Product Dossier definition
Examples of Product Dossier in a sentence
Please refer to the SmPC and Investigational Medicinal Product Dossier (IMPD) for more details about the active and placebo IMPs. Ratiopharm Spironolactone does not have any special storage conditions (Please see Appendix 1: 6.4 Special Precautions For Storage).
Concawe Product Dossier Nn. 01/54.· * Data compared to the previous version altered.
Despite any award or other provision to the contrary, absence on maternity leave does not break the continuity of service of an employee but should not be taken into account in calculating the period of service for any purpose of any relevant award or agreement.
Please refer to the Summary of Product Characteristics and Investigational Medicinal Product Dossier (IMPD) for more details about the active and placebo IMPs.
Further information on REALIST ORBCEL-C and Plasma-Lyte 148 (placebo control) can be obtained from the Investigational Medicinal Product Dossier (IMPD).
The Legal Manufacturer or Reseller must supply the testing laboratory with a full duplicate set of the Product Dossier already supplied to WHO in accordance with the requirements of specification clause 7.
WHO Guidance on Variations To A Prequalified Product Dossier, 20075.
Interim results for the three and six months ended June 30, 2016 are not necessarily indicative of results that may be expected for the year ending December 31, 2016.
Such costs are included in intangible assets as New Product Dossier and Filing Costs and are being amortized ona straight-line basis over the 8-year estimated useful life of the product.In November 2019, the Company entered into a License and Exclusive Supply Agreement with AFT Pharmaceuticals Ltd (“AFT”) to acquire a license to market, sell and distribute a portfolio of pain management products in Canada.The Company launched the Combogesic® product in Canada in December 2020.
Such costs are included in intangible assets as New Product Dossier and Filing Costs and are being amortized ona straight-line basis over the 8-year estimated useful life of the product.