SmPC definition

SmPC means the applicable Summary of Product Characteristics of a medicinal product. “Correct” means balanced representation of all the available data.T

More Definitions of SmPC

SmPC means the applicable Summary of Product Characteristics of a medicinal product.
SmPC has the meaning set forth in Article 6.5(a).
SmPC or “Summary of Product Characteristics” means the Summary of Product Characteristics as defined in Art. 11 of Directive 2001/83/EC (as amended). It is the basis of information for healthcare professionals on how to use the product safely and effectively. The package leaflet is drawn in accordance with the SmPC.
SmPC means the Summary of Product Characteristics that sets forth a description of the manner in which a Licensed Product is to be used for a specific treatment and that is approved in connection with the receipt of Regulatory Approval from the EMA.

Related to SmPC

  • MPC means Marathon Petroleum Corporation, a Delaware corporation.

  • NPS means nominal pipe size.

  • DSM means the most current edition of the Diagnostic and Statistical Manual of Mental Disorders published by the American Psychiatric Association.

  • BMS means the Company, all related companies, affiliates, subsidiaries, parents, successors, assigns and all organizations acquired by the foregoing.

  • APC means the Ambulatory Payment Classification system under 42 CFR 419.31 used by Medicare for grouping clinically and resource-similar procedures and services.

  • Novartis shall have the meaning set forth in the Preamble.

  • SMP : means Significant Market Power;

  • Elan means Elan Corp and its Affiliates.

  • DS Electric generation service that is provided at retail pursuant to the Applicable Legal Authorities under the Company’s retail electric tariffs and under any other agreements or arrangements between the Company and Customers, to any Customer that is not being served by an EGS. Default Allocation Assessment – shall have the meaning ascribed to it under the PJM Agreements. Delivery Period – The delivery period specified in an Appendix C Transaction Confirmation. Delivery Point – Means the applicable zone of the Company as designated by PJM. DS Customer(s) – Retail customers who are provided Default Service pursuant to the terms of this Agreement, the Applicable Legal Authorities and the Company’s retail tariffs.

  • Siemens means Siemens AG (Germany) and its Affiliates.

  • Merck has the meaning set forth in the preamble.

  • API means the American Petroleum Institute.

  • ONYX means Onyx Acceptance Corporation, and its successors.

  • BLS means Basic Life Support.

  • Raptor means all birds of the orders Falconiformes and Strigiformes, commonly called falcons,

  • Pfizer shall have the meaning set forth in the preamble.

  • Lilly has the meaning set forth in the Preamble.

  • BG means Bank Guarantee

  • CIMA means the Cayman Islands Monetary Authority whose contact details are available from www.cima.ky;

  • SPI means the information categories listed at Tex. Bus. & Com. Code § 521.002(a)(2).

  • PTC means the tax credit for electricity produced from certain renewable generation resources described in Section 45 of the Internal Revenue Code of 1986, as it may be amended or supplemented from time to time.

  • Spectrum means frequencies of electromagnetic spectrum used to provide fixed or mobile communications services as licensed or authorized by the FCC.

  • TMDL means the total maximum daily load limitation of a parameter, representing the estimated assimilative capacity for a water body before other designated uses are adversely affected. Mathematically, it is the sum of wasteload allocations for point sources, load allocations for non-point and natural background sources, and a margin of safety.

  • CPL means the Carolina Power & Light Company.

  • CMC means Comprehensive maintenance Contract (labour, spare and preventive maintenance)

  • SDS means safety data sheets;