Article R5139-8
I. - In addition to the cases mentioned in article R. 5139-3-1, authorisation is also refused if the operation or operations envisaged in the application present or are likely to present a risk to pub…
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Showing 10051–10060 of 36632 articles for “Art. al. 5”
I. - In addition to the cases mentioned in article R. 5139-3-1, authorisation is also refused if the operation or operations envisaged in the application present or are likely to present a risk to pub…
The emergency contraception determined in article D. 5134-5 may be administered by nurses attached to an establishment with premises where confidentiality can be respected.
The minority to which the free dispensing provided for in article L. 5134-1 is subject is justified by an oral declaration made to the pharmacist by the person concerned.
The immediate packaging and the outer packaging, within the meaning of Article R. 5121-1, include the following information written in French for the user: 1° The name of the reagent ; 2° The name and…
The provisions of this section apply to substances or plants having a psychoactive effect, as well as to medicines or other products containing them, with the exception of ethyl alcohol and tobacco.
The Director General of the Agence nationale de sécurité du médicament et des produits de santé keeps an up-to-date list of authorisation holders and authorised persons. These lists are accessible at…
When the application for authorisation concerns all or part of the micro-organisms or toxins or products containing them, intended for veterinary use, the Director General of the Agence nationale de s…
Active substances may only be imported for the manufacture of medicinal products for human use from a third country into the European Union if they are accompanied by written confirmation from the com…
The certificate of compliance with good manufacturing practice referred to in article L. 5138-4 is issued following an inspection of the establishment if the good practices provided for in article L.…
The descriptive file provided for in Article L. 5138-1 and accompanying the declaration shall be sent to the Agence nationale de sécurité du médicament et des produits de santé by any means capable of…
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