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 lays down the provisions governing marketing, manufacture and distribution of medicinal products for human use. The Directive defines a medicinal product as:
'Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis'.
Under European and legislation, all medicinal products must be authorised before being placed on the market. Pharmaceutical companies and wholesalers must satisfy regulators that the manufacture, distribution, and supply of the medicine meet required safety and quality standards.
The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe.
BSI British Standards has a range of publications that help manufacturers to achieve this aim, including clean rooms and controlled environment standards, product standards for drug delivery devices such as syringes and medical gas supply systems, and quality management systems for primary packaging.
This quality management system standard combines ISO 9001:2000 and Good Manufacturing Practice for the design, manufacture and supply of primary packaging materials for medicinal products. The standard also contains guidance annexes on risk management and validation.
