Biomedicines: obtained from biological fluids or tissues of animal origin or through biotechnological procedures Blood derivatives: obtained from human plasma, subjected to industrialization and standardization processes Probiotics: preparations containing viable microorganisms in sufficient quantity to change the microbiota Vaccines: immunobiological medications that contain one or more antigenic substances capable of inducing immunity to protect against disease, reduce its severity or fight it The regulatory status of vaccines, which determines their marketing and distribution, may be one of the following established by Anvisa: Sanitary vaccine registration: definitive, for approved drugs Temporary emergency use authorization: similar to a US Emergency Use Authorization Exceptional import authorization COVAX Facility: temporarily lifts the requirement of registration or emergency use authorization for vaccines purchased by the Ministry of Health that are under the Emergency Use Listing of the World Health Organization Vaccines can only be administered in public health centers or authorized private vaccination services. Canada In Canada, regulation of therapeutic goods are governed by the Food and Drug Act and associated regulations. In addition, the Controlled Drugs and Substances Act specifies additional regulatory requirements for controlled drugs and drug precursors. In Ontario, the Drug and Pharmacies Regulation Act governs "any substance that is used in the diagnosis, treatment, mitigation or prevention of a disease in humans, animals or fowl." China The regulation of drugs in China is governed by the China Food and Drug Administration. European Union The European Union (EU) medicines regulatory system is based on a network of around 50 regulatory authorities from the 31 EEA countries (28 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and European Medicines Agency (EMA). EMA and the Member States cooperate and share expertise in the assessment of new medicines and of new safety information. They also rely on each other for exchange of information in the regulation of medicine, for example regarding the reporting of side effects of medicines, the oversight of clinical trials, and the conduct of inspections of medicines' manufacturers and compliance with good clinical practice (GCP), good manufacturing practice (GMP), good distribution practice (GDP), and good pharmacovigilance practice (GVP). EU legislation requires that each Member State operates to the same rules and requirements regarding the authorisation and monitoring of medicines. Within the EU, EudraLex maintains the collection of rules and regulations governing medicinal products in the European Union, and the European Medicines Agency acts to regulate many of these rules