In the draft Law amending and supplementing a number of articles of the Pharmacy Law, the Ministry of Health proposes to amend and supplement regulations on registration and circulation of drugs and medicinal ingredients.
The Ministry of Health proposes to amend and supplement regulations on registration and circulation of drugs and medicinal ingredients
Specifically, the Ministry of Health proposes to amend point a, clause 2, Article 54 of the Pharmacy Law, accordingly, medicinal ingredients used to produce drugs according to drug registration dossiers that already have a certificate of registration for circulation in Vietnam do not have to be processed. registration for circulation to reduce and simplify administrative procedures.
The draft also proposes to supplement Clause 6, Article 56 of the Pharmacy Law, in which, no further extension of the validity of the circulation registration certificate for drugs and medicinal ingredients that have not been circulated on the market within the validity period has been granted. circulation registration certificate.
At the same time, it is proposed to amend and supplement Clauses 2, 3, 4, Article 55 and Clauses 1, 3, 5 and 6, Article 56 of the Pharmacy Law: Simplifying dossiers and procedures for extending, changing and supplementing Registration Certificates. registration of circulation of drugs and medicinal ingredients; stipulates cases of extension, change, and supplementation of the Circulation Registration Certificate that do not have to go through the Advisory Council for granting the Circulation Registration Certificate to simplify administrative procedures; Reduce the time to renew the Circulation Registration Certificate (reduced from 03 months to 01 month in case of extension not having to go through the Council). 06 months before the expiration of the Circulation Registration Certificate, the registration facility submits a request for extension to the management agency. After submitting the application for extension according to regulations, the registration for circulation of drugs and medicinal ingredients can continue to be used until the Ministry of Health issues a document to stop/temporarily suspend the registration for circulation on the basis of appraisal. , advice of the Advisory Council on issuance of Certificate of Circulation Registration of drugs and medicinal ingredients due to the safety, effectiveness and legality of drugs and medicinal ingredients.
Resolve problems related to the Certificate of Pharmaceutical Product (CPP) provided in the marketing registration dossier
The Ministry of Health said that Point a, Clause 2, Article 56 of the Pharmacy Law stipulates that the application for a certificate of circulation for imported drugs must include the original or a certified copy of the remaining pharmaceutical product certificate. validity period. However, during the COVID-19 epidemic, most countries do not issue CPP for COVID-19 vaccines. Therefore, the regulation that registration establishments must submit CPP for imported drugs according to the current Pharmacy Law is very difficult.
In the draft, the Ministry of Health proposes to amend and supplement Clause 2, Article 56 of the Pharmacy Law, specifically:
Allows the replacement of Certificate of Pharmaceutical Products (CPP) with documents proving that the drug is licensed in cases where it meets urgent needs for national defense, security, disease prevention and control, and overcoming natural consequences. disaster, disaster.
In addition, acknowledge the results of appraisal of technical dossiers and clinical dossiers in drug registration dossiers and GMP certificates of finished drug manufacturing facilities for new drugs licensed for circulation in foreign countries. The country has a strict pharmaceutical management agency, the European Medicines Agency (EMA) to serve epidemic prevention and control.
Exemption from submitting clinical dossiers for new drugs produced domestically to meet urgent needs for national defense, security, disease prevention and control, overcoming the consequences of natural disasters and disasters with the same active ingredients and dosage form , the route of administration of the drug has been licensed for circulation by one of the management agencies on the list of strict pharmaceutical management agencies when submitting an application for a Certificate of Circulation Registration.
In addition, the draft also proposes to amend Clause 1, Article 87 of the Pharmacy Law in the direction of accepting the results of the mid-term phase 3 assessment of the safety and therapeutic effectiveness of drugs or the protective effectiveness of vaccines based on data on vaccine immunogenicity; There is approval from the National Council of Ethics in Biomedical Research and approval from the Advisory Council for issuance of circulation registration certificates for drugs and medicinal ingredients to consider and decide on the decision. Granting Certificate of Circulation Registration for domestically produced drugs.
Proposal to amend and supplement point b, Clause 1, Article 89 in the direction of amending the clinical trial regulations for herbal drugs with new combinations of medicinal materials that have been used as drugs in Vietnam and have indications for diseases on the list promulgated by the Minister of Health as traditional drugs with new combinations of medicinal herbs… and transferred to regulations in Article 72 of the Pharmacy Law./.
