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DPRK’s Legal Requirements for Production of Medicines

The DPRK sees that state planning organ, central guidance organs in charge of chemical industry and public health, local power organs and relevant organs work out plans of producing medicines on the basis of accurate calculation of the needs for medicines, and implement them exactly.
Medicines are modern ones suited to the DPRK Pharmacopoeia(Korean Pharmacopoeia) and the national standard of medicine, traditional Korean ones and their manufacturing and the ones imported from abroad.
Medicines are produced only by organs, enterprises and groups which are permitted to produce medicines, and the permission is given by central guidance organ in charge of public health or the Cabinet according to kinds of medicines.
Preventive and curative organs create capacities so as to produce medicines to be used in their organs and make their technicians display high sense of responsibility.
The DPRK sees that central guidance organs in charge of chemical industry and public health, local power organs and relevant organs distribute the medicine-producing organs, enterprises and groups in a rational way and create their capacities of producing medicines in keeping with needs of the public health sector, and at the same time make the technical personnel fulfill their responsibility and role in producing medicines.
Medicines are produced personally by the one with relevant technical qualifications of being pharmaceutical expert, Koryo pharmacist, synthetic pharmaceutical engineer, biomedicinal engineer, antibiotic engineer, Koryo medicine engineer and Koryo medicine pharmaceutist or under his or her technical guidance.
Standards, technical regulations and standard operation instructions are observed in producing and packing medicines.
The DPRK has built many modern pharmaceutical factories including Taedonggang Syringe Factory which produce medicines professionally. As a result, the DPRK is now making weighty contributions to the improvement of the people’s health.