Loading...

產業新聞

Home / News

Asia: New Zealand clarifies acceptable overseas evidence of GMP in updated medicine guidelines

2023/08/24  MEDSAFE

Medsafe requires evidence of compliance with Good Manufacturing Practice (GMP) for sites used to manufacture and pack medicines. This evidence is required for medicines in New Zealand whether or not they are considered medicines in the country of origin.

For overseas manufacturers and packers, Medsafe requires that current certification be included with each NMA or CMN which relates to a change of site, even if the site already supplies product to New Zealand and certification has been supplied previously with an earlier application or notification. This reduces delays associated with locating other files, and because it is desirable for the certification to be product-specific and up-to-date.

If acceptable evidence of GMP compliance is not available, an audit of the site by Medsafe auditors can be arranged at the applicant’s request and expense.

Medsafe also requires sponsors to continue supplying evidence of current GMP compliance on an ongoing basis, to ensure registered products continue to meet consented requirements. Updated evidence should be submitted, to [email protected], as soon as it becomes available for each site involved in the manufacturing activities listed above. There is no associated fee.

Medsafe recognises any GMP certification document issued by a recognised authority that confirms GMP compliance. Acceptable evidence normally consists of copies of appropriate certificates, manufacturing licences or reports

Medsafe prefers product-specific certification such as certification in the WHO format or a manufacturing or product licence listing the product. If product-specific certification cannot be obtained, the certification must relate to a medicine or medicines of the same class(es) as the one which is the subject of the application or notification. A medicine may belong to more than one class. In such cases, the certification should be for a product belonging to the same classes.

Medsafe recognises GMP certification issued by the authorities. These authorities include the competent authorities in the European Union accepted under the EUNZ Mutual Recognition Agreement, certain member authorities of the PIC and/or PIC/S organisations, and other authorities where Medsafe has information that GMP assessment systems that are compatible with New Zealand expectations exist. The inclusion of the listed European Union competent authorities is a consequence of the Mutual Recognition Agreement in Relation to Conformity Assessment that became effective between New Zealand and the European Community on 1 January 1999. Medsafe added further authorities to this list in August 2023 after completing an assessment of the authorities’ systems. Omission of an authority from the list generally indicates that Medsafe has not assessed that authority’s systems and should not be construed in any way as an adverse reflection on the competence of the authority itself.

To continue reading this article please go to MEDSAFE .