These regulations are promulgated pursuant to the authority of Article 104-3 of the Pharmaceutical Affairs Act.
Competent health authorities at various levels (referred to as “delegate or commission authority” hereunder), for the purpose of research, investigation, quality control or other purpose of administration, may delegate or commission to an authorized agency (institution) to enforce medicaments spot-check and test.
The delegated authorized agency under the preceding paragraph at central level referred to Food and Drug Administration, Ministry of Health and Welfare; at local level shall be delegated by the municipal or county (city) competent health authority.
The rights and obligations shall be defined by the delegate authority.
The commissioned authorized agency (institution) for enforcement of medicaments spot-check (referred to as “ commissioned spot-check agency ” hereunder) shall be government authority (institution) or approved juridical persons established in accordance with the laws, and qualified with the following conditions:
1. Possessed with related facilities, equipments and place for specimen storage.
2. Established operation procedure and quality assurance plan to the commissioned business.
3. Personnel who have medicaments related background with spot-check working experience and personnel who have studied courses of Criminal Code, Civil Code, Code of Criminal Procedure, Code of Civil Procedure and Administrative Law and completed with at least 15 credits in domestic university. All of the courses shall be received more than 0 points of the score and credit certificate shall be offered.
The commissioned authorized agency (institution) for enforcement of medicaments test (referred to as “ commissioned test agency ” hereunder), shall be government authority (institution), school or approved juridical persons established in accordance with the laws, and qualified with the following conditions:
1. Possessed with test abilities of test items, related facilities, equipments and place.
2. Established test operation process and quality assurance plan.
The commission authority shall stipulate a commission contract to the commissioned spot-check agency or commissioned test agency. The contract content shall include the following:
1. Commission items.
2. Commission schedule.
3. Supervision, audit rights and audit mechanisms of commission authority.
4. Personal information and trade secret which commissioned spot-check agency and commissioned test agency obtained from processing the commissioned items shall fulfill the obligation of confidentiality.
5. The requirement for contract rescission and termination.
6. The obligation of commissioned spot-check agency and commissioned test agency after contract rescission and termination.
7. Mechanism to deal with contract disputes
8. Other items of rights and obligations.
When the commissioned spot-check agency enforces spot-check of medicaments, the verifying documents and identification documents of the personnel to support the commissioned enforcement shall be displayed to the spot-checked unit. The reason for spot-check shall be informed and on-site spot-check shall be made as a record, signed or stamped by the spot-check unit.
The commissioned spot-check agency shall pack the specimen properly, strip sealed the specimen with indication information, stored the specimen properly according to the specification, and sent the specimen to the commission authority or a designated place along with the related records.
The spot-checking records under the preceding Article shall include the following items; photographs or video records shall be taken when necessary:
1. Name, address and telephone number of the commissioned spot-check agency and the signature or stamp of the spot-check enforcement personnel.
2. Name, address and number of the commission spot-check sheet of the commission authority.
3. Spot-check item, quantity, location and date.
4. Brand, model number, serial number or batch number, manufacturer, license number, manufacturing date, and effective period or expiry date or other related information of the spot-check specimen.
5. Name of the spot-checked unit, commercial and industrial registration information, pharmaceutical firm registration information, responsible person identification information and signature or stamp of the on-site checking representative.
6. Certificate of purchase, proof of purchase, and other related declaration forms of the specimen.
The commissioned test agency shall provide a receipt and obligated to secure and store the specimen when receiving medicaments specimen for commission testing.
The commissioned test agency shall provide a test analysis report after the test is completed; test result may be sent prior through electronic transmission according to the request of commission authority if necessary.
The test report under the preceding Article shall indicate the following requirements:
1. Name, address and telephone number of the commissioned test agency.
2. Name, address and number of the commission test sheet of the commission authority.
3. Exterior appearance or physical characteristics description of the medicaments specimen and photograph, name or code of the specimen, date of receiving, enforcement date of test, name of test equipment, test method, the basis of test method, test method and assigned related items of the contract.
4. Brand, model number, serial number or batch number, manufacturer, license number, manufacturing date, effective period or other related information of the medicaments specimen.
5. Date of the analysis report and signature or stamp of the analysis report signatory or responsible person.
Commissioned spot-check agency shall not consign the commission items to the third party.
Commissioned test agency may consign the commission items to the third party after approval of the commission authority; those who stipulate contracts according to the Government Procurement Act shall follow the rules of subcontracting
Commissioned spot-check agency and commissioned test agency shall fulfill the obligation of confidentiality and are prohibited to disclose any information to public related to the commissioned items and test results.
These regulations shall be effective as of the date of promulgation.