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Showing 4961–4970 of 65683 articles for “Art. al. 4 and L 227-11”
Failing an appointment made pursuant to Article 448, the judge shall appoint, as curator or guardian, the spouse of the protected person, the partner with whom he or she has entered into a civil solid…
No one is obliged to retain curatorship or guardianship of a person beyond five years, with the exception of the spouse, partner in a civil solidarity pact and children of the person concerned, as wel…
Curatorship and guardianship are personal charges. However, curators and guardians may, under their own responsibility, enlist the assistance of third parties who are adults and not subject to a legal…
The safety features may only be replaced by equivalent safety features in order to verify the authenticity, identify and provide proof of unlawful handling of the medicinal product. This replacement i…
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…
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…
Changes other than those mentioned in articles R. 4211-43 and R. 4211-44 are declared in the annual activity report provided for in article R. 4211-47.
In the event of non-compliance with the legislative and regulatory provisions or the conditions of the authorisation, the suspension, which may not exceed one year, and the withdrawal of the authorisa…
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