Irish Medicines Board definition
Examples of Irish Medicines Board in a sentence
The price reductions will apply to specific dosage forms of patent expired medicines where the identical pharmaceutical form of that medicine, approved by the Irish Medicines Board or EU Commission, is available for prescription in the Schemes and all medicines supplied to the HSE, State-funded hospitals and to State agencies whose functions normally include the provision of medicines.
New medicines, including new presentations and applications, granted a marketing authorisation by the Irish Medicines Board or European Commission will become reimbursable in the Schemes, within 60 days of the date of the reimbursement application, subject to the provisions of Clauses 4.3 and 5.2. Products which are subject to pharmacoeconomic assessment under Clause 4.3 will become reimbursable in the Schemes within 40 days of a positive reimbursement decision.
CPL represents and warrants to CryoLife that it has applied for and received a Free Sale Certificate from the Irish Medicines Board for CPL Products in the Permitted Clinical Applications within.
SMI and CPL jointly and severally represent and warrant that the Free Sale Certificate from the Irish Medicines Board for CPL Products as obtained is in good standing and has never been revoked or suspended for any reason.
Section 7(2) (b) of the Act also gives the Council of the PSI the power to authorise persons to exercise the powers of entry and inspection of drugs and documents, as set out in section 24 of the Misuse of Drugs Act 1977 and to appoint persons as authorised officers for the purposes of Section 32B of the Irish Medicines Board Acts 1995 (as amended).
In the event that a product recall or defect notice is issued by the manufacturer, (original supplier) or a medical device regulatory body (such as the Irish Medicines Board) in any country in the world, in relation to the Supplies, or similar goods or services from the same manufacturer, the Supplier shall notify the Purchaser of said recall or defect within five days of the earliest recall or defect.
Upon completion of the Proposed Clinical and if the Proposed Clinical is successful, the Company shall file an amended Marketing Authorization Application (MAA) with the Irish Medicines Board (IMB), and if such MAA is approved, the Company and the Executive shall enter into an amendment to this Agreement to provide for a term of employment for the Manufacturing Plant Period (approximately three (3) years), the terms and conditions of such extended term to be agreed upon by the parties hereto.