26.05.2004

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GMP News No. 422

GMP News
26 May 2004

Latest News on MRA Agreements

The Mutual Recognition Agreements (MRAs) are the basis for the mutual recognition of GMP inspections. Recently there have been two new developments in this area published on the Pharmacos website which we will summarise in the following.

1. Operational phase of the EC-Japan Mutual Recognition Agreement will

enter into force on 29 May 2004

On 28 April 2004 the European Communities and Japan have exchanged diplomatic notes confirming the completion of the preparatory work under the Mutual Recognition Agreement's Sectoral Annex on Good Manufacturing Practice (GMP) for Medicinal Products. Following this exchange of diplomatic notes, the Sectoral Annex on GMP will become operational on 29 May 2004. Under the Sectoral Annex on GMP for Medicinal Products, certificates issued for confirmed manufacturing facilities in compliance with the GMP requirements of one of the Parties and in accordance with the provisions of the MRA will be accepted in the EC and Japan without additional testing. Therefore, both parties expect that the MRA will facilitate trade between the Parties by reducing costs for companies. For the moment the Sectoral Annex will cover a limited number of human medicinal products. The Parties will review the scope for its possible expansion in the future.

Please click here in order to read more about the MRAs.

2. Impact of MRAs to new Member States following accession

2.1 Impact on imports from MRA partners
With the accession of new Member States the operation of the Single Market has been extended to their economies. As of the day of accession products, imported to the EU under the terms of MRAs concluded between the EC and third countries, will circulate freely to the economies of new Member States. Additionally, new Member States have been obliged to accept certificates or data issued on the territory of the MRA partner, in accordance with the provisions of the MRAs from 1 May 2004 onwards.

2.2 Impact on exports to MRA partners
Regarding the acceptance of certificates by MRA partners and data issued on the territory of the new Member States, the procedures set up under each specific annex of the MRAs must be applied. In the GMP sector new MSs will only be able to export to MRA partner countries under the terms of the relevant MRA if their Competent/Regulatory Authorities (CAs) are listed in the GMP Annex. The new CAs will be included following the procedures set up by the relevant MRA for the amendment of this Annex. While all new Member States will have to accept data generated for products under the GMP annex at the time of accession, the MRA partner will not be automatically obliged to accept medicinal products authorised by the authorities of new Member States.

2.3 The way forward for mutual recognition of GMP
GMP sectors present certain difficulties, since they generally rely on mutual recognition of systems on the basis of reciprocal evaluations carried out to build up confidence in each other's inspection systems. In this respect, the situation will differ in those MRAs that have directly been implemented (Australia, New Zealand, Switzerland) and those that foresee a period of confidence building (Canada, Japan, and USA).

If you would like to read the "Note on GMP Sectoral Annexes in MRAs" and about its impact on the new Member States, please click here.

Source:
Pharmacos, European Commission, Enterprise DG, Unit F2 Pharmaceuticals
(http://pharmacos.eudra.org)

Compiled by:
Oliver Schmidt
CONCEPT HEIDELBERG

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