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Mutual Recognition Agreement for Good Manufacturing Practice with EU

Regular contact continues between the ACVM Group and the European Medicines Evaluation Agency (EMEA) in London to develop the Mutual Recognition Agreement (MRA) for the assessment of Good Manufacturing Practice (GMP).

Progress has been made on agreeing how the EMEA will assess inspection equivalence. It has been decided that during the GMP inspections due to be carried out by the  Medicines Control Agency (MCA) for the EMEA in July 2001, a further week will be added to the inspector’s visit to observe an inspection being carried out by a New Zealand inspector. In addition, the MCA inspector will review the management of the GMP programme by MAF.

Meanwhile MAF will observe Veterinary Medicines Directorate (VMD) inspections carried out in New Zealand in March and the MCA inspections to be carried out in July. MAF will also observe two inspec-tions within the EU conducted by European inspectors to assess parity of inspections. Selection will be based on importation statistics relating to products coming into New Zealand. The European GMP management system will also be reviewed. This is likely to be in October to coincide with an ad hoc meeting of European inspectors.

Both parties agree to do all possible to complete the transitional confidence building period by 31 December 2001, including preparation of a joint MAF and EMEA report to the Joint Sectorial Committee. A framework and format for the report have been agreed.

Given the timetable for the VMD and MCA inspections, and the dates for ad hoc meetings of the EU inspectors, the following timeline has been developed for completion of the MRA:

Mar: VMD visit NZ
July: MCA visit NZ
Oct: MAF visit EU
Nov: Development of joint report
Dec: Sign off veterinary pharmaceutical GMP agreement
Jan 2002 onwards: MRA maintenance programme assures agreement remains valid.

Harmonised Batch Certification

In the framework of Mutual Recognition Agreements, the Sectoral Annex on Good Manufacturing Practices (GMP) requires a batch certification scheme for veterinary medicinal products covered by the Pharmaceutical Annex. The internationally harmonised requirements for the content of a batch certificate have now been agreed by Australia, Canada, the European Community, New Zealand and Switzerland.

This means that products passing between these countries should be accompanied by a batch certificate set out in the prescribed and agreed format.

A batch certificate will be issued by the manufacturer in the exporting country following full qualitative and quantitative analysis of all active and other relevant constituents to ensure that the quality of the products complies with the requirements of the Marketing Authorisation of the importing country.

This certificate will detail the specifications of the product, the analytical methods referenced and the analytical results obtained. It will also contain a statement that the batch processing and packaging quality control records were reviewed and found in conform-ity with GMP. It will attest that the batch meets the specifications and has been manufactured in accordance with the Marketing Authorisation of the importing country.

The batch certificate will be signed by the person responsible for releasing the batch for sale or supply/export at the manufacturing site.

The importer of the batch is to receive and maintain the batch certificate issued by the manufacturer. Upon request, the certificate must be readily available to the staff of the Regulatory Authority of the importing country. This certification by the manufacturer of the conformity of each batch is essential to exempt the importer from re-control (re-analysis) in the importing country.

Although New Zealand has not completed its MRA with the European Union (see article above), the ACVM Group is promoting the introduction of the new batch certificate to stand-ardise the batch information passing to Europe.

The batch certificate template can be found on the website ( www.maf.govt.nz/acvm/ ) under B in the Index.