Heads of Medicines Agencies Strategy for the European Medicines Regulatory Network.

HMA (Joint Human and Veterinary) formally adopted the HMA Strategy Paper on the European Medicines Regulatory Network (ERMN), which was drafted by the UK Presidency on behalf of the HMA. The HMA (Joint) agreed to the formation of an Implementation Group, which Jean Marimbert, Director General of the French Agency for the Safety of Health Products (Afssaps) agreed to chair along with members from 6 other member states. The group will be responsible for taking forward the work set out in the Strategy Paper. A consultation process has been launched in March 2006 and a meeting with partners and stakeholders will be held under the auspices of the Austrian presidency.

The Strategy Implementation Group would appreciate receiving any comments you will have on the HMA Strategy Paper by 31 May 2006, addressed to the HMA Permanent Secretariat on
e-mail: hma-ps@imb.ie

Consultation process

 Introductory Note and Questionnaire

HMA Strategy Paper

INDEX

1.        Explanatory Note

2.        HMA Strategy Paper

3.        Communication and Information
-  3(i) Stakeholders
-  3(ii) Defining communication roles Competent Authorities
-  3(iii) Legal environment
-  3(iv) Daily life communication vs. Crisis communication
-  3(v) Solutions and actions

4.        Scientific Resources

5.        Scientific Assessment Process: New products and referrals

6.        Pharmacovigilance

7.        Inspection, Laboratory Control and Enforcement

8.        IT information systems

(Information added March 2006)

Questionnaire