Article L5121-2
Products presented as suppressing the desire to smoke or reducing tobacco addiction are considered to be medicines.
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Showing 3941–3950 of 60182 articles for “Art. I · Art. L 227-9”
Products presented as suppressing the desire to smoke or reducing tobacco addiction are considered to be medicines.
Any proprietary medicinal product or any other medicinal product manufactured industrially or by a method involving an industrial process, as well as any generator, kit or precursor which is not the s…
The marketing authorisation provided for in Article L. 5121-8 may only be granted for a blood-derived medicinal product when it is prepared from blood or blood components collected under the condition…
Any medicinal product intended for magistral preparations in pharmacies and identified by a special name is subject to the provisions of this chapter and those of article L. 5124-6.
The procedures for applying this chapter are determined by decree in the Conseil d'Etat, and in particular :1° The scientific criteria justifying, where appropriate, exemption from bioavailability stu…
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…
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