Conditions for assurance of medicine quality of medicine manufacturers or preparers

Medicine manufacturers or preparers shall satisfy the following requirements of medicine quality management in the course of manufacture:

They apply good practice principles and standards to manufacturing, distributing, storing and testing medicines and/or other appropriate management systems in order to assure that the quality of their products conforms to their quality standards already registered and approved by the Ministry of Health (for medicines in circulation) or announced (for medicines prepared for use).

They register their medicines under the Law on Pharmacy and relevant regulations and label them under regulations on goods labeling.

They comply with technical regulations relevant to the process of manufacture, preparation, quality inspection and storage, quality standards and other relevant regulations.

They submit to inspection by medicine management and state quality inspection agencies under Article 24 of this Circular.

Conditions for assurance of medicine quality of exporters, importers, wholesalers, retailers, storehouses, transporters or users

Medicine exporters, importers, wholesalers, retailers, storehouses, transporters or users shall satisfy the following quality management requirements:

1. They apply good practice principles and standards to medicine storage and distribution to consumers and other appropriate measures to maintain the quality of medicines in conformity with their quality standards already registered and approved by the Ministry of Health:

a/ Recruiting, training and arranging professionally qualified personnel under regulations;

b/ Equipping devices to store and transport medicines to assure required storage conditions in the course of medicine storage and transportation;

c/ Opening and keeping dossiers and books for monitoring the circulation of medicines they trade in.

For imported medicines, apart from complying with the above provisions, importers shall assure medicine quality under regulations on medicine import.

2. They submit to medicine quality inspection by medicine management and state quality inspection agencies under Article 24 of this Circular.

Quality inspection of medicines by medicine traders

1. All medicines (including materials and packages) arc subject to quality inspection. Only medicines that attain quality standards and comply with relevant regulations can be manufactured, prepared and circulated.

2. Heads and professional managers of medicine traders, preparers or users shall take responsibility for the management and inspection of medicine quality at their establishments and for the quality of medicines their establishments trade in, prepare or use.

3. Medicine traders, preparers or users shall organize and conduct the inspection and control of medicine quality at their establishments.

4. Medicine manufacturers or preparers shall have suitable technical devices and professional staffs to test, determine and assess the quality of medicines in the manufacture and ex-works delivery.

5. Medicine exporters, importers, traders, storehouses and users are encouraged to organize, depending on the scope of their operations, the testing of medicines in order to monitor the quality of medicines they trade in.

6. Medicine traders (medicine registrants and importers) shall supply, upon request, documents on medicine quality standards already approved by the Ministry of Health to medicine quality inspection agencies in localities where these medicines are circulated.

Contents of quality inspection of medicines by medicine traders

Depending on the scope of their operations, medicine traders shall conduct medicine quality inspection by themselves according to the contents specified in Article 25 of this Circular and their internal regulations in order to assure the quality of manufactured and traded medicines.

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