Directive 2001/83/EC
Sign in to saveAlso known as Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001
European Union Directive (EU) 2001/83
Full text
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
legislation.gov.uk →We're always trying to make legislation.gov.uk better. Please tell us what you think by taking our survey.Tell us what you think Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include: Latest Available (revised): The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area. 1. Article 1. For the purposes of this Directive, the following terms shall... 2. Article 3. This Directive shall not apply to: Any medicinal product prepared... 6. Article 10a. By way of derogation from Article 8(3)(i), and without prejudice... 7. Article 10b. In the case of medicinal products containing active substances used... 8. Article 10c. Following the granting of a marketing authorisation, the authorisation holder... 10. Article 12. (1) The applicant shall ensure that, before the detailed summaries... 1. Article 13. (1) Member States shall ensure that homeopathic medicinal products manufactured... 9. Article 16i. Before 30 April 2007, the Commission shall submit a report... 4. Article 20. Member States shall take all appropriate measures to ensure that:... 7. Article 22. In exceptional circumstances and following consultation with the applicant, the... 10. Article 22c. (1) The marketing authorisation holder shall incorporate any conditions referred... 12. Article 23a. After a marketing authorisation has been granted, the holder of... 15. Article 25. Authorization shall not affect the civil and criminal liability of... 4. Article 43. The Member States shall take all appropriate measures to ensure... 6. Article 45. The competent authority of the Member State may require from... 9. Article 46b. (1) Member States shall take appropriate measures to ensure that... 13. Article 49. (1) Member States shall ensure that the qualified person referred... 16. Article 52. Member States shall ensure that the duties of qualified persons... 17. Article 52a. (1) Importers, manufacturers and distributors of active substances who are... 2. Article 54a. (1) Medicinal products subject to prescription shall bear the safety... 11. Article 62. The outer packaging and the package leaflet may include symbols... 13. Article 64. Where the provisions of this Title are not complied with,... 14. Article 65. In consultation with the Member States and the parties concerned,... 16. Article 67. The competent authority shall ensure that a detailed instruction leaflet... 5. Article 74. When new facts are brought to their attention, the competent... 7. Article 75. Each year, Member States shall communicate to the Commission and... 3. Article 78. Member States shall ensure that the time taken for the... 5. Article 80. Holders of the distribution authorization must fulfil the following minimum... 8. Article 83. The provisions of this Title shall not prevent the application... 12. Article 85b. (1) Persons brokering medicinal products shall ensure that the brokered... 1. Article 85c. (1) Without prejudice to national legislation prohibiting the offer for... 2. Article 85d. Without prejudice to the competences of the Member States, the...
Excerpt from the full text · 40,000 chars · not written by Vinony