Health Regulatory Authority definition

Health Regulatory Authority means the FDA.

Health Regulatory Authority means the statutory or Governmental Authorities authorized under applicable laws to protect and promote public and animal health through regulation and supervision of therapeutic drug candidates intended for use in humans, including, without limitation, institutional review boards, the FDA, Health Canada, the European Medicines Agency and the U.K. Medicines and Healthcare Products Regulatory Authority;

Health Regulatory Authority means any Governmental Authority administering, overseeing, or regulating any certificates of need and other licensure and regulatory approvals required for the operation of the Facility (including any approvals required to obtain reimbursement under Medicare, Medicaid and CHAMPUS, and other Department of Veterans Affairs benefits, as applicable.)

Examples of Health Regulatory Authority in a sentence

• Exhale shall inform and consult with Schering prior to each regulatory submission to the Health Regulatory Authority, provided however, that prior to and following Regulatory Approval or Orphan Drug Approval, Exhale shall be solely responsible for * CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION interactions with Health Regulatory Authority.

• Borrowers shall correct any deficiency on any report delivered pursuant to this Section 4.6 or otherwise received by Borrowers within the date required by the Health Regulatory Authority or other such government agency.

• MILESTONES PAYMENT (US$) Upon first acceptance for filing of the Product NDA in the Field by the Health Regulatory Authority 7,000,000 [***] [***] [***] [***] [***] [***] Exhale shall notify Schering promptly in writing of the occurrence of any of the above milestones.

• Any subcontracting which requires notification of the Health Regulatory Authority shall be subject to CoTherix’ consent; such consent not to be withheld unreasonably.

• MILESTONES PAYMENT (US$) Upon first acceptance for filing of the Product NDA in the Field by the Health Regulatory Authority 7,000,000 Upon Regulatory Approval of the Product in the Field by the Health Regulatory Authority 9,000,000 When annual Net Sales of the Product first exceed US$ 25 million 4,000,000 When annual Net Sales of the Product first exceed US$ 100 million 10,000,000 Exhale shall notify Schering promptly in writing of the occurrence of any of the above milestones.

• Schering agrees that any changes in the manufacture of the Product affecting the Marketing Authorization must be previously authorized in writing by NexMed within thirty days (30) from receipt hereof, even if imposed by the local Health Regulatory Authority.

• Schering shall be entitled to appoint an Affiliate or any Third Party as subcontractor for the full or partial Manufacturing and Packing of Clinical Development Product and Commercial Product without CoTherix’ consent, only in those instances where CoTherix would not be required to notify the Health Regulatory Authority of the respective subcontracting.

• BMS hereby covenants that [THIS PORTION HAS BEEN REDACTED] it will not take any action that seeks to block or delay (or has the effect of blocking or delaying) approval by the Canadian Health Regulatory Authority of a Canadian equivalent of a Paclitaxel ANDA or marketing of paclitaxel in Canada pursuant to a Canadian equivalent of a Paclitaxel ANDA solely for the treatment of second line ovarian cancer or metastatic breast cancer.

• The Parties will assist each other in investigating any such situation and all regulatory contacts that are made and all activities concerning seizure, recall, withdrawal or field correction will be jointly coordinated by Schering and CoTherix, with CoTherix serving as the primary point of contact for communications involving the Health Regulatory Authority.

• For the avoidance of doubt, any official advice received from a relevant Health Regulatory Authority regarding the requirements of GMP will be conclusive, unless Praecis can reasonably demonstrate that such advice is erroneous, and, unless Praecis so demonstrates, Praecis will implement any such requirements.

More Definitions of Health Regulatory Authority

Health Regulatory Authority means EMEA, the national competent authorities of the EU member states, FDA and other government entity that has jurisdiction to grant Regulatory Approvals including, but not limited to, Marketing Authorizations..

Health Regulatory Authority means any provincial, state, federal or foreign Governmental Entity that has jurisdiction over or responsibility for (i) the safety, efficacy, approval, possession, development, testing, labeling, packaging, manufacturing, fabrication, storage, marketing, promotion, sale, commercialization, shipment, import, export, sale or distribution of any health products, including biological products, blood products, controlled or scheduled substances, drugs and pharmaceuticals, medical devices, radiopharmaceuticals, and vaccines, (ii) the safety or regulation of drug establishments or health, laboratory, specimen-collection or patient-care facilities, (iii) the activities or conduct of health or healthcare professionals or personnel, (iv) payment or reimbursement for any health or healthcare services, including diagnostic tests and specimen collections, (v) any other regulated health or healthcare activities of the Acquired Entities or (vi) quality control, standards assessment or accreditation of any of the foregoing. For greater certainty, “Health Regulatory Authority” includes Health Canada, the Canadian Office of Controlled Substances, the Public Health Agency of Canada, the Canadian Food

Health Regulatory Authority means the Governmental Bodies authorized under applicable Laws to protect and promote public through the regulation and supervision of medical products, including, without limitation, Health Canada, the United States Food and Drug Administration, the European Medicines Agency and similar regulatory agencies having jurisdiction over the Corporation or its activities;

Health Regulatory Authority means as Authority constituted by Government under section 20 for the purposes mentioned in the said section;

Health Regulatory Authority means Health Canada;