05 Nov New Regulations For Pharmacy Business On The Establishment Of Representative Office in Vietnam
PHARMACY BUSINESS SHALL ESTABLISH A REPRESENTATIVE OFFICE IN VIETNAM BEFORE APPLICATION FOR ISSUANCE, RENEWAL, REVISION OF MARKETING AUTHORIZATION FOR DRUGS/MEDICINAL INGREDIENTS.
Based on Circular: No. 32/2018/TT-BYT, date November 12, 2018 comes into force from September 01, 2019 Replace Circular No. 44/2014/TT-BYT dated November 25, 2014 of the Minister of Health on drug registration which shall be expired from the effective date of this Circular.
PROVIDES FOR MARKETING AUTHORIZATION OF DRUGS AND MEDICINAL INGREDIENTS IN PHARMACY BUSINESS
Establish a foreign representative office in Vietnam with office license is one of 18 kinds of documents in the application for issuance, renewal, revision of marketing authorization for drugs/medicinal ingredients of a pharmacy business.
1. Documents issued by foreign regulatory authorities shall be consularly legalized in accordance with regulations of law on consular legalization, except for the cases in which consular legalization is exempted by law.
2. Licenses, certificates, confirmations, registration certificates (hereinafter referred to as “legal documents”) must be effective on the date of receipt of the application (according to the receipt note) and written in English or Vietnamese language. If the expiration date is not written on the CPP, its effective period will be 24 months from its issuance date.
3. Original copies or certified true copies of legal documents:
a) The original copy shall bear the signature, name of the signer and seal of the issuing authority;
b) The certified true copy shall be authenticated by a Vietnamese competent authority in accordance with Vietnam’s regulations of law on document authentication. The original copy may be required;
c) If an electronic document does not bear the signature, full name of the signer and seal of the issuing authority, the applicant shall send a document specifying the link to the website (English) of the issuing authority and assume responsibility for the legitimacy of such document.
a) A CPP shall bear the signature, name of the signer and seal of the issuing authority;
b) The CPP shall be issued by a national-level drug regulatory authority.
5. The application form and other administrative documents shall bear the signature and seal of the President of the Member Assembly, Board of Directors, General Director or Director or a person authorized by them (signature stamp is not acceptable).
6. An authorization letter (Form No. 8/TT) is required in the following cases:
a) A person is authorized to act as the applicant (Form No. 8A/TT enclosed herewith). An authorization letter of a foreign applicant shall bear an authenticated signature and be consularly legalized as prescribed. Each application dossier shall contain an original copy or certified true copy of the authorization letter.
b) A person is authorized to sign the application (Form No. 8B/TT); if the authorized person is not the representative office manager, the authorization letter shall bear the seal and signature of the representative office manager in Vietnam. Each application dossier shall contain an original copy or certified true copy of the authorization letter which bears the seal of the representative office (for foreign applicants) or the Vietnamese applicant.
7. A copy of the technology transfer agreement certified by the applicant, manufacturer or representative office (for foreign applicants).
8. The Certificate of Eligibility for Pharmacy Business which permits manufacture, wholesaling, export or import of drug/medicinal ingredient (for Vietnamese applicants).
9. The license to establish a representative office in Vietnam. If the name or address of the applicant on the license to establish a representative office in Vietnam is different from those on the legal documents issued by foreign authorities, proof must be provided.
10. For foreign applicants: Legal documents issued by foreign authorities permitting at least one of the following: manufacture, wholesaling, export, import of drugs/medicinal ingredients.
11. If the applicant is already included in the list of applicants for drugs/medicinal ingredients posted on the website of Drug Administration of Vietnam, the documents mentioned in items 8, 9, 10 above are not required.
12. Legal documents proving compliance with GMP submitted by a manufacturer of active ingredients, excipients, capsule shells, semi-finished herbal ingredients and herbal ingredients (for manufacture of herbal drugs) may be any of the following documents:
a) The GMP certificate;
b) The manufacturing license that certifies GMP compliance;
c) The CPP if the active ingredient is conformable with GMP;
d) The Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP).
13. Samples of the label of the drug/medicinal ingredient and the package insert of the drug that has been marketed in the country of origin or the country in which the CPP is issued which bears the seal of the representative office or applicant or manufacturer. If the package insert of the drug is marketed in the country of origin is not written in English, a Vietnamese translation bearing the seal of the representative office, applicant or manufacturer is required.
14. The label sample, the package insert of the to-be-marketed drug shall comply with regulations of the Minister of Health on labeling of drugs/medicinal ingredients and the following requirements:
a) The label sample and package insert shall bear the seal of the representative office, applicant or manufacturer;
b) The secondary package shall have a bar code, QR code or DataMatrix Code (DMC) in accordance with Point 1 Clause 1 Article 50 of this Circular.
15. If the manufacturer is already included in the list of GMP manufacturers posted on the website of Drug Administration of Vietnam, the GMP documents are not required.
16. Specifications, test method, test report and stability study documents (for both active ingredients and drug product) shall be original copies bearing the signature and seal of the manufacturer; copies shall bear the seal of the applicant (or representative office of the foreign applicant).
17. The test report, results of validation of specifications and test method in Vietnam: The test report, results of validation of specifications and test method in Vietnam (for manufacturers that have not applied GMP under the roadmap of the Ministry of Health or those required by Drug Administration of Vietnam according to Appendix III hereof) shall be certified by a state-owned drug testing laboratory that satisfies GLP requirements or a profitable drug testing laboratory that has a certificate of eligibility (original copy or certified true copy).
18. The certificate that the medicinal ingredient is permitted to be manufactured or marketed in the country of origin, on which the following information is mandatory: name of the ingredient, name and address of the manufacturer, the country of origin, signature and full name of the signer.
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