The Code exists to ensure that the advertising of therapeutic goods to the public is conducted in a manner that:
• Promotes the safe and effective use of therapeutic goods by minimising misuse, overuse or underuse
• Is ethical and does not mislead or deceive the consumer or create unrealistic expectations about product performance
• Supports informed health care choices
• Is not inconsistent with relevant current public health campaigns

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FDA’s unique device identification system is designed to adequately identify devices through distribution and use.Its requirements were designed to be phased in over seven years according to established compliance dates based primarily on device classification.

The compliance dates established for class I and unclassified devices, other than implantable, life-supporting, or life-sustaining (I/LS/LS) devices are:

· September 24, 2018, for the following requirements:
o Standard date formatting (21 CFR 801.18),
o Labeling (21 CFR 801.20, 21 CFR 801.50), and
o Global Unique Device Identification Database (GUDID) data submission (21 CFR 830.300); and
· September 24, 2020, for direct mark requirements (21 CFR 801.45).

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This guideline describes the following points;

  • Annex 1 Manufacture Of Sterile Medicinal Products
  • Annex 2 Manufacture Of Biological Medicinal Substances And Products For Human Use
  • Annex 3 Manufacture Of Radiopharmaceuticals
  • Annex 4 Manufacture Of Veterinary Medicinal Products Other Than Immunologicals
  • Annex 5 Manufacture Of Immunological Veterinary Medical Products
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This Guide applies to the manufacture of APIs for medicinal products for both human and veterinary use. It applies to the manufacture of sterile APIs only up to the point immediately prior to the APIs being rendered sterile. The sterilization and aseptic processing of sterile APIs are not covered but should be performed in accordance with the principles and guidelines of GMP as laid down in national legislations and interpreted in the GMP Guide including its Annex 1.

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The holder of a Manufacturing Authorisation must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorisation or Clinical Trial Authorisation, as appropriate, and do not place patients at risk due to inadequate safety, quality or
efficacy. The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment by staff in many different departments and at all levels within the company, by the company’s suppliers, and by its distributors. To achieve this quality objective reliably there must be a comprehensively designed and correctly implemented Pharmaceutical Quality System incorporating Good Manufacturing Practice and Quality Risk Management. It should be fully documented and its effectiveness monitored. All parts of the Pharmaceutical Quality System should be adequately resourced with
competent personnel, and suitable and sufficient premises, equipment, and facilities. There are additional legal responsibilities for the holder of the Manufacturing Authorisation and for the Authorised Person(s).

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