EU-Israel mutual recognition agreement (MRA)

 

SUMMARY OF:

Agreement on mutual recognition of OECD principles of good laboratory practice (GLP) and compliance monitoring programmes between the European Community and Israel

Council Decision 99/662/EC approving the agreement

WHAT IS THE AIM OF THE AGREEMENT AND OF THE DECISION?

This mutual recognition agreement (MRA)* between the European Community (now the EU) and Israel relates to the Organisation for Economic Co-operation and Development (OECD) principles of good laboratory practice (GLP) and compliance monitoring programmes.

The decision approves the MRA on behalf of the EU countries.

KEY POINTS

The chemicals covered by the agreement are:

• cosmetics,
• industrial chemicals,
• medicinal products/pharmaceuticals,
• food additives,
• animal feed additives,
• pesticides.

Main features of the agreement:

• both parties (the EU and Israel) will ensure the high quality, validity and reliability of safety evaluation data obtained during non-clinical chemical testing;
• both parties recognise that each other’s GLP compliance monitoring programmes are equivalent;
• each party accepts the data produced by test facilities located on the territory of the other party if they participate in the GLP compliance monitoring programme, and agree that it can be used in decisions to place chemicals on the market;
• good laboratory practice, test facility inspection and study audits conform to the principles adopted by the OECD;
• test facilities conform with good laboratory practice according to the respective principles of each party;
• the two parties will keep each other informed of changes to their legislation that could affect good laboratory practice compliance standards or programmes;
• the EU will verify that the laboratories and national monitoring system in Israel conform;
• the MRA provides for a 2-year transitional period to establish a national GLP monitoring system;
• the MRA automatically lapses if the parties fail to agree on Israel’s national GLP monitoring system and on its extension after the initial period.

FROM WHEN DOES THE AGREEMENT APPLY?

It has applied since 1 May 2000.

BACKGROUND

In their resolution of 21 December 1989, EU countries agreed on the principle of MRAs. On 21 September 1992, they authorised the European Commission to negotiate mutual recognition agreements on behalf of the EU with certain non-EU countries.

See also:

• Mutual Recognition Agreement (European Commission)
• Good Laboratory Practice (European Commission).

KEY TERMS

MAIN DOCUMENT

Agreement on mutual recognition of OECD principles of good laboratory practice (GLP) and compliance monitoring programmes between the European Community and the State of Israel — Agreed Minutes (OJ L 263, 9.10.1999, pp. 7-18)

Council Decision 99/662/EC of 19 July 1999 concerning the conclusion of the Agreement on mutual recognition of OECD principles of good laboratory practice (GLP) and compliance monitoring programmes between the European Community and the State of Israel (OJ L 263, 9.10.1999, p. 6)

RELATED DOCUMENTS

Consolidated version of the Treaty on the Functioning of the European Union — Part Five — The Union’s external action — Title II — Common commercial policy — Article 207 (ex Article 133 TEC) (OJ C 202, 7.6.2016, pp. 140-141)

Agreement on the European Economic Area — Protocol 12 on conformity assessment agreements with third countries (OJ L 1, 3.1.1994, pp. 174-175)

Uruguay Round of Multilateral Trade Negotiations (1986-1994) — Annex 1 — Annex 1A — Agreement on Technical Barriers to Trade (WTO-GATT 1994) (OJ L 336, 23.12.1994, pp. 86-99)

Council Resolution of 21 December 1989 on a global approach to conformity assessment (OJ C 10, 16.1.1990, pp. 1-2)

last update 26.10.2018