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Showing 3881–3890 of 13520 articles for “Art. Rapport d’activité CEPC 2002-2003”
A coordinator who has exercised his function at a given level of competence for five years may be recognised as having the level of competence immediately above, if he has previously acquired, on comp…
At the request of the Labour Inspectorate, the project owner must provide proof of the competence of the coordinator he has appointed.
I.-Establishments or organisations that prepare or import investigational advanced therapy medicinal products prepared on an ad hoc basis ensure that all preparation operations are carried out in acco…
I. - Substantial changes to the activities authorised in application of this section which relate to: - the preparation of a new pharmaceutical form of an advanced therapy medicinal product prepared o…
I. - Any changes relating to: 1° The name or administrative address of the registered office of the establishment or authorised body; 2° The appointment of a new director of the establishment or autho…
For the application of the provisions of sub-section 1, army hospitals and the army blood transfusion centre shall be considered as health establishments and a blood transfusion establishment respecti…
Establishments and authorised organisations shall implement a procedure for the withdrawal of advanced therapy medicinal products prepared on an ad hoc basis in accordance with the rules of good pract…
Establishments or authorised organisations shall draw up and keep up-to-date a full list of the agreements they have entered into with third parties whose involvement has an influence on the quality a…
Advanced therapy medicinal products prepared on an ad hoc basis are distributed, under the responsibility of the person in charge referred to in article R. 4211-37 or, where applicable, the person in…
An authorised establishment or organisation may transfer to another authorised establishment or organisation advanced therapy medicinal products prepared on an ad hoc basis with a view to their storag…
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