Employees who ship hazardous material including radioactive material
must have hazmat training to be able to recognize and identify hazardous
material, to conduct their specific function, and to enforce safety procedures
to protect the public. The training must be given to a new employee within
90 days of employment and then repeated every three years. The training
is provided by the hazmat employer or other public or private sources, and
a record of training must be made.
European Regulations Governing Radiopharmaceuticals
The European Union (EU) is a union of 25 member countries in Europe,
which adopt various rules and regulations that are uniformly applicable to
all member states. Regulation governing the use of ionizing radiations
varied among member states until 1989 when the EU applied uniform reg-
ulations for radiopharmaceuticals to be implemented by each member
state. The European Regulatory Organizations of the EU have three main
instruments: directives, guidelines, and regulations. Directives are manda-
tory to be translated into national legislation and implemented in each
member country. Guidelines are recommendations (not mandatory) for
implementation of the directives by each member country. Regulations are
mandatory for all member countries without adoption into individual
national legislation.
Similar to the US Codes of Federal Register (CFR), the European
Economic Council (EEC) directives are issued for regulation of all food
and drugs. Directive 65/65 EEC defines medicinal products and details
the requirements for registration for commercialization of the medicinal
products by each member state. This directive has since been amended by
83/570 EEC, 87/21 EEC, and 89/381 EEC to include medicinal products
derived from human blood or plasma. Directive 89/341 EEC exempts
certain drugs from the registration requirements, which include those com-
pounded by the pharmacy for patients and those for research and clinical
trials.
Directive 75/319 EEC establishes the requirements for application for
authorization to market a medicinal product, which is drawn up by quali-
fied experts and approved by a Committee for Proprietary Medicinal Prod-
ucts. This directive facilitates the free movement of medicinal drugs among
the member states, and sets guidelines for production of quality medicinal
products using good manufacturing methods supervised by qualified per-
sonnel. This directive also controls the importation of medicinal products
from a third country, particularly regarding the quality and integrity of the
products. Until 1989, radiopharmaceuticals were exempt from these regu-
lations, and then in 1990, Directive 89/343 EEC was adopted regulating all
radiopharmaceuticals as to their production, quality control, packaging, and
labeling.
European Regulations Governing Radiopharmaceuticals 295