Common use of Official Batch release Clause in Contracts

Official Batch release. The official batch release procedure is an additional verification of safety and efficacy of immunological medicinal products (vaccines) and blood derivatives, carried out by the competent authorities before the distribution of each batch of product. This Agreement does not encompass mutual recognition of official batch releases. However, when an official batch release procedure applies, the manufacturer will provide, at the request of the importing Party, the official batch release certificate if the batch in question has been tested by the control authorities of the exporting Party. For the European Community, the official batch release procedure for medicinal products for human use is specified, in document "Administrative EC Batch Release Procedure III/3859/92" and different specific batch release procedures. For New Zealand, the official batch release procedure is specified in document "WHO Technical Report Series, No. 822, 1992."

Official Batch release. The official batch release procedure is an additional verification of safety and efficacy of immunological medicinal products (vaccines) and blood derivatives, carried out by the competent authorities before the distribution of each batch of product. This Agreement does not encompass this mutual recognition of official batch releases. However, when an official batch release procedure applies, applies the manufacturer will shall provide, at the request of the importing Party, the official batch release certificate if the batch in question has been tested by the control authorities of the exporting Party. For the European Community, the official batch release procedure for medicinal products for human use is specified, in document "Administrative EC Batch Release Procedure III/3859/92" and different specific batch release procedures. For New ZealandAustralia, the official batch release procedure is specified in document "WHO Technical Report Series, No. 822, 1992."