products: Quality, Safety, Innovation
Directorate General for Health and Food safety
European Commission
Phone: +32 229 57667
Email:
SANTE-PHARMACEUTICALS-B4@ec.europa.eu EMA: mra@ema.europa.eu DG Trade contact:
Assistant Policy Officer, Unit G3 - Market Access, Industry, Energy and Raw Materials, Directorate General for Trade, European Commission
Phone: +32 229 66925
Email: TRADE-G3-SEC@ec.europa.eu.
Procedure for evaluating New Regulatory Authorities – Article 15.3 (f)Manager, Mutual Recognition Agreement & International Affairs Unit (HPIL)
Regulatory Operations and Enforcement Branch (ROEB)
Health Canada
Telephone: (001) 450 928 4209
Email:
hc.drug.international.affairs-affaires.internationales.drogue.sc@canada.ca
Policy Officer, Unit B 4. Medical products: Quality, Safety, Innovation
Directorate General for Health and Food safety
European Commission
Phone: +32 229 57667
Email:
SANTE-PHARMACEUTICALS-B4@ec.europa.eu EMA: mra@ema.europa.eu DG Trade contact:
Assistant Policy Officer, Unit G3 - Market Access, Industry, Energy and Raw Materials, Directorate General for Trade, European Commission
Phone: +32 229 66925
Email: TRADE-G3-SEC@ec.europa.eu.
Equivalence Maintenance Program
– Article 15.3(g)
Manager, Mutual Recognition Agreement & International Affairs Unit (HPIL)
Regulatory Operations and Enforcement Branch (ROEB)
Health Canada
Phone: (001) 450 928 4209
Email: hc.drug.international.affairs-affaires.internationales.drogue.sc@canada.ca
Policy Officer, Unit B 4. Medical products: Quality, Safety, Innovation
Directorate General for Health and Food safety
European Commission
Phone: +32 229 57667
Email:
SANTE-PHARMACEUTICALS-B4@ec.europa.eu EMA: mra@ema.europa.eu EU National Competent Authorities:  as provided in the annual reports under the Equivalence Maintenance Programme (Appendix A to Adm. Arrangements Article 15.3(g) ) DG Trade contact:
Assistant Policy Officer, Unit G3 - Market Access, Industry, Energy and Raw Materials, Directorate General for Trade, European Commission
Phone: +32 229 66925
Email: TRADE-G3-SEC@ec.europa.eu.
Date Modified: