Medicine mutual recognition procedures updates
New arrangements take account of technical and administrative developments
The European Union (EU) has updated its agreements on the mutual recognition of conformity procedures for medicines with Australia and New Zealand.
The new deals have been negotiated by the European Commission and take account of developments in technical and administrative practices since the initial agreements were struck in 1999.
The new arrangements will ease the recognition within the EU of inspections by manufacturers in Australia and New Zealand and EU inspections within these Australasian countries. ‘In addition, the manufacturer’s certification of the conformity of each batch to its specifications will be recognised by the other party without re-control at import,’ says the agreement.
It also lays down checks that can be demanded by foreign regulators, importers or exporters of local regulators to make sure manufacturers’ inspections are effective.