Rights and Obligations of the Ordering Party and the Contract Manufacturing Party for Pharmaceuticals

According to the provisions of Article 4 Circular 23/2013/TT-BYT, the Contracting Party and the Contract Manufacturing Party must ensure the following rights and obligations:

Illustration (source: internet)

1. For the Contracting Party:

- Ownership of the registration number and contract-manufactured product;- The right to contract out one or several production stages to Contract Manufacturing Parties;- The right to receive contract-manufactured products according to the method, timeline, and conditions agreed upon in the contract;- Responsibility for registering contract-manufactured drugs according to the procedures stipulated in Circular 22/2009/TT-BYT;- Execution of the rights and obligations of a drug registration entity as prescribed in Circular 22/2009/TT-BYT, rights of export and import as prescribed by the law on drug import and export;- Providing the production process, technical standards, and methods for testing raw materials, semi-processed, and finished products, and other documents related to drug contract manufacturing;- Paying the remuneration for contract manufacturing as agreed upon in the contract;- Responsibility for the quality, safety, and efficacy of the contract-manufactured drug throughout its circulation;- Responsibility for issues related to the intellectual property of the registered drug and other rights and obligations as prescribed by the law on contract manufacturing in trade.

1. For the Contract Manufacturing Party:

- Receiving remuneration according to the agreement in the contract;- The right to request the Contracting Party to deliver the raw materials in the correct quantity, quality, timeline, and location as agreed upon in the contract. If the Contract Manufacturing Party supplies the raw materials itself, it must ensure their quality according to the standards of the Contracting Party;- The right to refuse contract manufacturing if the Contracting Party provides raw materials that do not meet the quality standards as agreed upon in the contract;- Requesting the Contracting Party to provide the production process, technical standards, and methods for testing raw materials, semi-processed, and finished products, and other documents related to drug contract manufacturing;- Conducting drug production according to the process and technical standards, ensuring the quality of the drug according to the registration dossier and the requirements of the Contracting Party as stipulated in the signed contract;- Keeping records, documents, and drug samples related to the production process and providing them to competent state management agencies upon request;- Responsibility for product quality inspection throughout the production process and ensuring the quality of the product until delivering the contract-manufactured product to the Contracting Party;- Handling leftovers, waste, and defective products after completing the contract manufacturing as agreed in the contract in compliance with the law;- Other rights and obligations as prescribed by the law on contract manufacturing in trade.

See the full text of the provision at Circular 23/2013/TT-BYT, effective from October 1, 2013.

Thu Ba

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