Common use of Batch Testing Clause in Contracts

Batch Testing. In the EU, as provided in Article 51 paragraph 2 of Directive 2001/83/EC of the European Parliament and of the Council (1) and in Article 55 paragraph 2 of Directive 2001/82/EC of the European Parliament and of the Council (2), the qualified person will be relieved of responsibility for carrying out the controls laid down in Article 51 paragraph 1 of Directive 2001/83/EC and in Article 55 paragraph 1 of Directive 2001/82/EC provided that these controls have been carried out in the United States, the product was manufactured in the United States and that each batch/lot is accompanied by a batch certificate (in alignment with the WHO certification scheme on the quality of medicinal products) issued by the manufacturer certifying that the product complies with requirements of the marketing authorization and signed by the person responsible for releasing the batch/lot.

Batch Testing. In the EU, as provided in Article 51 paragraph 2 of Directive 2001/83/EC of the European Parliament and of the Council (1) and in Article 55 paragraph 2 of Directive 2001/82/EC of the European Parliament and of the Council (2), the qualified person will be relieved of responsibility for carrying out the controls laid down in Article 51 paragraph 1 of Directive 2001/83/EC and in Article 55 paragraph 1 of Directive 2001/82/EC provided that these controls have been carried out in the United States, the product was manufactured in the United States and that each batch/lot is accompanied by a batch certificate (in alignment with the WHO certification scheme on the quality of medicinal products) issued by the manufacturer certifying that the product complies with requirements of the marketing authorization and signed by the person responsible for releasing the batch/lot.lot.‌