Content and Form of Drug Processing Contracts: What Constitutes Legal Compliance?

Contract manufacturing of pharmaceuticals is an agreement between parties, whereby the contractors perform tasks to create a product as required by the contractees, and the contractees receive the product and pay the manufacturing fee.

Illustration (source: internet)

Specifically: the content and form of drug contract-manufacturing agreements are detailed in Article 5 of Circular 23/2013/TT-BYT as follows:

First, regarding the form of the drug contract-manufacturing agreement: The drug contract-manufacturing agreement must be made in writing and must comply with the provisions of Vietnamese law on economic contracts.

Second, mandatory contents of the drug contract-manufacturing agreement:

- Agreement on the supply of raw and auxiliary materials, the provision of production processes, technical standards, and methods for testing initial raw materials, semi-finished products, finished products, and other documents related to the contract manufacturing of drugs;- The rights and responsibilities of each party regarding the inspection of the quality of raw materials, semi-finished products, finished products, the packaging process, product labels, and clearly stipulate the inspection slip of each batch of finished products and the shipment release note;- The rights and responsibilities of each party in retaining records related to production, quality inspection, distribution, circulation of drugs, retaining samples, resolving issues related to quality, complaints, and product recalls on the market;- The contractee's responsibility regarding issues related to the intellectual property of the registered drug;- Procedures for inspecting the manufacturing facility of the contractor;- Cases of contract termination;- The agreement must have the consent of the manufacturing facility for contract manufacturing of drugs which has been granted a valid registration number by the Ministry of Health of Vietnam (in cases where the registrant is different from the manufacturer).

For additional regulations, see Circular 23/2013/TT-BYT effective from October 1, 2013.

Thu Ba

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