Vietnam: What is a Certificate of Pharmaceutical Product (CPP)? In what cases is the CPP required to verify its authenticity before issuing a marketing authorization?
- What is a Certificate of Pharmaceutical Product (CPP) in Vietnam?
- In what cases is the CPP required to verify its authenticity before issuing a certificate of marketing authorization in Vietnam?
- What are the criteria for a CPP in the application for marketing authorization of drugs and medicinal materials in Vietnam?
What is a Certificate of Pharmaceutical Product (CPP) in Vietnam?
Pursuant to the provisions of Clause 8, Article 2 of Circular 08/2022/TT-BYT on registration of marketing authorization of drugs and medicinal materials as follows:
Certificate of Pharmaceutical Products (CPP) is a certificate issued under the System of Quality Certification of Pharmaceutical Products in International Trade of the World Health Organization (WHO).
Thus, a CPP is a pharmaceutical product certificate. The CPP is issued according to the World Health Organization (WHO) System of Quality Certification of Pharmaceutical Products in International Trade.
In what cases is the CPP required to verify its authenticity before issuing a certificate of marketing authorization in Vietnam?
According to the provisions of Clause 1, Article 12 of Circular 08/2022/TT-BYT, the regulations on verifying the authenticity of legal documents, the CPP must verify the authenticity before issuing marketing authorizations of drugs in the following cases:
- CPP shows signs of erasing or correcting information;
- CPP in drug registration applications of manufacturing facilities, registering establishments administratively sanctioned by Vietnamese authorities for providing information related to technical applications are not based on the research or actual production of the manufacturing facility on the list published on the website of the Drug Administration of Vietnam. The time limit for application of CPP authentication is 2 years from the end of the time limit for suspending receipt of applications for issuance or renewal of marketing authorization;
- CPP of the drug manufactured by the facilities having marketing authorizations of drugs in Vietnam for the first time, except for the case where the drug has many manufacturing facilities, in which at least one facility has a certificate of free sale in Viet Nam;
- CPP is an electronic version provided by self-searching from an English website or database of an issuing agency or a competent authority of other countries, but it is not possible to search online using the link of the website provided by the facility in the application;
- The CPP does not have the certification stamp of the competent authority of the issuing country;
- Cases required by the Council to perform authentication.
Thus, the CPP in the above cases must verify its authenticity before issuing marketing authorizations .
What are the criteria for a CPP in the application for marketing authorization of drugs and medicinal materials in Vietnam?
Pursuant to Clause 4, Article 22 of Circular 08/2022/TT-BYT as follows:
- The CPP must be issued by a competent authority and contain sufficient contents according to the WHO form published on the WHO website (https://www.who.int).
- CPP must have signature, signer's name, date of issue and seal of CPP issuing authority. In case the CPP does not have a seal certified by a competent authority of the issuing country, the registrant shall provide documents proving that the CPP does not require a seal according to the regulations in the host country.
- For generic drugs, herbal drugs, probiotics, drugs that renew, change or supplement marketing authorizations:
+ There must be 01 CPP issued by a competent authority of the producing country certifying that the drug is licensed and actually circulated in that country.
+ In case the CPP confirms that the drug is not licensed for circulation in the country of manufacture or licensed but not actually circulated in the country of manufacture, the registrant must provide an additional legal document issued by the regulatory agency. The regulations prescribed in Clause 9 Article 2 of this Circular certify that the drug is licensed and actually circulated in that country with the following minimum contents: name of the drug, active ingredient, concentration or content of active ingredient, dosage form, name and address of the manufacturing facility.
- For new pharmaceutical drugs, vaccines and imported biological products, except for probiotics:
+ There must be 01 CPP issued by a competent authority of the manufacturing country for certifying that the drug is licensed and actually circulated in that country.
+ In case the competent authority of the manufacturing country issues a CPP on the list specified in Clause 9 Article 2 of this Circular, only 01 CPP must be submitted.
+ In case the competent authority of the manufacturing country issues a CPP that is not on the list specified in Clause 9 Article 2 of this Circular, there must be additional legal documents issued by the management authority specified in Clause 9 Article 2 of this Circular for certifying that the drug is licensed and actually circulated in that country with the following minimum details: name of the drug, active ingredient, concentration or content of active ingredient, dosage form, name and address of the manufacturer or documents proving that the drug is on the WHO list of pre-appraisal drugs.
- For drugs proposed to be classified as generic drugs or reference biological products:
+ There must be 01 CPP issued by a competent authority of the manufacturing country for certifying that the drug is licensed and actually circulated in that country.
+ In case the competent authority of the manufacturing country issues a CPP on the list specified in Clause 9 Article 2 of this Circular, only 01 CPP must be submitted.
+ In case the competent authority of the manufacturing country issues a CPP that is not on the list specified in Clause 9 Article 2 of this Circular, there must be additional legal documents issued by the management authority specified in Clause 9 Article 2 of this Circular for certifying that the drug is licensed and actually circulated in that country with the following minimum details: name of the drug, active ingredient, concentration or content of active ingredient, dosage form, name and address of the manufacturer.
- For imported drugs, vaccines and biological products that cannot provide CPP meeting the provisions of Points c and d of this Clause, the Minister of Health shall consider and decide on the basis of the Council's advice when the drug is not licensed for marketing authorization by at least one competent authority in the world and in one of the following cases:
+ Medicines, vaccines and biological products to meet the needs for national defense and security; prevention and control of epidemics and diseases, overcoming of consequences of natural disasters and disasters, drugs in service of the state health program;
+ Vaccines used for the national expanded immunization program for which there are no other vaccines available on the market that are capable of replacing in terms of quantity, quality, safety, effectiveness or cost of using vaccines;
+ In other special cases, there is a written agreement and mutual recognition between the competent authorities on the conditions for production and circulation of drugs, vaccines and biological products.
- The information shown on the CPP must be consistent with relevant information in the drug registration application. In case the information shown on the CPP is not consistent with the administrative documents in the drug registration application, the registering facility shall provide a written explanation enclosed with proving documents.
Thus, on a case-by-case basis, the CPP in the application for marketing authorization of drugs and medicinal materials must satisfy the conditions specified above.
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