Ann Godsell Regulatory

Homeopathic Medicines                                                                                                                            Home

A homeopathic remedy is a natural substance that has been diluted many times. Homoeopathy is a complementary medicine where a minute amount of a substance is given that would actual cause symptoms of a disease if given in large quantities. It is based on the principle that 'like cures like' and derives from two Greek words, homeo (similar) and pathos (disease/suffering).   

All medicines legislation is controlled in the EU by 2001/83/EC Directive as amended. It defines a homoeopathic medicinal product as: 'Any medicinal product prepared from substances called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in the Member States. A homeopathic medicinal product may contain a number of principles'.

The EU Simplified Registration Scheme was introduced in 1992 and does not allow indications. The National Rules Scheme was introduced in the UK in September 2006 to allow homoeopathic products to be indicated for the relief or treatment of mild, self-limiting conditions. 

In the UK there are two possible routes to achieve registration: 

              ·    The Simplified Scheme 
                    Directive 92/73/EC introduced a "Simplified Scheme" for homoeopathic medicines. No medicinal claims are allowed,
                    the use must be oral or external, and safety and quality has to be demonstrated.

                  ·    The National Rules Scheme
                     This Scheme in the UK does allow indications for the relief or treatment of minor symptoms for homoeopathic medicines.
                    Quality, safety and efficacy have to be demonstrated.

 

 

 

 

 

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