Licence for a pharmaceutical or medical product business, and product registration
药政/药品注册经营
ໃບອະນຸຍາດດຳເນີນທຸລະກິດ ກ່ຽວກັບ ຢາ ແລະ ຜະລິດຕະພັນການແພດ ແລະ ການຂຶ້ນທະບຽນຜະລິດຕະພັນ
Handling agency: Food and Drug Department (MOH)
Source: 卫生部食药司FDD官方站 (http://fdd.gov.la/download/contentfiles/2017-12-21_032602pm_%E0%BA%84%E0%BB%8D%E0%BA%B2%E0%BA%AE%E0%BB%89%E0%BA%AD%E0%BA%87%E0%BA%82%E0%BB%8D%E0%BA%8D%E0%BA%BB%E0%BA%81%E0%BA%8D%E0%BB%89%E0%BA%B2%E0%BA%8D%E0%BA%9A%E0%BB%8D%E0%BA%A5%E0%BA%B4%E0%BA%AA%E0%BA%B1%E0%BA%94.docx)
Where to apply
For the licence, register the enterprise with the industry and commerce sector first, then apply to the public health sector on the ministry form (Art. 83); administration runs at three levels (Arts. 99, 101 and 102). Product registration goes through the online system to the Food and Drug Department (Agreement, Arts. 10 and 34), and cosmetics import, export and transit go to the capital or provincial health department (Arts. 49 and 50).
Procedure
- First register the enterprise with the Industry and Commerce sector and obtain the enterprise registration certificate (Art. 83)
- Apply to the public-health sector on the ministry’s form; the ministry decides within fifteen days of receiving a complete and correct application with its attachments, and if it refuses it must give written reasons inside the same period (Art. 85)
- The business licence only settles whether the company may trade; every single medicine and medical product must be registered separately with the ministry (Art. 53) through the online registration system (Registration Agreement, Arts. 10, 34)
- After the technical study the Food and Drug Department issues the registration certificate, with the registration number set by the online system within 10 working days; the certificate is generated in the system and can be printed by the holder (Agreement, Arts. 14, 15)
- The registration certificate runs 5 years from the date of signature, and renewal must be filed through the online system within 90 working days before it expires (Agreement, Art. 16)
Statutory time limit
Business licence: fifteen days from a complete and correct filing (Art. 85) — the clock starts on the day the file is complete and correct, not the day you first hand it in. Product registration: the number is set by the online system within 10 working days (Agreement, Art. 14). Renewal runs 5, 15, 30 or 45 working days depending on risk class and whether anything changed (Agreement, Art. 17). There is no single validity period: Art. 85 only says each business type has its own, renewable under the relevant rules — read the expiry printed on your certificate.
Common questions and pitfalls
- Do not conflate the two gates: the licence is about whether your company may trade, the registration is about whether one particular medicine may be sold in Laos, and Art. 53 requires every medicine and medical product made, imported, exported or distributed to be registered on its own
- Do not follow the 2012 price list — Art. 60 of the 2021 decree No. 002/PPT expressly replaced it, though copies still circulate online and among agents
- The fifteen days run from the day the file is complete and correct (Art. 85) — the clock does not run while documents are missing, so it pays to get the attachments right the first time
- Do not miss the 90-working-day line: the registration runs five years and renewal must be filed online within 90 working days before expiry (Agreement, Art. 16) — that is about four and a half months, not three
- Import and export has two layers (Art. 49): the company itself registers or declares with the ministry, and every consignment of medicines and medical products, raw materials included, needs its own permit and inspection at the international checkpoint; cosmetics go to the capital or provincial health department instead
- After revocation the health sector must notify the Industry and Commerce sector and other concerned bodies within five working days (Art. 87) — so it does not stop at losing one certificate, it reaches your enterprise registration
15 items to fill in