WebOnce you have an EMA account you can request access on behalf of your organisation for EMA applications such as CTIS*, SPOR, IRIS, EudraVigilance and UPD here or using the new access request process, here. For more information on how to request access and track the status of your requests, refer to the "Request user access" guide.To be able to request … Web(NCA) or the European Medicine Agency (EMA), the MAH needs to provide a copy of the PSMF within a seven-day timeframe. ii. How Can PSMFs Be Inspection-Ready? PSMF maintenance can be a complex task, especially for companies where the PV system is distributed globally, or subcontractors are used. Companies need to have a mechanism to
What is SmPC? summary of product characteristics, Pharmaceutical, EMA
WebTwinrix® Adult when provided to those from 16 to 18 years of age • refer to vaccine incident guidelines in off-label and storage sections • remove reference the protocol for ordering … WebFeb 16, 2024 · The information in a product information document has been written by the pharmaceutical company responsible for the medicine and has been approved by the TGA. It provides objective information about the quality, safety and effectiveness of the medicine, as demonstrated in the data provided to the TGA by the pharmaceutical company. telefone das casas bahia maringá
Twinrix (720/20) The Australian Immunisation Handbook
WebJan 20, 2024 · SmPC and it's sections/ contents: High-level overview of various key SPC sections and its contents Section 4.1 should define unambiguously for whom the medicine is indicated specifying any ... WebThe SmPC is the basis of information for healthcare professionals on how to use the medicinal product safely and effectively. The Package Leaflet (PL) shall be drawn up in … WebDec 8, 2024 · Recommended Dose and Schedule. Standard dosing schedule consists of 3 doses (1-mL each), given intramuscularly at 0, 1, and 6 months. Alternatively, an … telefone da sefaz bahia