Outsourced operations
Article 12
1. The Member States shall require that any manufacturing or import operation or operation linked thereto which is outsourced is 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 referred to in Article 48 of Directive 2001/83/EC 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 Union and shall submit to inspections carried out by competent authorities pursuant to Article 111 of Directive 2001/83/EC.