European View toward Incorporating Adverse Events into Package Inserts

Abstract

The information contained in package inserts varies from country to country in Europe, although other regulatory aspects of data presentation are quite similar. West Germany's Drug Law of 1976 requires 11 items to be included in the package insert for both patient and health professional: 1) name/address of manufacturer; 2) drug name 3) active constituents; 4) indications; 5) contraindications; 6) side effects; 7) drug interactions; 8) dosage instructions; 9) method and duration of application; 10) statement that drug should not be used after expiration date; and 11) statement that drug should be kept out of reach of children. All information must be submitted to the Health Office at the time of application or the applicant is liable for criminal prosecution. Documentation of side effects must be complete, although no special form is required. Similarly, causality assessment needs to be made even though specific algorithms are not required. Proposed amendments to the Drug Law will include additional information to physicians concerning the overdose instructions, pharmacological properties, and bioavailability of the drug. Registration procedures are the same throughout Europe and are called Summary of Products Characteristics. Assessment reports are also required for each new chemical entity in the European Community.