Regulation .03-1 Minimum Application Requirements for Virtual Manufacturers.
Regulation .03-1 Minimum Application Requirements for Virtual Manufacturers.LinkCopy Citation
The information and qualification requirements for obtaining a permit under Regulation .03 of this chapter, beyond that required by federal law, do not apply to a virtual manufacturer that meets the following requirements:
A.
Provides a list of drug or device products it distributes;
B.
Provides a list of the NDA or ANDA numbers associated with each drug it distributes;
C.
Provides a list of the UDI numbers, as available, associated with each device it distributes;
D.
Provides the name and facility address of the contract manufacturer for each drug or device product it distributes;
E.
Provides verification of current FDA registration for each contract manufacturing facility listed;
F.
If the contract manufacturer distributes into this State, provides the wholesale distributor permit number for the contract manufacturer;
G.
If the contract manufacturer does not distribute into this State, provides name and Maryland’s wholesale distributor permit number for the entity that physically distributes the product into this State;
H.
Provides a statement affirming that the virtual manufacturer does not contract the manufacture or distribution for drugs or devices other than those for which it owns the NDA, ANDA, or UDI numbers;
I.
Provides an attestation by the owner of the virtual manufacturer that it does not hold product;
J.
Provides a copy of existing licensure from the state in which it is located, if applicable; and
K.
Has valid federal licensure or registration, as verified by the Board.