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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 computerized system applies to records in electronic form that are used to create, modify, maintain, archive, retrieve, or transmit clinical data required to be maintained, or submitted to the FDA. Because the source
data2 are necessary for the reconstruction and evaluation of the study to determine the safety of food and color additives and safety and effectiveness of new human and animal drugs, and medical devices, this guidance is intended to assist in ensuring confidence in the reliability, quality, and integrity of electronic source data and source documentation (i.e., electronic records).

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This guidance provides recommendations on the following:

  • How to decide which adverse reactions or other potential safety hazards are significant enough to warrant inclusion in the warnings and precautions section; what information to include when describing those adverse reactions; and how to organize the warnings and precautions section.
  • What situations warrant a contraindication; what information to provide in those  situations when the use of the product is contraindicated; and how to organize the contraindications section
  • When to include a boxed warning; and what information to include in the boxed warning section

 

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This guideline is applicable to the manufacture of the finished dosage form of chemical and herbal medicinal products for human use intended for marketing authorisation. It also applies to variations for authorised products in cases where changes to the manufacturing process affecting the MA are proposed.

The principles described are in general also applicable to biological medicinal products. Where relevant, the principles of this guideline may also be applied to radiopharmaceuticals and to chemical investigational medicinal products.

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Import of tissues or cells for human application is defined as receipt of tissues/cells from countries outside the EEA (i.e. third countries). This is a prescribed activity which tissue establishments must be authorised to perform.

Please note that the import of tissues and cells for human application from third countries (routine or non-routine) can only be performed by tissue establishments authorised for the purposes of this activity by the HPRA.

Application form for Notification of Non-Routine Import-Export of Tissues and Cells for Human Application has been attached.

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