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Showing 9171–9180 of 62389 articles for “Art. L 224-4 I”
For a generic or hybrid medicinal product defined in 5° of Article L. 5121-1, the marketing authorisation may be granted before the expiry of the intellectual property rights attached to the reference…
Persons liable for the contribution provided for in I of Article L. 245-6 of the Social Security Code and persons liable for value added tax pursuant to Article 256 A of the General Tax Code who make…
Homeopathic medicinal products which satisfy all the conditions listed below are not subject to the marketing authorisation provided for in Article L. 5121-8: 1° Oral or external administration ; 2° N…
Non-clinical trials intended to assess the properties and safety of medicinal products for human use must comply with good laboratory practice, the principles of which are laid down by decision of the…
For the preparations mentioned in 1°, 2° and 3° of Article L. 5121-1, only raw materials meeting the specifications of the pharmacopoeia may be used, unless no raw material meeting these specification…
I. - Early access as defined in this article governs the use, on an exceptional basis, of certain medicinal products, in specific therapeutic indications, intended to treat serious, rare or incapacita…
The preparation, import, export, wholesale distribution and brokering of medicinal products, as well as pharmacovigilance, must be carried out in accordance with good practice, the principles of which…
The registration provided for in Article L. 5121-13 may cover a series of homeopathic medicinal products obtained from the same homeopathic stock or stocks. The application for registration must be ac…
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…
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