Overseas production of repackaged drugs shall meet the following requirements:
1, the health administrative department is in charge of the supervision and administration of imported drugs nationwide. The health departments of all provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the supervision and administration of overseas production of sub-packaged drugs within their respective jurisdictions;
2. Packaged drugs produced overseas must be inspected by the port drug inspection office according to law;
3. Packaged drugs produced overseas must be safe and effective varieties for domestic medical needs.
Second, detailed analysis
Sub-packaging of drugs produced overseas refers to drugs that have completed the production process of final preparations abroad, changed from large packaging specifications to small packaging specifications in China, or packaged by means of internal packaging, placing instructions, and pasting labels. Sub-packaging and changes shall be filed in the drug testing center. Before filing, the enterprise as a legal person in China designated by the drug marketing license holder shall first report to the drug testing center for filing the packaging specifications of the new large package. If the information of drug registration certificate is changed, the corresponding information of drug packaging can only be changed after the change.
3. What information do I need to apply for the registration certificate for overseas production of sub-packaged drugs?
1. A certificate issued by the health department of the drug-producing country approving the production, sale and export of the drug and conforming to good manufacturing practice, with a Chinese translation attached;
2. Patent documents;
3, drug instructions and Chinese translation;
4. Drug prescription, including the names and dosage of active ingredients and excipients, drug production methods, drug quality standards and inspection methods, with Chinese translation, pharmacological and toxicological experiment abstracts and literature.