Regulatory Documents. 3.01 SUPPLIER is responsible for maintaining the appropriate registration documents for the PRODUCT (i.e. dossier for CEP, DMF or equivalent) in countries where these documents have been submitted already. ☐ ☒ ☐ 3.02 Upon mutual agreement with CUSTOMER, SUPPLIER will prepare and submit registration documents in countries where SUPPLIER has not yet registered the product. ☐ ☒ ☐ 3.03 SUPPLIER is responsible for all regulatory contacts with the relevant regulatory authority with jurisdiction over the PRODUCT. ☐ ☒ ☐ 3.04 SUPPLIER will provide current information to CUSTOMER Affiliates reasonably requested for submission of any regulatory dossier by CUSTOMER Affiliates for finished drug products made from PRODUCT. Such information will include either access to CEP (including the appropriate stability data for the respective PRODUCT, if no retest date is defined in the CEP), or applicants’ part to DMF, or equivalent. ☐ ☒ ☐ 3.05 CUSTOMER Affiliates are responsible for submitting the regulatory dossier for the Marketing Authorization Application associated with any finished drug product made from the respective PRODUCT. Such regulatory dossier, as it pertains to SUPPLIER, will refer to SUPPLIER’s CEP, DMF or equivalent, where applicable. ☒ ☐ ☐
Appears in 4 contracts
Samples: Quality Assurance Agreement, Quality Assurance Agreement, Quality Assurance Agreement
