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Directive 2001/83/EC of the European Parliament and of the CouncilShow full title
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
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Revised version PDFs
- Revised 26/07/20194.19 MB
- Revised 28/01/20191.47 MB
- Revised 16/11/20121.37 MB
- Revised 21/07/20111.88 MB
- Revised 20/01/20111.76 MB
- Revised 05/10/20090.46 MB
- Revised 20/07/20090.45 MB
- Revised 30/12/20080.45 MB
- Revised 21/03/20080.44 MB
- Revised 26/01/20070.44 MB
- Revised 30/04/20040.42 MB
- Revised 01/07/20030.38 MB
- Revised 08/02/20030.31 MB
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[F1Article 116 U.K.
The competent authorities shall suspend, revoke or vary a marketing authorisation if the view is taken that the medicinal product is harmful or that it lacks therapeutic efficacy, or that the risk-benefit balance is not favourable, or that its qualitative and quantitative composition is not as declared. Therapeutic efficacy shall be considered to be lacking when it is concluded that therapeutic results cannot be obtained from the medicinal product.
[X1A marketing authorisation may also be suspended, revoked or varied where the particulars supporting the application as provided for in Articles 8, 10, 10a, 10b, 10c or 11] are incorrect or have not been amended in accordance with Article 23, or where any conditions referred to in Articles 21a, 22 or 22a have not been fulfilled or where the controls referred to in Article 112 have not been carried out.
[F2The second paragraph of this Article also applies in cases where the manufacture of the medicinal product is not carried out in compliance with the particulars provided pursuant to point (d) of Article 8(3), or where controls are not carried out in compliance with the control methods described pursuant to point (h) of Article 8(3).] ]
Editorial Information
X1 Substituted by Corrigendum to Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use (Official Journal of the European Union L 348 of 31 December 2010).
Textual Amendments
F1 Substituted by Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use (Text with EEA relevance).
F2 Inserted by Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (Text with EEA relevance).
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