CPMP definition
Examples of CPMP in a sentence
In addition, at the request of Schering, ICN shall provide to Schering chemistry-pharmacy data and any other technical information which Schering may reasonably require in order to obtain any CPMP Opinion or Regulatory Approval for the Product in the Territory.
In connection with any health registration application of ICN relating to the Product pending as of the Effective Date with the CPMP or FDA or any successor to the CPMP or FDA, ICN shall, at Schering's request, provide to Schering in a prompt manner, but in no event later than December 31, 1995, responses to non-clinical questions which have been raised by the CPMP or FDA.
ICN shall advise and assist Schering, upon request, in the CPMP process and the local registration process.
The Regulatory Approval of the Product in the European Union (including, as applicable, the CPMP or the European Agency for the Evaluation of Medicinal Products) with Minimum Labelling (as defined in the License Agreement) in at least [REDACTED] of the [REDACTED], shall have occurred.
Portland also implemented HUD directives regarding use of the CPMP tool, reporting of outcome measures using HUD prescribed categories, and reporting on efforts to address chronic homelessness.
Project updates will be included as part of the electronic CPMP to be submitted to the U.S.
The Regulatory Approval of the Product in the European Union (including, as applicable, the CPMP or the European Agency for the Evaluation of Medicinal Products) with Minimum Labelling (as defined in the License Agreement) in at least [REDACTED] of the [specified European countries REDACTED], shall have occurred.
In no event will Pharmacyclics communicate directly with the Reference Member State, members of the CPMP, the Commission and/or the Competent Authority during the Decentralized Procedures relating to GADOLITE(R).
The parties agree that, should a decision be made to withdraw the Decentralized Application from one or more member states, or a positive opinion of the CPMP not be obtained, or the Commission not ratify the opinion of the CPMP so as to make the CPMP opinion into a binding Commission decision, the parties agree to consult.
INDEVUS is responsible for providing ORION with the necessary information for the PSUR as defined in the above CPMP Guidelines and as needed by ORION for the preparation of PSURs. INDEVUS shall provide this information as soon as possible and at least within 3 weeks of the data lock point (the last day of that PSUR period, or “DLP”).