Regulatory references and resources

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.

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 (Consolidated version: 30/12/2008).

Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market.

Heukelbach J, Canyon D, Speare R. The effect of natural products on head lice: in vitro tests and clinical evidence. J Pediatr Inf Dis 2007; 2:67-76.

Heukelbach J, Canyon DV, Oliveira FA, Muller R, Speare R. In vitro efficacy of over-the-counter botanical pediculicides against the head louse Pediculus humanus var capitis based on a stringent standard for mortality assessment. Med Vet Entomol 2008;22:264-272.

ISO 14971: 2007 Medical devices - Application of risk management to medical devices.

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Consolidated version: 6/7/2009).

The Rules governing Medicinal Products in the European Community, The Notice to Applicants, Volume 2A Procedures for marketing authorisation, Chapter 1 - Marketing Authorisation, November 2005.

The Rules governing Medicinal Products in the European Community, The Notice to Applicants, Volume 2A Procedures for marketing authorisation, Chapter 2 - Mutual Recognition, February 2007.

The Rules governing Medicinal Products in the European Community, The Notice to Applicants, Volume 2A Procedures for marketing authorisation, Chapter 4 - Centralised Procedure, April 2006.

The Rules governing Medicinal Products in the European Community, The Notice to Applicants, Volume 2A Procedures for marketing authorisation, Chapter 6 - Community Marketing Authorisation, November 2005.

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