Templates for industry

Transfer of a marketing authorisation templates

Template - Application for transfer of marketing authorisation from transferor to transferee, cover letter (human)

Transfer of MA templates Attachment 1

Summary:

The name of the medicinal product concerned, the authorisation number(s) and the date(s) on which the authorisation(s) was (were) granted

Transfer of MA templates Attachment 2

Summary:

The identification (name, address, contact person at address, telephone and email) of the Transferor and the Transferee

Transfer of MA templates 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

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 5

Summary:

Proof of establishment of the Transferee within the European Economic Area

Transfer of MA templates Attachment 6.1

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

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

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

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

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 7

Summary:

If the medicinal product concerned has not yet been marketed in the EU in any of its presentations, this should be specified in a signed statement

Transfer of MA templates Attachment 8

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

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