Abstract
Radioactive substances used for diagnosis and therapy in nuclear medicine and research were recognized as drugs in some European countries more than 20 years ago, while in other countries this will not happen until the first of January 1992, when European Community (EEC) directives require national regulations to be established. Radiation protection regulations however were introduced in most countries in the fifties or sixties covering both radiation protection of workers and the general population including patients.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
References
Good Practice in the Manufacture of Radiopharmaceuticals. A proposal put forward by a group of Pharmacists from the Nordic countries. Arch Pharm Chem 78: 1002–1009, 1971.
Pharmacopoea Nordica, Copenhagen 1963.
Radiopharmaceuticals, Drug Applications. Nordic Guidelines. Nordic Council on Medicines publication 20, Uppsala 1988 ISBN 91–86432–19–2.
Radiopharmacy. Preparation and Control of radiopharmaceuticals in hospitals. Nordic Council on Medicines publication 26, Uppsala 1989 ISBN 91–86432–25–7.
Council of Europe, European Pharmacopeia 2nd Edition, Parts I-II. Maisonneuve S.A. (1980–1989).
The Rules Governing Medicinal Products in the European Community vol 1: The rules governing medicinal products for human use in the EEC, EEC Bruxelles 1989, ISBN 95–825–9563–3.
The Rules Governing Medicinal Products in the European Community, vol III: Guidelines on Quality, Safety and efficacy of medicinal products for human use, EEC Bruxelles 1989, ISBN 95–825–9619–2.
Council directive of 3 May 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC and laying down additional pervisions for radiopharmaceuticals 89/343/EEC.
The Rules Governing Medicinal Products in the European Community vol IV: Guide to Good Manufacturing practice for medicinal products EEC Bruxelles 1989 ISBN 92–825–9572–2.
EFTA, Basic Standards of Good Manufacturing Practice for Pharmaceutical Products, Document PH 3/83 (Revised version), EFTA Secretariate, Geneva (1983).
Institute of Physical Sciences in Medicine: Hospital Radiopharmacy. Principles and Practice. Report no.56, London, 1988.
Kristensen, K., Preparation and Control of Radiopharmaceuticals in Hospitals, IAEA, Vienna, (1979).
C.R. Lazarus: Training and Education in Kristensen K. and Norbygaard E. (editors), Safety and efficacy of radiopharmaceuticals, Martinus Nijhoff Publishers (1987).
European Association of Nuclear Medicine, Task Group on Radiopharmaceuticals and The Council of Europe: Training of radiopharmacists and radiochemists, to be published European Journal of Nuclear Medicine.
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 1991 Springer Science+Business Media New York
About this chapter
Cite this chapter
Kristensen, K. (1991). Development of European Regulations on Radiopharmaceuticals. In: Emran, A.M. (eds) New Trends in Radiopharmaceutical Synthesis, Quality Assurance, and Regulatory Control. Springer, Boston, MA. https://doi.org/10.1007/978-1-4899-0626-7_46
Download citation
DOI: https://doi.org/10.1007/978-1-4899-0626-7_46
Publisher Name: Springer, Boston, MA
Print ISBN: 978-1-4899-0628-1
Online ISBN: 978-1-4899-0626-7
eBook Packages: Springer Book Archive