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Showing 2971–2980 of 46455 articles for “Art. I bis”
Once the authorisation provided for in Article L. 5121-8, the Agence nationale de sécurité du médicament et des produits de santé may, under conditions laid down by decree in the Conseil d'Etat, requi…
In the absence of the authorisation or compassionate prescribing framework mentioned in article L. 5121-12-1 for the indication in question, a medicinal product may only be prescribed in a manner that…
I.-For the application of article L. 5121-1 :1° Army hospitals are considered to be health establishments ;2° The Armed Forces Central Pharmacy may be authorised to make the hospital preparations ment…
Cosmetic products imported or made available on the market shall comply with the provisions of the aforementioned Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 Novem…
In the event of serious doubt as to the safety of a substance used in the composition of a cosmetic product, the Agence nationale de sécurité du médicament et des produits de santé may give formal not…
I. - In addition to their obligations under Article 23 of the above-mentioned Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009, any responsible person and…
The opening and operation of any establishment for the manufacture or packaging, even on an ancillary basis, of cosmetic products, as well as the extension of the activity of an establishment to inclu…
Cosmetic product means any substance or mixture intended to be placed in contact with the superficial parts of the human body (the epidermis, the hair and capillary systems, the nails, the lips and th…
The Agence nationale de sécurité du médicament et des produits de santé publishes the principles of good laboratory practice applicable to non-clinical safety studies intended to assess the safety of…
A decree in the Conseil d'Etat shall determine the procedures for applying this chapter, in particular : 1° The presentation and content of the declaration provided for in Article L. 5131-2 ; 2° The l…
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