Article R5121-101
I. - The applicant or the holder of the registration shall forward to the Agency without delay, indicating the scope of the information, any new information which it has or becomes aware of after the…
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Showing 4941–4950 of 68114 articles for “Art. s. R 225-136-1 and R 123-107”
I. - The applicant or the holder of the registration shall forward to the Agency without delay, indicating the scope of the information, any new information which it has or becomes aware of after the…
Pharmacovigilance is carried out :1° For medicinal products and for products which must be covered by the marketing authorisation provided for in article L. 5121-8, after this authorisation has been i…
When registration is suspended or withdrawn, the holder informs the stockholders without delay. They must take all necessary steps to stop the distribution of the medicinal product. If these steps are…
Without prejudice to the information required by other legislative and regulatory provisions, the labelling of the outer packaging or, where there is no outer packaging, the labelling of the immediate…
Registration of homeopathic medicinal products and traditional herbal medicinal products, as well as suspension and withdrawal of registration, are made available to the public by the Director General…
I.- In addition to the company's distinctive sign, the outer packaging may include signs or pictograms explaining some of the above information, as well as other information compatible with the summar…
The duration of the practical experience provided for in article R. 5124-16 is reduced to one year for pharmacists whose studies were carried out under a five-year system. It is reduced to six months…
The pharmacist in charge and the interim pharmacist in charge of the companies or organisations mentioned in 4°, 5°, 6°, 7°, 8°, 10°, 11°, 12°, 13°, 14° and 15° of article R. 5124-2 provide proof of a…
All pharmaceutical acts are carried out under the effective control of a pharmacist who meets the conditions for practising pharmacy in France.
The Prefect submits each group or company agreement implementing the employment obligation set out in article L. 5212-2 to:1° The regional coordination committee for employment and vocational training…
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