BAID
BAID – Medicinal Product Batch Identifier used in IDMP to identify medicinal products
BAID (1) = Medicinal Product Batch Identifier (outer packaging)
BAID (2) = Medicinal Product Batch Identifier (immediate packaging)
BAID – Medicinal Product Batch Identifier used in IDMP to identify medicinal products
BAID (1) = Medicinal Product Batch Identifier (outer packaging)
BAID (2) = Medicinal Product Batch Identifier (immediate packaging)
GINAS and ISO 11238 specifically addresses the identification and exchange of regulated information on substances. GINAS supports all substance types described in the 11238 standard and provide multiple language capability for the naming of substances and controlled terminology used within the IDMP.
The Global Ingredient Archival System (GINAS) represents a major opportunity for regulators worldwide to tackle the challenges of sharing ingredient information. This tool makes it possible to create a global standard for defining substances and a common identifier to identify ingredients in medicinal products. This will enable the global health community to share and use information to significantly improve health care delivery, the proper use of medications, and the management of risks involved in their use.
The project’s main goal is to provide a consistent definition of substances globally, and a common identifier for all the substances used in marketed medicinal products as well as active substances under clinical investigation. It is envisioned that a consortium of regulators from different national and international agencies would operate and maintain the platform in a secure and trusted manner. This centralized database will result in higher quality data while still respecting confidentiality requirements.
The software tools used in this project are developed, maintained, and distributed to project members and other interested parties by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH). As well as containing definitional information and identifiers, the system is able to store a wide variety of structured information on the identification, analysis, use, manufacture, pharmacology, and toxicology of medical product substances.
Health Level-7 or HL7 refers to a set of international standards for transfer of clinical and administrative data between software applications used by various healthcare providers. These standards focus on the application layer, which is “layer 7” in the OSI model. The HL7 standards are produced by the Health Level Seven International, an international standards organization, and are adopted by other standards issuing bodies such as American National Standards Institute and International Organization for Standardisation.
Periodic Safety Update Report (PSUR)
The objective of the PSUR is to present a comprehensive and critical analysis of the risk-benefit balance of the product taking into account new or emerging safety information in the context of cumulative information on risk and benefits.
1 September 2015, companies should use the xml delivery file for all PSUR submissions to the EMA via the eSubmission Gateway/Web Client websites
The PSUR XML delivery file for EMA submission is introduced to harmonise the submission mechanism for all PSURs submitted to EMA and it will apply to all types of PSUR and PSUR supplementary information submissions.