递交US-DMF所需要的资料 

 

I.         Original Submission

1.      Cover letter;

2.      Transmittal Letters;

1)        Identification of submission: Original, the type of DMF as classified in Section III, and its subject.

2)        Identification of the applications, if known, that the DMF is intended to support, including the name and address of each sponsor, applicant, or holder, and all relevant document numbers.

3)        Signature of the holder or the authorized representative.

4)        Typewritten name and title of the signer.

3.      Administrative Information;

a. Names and addresses of the following:

1)        DMF holder.

2)        Corporate headquarters.

3)        Manufacturing/processing facility.

4)        Contact for FDA correspondence.

5)        Agent(s), if any.

b. The specific responsibilities of each person listed in any of the categories in Section a.

4.      Statement of commitment;

A signed statement by the holder certifying that the DMF is current and that the DMF holder will comply with the statements made in it.

5.      Letter of authorization;

6.      Agent appointment letter;

7.      FDA Registration information (Establishment Registration Number);

8.      DMF.

II.      Annual Update

1.      Transmittal Letters;

1)        Identification of submission: Original, the type of DMF as classified in Section III, and its subject.

2)        Identification of the applications, if known, that the DMF is intended to support, including the name and address of each sponsor, applicant, or holder, and all relevant document numbers.

3)        Signature of the holder or the authorized representative.

4)        Typewritten name and title of the signer.

2.      Administrative Information;

a. Names and addresses of the following:

a)        DMF holder.

b)        Corporate headquarters.

c)        Manufacturing/processing facility.

d)        Contact for FDA correspondence.

e)        Agent(s), if any.

b. The specific responsibilities of each person listed in any of the categories in Section a.

3.      Statement of commitment.

III.   Amendment

1.      Transmittal Letters;

5)        Identification of submission: Original, the type of DMF as classified in Section III, and its subject.

6)        Identification of the applications, if known, that the DMF is intended to support, including the name and address of each sponsor, applicant, or holder, and all relevant document numbers.

7)        Signature of the holder or the authorized representative.

8)        Typewritten name and title of the signer.

2.      Administrative Information;

a. Names and addresses of the following:

a)        DMF holder.

b)        Corporate headquarters.

c)        Manufacturing/processing facility.

d)        Contact for FDA correspondence.

e)        Agent(s), if any.

b. The specific responsibilities of each person listed in any of the categories in Section a.