Common use of Operational Provisions Clause in Contracts

Operational Provisions. 1. Transmission of inspection reports Upon reasoned request, the relevant inspection services will forward a copy of the last inspection report of the manufacturing or control site, in case analytical operations are contracted out. The request may concern a ''full inspection report'' or a ''detailed report'' (see point 2). Each Party will deal with these inspection reports with the degree of confidentiality requested by the Party of origin. If the manufacturing operations of the medicinal product in question have not been inspected recently, i.e. when the last inspection dates back to more than two years or a particular need to inspect has been identified, a specific and detailed inspection may be requested. Parties will ensure that inspection reports are forwarded in no more than 30 calendar days, this period being extended to 60 calendar days should a new inspection be carried out.

Operational Provisions. 1. Transmission of inspection reports Upon reasoned request, the relevant inspection services will forward a copy of the last inspection report of the manufacturing site or control site, in the case where analytical operations are contracted out. The request may concern a ''‘full inspection report'' ’ or a ''‘detailed report'' ’ (see point 2item 2 below). Each Party will deal with these inspection reports with the degree of confidentiality requested by the Party of origin. If the manufacturing operations of the medicinal product in question have not been inspected recently, i.e. when the last inspection dates back to more than two years or a particular need to inspect has been identified, a specific and detailed inspection may be requested. Parties will ensure that inspection reports are forwarded in no more than 30 calendar days, this period being extended to 60 calendar days should a new inspection be carried out.

Operational Provisions. 1. Transmission of inspection reports Upon reasoned request, the relevant inspection services will shall forward a copy of the last inspection report of the manufacturing site or control site, in the case where analytical operations are contracted out. The request may concern a ''‘full inspection report'' ’ or a ''‘detailed report'' ’ (see point 2item 2 below). Each Party will shall deal with these inspection reports with the degree of confidentiality requested by the Party of origin. If the manufacturing operations of the medicinal product in question have not been inspected recently, i.e. when the last inspection dates back to more than two years or a particular need to inspect has been identified, a specific and detailed inspection may be requested. Parties will shall ensure that inspection reports are forwarded in no more than 30 calendar days, this period being extended to 60 calendar days should a new inspection be carried out.

Operational Provisions. 1. Transmission of inspection reports Upon reasoned request, the relevant inspection services will forward a copy of the last inspection report of the manufacturing or control site, in the case where analytical operations are contracted out. The request may concern a ''‘full inspection report'' ’ or a ''‘detailed report'' ’ (see point (2). Each Party will deal with these inspection reports with the degree of confidentiality requested by the Party of origin. If the manufacturing operations of the medicinal product in question have not been inspected recently, i.e. when the last inspection dates back to more than two years or a particular need to inspect has been identified, a specific and detailed inspection may be requested. Parties will ensure that inspection reports are forwarded in no more than 30 calendar days, this period being extended to 60 calendar days should a new inspection be carried out.

Operational Provisions. 1. Transmission of inspection reports Upon reasoned request, the relevant inspection services will forward a copy of the last inspection report of the manufacturing or control site, in case analytical operations are contracted out. The request may concern a ''“full inspection report'' ” or a ''“detailed report'' ” (see point (2). Each Party will deal with these inspection reports with the degree of confidentiality requested by the Party of origin. If the manufacturing operations of the medicinal product in question have not been inspected recently, i.e. when the last inspection dates back to more than two years or a particular need to inspect has been identified, a specific and detailed inspection may be requested. Parties will ensure that inspection reports are forwarded in no more than 30 calendar days, this period being extended to 60 calendar days should a new inspection be carried out.