Basic content of the proposed amended and supplemented Law on Pharmacy (Image from the internet)
Basic contents of the proposed amendments and supplements to the Law on Pharmacy
According to the draft Law amending the Law on Pharmacy, the scope of regulation of the draft Law remains the same as the scope of regulation of the 2016 Law on Pharmacy; only amending and supplementing a number of provisions related to the interpretation of terms, State policies in the pharmaceutical field, regulations on pharmaceutical practice, trading of drugs, pharmaceutical ingredients, registration, export, import of drugs, pharmaceutical ingredients, drug recall, information, drug advertising, clinical drug trials, drug quality management and drug price management.
Specifically, the basic contents of the Law on Pharmacy proposed to be amended and supplemented include:
1 Amendment and supplement of some terms of the Law on Pharmacy
Amend and supplement the explanation of terms in Clauses 5, 8, 9, 17, 18, 19, 26, 37, Article 2 and add Clauses 44, 45, 46, 47, 48, 49 to Article 2 of the Law on Pharmacy to clarify the terms and have a unified and specific understanding: Traditional medicine, psychotropic drugs, addictive drugs, precursor drugs, Good Practice, semi-finished products, pharmacy chains, medical oxygen, drug research and development, reference, acknowledgement, recognition.
2 Medical oxygen management
– Supplement the regulation on the term “Medical Oxygen” in Clause 46, Article 2 of the Law on Pharmacy to clearly define the difference with pharmaceutical products in general and assign the Government to specify in detail to ensure flexibility and feasibility in the implementation process.
– Amend and supplement Clauses 5 and 7, Article 6, Clause 9, Article 7 of the Law on Pharmacy regarding prohibited acts and the encouragement of technology transfer for medical oxygen production.
– Amend and supplement Article 33 on operating conditions for medical oxygen business establishments in the direction of assigning the government to regulate this content.
– Amend and supplement Article 35 regulating operating conditions for medical oxygen production and trading establishments.
– Amend Articles 55, 56 and 58 regulating the issuance and revocation of Medical Oxygen Product Declaration Forms.
– Supplement regulations on circulation conditions for medical oxygen in Article 59.
– Amend and supplement Article 61 on labeling of medical oxygen products.
– Supplement the rights and responsibilities of medical oxygen business establishments in the provisions on the rights and responsibilities of pharmaceutical business establishments.
3 On promoting the development of the pharmaceutical industry
– Amend some provisions in Articles 7 and 8 of the Law on Pharmacy to attract investment and promote domestic production of raw materials in the following direction:
+ Regulations on preferential/special preferential investment contents for the production of new drugs, original brand-name drugs, herbal drugs and traditional drugs produced from available domestic herbal sources, drugs applying high technology in production, biotechnological drugs, and specialized drugs with technology transfer for production in Vietnam;
+ Facilitate procedures for submitting applications for registration of new drugs, generic drugs, specialized drugs, high-tech drugs, and biotech drugs with technology transfer produced in Vietnam.
+ Encourage research and production, receive technology transfer and attract foreign investment in the production of pharmaceutical ingredients, production of new drugs, original branded drugs, specialized drugs, biological drugs, herbal medicines with national brands, and pharmaceutical ingredients.
– Amend and supplement Clause 7, Article 10 of the Law on Pharmacy in the direction of adding the responsibility of the Ministry of Science and Technology in taking the lead in applying science and technology to develop the pharmaceutical industry.
4. On organizing and rearranging the business system, distribution of drugs and pharmaceutical ingredients to meet the situation of socio-economic development and international integration
– Amend and supplement Clause 1, Article 44 and supplement Article 53a of the Law on Pharmacy in the direction of supplementing a number of regulations related to the drug distribution rights of FIE pharmaceutical business establishments, adjusting the drug distribution rights and drug ingredients of these enterprises to ensure compliance with reality.
– Amend and supplement Articles 6, 19, 30, 32, 33, 35, 42, 43, 44, 46, 51, supplement Article 47a of the Law on Pharmacy in the direction of supplementing a number of business types and business conditions for pharmacy chain business, drug transportation and research and development services; drug trading by e-commerce method and rights and responsibilities of establishments providing the above services.
– Amend and supplement Point a, Clause 2, Article 35 of the Law on Pharmacy, thereby adding regulations on granting Certificates of eligibility for pharmaceutical business to public service units that collect fees in pharmaceutical activities.
5 On registration and circulation of drugs and pharmaceutical ingredients
– Amend Point a, Clause 2, Article 54 of the Law on Pharmacy, accordingly, pharmaceutical ingredients for the production of drugs according to drug registration dossiers that have been registered for circulation in Vietnam do not have to be registered for circulation in order to reduce and simplify administrative procedures.
– Add Clause 6, Article 56 of the Law on Pharmacy, stating that the validity of the circulation registration certificate for drugs and pharmaceutical ingredients that have not been circulated on the market within the validity period for which the circulation registration certificate has been granted will not be extended.
– Amend and supplement Clauses 2, 3, 4, Article 55 and Clauses 1, 3, 5 and 6, Article 56 of the Law on Pharmacy: Simplify the dossier and procedures for extending, changing and supplementing the Certificate of Circulation Registration of drugs and pharmaceutical ingredients; stipulate cases of extending, changing and supplementing the Certificate of Circulation Registration without going through the Advisory Council for granting the Certificate of Circulation Registration of drugs to simplify administrative procedures; reduce the time for extending the Certificate of Circulation Registration (reduced from 03 months to 01 month for cases of extension without going through the Council). 06 months before the expiry of the Certificate of Circulation Registration, the registration facility shall submit an application for extension to the management agency. After submitting the application for extension as prescribed, the drug and pharmaceutical ingredient circulation registration certificate shall continue to be used until the Ministry of Health issues a document to stop/temporarily suspend the drug circulation registration certificate based on the assessment and consultation of the Drug and Pharmaceutical Ingredients Circulation Registration Advisory Council due to issues related to the safety, effectiveness and legality of the drug and pharmaceutical ingredient.
– Amend and supplement Clause 2, Article 56 of the Law on Pharmacy, specifically:
+ Allows replacing the Certificate of Pharmaceutical Product (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 the consequences of natural disasters and catastrophes.
+ Recognize the results of the appraisal of technical documents, clinical documents in the drug registration dossier and GMP certificate of the finished drug manufacturing facility for new drugs licensed for circulation in countries with strict drug management agencies, the European Medicines Agency (EMA) to serve the work of disease prevention and control;
+ Exemption from submitting clinical dossiers for new domestically produced drugs that meet urgent needs for national defense, security, disease prevention and control, and overcoming the consequences of natural disasters and catastrophes with the same active ingredient, dosage form, and route of administration as drugs that have been licensed for circulation by one of the management agencies on the list of strict drug management agencies when submitting applications for a Certificate of Circulation Registration.
– Amend Clause 1, Article 87 of the Law on Pharmacy in the direction of accepting the results of the mid-term assessment of phase 3 on the safety and therapeutic efficacy of drugs or the protective efficacy of vaccines based on data on the immunogenicity of vaccines; have the approval of the National Council of Ethics in Biomedical Research and the approval of the Advisory Council for the issuance of certificates of circulation of drugs and pharmaceutical ingredients to consider and decide on the issuance of a certificate of circulation of domestically produced drugs.
– Amend and supplement Point b Clause 1 Article 89 in the direction of amending the clinical trial regulations for herbal medicines with new combinations of herbal medicines that have been used as medicines in Vietnam and are indicated for diseases in the list issued by the Minister of Health into traditional medicines with new combinations of herbal medicines… and move them up to the regulations in Article 72 of the Law on Pharmacy.
6. Regarding drug and pharmaceutical ingredient recall
– Decentralize the authority to recall drugs to the Department of Health in case of mandatory recall of drugs violating level 3 quality detected in the area in Clause 1, Article 65 of the Law on Pharmacy.
– Amend and supplement the contents related to decentralization to the Department of Health to recall drugs and pharmaceutical ingredients at points a and b, clause 1, Article 63, and add clause 4a to Article 64.
7. On delegating professional initiative to the Minister of Health in promulgating and accepting the principles and standards of Good Manufacturing Practice for drugs and pharmaceutical ingredients of other countries.
Amending and supplementing Clause 37, Article 2 of the Law on Pharmacy on the concept of “Good Practice” in the direction of adjusting the content of assigning the Minister of Health to promulgate or recognize the sets of principles and standards of Good Practice of other countries to assess the compliance with the conditions of drug and pharmaceutical ingredient manufacturing establishments abroad in cases of recognition and recognition of assessment results of the management agency of the host country or assessment of records related to production conditions.
8. On drug export and import management
– Supplement point b, clause 3, Article 60 of the Law on Pharmacy on pharmaceutical ingredients permitted for import in cases where pharmaceutical ingredients are semi-finished pharmaceutical products for export.
– Add clause 5a after clause 5, Article 60 of the Law on Pharmacy in the direction that drugs without a circulation registration certificate in Vietnam used for clinical trials can be imported without having to obtain an import license, except in cases where the drugs are subject to special control.
– Add Clause 8 to Article 60 of the Law on Pharmacy in the direction of assigning the Minister of Health to consider and decide on the use of pharmaceutical ingredients that have been licensed for import for other purposes to produce domestic drugs to prevent and treat epidemics based on the request of the manufacturing facility.
9. About drug information and advertising
– Eliminate the procedure for confirming the content of information and drug advertising in Clause 3, Article 78 of the Law on Pharmacy and the procedure for confirming the content of drug advertising in Clause 3, Article 79 according to the plan to reduce and simplify administrative procedures approved by the Prime Minister in Clauses 38, 39, 40 and 41, Section I, Part II of Decision No. 1661/QD-BYT.
– Amend, supplement and abolish regulations on the responsibilities of drug information and advertising establishments to comply with the new management mechanism (post-inspection) in Clause 10, Article 6; adjust regulations in Clause 3, Article 76 of the Pharmacy Law in the direction of assigning the Government to specify the basis for developing drug information content for medical practitioners.
10. Regarding testing of drugs, pharmaceutical ingredients, and packaging in direct contact with drugs
Amend and supplement Clause 5, Article 103 of the Law on Pharmacy in the direction of assigning the Minister of Health to specify in detail:
– Drug testing, application of alternative management measures (modern management methods for drug quality control specified in GMP documents to reduce or exempt some tests in drug and drug ingredient quality control) of drug and drug ingredient manufacturing facilities; recognition/acceptance of drug and drug ingredient assessment and testing results by foreign drug management agencies;
– Exemption from testing by designated drug testing facilities and exemption from or reduction from providing documents on drug quality control processes and drug quality standards by drug manufacturing and trading establishments in cases where it is necessary to meet urgent needs regarding national defense, security, disease prevention, and overcoming the consequences of natural disasters and catastrophes.
11. On drug price management
– Amend and supplement Clause 3, Clause 5, Article 107 and Clause 5, Article 109 of the Law on Pharmacy in the following direction:
+ Assign the Government to regulate and adjust the list of drug groups that must declare drug prices and promulgate principles and technical criteria for selecting drug groups and the list of drugs that must be declared;
+ Assign the Prime Minister to decide on price declaration for drugs and vaccines used free of charge for the people to meet urgent needs for national defense, security, disease prevention and control, and overcoming the consequences of natural disasters and catastrophes according to the agreement of the manufacturing facility and supplier.
– Amend and supplement Article 109 and Article 110 of the Law on Pharmacy in the direction of adding the responsibilities of the Ministry of Health, the Ministry of Finance, and Vietnam Social Security in coordinating with the Ministry of Health to submit to the Government for promulgation and adjustment of groups of drugs that must declare prices and the principles and technical criteria for selecting lists of drug groups and lists of drugs that must be declared.
– Amend and supplement Article 112 of the Law on Pharmacy in the direction of continuing to decentralize the Provincial People’s Committee to receive, announce, review post-inspection of declared drug prices, re-declaration of drugs produced in the area and publicize prices on the Provincial Electronic Information Portal.
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