Proprietary medicinal products for human use intended to be placed on the market and to industrially manufactured medicinal products, the marketing of which has been authorized by a Medicines Regulatory Agency. However, the provisions do not apply to: i) medicinal products prepared according to prescription (e.g. prepared in a pharmacy from a prescription intended for a specific patient), ii) medicinal products prepared in accordance with an official formula (e.g. prepared in a pharmacy in accordance with the instructions in a pharmacopoeia and intended to be given direct to the patient by the pharmacy), iii) medicinal products intended for research and development trials and to iv) intermediate products intended for subsequent processing by an authorized manufacturer.
Fast Healthcare Interoperability Resources (FHIR) is a draft standard describing data formats and elements (known as “resources”) and an application programming interface (API) for exchanging electronic health records. The standard was created by the Health Level Seven International (HL7) health-care standards organization.
Its goal is to facilitate interoperation between legacy healthcare systems, to make it easy to provide healthcare information to healthcare providers and individuals on a wide variety of devices from computers to tablets to cell phones, and to allow third-party application developers to provide medical applications which can be easily integrated into existing systems.
FHIR provides an alternative to document-centric approaches by directly exposing discrete data elements as services. For example, basic elements of healthcare like patients, admissions, diagnostic reports and medications can each be retrieved and manipulated via their own resource URLs (Uniform Resource Locators). FHIR was supported at an American Medical Informatics Association meeting by many EHR (Electronic health Record) vendors which value its open and extensible nature.