The Ministry of Health promulgates the latest Circular on registration of circulation of drugs and medicinal ingredients Posted on September 13, 2022 | 10:33 | View: 38 The Ministry of Health has just issued Circular 08/2022/TT-BYT regulating the…

Circular 08 stipulates that a series of administrative procedures in the field of registration of circulation of drugs and medicinal ingredients, application for extension of circulation registration certificates, etc. have been simplified compared to the old regulations.

Circular 08 regulates the application of information technology to the entire drug registration procedure, from application submission, appraisal to result return. Simplify administrative procedures, strengthen harmonization with regulations of countries in the region and the world, especially remove the concept of a reference management agency as recommended by the EU, pharmaceutical associations and approved by the EU. revised into the concept of the European Medicines Agency (EMA) and the Strict Drug Regulatory Authority (SRA) according to the classification of the World Health Organization (WHO).

Circular 08 also stipulates that the certificate of pharmaceutical product (CPP) has sufficient content according to the form of WHO published on the website of WHO.

At the same time, to increase access to drugs, especially new drugs, to meet special treatment needs, two CPPs are not required, but only one CPP from the SRA country. This circular also does not stipulate 100% authentication of dossiers, but only authentication when in doubt before licensing, avoiding prolonging the time of granting circulation registration certificates for drugs and medicinal ingredients.

Circular 08 omits the form of authorization letter, does not require authentication of the author’s signature because the Ministry of Health determines that the authorization letter is an internal document of the enterprise. In addition, in order to avoid issuing too many circulation registration certificates for the same drug, causing difficulties for management, the regulation only issues two circulation registration certificates for drugs of the same manufacturer with the same active ingredient. or medicinal ingredients; dosage forms; route of use; content or concentration in one dose unit, a marketing authorization with a trade name and an international generic name marketing authorization. However, this does not apply to drugs that are processed and manufactured only for export.

Along with that, Circular 08 stipulates that drug registration establishments are only allowed to amend and supplement dossiers no more than three times for applications for issuance, extension, change or supplementation of circulation registration certificates. drugs and medicinal ingredients. In the past, the quality of preparation of registration documents was not good, so the application had to be supplemented many times, prolonging the appraisal time. This new regulation aims to increase the responsibility of drug registration establishments in the preparation of dossiers, and at the same time reduce pressure on management agencies.

Another new feature is that Circular 08 allows submission of rolling documents, not required to submit test sheets, quality standards and testing methods certified by the National Institute for Accreditation of Vaccines and Medical Biologicals at the time. Point of application for registration of vaccines, serum containing antibodies, derivatives of human blood and plasma in order to shorten the review time. Supplementing guidelines on the announcement of drugs with proven bioequivalence, the announcement of original brand-name drugs, and reference biological products; announce the list of domestically produced drugs licensed for circulation by one of the drug management agencies of the country on the SRA list, the list of drugs with registered use of certified raw materials (pharmaceuticals) CEP to produce for bidding.

Supplementing regulations on the application of barcodes and QR codes on the outer packaging of drugs and medicinal ingredients of production facilities in order to manage, identify and trace the origin of drugs, etc. About the application documents To extend the circulation registration certificate, Circular 08 has reduced the maximum amount to meet the requirements of the Pharmacy Law for the documents specified in the application file for extension. On the other hand, Circular 08 clearly stipulates that the establishment does not change the label and instructions for use in the application for renewal. The change of labels, instructions for use, the establishment will submit according to the procedures for changes and supplements after the drug is extended the circulation registration certificate…