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Showing 12621–12630 of 15302 articles for “Art. 12 al. 2”
…ation provided for in Article L. 513-11-1, pharmacies for internal use authorised under Article L. 5126-4 or pharmaceutical establishments authorised under Article L. 5124-3 may obtain authorisation t…
…e authorisation, whether in the Community or in a third country, and the reasons for this decision; 12° Proof that the applicant has a qualified person responsible for pharmacovigilance and that he ha…
…ions for variations are examined in accordance with the provisions of Commission Regulation (EC) No 1234/2008 of 28 November 2008 concerning the examination of variations to the terms of a marketing a…
…s contraceptives pursuant to article R. 5134-4-1 : 1° He may not, in application of article R. 5132-12 and under the conditions set out in paragraph 1 of article R. 5132-14, dispense on a single occas…
The managers of the establishments mentioned in articles L. 5124-2 and L. 5142-1 carrying out operations relating to medicinal products containing one or more psychotropic substances are subject to th…
…uring substances comply with the monographs of the European pharmacopoeia mentioned in Article L. 5112-1 or, failing this, with a national monograph or other specifications allowing an equivalent or h…
…set out in articles R. 5132-6 and R. 5132-7 and in the last two paragraphs of I of article R. 5141-112. The quantities dispensed are expressed in units of administration. A copy of the prescription be…
The provisions of the second paragraph of article R. 5122-2 and those of articles R. 5122-2-1, R. 5122-5, R. 5122-6, R. 5122-7, R. 5122-9 and R. 5122-13 to R. 5122-16 are applicable to advertising for…
…"Preparation of faecal microbiota": the magistral or hospital preparation mentioned in Article L. 5121-1, prepared from the faeces defined in 2°; 4° "Medicinal product containing faecal microbiota":…
Persons who have access to the information referred to in article R. 513-10-12 are bound by professional secrecy under the conditions set out inarticle 226-13 of the French Criminal Code.
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