Modelo Guía para la Implementación de un Sistema Integrado de la Calidad en la Industria Alimentaria ISO9001-HACCP-Edición Única
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In medicinal products containing more than one manufactured item (e.g., contraceptive having different strengths and fixed dose combination as part of the same medicinal
Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in
Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in
This section provides guidance with examples on encoding medicinal product packaging information, together with the relationship between Pack Size, Package Item (container)
Package Item (Container) Type : Vial (100000073563) Quantity Operator: equal to (100000000049) Package Item (Container) Quantity : 1 Material : Glass type I (200000003204)
If certification of devices under the MDR has not been finalised before expiry of the Directive’s certificate, and where the device does not present an unacceptable risk to health
In addition to the requirements set out in Chapter VII MDR, also other MDR requirements should apply to ‘legacy devices’, provided that those requirements
The notified body that issued the AIMDD or MDD certificate may confirm in writing (after having reviewed manufacturer’s description of the (proposed) change) that the
