- Print Friendly - Help

Previous page  | Contents |  Next page

Update: Mutual Recognition Agreement for Good Manufacturing Practice

New Zealand and the EC propose to implement the Mutual Recognition Agreement (MRA) for Good Manufacturing Practice (GMP) of Veterinary Medicines on 1 April 2002.

Significant activity occurred on this project during November and December 2001. Following the visits to the EMEA, MCA and VMD reported in AgVetLink 29, return visits by two European officials were made to New Zealand for inspections and for the preparation of documentation to complete the transition period.

In November, an inspector from the MCA visited and inspected a manufacturer of veterinary medicines in Auckland, part of which was observed for MAF’s ACVM Group. This was followed by an inspection of another veterinary medicines manufacturer by two AgriQuality New Zealand inspectors, which was observed by the MCA inspector.

In December, Katrin Nodop, Principal Administrator with the EMEA,  made a first visit to New Zealand to prepare for the completion of the transitional period, and the implementation of the full mutual recognition agreement for veterinary medicines. Dr Nodop gave a presentation of the European system for GMP control, and held meetings with MAF and Medsafe relating to the operation of the agreement and the maintenance programme that will be implemented to keep the agreement current.

Agreement was reached on specific documentation items to be used between the parties in respect of exported goods. These include a harmonised batch certificate, a common format for a GMP certificate, and a format for notification of product recalls due to defective manufacture. Terms of reference for a Joint Sectorial Committee to administer the MRA maintenance programme were developed, and a final joint (NZ/EC) report to the Joint Committee for the MRA was prepared recommending implementation of the full agreement for veterinary medicines on 1 April 2002.

As a result of this development the ACVM Group will refine its GMP inspection processes to provide more information to manufacturers and to meet its obligations under the agreement. These refinements will include:

• the change of certification of manufacturers to the new format as inspections progress and new certificates are required to be issued;
• the provision of more specific pharmaceutical expertise for inspections of veterinary pharmaceutical manufacturing premises;
• changes to the standard to make regulatory intervention and corrective action steps and timeframes clearer for all parties;
• the adoption in New Zealand of the rapid alert system used in Europe to notify regulatory authorities of the recall of products due to faulty manufacture.

We look forward to confirming the implementation of the agreement to manufacturers in April.

Electronic copies of labels/label content

The ACVM Group clarified some time ago that a product registration would consist of three components: the registration certificate, the Product Data Sheet (PDS) and the approved label content. Recently, the ACVM Group requested that, in addition to paper copies of the PDS, an electronic copy should also be supplied. We have reviewed the effectiveness of this and are now extending the requirement to include electronic copies of the final label or the approved label content wherever possible.

Under the ACVM Act the approved label content will form part of the registration and therefore the public register. It is a major undertaking to enter all of the use patterns for products, especially for the plant compound products where the pest/species combinations can be considerable. In most cases the registration certificate will reference the label information as part of the approval so it is a logical step to provide for an electronic copy of the label (or the relevant part of the label) to go on the public register.

We also expect that the electronic versions of labels will provide for more robust checking by Border Services staff, and that it will provide a useful resource for other groups such as regional councils, contractors and consumers.

The ACVM Group believes that as more and more companies are becoming ‘e-commerce’ oriented it should not be difficult to supply electronic versions of labels/label content and PDSs. The ACVM Group has access to scanning equipment or digital cameras where electronic copies cannot be provided.

It is intended to make label information available on the website, under the ‘Registers and Lists’ pathway. If you have any comments or concerns about this proposal, please contact Maree Zinzley, Customer Services Manager (email: zinzleym@maf.govt.nz ).