Licenses library · 685
Licensing Pharmacist to Establish a Medical Equipment Factory
药师开办医疗器械工厂许可
ໃບທະບຽນວິຊາຊີບເພສັດຊະກຳເພື່ອສ້າງຕັ້ງໂຮງງານຜະລິດອຸປະກອນການແພດ
Individuals or Organizations that intend to manufacture medical equipment shall obtain the approval and technical permission of the Ministry of Health first. Apply at Food and Drugs Department.
Who needs this
Individuals or Organizations that intend to manufacture medical equipment shall obtain the approval and technical permission of the Ministry of Health first.
Requirements
- Have a pharmacist with at least five years of experience
- Never be convicted on drugs or narcotics or medical products
- Have pharmaceutical and business ethics
- Have competent personnel
- Have good health, no mental illness or infectious disease
- Have measures to protect the safety and the environment
- Have a suitable setting and necessary facilities, a standardized warehouse, and transporting vehicles. The factory also needs to have a production room, a laboratory with complete sets of equipment.
Documents — first application
| Document | Note |
|---|---|
| Application Form | 1 copy |
| Curriculum Vitae | with photo (taken within 1 year), 1 copy |
| Education Certificate | 1 copy |
| Retirement Card or Resignation Letter | or Resignation Certificate from Public Servant or Appointment Letter of the organization (if it is a state-enterprise), 1 copy |
| Certificate of Pharmacist Practices | 1 copy |
| Photo (3x4) | taken within 1 year, 1 copy |
| Location Map of the Factory | 1 copy |
| Site Plans of the Factory | 1 copy |
| Certificate of Ownership of the House | or Lease Agreement, 1 copy |
| Court Clearence | 1 copy |
| Certificate of Nationality | for an alien. - for a foreigner, it is required to have the certificates and permits in accordance with the regulations of Lao PDR |
| Copy of Enterprise Registration Certificate | 1 copy |
| Feasibility Study of Medical and Medical Devices Business | indicate the product's information, materials, origins, and other relevant technical information, 1 copy |
| Certification of Health | 1 copy |
| Address Certification | with photo (taken within 3 months), 1 copy |
| Report for the location inspection | issued by the FDD authorities, 1 copy |
Documents — renewal
| Document | Note |
|---|---|
| Application form for renewal | This application is required to receive official comments from the District Office of Health and Provincial Department of Health before sending to the Food and Drug Department, Ministry of Health for its consideration and approval. |
| Address Certification | 1 copy |
| Performance report | and the plan for next year |
| Licensing Pharmacist | original |
| Report for the location inspection | issued by the FDD authorities, with 6 copies of evidence on importing materials and packaging tools |
Legal framework
- Law on Drugs and Medical Products (Amended)
- Provision on the Manufacture of Medicine and Medical Products
- Presidential Ordinance on Fees and Service Fees
How to submit
- Means of presentation
- At the Authority Offices
- Address of authority
- Food and Drugs Department, Ministry of Public Health
- Processing time
- 45 The application's consideration period is within 45 days
Validity and renewal
- Has an expiry date
- YES
- Validity
- 36 months
- Renewal process
- Licensing Pharmacist is valid for 3 years. 3 months before the date of expiry, the business must apply for a renewal. Food and Drug Department is in charge of the license approval after the application got approved through the relevant authorities at the district, provincial-capital levels. The conditions for license renewal are related to Section III, Section IV of the Instructions on Drugs and Medical Products Manufacturing No. 937/MOH, 15.05.2004, and other relevant regulations. Conditions for non-renewal are stipulated in Article 6.3 (Instructions on the Drugs and Medical Products Manufacturing No. 937/MOH, 12.05.2004). Temporary suspension or termination of the business operation is subjected to: -Death of the pharmacist. -In case of warning and have been fined more than 3 times - In case of misconduct or violation of the Laws - Has been filed a lawsuit by the affected people and the victims or prosecuted by the court
Additional comment
Article 4. Conditions on the settings of Drug and Medical products factory (Instructions on Drug and Medical Product Manufacturing 937/MoH 12/05/2004)