Division 10 Information and Cooperation

The Parties to the Protocol shall regularly exchange information on the implementation and operation of this Annex.

They shall keep each other informed on training sessions for inspectors and scientists from Official Medicines Control Laboratories. Such sessions, organised by one Party, shall where practicable be made accessible to the other Party.

Representatives of Israel are encouraged to participate regularly in the discussions on GMP and quality related topics of working groups coordinated by the European Medicines Agency and the network of OMCLs coordinated by the European Directorate for the Quality of Medicines and Healthcare (EDQM) under the auspices of the Council of Europe. In addition, Israel is encouraged to participate in coordinated inspection activities in third countries.

As part of its implementation of relevant EU law, Israel shall participate in the operation of the Community database on GMP managed by the European Medicines Agency.

For the purposes of demonstration of capability and compliance of GMP inspection systems and OMCLs with European standards and requirements in the evolving regulatory systems, the parties shall participate in the Joint Audit Programme of the Member States of the EU, as published by the EMEA, and the Mutual Joint Audit Programme, as established by the EDQM and any future comparable audit programme.

Additional specific information shall on request be supplied by a Party in relation to its official inspection service and Official Medicines Control Laboratories. Such specific information may include training, observed audits, general information and document exchange, transparency of agency audits, exchanges of external assessments and review reports relating to official inspection services.

Parties agree to facilitate information exchange and interdisciplinary cooperation in cases when actors in the manufacturing and distribution chain are suspected of contravening the legislation.

With respect to medicinal products covered by the scope of this Annex, but not covered under Section II.3, the Parties may cooperate in planning and performing inspections and in exchanging information on such inspections.

The Parties will agree to meet upon reasonable request of either party to discuss issues of preparation, implementation of and compliance with relevant EU and Israeli national law.

Requests for cooperation under this clause should be made through the contact points referred to in clause 11.