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Recent EU Regulatory Law Developments for the Pharmaceutical Industry

Published online by Cambridge University Press:  20 January 2017

Audrey Chenesseau  and
Anna Pavlou
Audrey Chenesseau
Affiliation:
Brussels office, Sidley Austin LLP
Anna Pavlou
Affiliation:
Brussels office, Sidley Austin LLP
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Abstract

The present Flash News Report sets outs recent EU regulatory law developments (as of 25 June 2012) which pharmaceutical companies should be aware of in the areas of Pharmacovigilance, Information on Medicines, Pricing and Reimbursement, EU Data Protection and Advanced Therapy Medicinal Products.

Type
Reports
Information
European Journal of Risk Regulation , Volume 3 , Issue 3 , September 2012 , pp. 421 - 424
Copyright
Copyright © Cambridge University Press 2012

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References

1 The draft GVP Modules are available on the EMA's website at <http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000345.jsp&mid=WC0b01ac05804fcdb1> (last accessed on 18 July 2012).

2 Directive 2001/83/EC on the Community code relating to medicinal products for human use, OJ L 311, 28.11.2004, p. 67 (the “Medicinal Products Directive”).

3 The Draft Implementing Regulation is available on the Commission’s website at <http://ec.europa.eu/enterprise/tbt/tbt_repository/EU29_EN_1_1.pdf> (last accessed on 18 July 2012).

4 The Proposed Transparency Directive is available on the Commission’s website at <http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/transpadir_finalprop01032012_en.pdf> (last accessed on 18 July 2012).

5 Council Directive 89/105/EEC relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems, OJ L 40, 11.02.1989, p. 8.

6 Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, OJ L 136, 30.4.2004, p. 136.

7 The updated mandatory requirements are available on the EMA’s website at <http://www.ema.europa.eu/docs/en_GB/document_library/Other/2012/03/WC500123660.pdf> (last accessed on 18 July 2012).

8 Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data, OJ L 281, 23.11.1995, p.31–50.

9 The reflection paper is available on the EMA website at <http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2012/04/WC500126681.pdf> (last accessed on 18 July 2012).

10 Regulation (EC) No 1394/2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004, OJ L 324, 10.12.2007, p. 121 (‘the ATMP Regulation’).