Примери за използване на Suspected serious на Английски и техните преводи на Български
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The EMA refused his request, arguing that the EU rules on access to documents did not apply to reports concerning suspected serious adverse reactions to drugs.
The Member States shall ensure that reports of suspected serious adverse reactions that have taken place on their territory are immediately made available to the marketing authorisation holder, and in any case within 15 calendar days of their notification, at the latest.
(53) Healthcare professionals and patients should be empowered to report suspected serious incidents at national level using harmonised formats.
The Member States shall ensure that reports of suspected serious adverse reactions that have taken place on their territory are immediately made available to the marketing authorisation holder, and in any case within 15 calendar days of their notification, at the latest.
In particular, promoting a safe,secure and more resilient environment requires a systematic reporting of incidents of a suspected serious criminal nature to law enforcement authorities.
Making use of the network foreseen in paragraph 1, Member States shall ensure that reports of suspected serious adverse reactions that have taken place on their territory are immediately made available to the Agency and the other Member States, and in any case within 15 calendar days of their notification, at the latest.
An Irish citizen asked the European Medicines Agency(EMA)for access to documents containing details of all suspected serious adverse reactions relating to an anti-acne drug.
Making use of the networkforeseen in paragraph 1, Member States shall ensure that reports of suspected serious adverse reactions that have taken place on their territory are immediately made available to the Agency and the other Member States, and in any case within 15 calendar days of their notification, at the latest.
Standard structured forms for electronic and non-electronic reporting,including a minimum data set for reporting of suspected serious incidents by healthcare professionals, users and patients;
The marketing authorisation holder shall record all suspected serious adverse reactions and human adverse reactions relating to the use of veterinary medicinal products that are brought to his attention, and report them promptly to the competent authority of the Member State on whose territory the incident occurred, and no later than 15 days following receipt of the information.
Have procedures in place to communicate to the competent authority without delay all relevant available information about suspected serious adverse events as referred to in paragraph 1(a) and(b);
The marketing authorisation holder shall also record all suspected serious adverse reactions and human adverse reactions related to the use of veterinary medicinal products of which he can reasonably be expected to have knowledge, and report them promptly to the competent authority of Member State on whose territory the incident occurred, and no later than 15 days following receipt of the information.
The competent authorities and the single points of contact shall notify inform the market operators concerned about the possibility of reporting incidents of a suspected serious criminal nature to the law enforcement authorities.
Pursuant to paragraph 2 of this Article, making use of the abovementioned network Member States shall ensure that reports of suspected serious adverse reactions that have taken place on their territory are immediately made available to the Agency and the other Member States and in any case within 15 days of their notification.
The Member States shall take all appropriate measures, including targeted information campaigns, to encourage and enable healthcare professionals, including doctors andpharmacists, users and patients to report to their competent authorities suspected serious incidents referred to in point(a) of paragraph 1.
The Member States may impose specific requirements on veterinary practitioners andother health care professionals in respect of the reporting of suspected serious or unexpected adverse reactions and human adverse reactions, in particular where such reporting is a condition of the marketing authorization.
The marketing authorization holder shall be required to record and report all other suspected serious adverse reactions which meet the reporting criteria in accordance with the guidance referred to in Article 106(1) of which he can reasonably be expected to have knowledge immediately to the competent authority of the Member State in whose territory the incident occurred, and in no case later than 15 calendar days following the receipt of the information.
Member States may impose specific requirementson veterinary practitioners and other health-care professionals in respect of the reporting of suspected serious or unexpected adverse reactions and human adverse reactions.
Following an investigation concerning him carried out by the Federal Police in Graz on the ground of suspected serious fraud in the exercise of his profession, he was examined as the accused by the Landesgericht für Strafsachen(Regional Criminal Court) in Graz in July 1995.
In 1995 he transferred his residence to Munich(Germany), after being heard by the Landesgericht für Strafsachen Graz(criminal court of Graz)in an investigation concerning him opened on account of suspected serious fraud on an occupational basis in the exercise of his profession, which he denies.
The Member States may impose specific requirements on doctors andother health care professionals, in respect of the reporting of suspected serious or unexpected adverse reactions, in particular where such reporting is a condition of the marketing authorization.
(1) the medical professionals are required to report without delay to the holder of the marketing authorisation or of the FDA for any suspected serious adverse drug reaction and to provide, upon request, additional information on the follow-up of the case.
Of the Medicinal Products in Human Medicine Act all medical specialists need to immediately notify the marketing authorization holder and the BDA of any suspected, serious or unexpected adverse drug reaction, regardless of whether the medicinal product is used or not in compliance with the Summary of Product Characteristics.
Where the risk or incident subject to an early warning is of a suspected criminal nature, the competent authorities or the Commission andwhere the concerned market operator has reported incidents of a suspected serious criminal nature as referred to in Article 15(4), the Member States shall inform ensure that the European Cybercrime Centre within Europol is informed, where appropriate.
Doctors in this case suspect serious blood diseases caused by malfunctions in the cardiovascular system.
Not enough blood to confirm death, butcertainly enough to suspect serious injury.
To rule out or suspect serious pathological conditions, the doctor may ask the patient the following.
Reporting of suspected unexpected serious adverse reactions by the sponsor to the Agency.
Reporting of suspected unexpected serious adverse reactions by the sponsor to the Eudravigilance database; and.
Reports on serious suspected adverse drug reactions(ADRs) in animals and humans.