- Print Friendly - Help

Previous page  | Contents |  Next page

Operational agreement with Medsafe

Under section 13 of the ACVM Act 1997 the ACVM Group must notify government departments that have expressed an interest in applications to register agricultural compound trade name products. Section 14 provides circumstances under which notification does not have to occur. In effect and for the purpose of the operational agreement, all applications that involve issues that the Ministry of Health (MoH) has not had a previous opportunity to comment on will be notified to them.

In addition, subsection 21(4) of the ACVM Act 1997 states that:
The Director-General must not register a trade name product under this section without the consent of the Director-General of Health if that product is a prescription medicine within the meaning of section 3 of the Medicines Act 1981.

The ACVM Group considers that the Director-General of Health would also be interested in substances that are restricted medicines and any Class A, B, or C drugs as scheduled in the Misuse of Drugs Act 1975. Therefore, the ACVM Group will consider that the obligation in subsection 21(4) extends to the issuing of registrations for any of these groups of medicines and drugs to be used as agricultural compounds.

Section 16 of the ACVM Act places a time limitation on the processing of applications for registration. Since, in most cases, the decision must be made within 40 days, it will be important that a response from MoH can be processed in time for the ACVM Group to meet its statutory deadlines.

When the ACVM Group receives an application for registration of an agricultural compound trade name product, it will screen the formulations to identify any ingredient that is a:

• Prescription medicine
• Restricted medicine
• Class A drug
• Class B drug or
• Class C drug,

and will advise MoH accordingly.

The ACVM Group is currently in discussions with MoH and we expect the agreement to be signed off in the very near future. In the meantime, MoH is testing the operational agreement by processing those applications in the system that fall within the above categories.

As mentioned above, section 21(4) of the ACVM Act states:

The Director-General must not register a trade name product under this section without the consent of the Director-General of Health if that product is a prescription medicine within the meaning of section 3 of the Medicines Act 1981.

The ACVM Group advises that this has the potential to delay the approval of your products. However, we are meeting with the Ministry of Health to work through the regulatory obligations that we have in meeting deadlines.

Mutual Recognition Agreement for GMP

The EC has agreed to implement the Mutual Recognition Agreement on Good Manu-facturing Practice with New Zealand from 1 June 2002.

This is the result of work over the last five years that included a number of meetings in Europe and New Zealand, and a three-year transition period during which the exchange and analysis of relevant legislation, standards and procedures took place. Technical reviews of the conduct of inspections and of the management of the inspection process were also carried out.

The effect of this agreement is that the inspections by ACVM inspectors, of manufacturers who are supplying veterinary medicines to the European market, will be accepted by the EC. There will no longer be a requirement for European inspectors to visit New Zealand to conduct GMP inspections of manufacturers exporting to the EC.

As part of the agreement, there will be a programme to maintain contact with the Europeans on any changes to standards, structures or procedures that take place in either territory, and for the emergency recall of deficient products.

The ACVM Group will continue to work with service providers to improve the systems and provide added value from the inspection process.