22/23 May 2024
The European Medicine Agency EMA has updated its Questions and Answers and discusses the "Chain of Contracts", a "setup where one or more parties (sites/companies) are acting as signatory in a chain of contracts that links them together. Thus, the setup introduces one or several separate legal entities between the contract giver - e.g. a MIA holder responsible for QP certification and the contract manufacturer as a contract acceptor. In fact, the GMP activities concerned are sub-contracted over one or several levels".
The answer clarifies in which exceptional cases such a set-up would be acceptable instead of direct written contracts, for example:
However, "direct written contracts" are still preferred: These are contracts "signed between the parties, that actually perform the activities stated in the contract", e.g. MAH as a contract giver and the MIA holder responsible for QP certification as a contract acceptor or the MIA holder responsible for QP certification as a contract giver and contract manufacturers."