S.L. 458.42 Art. 13Outsourced operations. Cap. 458.

(1) Any manufacturing operation or import operation or operation linked thereto which is outsourced shall be the subject of a written contract.

(2) The contract shall clearly define the responsibilities of each party and shall define, in particular, the observance of good manufacturing practice to be followed by the contract-acceptor and the manner in which the qualified person responsible for certifying each batch is to discharge his responsibilities.

(3) The contract-acceptor shall not subcontract any of the work entrusted to him under the contract without written authorisation from the contract-giver.

(4) The contract-acceptor shall comply with the principles and guidelines of good manufacturing practice applicable to the operations concerned laid down in the European Union and shall submit to inspections carried out by the competent authorities as provided by the Medicines Act.