Pharmaceuticals (general)

Pharmaceuticals can be defined as "chemical substances used in the treatment, cure, prevention or diagnosis of disease or used to otherwise enhance physical or mental well-being".1  They may be prescribed for a limited duration or on a regular basis for chronic disorders.

Medicines can be for human or veterinary use.  In the UK the regulation of medicines really came into being in the 1950s and 1960s when Thalidomide, taken in the early stages of pregnancy to relieve morning sickness, caused unpredicted serious birth defects.  To prevent this from happening again, in 1963 the Committee on Safety of Drugs was set up.  Under the terms of the Medicines Act of 1968, this committee was renamed the Committee on Safety of Medicines and later, the Commission on Human Medicines.  This Act requires that medicines must be licensed before they can be sold in the UK.  Licences for medicines are only granted when a product meets high standards of safety and quality and works for the purpose intended.

With advances in technology new challenges are faced by Health Authorities and the rules and regulations surrounding pharmaceuticals are continually changing and increasing.

Please refer to our regulatory services for further information or contact us with your specific regulatory compliance requirements.

  1. Source: Dictionary.com