ຄັງໃບອະນຸຍາດ · 731
ໃບຢັ້ງຢືນການຂຶ້ນທະບຽນຢາພື້ນເມືອງທີ່ຜະລິດພາຍໃນ
Certificate of Registration for Domestic Manufactured Traditional Medicine
国产传统药品注册证明
Applicants that are eligible to register the traditional medicine are factories, import-export companies that operate the business in traditional medicine, which are properly licensed by the health sector.
ຜູ້ທີ່ຕ້ອງການ
Applicants that are eligible to register the traditional medicine are factories, import-export companies that operate the business in traditional medicine, which are properly licensed by the health sector.
ເງື່ອນໄຂ
- 全部手续须符合卫生部规定。
ເອກະສານຄັ້ງທຳອິດ
| ເອກະສານ | ໝາຍເຫດ |
|---|---|
| ຄຳຮ້ອງຂໍອະນຸຍາດຜະລິດຢາພື້ນເມືອງພາຍໃນປະເທດ | 1. Proposal from a factory/processing lab, 1 copy 2. Enterprise registration certificate, 1 copy 3. Licensing pharmacist, 1 copy 4. Box, container, label (every size), 2 sets 5. Prescription (Lao/English), 2 sets 6. Documents about method/techniques/procedures for production and processing, 1 set 7. Supporting documents referring to the properties and the origin of the formula, 1 set |
| ຄຳຮ້ອງຂໍອະນຸຍາດຂຶ້ນທະບຽນຜະລິດຕະພັນຢາພື້ນເມືອງພາຍໃນປະເທດ | 1. Proposal from a factory/processing lab, 1 copy 2. Notification to submit Form 2 from the Food and Drugs, 1 copy 3. Box, container, label (all sizes), 2 sets 4. Prescription (Lao/English), 2 sets 5. Supporting documents referring to the properties and the origin of the formula, 1 set 6. Supporting documents of sources of raw materials (medicinal plants),1 set 7. Certificate of Analysis of Raw Materials (Medicinal Plants), 1 set 8. Documents about method/techniques/procedures for production and processing, 1 set 9. Final product analysis certificate, 1 set 10. Documents about the result of product validity study or references, 1 set 11. Samples to inspect and monitor quality (production package shall match the analysis certificate) of every size |
ເອກະສານຕໍ່ອາຍຸ
| ເອກະສານ | ໝາຍເຫດ |
|---|---|
| ຄຳຮ້ອງຂໍອະນຸຍາດຕໍ່ທະບຽນຜະລິດຕະພັນຢາພື້ນເມືອງພາຍໃນປະເທດ | 1. Proposal from a factory/processing lab, 1 copy 2. The previous certificate (Original), 1 copy 3. Box, container, label (every size), 2 sets 4. Prescription (Lao/English), 2 sets 5. Supporting documents of sources of raw materials (medicinal plants), 1 set 6. Certificate of Analysis of Raw Materials, 1 set 7. Documents about method/techniques/procedures for production and processing, 1 set 8. Final product analysis certificate (Quality certified by the Medical and Traditional Medicine Institute), 1 set |
ກົດໝາຍທີ່ກ່ຽວຂ້ອງ
- ກົດໝາຍວ່າດ້ວຍ ຢາ ແລະ ຜະລິດຕະພັນການແພດ (ສະບັບປັບປຸງ)
- ລັດຖະບັນຍັດຂອງປະທານປະເທດ ສປປ ລາວ ວ່າດ້ວຍ ຄ່າທຳນຽມ ແລະ ຄ່າບໍລິການ
ການຍື່ນເອກະສານ
- ວິທີຍື່ນ
- ຢູ່ທີ່ຫ້ອງການເຈົ້າຫນ້າທີ່
- ທີ່ຢູ່ໜ່ວຍງານ
- ກົມອາຫານ ແລະ ຢາ, ກະຊວງສາທາລະນະສຸກ
- ໄລຍະດຳເນີນ
- 180 Each time the applicant has to submit Form 1 first, which will take 3 months to consider. After Form 1 has been considered, the applicant then will be able to submit Form 2 which will take 6 months to consider.
ອາຍຸ ແລະ ການຕໍ່ອາຍຸ
- ມີກຳນົດອາຍຸ
- ມີ
- ຂັ້ນຕອນຕໍ່ອາຍຸ
- ໃບທະບຽນຜະລິດຕະພັນຢາພື້ນເມືອງມີອາຍຸ3ປີ; ໃກ້ຈະໝົດອາຍຸກ່ອນ 03 ເດືອນໃຫ້ທາງຜູ້ປະກອບການ ເຮັດໃບສະເໜີຂໍຕໍ່ໃບທະບຽນຄືນໃໝ່ ໂດຍປະກອບເອກະສານຕາມແບບຟອມຂອງກົມອາຫານ ແລະ ຢາ
ຄຳເຫັນເພີ່ມເຕີມ
Authorized individuals and organizations must comply with the obligations of the licensing agency to contribute to the maintenance and restoration of the ecosystem.