Pharmacovigilance Legal Requirements for Marketing Authorization Holders in Spain

2016 ◽  
Vol 2 (3) ◽  
Author(s):  
Jose Alberto Ayala Ortiz
Keyword(s):  
Marketing Authorization ◽  
Legal Requirements

scholarly journals Role of the EMA specific marketing authorization procedures for early access on the time to patient access in Bulgaria

Pharmacia ◽  
2021 ◽  
Vol 68 (2) ◽  
pp. 421-425
Author(s):  
Ivo Tsekov ◽  
Maria Dimitrova ◽  
Yulian Voynikov
Keyword(s):  
Market Access ◽  
Marketing Authorization ◽  
Patient Access ◽  
The European Union ◽  
Legal Requirements ◽  
Time To Market ◽  
The Public ◽  
Early Access ◽  
Pricing And Reimbursement

Despite the early access procedures for marketing authorization (MA) valid throughout the European Union still in the most of the Member states patient access to innovative medicines depends on cost-effectiveness, budget impact assessment and negotiations for price discount with the public payers. Retrospective analysis on the availability and time to market access of medicines authorized under the European medicines agency’s specific procedures for early access shows that despite the shortening of the time to market access after 2013, for most medicines still exceeds 365 days. This is due to the fact that requirements for pricing and reimbursement across EU is fixed to some degree and medicines with MA for early access are subject to the same legal requirements as the medicines with standard centralized marketing authorization. Some specific national legal requirements for pricing and reimbursement decisions, population of interest and manufactures intentions to enter certain markets should also be considered.

Drinking water quality and protection of resources

2010 ◽  
Vol 1 (1-2) ◽  
pp. 51-54
Author(s):  
J. Fettig
Keyword(s):  
Water Quality ◽  
Drinking Water ◽  
Water Resources ◽  
River Water ◽  
Spring Water ◽  
Public Water Supply ◽  
Legal Requirements ◽  
Reservoir Water ◽  
Water Lake ◽  
Treatment Step

Abstract The structure of public water supply in Germany and the water resources used are briefly described. An overview over the legal requirements for drinking water is given, and the sources for contaminants are outlined. Then the multiple-barrier approach is discussed with respect to the resources groundwater and spring water, lake and reservoir water, and river water. Examples for treatment schemes are given and the principle of subsurface transport of river water as a first treatment step is described.

Influence of Pumps on Salinity of a Coastal Aquifer with Legal Protection (A Zone in the North of Isla Cristina, Huelva, Spain)

1991 ◽  
Vol 24 (11) ◽  
pp. 251-260 ◽  
Author(s):  
A. González ◽  
E. Romero
Keyword(s):  
Coastal Aquifer ◽  
Salt Water ◽  
Legal Protection ◽  
Hydraulic Gradient ◽  
Water Mixture ◽  
Residual Flow ◽  
Legal Requirements ◽  
The North ◽  
North Side ◽  
Rational Distribution

In this article we show that the legal measures for protection of aquifers are not enough to lessen the pumping if the users are not associated and determined to have a rational distribution of water. The expansive agriculture on the North side of Isla Cristina (Huelva, Spain), based on citrus and strawberry growing, uses high volumes of groundwater that comes from a tertiary age detritic coastal aquifer with a significant lack of resources. This causes a decrease of the residual flow to the sea, deep pumpcones, and an inversion of the hydraulic gradient, which initiates the progressive salinization of the aquifer northwards, in the sense that the fresh-salt water mixture zone is moving. The problem is worsening because the number of uncontrolled pump-works in the areais increasing. This problem could be alleviated if a Users Community for the whole aquifer were created, itself to watch over the fulfilment of the legal requirements and to regulate the water extractions.

scholarly journals Development, piloting, and evaluation of an evidence-based informed consent form for total knee arthroplasty (EvAb-Pilot): a protocol for a mixed methods study

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Alina Weise ◽  
Julia Lühnen ◽  
Stefanie Bühn ◽  
Felicia Steffen ◽  
Sandro Zacher ◽  
...  
Keyword(s):  
Total Knee Arthroplasty ◽  
Informed Consent ◽  
Adverse Events ◽  
Knee Arthroplasty ◽  
Evidence Based ◽  
Nocebo Effect ◽  
Legal Requirements ◽  
Consent Forms ◽  
Link Type ◽  
Total Knee

Abstract Background Practitioners frequently use informed consent forms to support the physician-patient communication and the informed consent process. Informed consent for surgery often focuses on risk centered information due to high liability risks for treatment errors. This may affect patients’ anxiety of adverse events and the nocebo effect. This study focuses on the optimization of pre-surgical information on risks and complications, and at the same time reconciles these information with legal requirements. Methods The development, piloting, and evaluation of evidence-based informed consent forms for total knee arthroplasty (TKA) and related anesthesia procedures will follow the UK MRC Framework for developing and evaluating complex interventions. Conducting different sub-studies, we will (I) qualitatively explore the information acquisition and decision-making processes, (II) develop and pilot test evidence-based informed consent forms on the example of TKA and related anesthesia procedures, (III) conduct a monocentric interrupted time series (ITS) pilot study to evaluate the effects of evidence-based informed consent forms in comparison with standard consent forms, and (IV) perform a process evaluation to identify barriers and facilitators to the implementation of the intervention and to analyze mechanisms of impact. Discussion The evidence-based and understandable presentation of risks in informed consent forms aims at avoiding distorted risk depiction and strengthening the patients’ competencies to correctly assess the risks of undergoing surgery. This might reduce negative expectations and anxiety of adverse events, which in turn might reduce the nocebo effect. At the same time, the practitioners’ acceptance of evidence-based informed consent forms meeting legal requirements could be increased. Trial registration ClinicalTrials.gov, NCT04669483. Registered 15 December 2020. German Clinical Trials Registry, DRKS00022571. Registered 15 December 2020

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