Article R4313-7
…ll ensure, before it is placed on the market, that: 1° The relevant technical documentation; 2° The assembly instructions ; 3° The declaration of incorporation.
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Showing 3271–3280 of 23743 articles for “Art. Cass. 13 March 2008 – counterfeit as dispossession”
…ll ensure, before it is placed on the market, that: 1° The relevant technical documentation; 2° The assembly instructions ; 3° The declaration of incorporation.
The assembly instructions for partly completed machinery shall contain a description of the conditions to be fulfilled for its proper incorporation into the final machinery without compromising health…
Joint decrees by the ministers responsible for labour, agriculture, customs, industry and consumer affairs lay down : 1° The content of the declaration of conformity for machinery; 2° The model of the…
…uthorisation provided for in this section. The Director General of the Agency will make known his reasoned opposition to this amendment or, where appropriate, will update the authorisation within thre…
…may concern all or part of the authorised activity and may only be taken after the party concerned has been informed of the nature of the breaches observed and given formal notice to put an end to the…
…igation by one of his agents or an on-site investigation by an inspector mentioned in Articles L. 5313-1 and L. 5313-3, to enable him to reach a decision on the application. To this end, it may extend…
…s authorised under this section which distribute advanced therapy medicinal products must keep at least the following information for each incoming and outgoing transaction: 1° The date of the transac…
Changes other than those mentioned in articles R. 4211-58 and R. 4211-59 are declared in the annual activity report provided for in article R. 4211-62.
The authorised health care organisation sends the Director General of the Agence nationale de sécurité du médicament et des produits de santé and the Director General of the Regional Health Agency an…
…r limit its scope by issuing a new certificate, after the person responsible for the establishment has been given the opportunity to present his observations within a period set by the Agence national…
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