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Showing 2231–2240 of 5749 articles for “Art. 13 April 1983”
The correspondent mentioned in article R. 5121-181 who receives the report provided for in article R. 5121-196 immediately forwards it to the regional pharmacovigilance centre. If he is otherwise awar…
Organisations or companies exploiting blood-derived medicinal products which have knowledge of adverse reactions likely to be due to these medicinal products inform the Director General of the Agence…
When a person authorised to prescribe, dispense or administer medicinal products becomes aware of an adverse reaction which may be due to a blood-derived medicinal product, he/she shall report it imme…
For the purposes of this sub-section, army hospitals and the army blood transfusion centre are regarded as public health establishments and blood transfusion establishments respectively.
The investigator may ask the person taking part in a performance study, at the time he or she gives informed consent, to agree to his or her data being used in subsequent research exclusively for scie…
…Articles 59 to 62 of Regulation (EU) No 2017/746 of the European Parliament and of the Council of 5 April 2017 and Article L. 1126-6, is punishable by three years' imprisonment and a fine of €45,000.
Notwithstanding article 13 of the law of 16 and 24 August 1790 on the organisation of the judiciary, the judicial court has sole jurisdiction to rule on any action for compensation for damage resultin…
The promoter is responsible for compensating for the harmful consequences of the performance study for the person taking part in it and their dependants, unless it can prove that the damage is not att…
I.-The Data Protection Committee will give its opinion on the conditions for the validity of the performance study, in particular with regard to : the protection of individuals, in particular the prot…
Where a performance study is conducted at the Institution nationale des invalides or in a health establishment or army hospital with an in-house pharmacy, failure by the promoter to communicate in adv…
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