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ISO 11615:2017 pdf free

ISO 11615:2017 pdf free.Health informatics一Identification of medicinal products
pharmaceutical product or combination of pharmaceutical products that may be administered to human beings (or animals) for treating or preventing disease, with the aim/ purpose of making a medical diagnosis or to restore, correct or modify physiological functions
Note 1 to entry: A Medicinal Product may contain in the packaging one or more manufactured items (3.1.37) and one or more pharmaceutical products. In certain regions (3.1.73), a Medicinal Product may also be defined as any substance (3.1.80) or combination of substances which may be used to make a medical diagnosis.
Note 2 to entry: The provisions in this document apply to 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 authorised by a Medicines Regulatory Agency (3.1.56). 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), ii) Medicinal Products intended for research and development trials (see 11.2) and to iv) intermediate products intended for subsequent processing by an authorised manufacturer (3.1.38).[SOURCE: ENV 13607 and ENV 12610]
institutional body that, according to the legal system under which it has been established, is responsible for the granting of marketing authorisations (3.1.40), clinical trial authorisations (3.1.12) and manufacturing authorisations (3.1.39) for Medicinal Products (3.1.50)
Note 1 to entry: In certain regions (3.1.73), the role of the institutional body, which according to the legal system grants the marketing authorisation of Medicinal Products, may be complemented by an additional institutional body responsible for the evaluation and supervision of Medicinal Products. For example, in the EU, the European Commission is the institutional body that grants the marketing authorisation of Medicinal Products and the European Medicines Agency is the body responsible for the evaluation and supervision of Medicinal Products.ISO 11615 pdf download.

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