Transfer of marketing authorisation template - attachment 3
Summary:
A document certifying that the complete and up-to-date file concerning the medicinal product or a copy of this file including any data/documents related to the pediatric obligations has been made available to or has been transferred to the Transferee
Transfer of marketing authorisation template - attachment 3
Summary:
A document certifying that the complete and up-to-date file concerning the medicinal product or a copy of this file including any data/documents related to the pediatric obligations has been made available to or has been transferred to the Transferee
Transfer of MA templates Attachment 4 (Superseded)
Summary:
A document stating the date on which the Transferor and the Transferee finalise the transitional organisational arrangements. This is referred to as the implementation date
Transfer of MA templates Attachment 6.1 (Superseded)
Summary:
A document identifying the qualified person responsible for Pharmacovigilance (QPPV) within the meaning of Article 23 of Regulation (EC) No 726/2004, together with his/her Curriculum Vitae including home address, email address, telephone and fax number. The qualified person responsible for Pharmacovigilance must be permanently and continuously at the disposal of the Transferee and must reside within the European Economic Area
Transfer of MA templates Attachment 6.1.1 (No longer valid)
Summary:
In case a Detailed Description of the Pharmacovigilance System (DDPS – Module 1.8.1) is authorised as part of the Marketing Authorisation, and the transfer has resulted in a change of the QPPV, a signed statement from the Transferee and new QPPV must be included, confirming that the Transferee has the services of the new QPPV and has the necessary means for the collection and notification of any adverse reaction occurring either in the Community or in a third country
Transfer of MA templates Attachment 6.2 (Superseded)
Summary:
A document identifying the scientific service in charge of information about the medicinal product within the meaning of Article 98 of Directive 2001/83/EC, as amended, including the address, e-mail, telephone and fax number
Transfer of MA templates Attachment 6.3 (Superseded)
Summary:
A document identifying the person/company authorised for communication between the Transferee and the agency after authorisation on the Transfer of MA, including the address, e-mail, telephone and fax number
Transfer of MA templates Attachment 6.4 (Superseded)
Summary:
A document identifying the contact details of the person responsible for quality defects and batch recall within the meaning of Article 79 of Directive 2001/83/EC, as amended, including the address, e-mail, telephone and fax number
Transfer of MA templates Attachment 8 (Superseded)
Summary:
A Letter of Undertaking, signed by the Transferee, listing any remaining Follow-up Measures or Specific Obligations. Where no Follow-up Measures or Specific Obligations remain a letter stating this must be submitted
Transfer of MA templates Attachment 9 (Superseded)
Summary:
A signed statement that no other changes have been made to the product information other than those to the details of the MAH and, if appropriate, the details of the local representatives