Official regulation of medicines

This chapter describes the background to why it became necessary to regulate the use and supply of drugs, and the ways in which these processes are managed. 

Neither patients nor doctors are in a position to decide for themselves across the range of medicines that they use, which ones are pure and stable, and effective and safe. 

They need assurance that the medicines they are offered fulfil these requirements and are supported by information that permits optimal use. The information about and the usage of medicines gets out of date, and there is an obligation on licence holders continually to review their licence with particular regard to safety. Marketing Authorisation Holders (MAH), i.e. pharmaceutical companies, can also change the efficacy claims to their licence, e.g. new indications, extension of age groups, or 

The principles of official (statutory) medicines regulation are that 

The beginning of substantial government intervention in the field of medicines paralleled the prolifer- 

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Chapter 4. Evaluation of drugs in man Chapter 5. Official regulation of medicines Chapter 6. Classification and naming of drugs... 

Finally, it should be noted that many developing countries lack officials with the requisite pharmaco-economic expertise or access to information, sufficient to permit rational negotiation over medicines prices (WHO 2004). The WHO (1999) World Drug Situation Survey 1999 showed that of 135 countries surveyed, 40 per cent had no regulation of medicines prices at all. 

Directive 2001 /20/EC of the European Parhament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Eur-Lex. Official Journal of the European Communities 2001, L121 Vol. 44 34 4. http / / europa.eu.int/eur-lex/. 

Council Regulation 90/2377 EEC of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin. Official Journal of the European Communities. No. L 224, pp. 7-14. 

The prescription is the means by which medicines that are not considered safe for sale directly to the public are delivered to patients. Its format is officially regulated to ensure precision in the interests of safety... 

Commission regulation (EC) No. 1084/2003 of June 3,2003, concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a member state (Official Journal L 159, 27/6/2003, pp. 1-23), available http //ec.europa.eu/ enterprise/pharmaceuticals/eudralex/homevl.htm, accessed Apr. 10,2006. 

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