Tiêu đề CHECKLIST TT08 (Administrative documents).pdf ✅

Source: PTT- NĐS RA- SHARE DOCUMENTS AND PROFESSIONAL EXPERIENCE https://www.facebook.com/groups/256493465799855 CHECKLIST ACTD (As per Circular 08/2022/TT-BYT date 05/09/2022) No . Documents Requirements Dossier suggest to issue the Marketing Authority (MA) of new drugs, vaccine, biological Dossier suggest to issue the Marketing Authority (MA) of generic drugs, herbal drugs, drug material Dossier suggest to extend the Marketing Authority (MA) of pharmaceutical- chemical drugs, herbal drugs, drug material Dossier suggest to change, add the Marketing Authority (MA) of pharmaceutical- chemical drugs, vaccine, biological, herbal drugs, drug material Dossier suggest to issue the Marketing Authority (MA) following as the procedure of the abridged assessment ADMINISTRATIVE DOCUMENTS 1 Cover page Form 3/TT Except to submitting the online dossier x x x x x 2 Index Form 4/TT Except to submitting the online dossier x x x x x 3 Application form Form 5/TT 01 (one) original version 01 (one) copied version for vaccine; 02 (two) for remaining cases. x x x x x 4 Letter of authorization to the applicant's name (if any) Legalized (for foreign drugs). Original or notarized copy version. Contents: ­ Name and address of the MA holder or the authorizing manufacturer ­ Name and address of the authorized applicant ­ Name of drugs; concentration, contents of API; dosage form. ­ Contents of authorization. x x x In case of changing the applicant at the time of submitting the renewal dossier x
2 Source: PTT- NĐS RA- SHARE DOCUMENTS AND PROFESSIONAL EXPERIENCE https://www.facebook.com/groups/256493465799855 In case of authorizing lots of drugs, the letter is attached to the list of drugs that have enough above contents. 5 Letter of authorization for signing the registration dossier (if any) Original or copy version has the seal of the representative office (in case of the foreign applicant) or the seal of the domestic applicant. In case the authorized signer is not the header of the representative office, the letter must have the seal and signature of the header of the representative office in Vietnam. Contents: ­ I Name and address of the applicant; ­ Name and position of the authorizer and the authorized person ­ Name of drugs; concentration, contents of API; dosage form ­ Contents of authorization; ­ The authorization letter’s valid. In case of authorizing lots of drugs, the letter is attached to the list of drugs that have enough above contents. x x x x x 6 Report on circulation of drugs and drug material Form 8/TT x 7 Copy version of the Marketing Authorization of drugs, drug material in Vietnam x
3 Source: PTT- NĐS RA- SHARE DOCUMENTS AND PROFESSIONAL EXPERIENCE https://www.facebook.com/groups/256493465799855 8 Report on assessment of the safety and effectiveness; ­ Form 2/TT ­ As per item2 Article 2 this Circular x 9 Label of drugs, drug material, and leaflet of drugs that are planned for marketing. ­ 02 (two) sets ­ Online submission: 01 set. ­ Intending leaflet for marketing: Vietnamese language ­ Label: Language is not English that request to submit the version that is translated to Vietnamese with the seal of the representative office or the applicant or the manufacturer. ­ Having the seal of the representative office or the applicant or the manufacturer. ­ Designing on the suit paper size but is not smaller than A4 size. ­ Having to print Bar code or QR code (Quick response) or DataMatrix Code (DMC) as per the route regulated at point 1 item 2 article 48 this Circular. x x x 10 Label of drug, drug material and leaflet of drug that is marketing really in the manufacturing country or in the issuing CPP country for the foreign dossier; ­ 02 (two) sets ­ Online submission: 01 set. ­ Leaflet: Vietnamese language ­ Label: Language is not English that request to submit the version that is translated to Vietnamese with the seal of the representative office or the applicant or the manufacturer. ­ Having the seal of the representative office or the applicant or the x x x