pharmacovigilance oor Nederlands
pharmacovigilance
en
(medicine) The detection, assessment, understanding and prevention of adverse effects of medicines
Vertalings in die woordeboek Engels - Nederlands
geneesmiddelenbewaking
The new pharmacovigilance legislation provides a legal base for the Agency to charge fees for pharmacovigilance.
De nieuwe wetgeving inzake geneesmiddelenbewaking biedt een wettelijke basis voor het Bureau om vergoedingen aan te rekenen voor geneesmiddelenbewaking.
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- Amendments 89, 91 (partly) and 93 (partly) on the communication of pharmacovigilance information and on the information to the public of the Agency's database;
melding van alle grote posities ten minste viermaal per jaarEurLex-2 EurLex-2
The Agency shall be responsible for coordinating the existing scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicinal products.
Die man in de hoek.Wie is hij?Eurlex2019 Eurlex2019
coordinating the monitoring of medicinal products for human use which have been authorised within the Union and providing advice on the measures necessary to ensure the safe and effective use of these medicinal products for human use, in particular by coordinating the evaluation and implementation of pharmacovigilance obligations and systems and the monitoring of such implementation;
Ik kan niet slapen tot ik je weer zieEurLex-2 EurLex-2
Upon request by the Agency, particularly in the context of pharmacovigilance, the marketing authorisation holder shall provide the Agency with all data relating to the volume of sales of the medicinal product at Community level, broken down by Member State, and any data in the holder's possession relating to the volume of prescriptions.
Als het buiten # graden is, word je verkouden als je uitstaptnot-set not-set
Tiemann) — application for a declaration that, by failing to adopt the laws, regulations and administrative provisions necessary to comply with Commission Directive 2000/38/EC of 5 June 2000 amending Chapter Va (Pharmacovigilance) of Council Directive 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (OJ 2000 L 139, p. 28), or by failing to inform the Commission thereof, the Federal Republic of Germany has failed to fulfil its obligations under that directive — the Court (First Chamber), composed of: P.
De lessor verwerkt uit hoofde van de leaseovereenkomst zijn leasevordering en niet het geleasede actief zelfEurLex-2 EurLex-2
It is appropriate to strengthen the supervisory role for medicinal products for human use authorised through the centralised procedure by providing that the supervisory authority for pharmacovigilance should be the competent authority of the Member State in which the pharmacovigilance system master file of the marketing authorisation holder is located.
Die avond om half zeven preciesEurLex-2 EurLex-2
He shall place a note concerning the main findings of the audit on the pharmacovigilance system master file and, based on the audit findings, ensure that an appropriate corrective action plan is prepared and implemented.
Als jij dat wilEurLex-2 EurLex-2
It is also necessary to make provision for the monitoring of adverse reactions occurring in clinical trials using Community surveillance (pharmacovigilance) procedures in order to ensure the immediate cessation of any clinical trial in which there is an unacceptable level of risk
Ik heet Varnezeurlex eurlex
The holder of a marketing authorisation may not communicate information relating to pharmacovigilance concerns to the general public in relation to its authorised medicinal product without giving prior or simultaneous notification to the Agency.
Ja, dat beloof iknot-set not-set
Marketing authorisation holders shall record all pharmacovigilance information and ensure that it is handled and stored so as to allow for accurate reporting, interpretation and verification of that information.
' Daffy wordt opgeblazen. 'EurLex-2 EurLex-2
The ending of the requirement for funding to be public threatens to reduce the pharmacovigilance system to the status of service provider to pharmaceutical firms.
Het Ultradodelijk Serpent kan haar geen pijn gedaan hebben?not-set not-set
The Agency and the national public pharmacovigilance systems shall be organised and operate as a coherent and interactive pharmacovigilance system through which the monitoring of the occurrence of adverse reactions takes place continuously.
Een vaag gevoel, zeg je?EurLex-2 EurLex-2
As the legislation on pharmacovigilance encourages the conduct of joint post authorisation safety studies, marketing authorisation holders should share the applicable fee in case a joint study is submitted.
Het is verboden de volgende afvalstoffen in een centrum voor technische ingraving te storten vanaf # julinot-set not-set
This is combined with the strengthening of pharmacovigilance procedures and an increase in the frequency at which updated safety reports must be submitted (Article 13(1) and Articles 15 to 24).
Als in beladen of onbeladen toestand bij een vertragingsfactor tussen #,# en #,# beide wielen van de achteras en maximaal één wiel van de vooras blokkeren, voldoet het voertuig niet aan de voorschriften voor de blokkeringsvolgordeEurLex-2 EurLex-2
Notes that the implementation by Member States of the Europe-wide pharmacovigilance reporting system (the EudraVigilance database) was slower than expected; is, however, satisfied with the recent announcement by the Executive Director that the situation has substantially improved during 2005;
Als het aan mij lag, had ik je laten verrottenEurLex-2 EurLex-2
Unless there are justifiable grounds resulting from pharmacovigilance activities, individual Member States shall not impose any additional obligations on marketing authorisation holders for the reporting of suspected adverse reactions.
U wordt beschuldigd van de moord op Richard Irving Paradine op zes mei jongstledenEurLex-2 EurLex-2
Taking into consideration the level of the inflation rate for that year, it is considered justified to adjust, in accordance with Article 15(6) of Regulation (EU) No 658/2014, the amounts of the fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use.
MODELLEN VAN GEZONDHEIDSCERTIFICATEN VOOR HET INVOEREN UIT DERDE LANDEN VAN BEPAALDE DIERLIJKE BIJPRODUCTEN EN DAARVAN AFGELEIDE PRODUCTENEurlex2019 Eurlex2019
(1) Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products[15], Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use[16] and Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency[17], lay down harmonised rules for the authorisation, supervision and pharmacovigilance of medicinal products within the Community.
Niet gek voor iemand van zijn formaatEurLex-2 EurLex-2
The Agency and the Member States' competent authorities shall cooperate to continuously develop pharmacovigilance systems capable of achieving high standards of public health protection for all medicinal products, regardless of routes of authorisation, including the use of collaborative approaches, to maximise use of resources available within the ►M8 Union ◄ .
Zeg maar dat... mijn plotse vertrek... geen afwijzing isEurlex2019 Eurlex2019
Pharmacovigilance activities cover the whole life-cycle management of medicinal products for human use in relation to safety.
Gelet op het besluit van de Vlaamse Regering van # juli # houdende regeling van het beheer van het Investeringsfonds voor Grond-en Woonbeleid voor Vlaams-Brabant, en houdende regeling van de voorwaarden inzake woonprojecten met een sociaal karakter, inzonderheid op artikel #, #°, ingevoegd bij het besluit van de Vlaamse Regering van # juniEurLex-2 EurLex-2
The mandate of the Pharmacovigilance Risk Assessment Committee shall cover all aspects of the risk management of the use of medicinal products for human use including the detection, assessment, minimisation and communication relating to the risk of adverse reactions, having due regard to the therapeutic effect of the medicinal product for human use, the design and evaluation of post-authorisation safety studies and pharmacovigilance audit.’ ;
Zigeunerin spuwt ookEurLex-2 EurLex-2
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67) as last amended by Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance (OJ L 299, 27.10.2012, p.
Hij hield veel van haarEurLex-2 EurLex-2
The Agency shall levy a fee for the assessment carried out in the context of a procedure initiated as a result of the evaluation of pharmacovigilance data under the second subparagraph of Article 31(1), Article 31(2) and Articles 107i to 107k of Directive 2001/83/EC or under Article 20(8) of Regulation (EC) No 726/2004.
Overwegende dat de instellingen inzake kinderbijslag tijdig de nodige maatregelen moeten nemen met het oog op het verzekeren van de betaling van de kinderbijslag aan de nieuwe bedragen, die dienen toegepast te worden voor de periode vanaf # januariEurLex-2 EurLex-2
(4) The main tasks of the Agency in the area of pharmacovigilance laid down in Regulation (EC) No 726/2004 should be maintained and further developed, in particular as regards the management of the Community pharmacovigilance database and data-processing network (hereinafter referred to as 'the Eudravigilance database') and the coordination of safety announcements by the Member States.
Wanneer de deelnemers aan het zevende EG-kaderprogramma zich verzetten tegen een controle of verificatie ter plaatse, verlenen de Israëlische autoriteiten overeenkomstig de nationale voorschriften de controleurs van de Commissie de nodige bijstand om hen in staat te stellen hun taken met betrekking tot de controle of verificatie ter plaatse uit te voerenEurLex-2 EurLex-2
Rapporteur: Linda McAvan (A7-0153/2010) Report on the proposal for a directive of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use [COM(2008)0665 - C6-0514/2008- 2008/0260(COD)] - Committee on the Environment, Public Health and Food Safety.
actieve kennis hebben van Frans en Engels (ICAO-en ABIS-werktalennot-set not-set
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