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Showing 3911–3920 of 13058 articles for “Art. CE 7 Nov 2019 n° 424702”
…s for use referred to in point d of paragraph 1 of Article 19 of Regulation (EC) No 1223/2009 of 30 November 2009. "Adverse reaction" means a reaction which is harmful to human health attributable to…
The authorisation provided for in Article R. 5132-74 is issued by the Director General of the Agence nationale de sécurité du médicament et des produits de santé, after obtaining the opinion of the Di…
…label bears, in indelible and legible black characters, the following information: 1° For a substance, a plant or a part of a plant: the international non-proprietary name recommended by the World He…
Active substances may only be imported for the manufacture of medicinal products for human use from a third country into the European Union if they are accompanied by written confirmation from the com…
When the application for authorisation concerns all or part of the micro-organisms or toxins or products containing them, intended for veterinary use, the Director General of the Agence nationale de s…
The decision to administer emergency contraception is preceded by an interview with the student, whether she is a minor or an adult. The purpose of this interview is to enable the nurse to assess whet…
…d, suspended or withdrawn by the Director General of the Agency. Decisions to refuse, suspend or cancel registration are notified to the applicant. Reasons are given for the decision and the applicabl…
Decisions to register homeopathic veterinary medicinal products or to suspend or cancel these registrations are made public in an extract on the website of the Agence nationale de sécurité sanitaire d…
Medicinal products subject to clinical trials, on the one hand, and any reference medicinal products and placebos, on the other, are prepared in accordance with good manufacturing practice, defined in…
…of use and on which it is impossible to include all the information provided for in Article R. 5141-74, the information provided for in Article R. 5141-73 appears only on the outer packaging.
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