Product Liability Directive

Paragraph 1 of the schedule states that the supply of the unlicensed product must be for use by a doctor s or dentist s individual patients on his direct personal responsibility. Doctors should be aware of the product liability implications of using such products. 

Product Liability Directive 85/374/EEC and Consumer Protection Act 1987 (UK). NB. In some EU countries, claims under the Directive and its implementing legislation can not be made in relation to investigational medicinal products. 

The protocol must include the proposed tentative specifications of the in-process product with the acceptance criteria and directs the finalization of the specification at the end of the development stage. The specification should be proposed based upon the product design that is, the specification includes the size, shape, impurities, and nature of the materials, such as viscosity and tension. Developing the specifications of the final product and parts for assembly must be performed to specify the product efficacy and product liability based on the design concept and scientific data, such as stability data. 

Most countries operate with statutory state compensation schemes, which companies may need to supplement with other private-based insurances both usually include economic-based incentive systems to improve chemical safety40 [233]. Environmental and product liability generally establish when civil action can be successfully taken against a company or an individual [234]. If a company is in compliance with the law, it is possible that civil action becomes directed towards the regulator in the form of judicial review for... 

To complicate matters in some countries, liability may also arise in tort without proof of fault. This is known as strict liability. An important example of strict liability for pharmaceutical companies is what is commonly referred to as the European Products Liability Directive , which introduced a Europe-wide scheme of strict liability for defective products, (see Chapter 52 on Pharmaceutical Product Liability ). As liability is strict, the defences that are available in the legislation are most important. The UK legislation, for example, includes a development risk defence. This essentially means that, if the state of scientific knowledge was such that the producer could not have discovered the defect, this will provide a defence to the claim. 

This increase of CSF expansion length upon transformation to symmetry-adapted orbitals potentially affects any of the expansion forms that attempt to describe electron correlation in terms of localized orbitals and that are not invariant to transformations that mix the different localized orbitals. All of the product and direct product expansion forms (including the RCI, PPMC, PPGVB and SOGVB expansions) are potentially of this type. It often happens that these wavefunctions do have the full molecular symmetry even though they are described in terms of localized orbitals and not symmetry-adapted orbitals. The localized orbital description that results from these wavefunction optimizations is therefore both an asset and a liability it aids the chemical interpretability and results in more compact CSF expansions but the computations must be performed in an orbital basis that does not possess the full molecular symmetry. This is computationally important since many steps of the MCSCF wavefunction optimization can exploit such orbital symmetry when it is present. 

The hazardous nature of some of these chemicals, their cross-border transport and the legal regulations required for product liability have resulted in the passing of regulations, directives, and laws aimed at facilitating accurate assessments of the... 

The second line of argument directly attributes certain changes in fins R D portfolios to product liability. The examples to support this argument are somewhat more general than those given above, perhaps because of the confidential nature of most fins R D portfolios.20 Among the examples encountered by OTA ... 

Review of the effect of external factors on costs and returns on pharmaceutical R D, including new drug regulation, tax policy, product liability law, direct R D subsidies by the National Institutes of Health (NIH) and other government research bodies, and reimbursement policies (both private and public) for prescription drugs. 

Sterile products clearly place extra challenges on the pack in terms of the materials employed and the processes/procedures involved in the filling and packing operations. They also involve the greatest level of risk to the user/patient since the administration of sterile products involves direct injection, thus bypassing the body s natural defences. Because of this increased risk for the patient, the pharmaceutical company is exposed to a greater degree of responsibility and risk via product liability claims. 

The EC Directive on liability for defective products [4] was adopted in 1985. According to the directive the producer is to be held liable for damage caused by a defect in his product. It is based on a strict liability regime, ie, one does not have to prove negligence or fault to be able to get compensation. What the injured party has to prove, is the existence of the danuge, the defect of a product and the causal relationship between the damage and the defect (Art. 4). 

See 1 Frumer Friedman, Products Liability, 6.01 [1] and cases cited Noel, Manufacturer s Negligence of Design or Directions for Use of Product , 71 Yale... 

Biotechnology companies already anguishing over U.S. product liability concerns, as well as the lack of available coverage, are now facing strict liability laws in Europe. On July 25, the European Economic Community adopted new liability laws for defective products which member states "shall bring into force, not later than three years from the date of notification of this Directive," that is by July 25, 1988. 

A number of possible answers exist to the question why carry out a fire test" including direct legal requirements for duty of care or product liability reasons, by a purchase specification, etc., but ultimately the single answer must be to improve safety by reducing fire hazards. To achieve this, it is essential that the fire test carried out and the performance... 

Directives are the European laws published in the Official Journal that give us the essential health and safety requirements (EHSRs) that shall be followed by product suppliers. These are commonly called the Essential Requirements (ERs). The directives deal with legal and procedural issues, such as assessment procedures, certification, implementation, enforcement, technical files, declarations, CE marking, and other basic concepts. Examples of primary directives are the Low-Voltage, Machinery, and EMC directives. The General Product Safety and Product Liability Directives are basic directives dealing with enforcement and civil prosecution that are applied to all products. The directives also mandate the publication and mutual recognition of harmonized standards. 

European directives are laws that manufacturers must meet before affixing the CE marking to products. The directives are identified with the year and identifier number such as 85/375/EEC for the Product Liability Directive, which was published in the Official Journal on August 7, 1985. Most directives are adopted at a later date, within a specified time limit. For example, article 19 of the Produet Liability Directive 85/375/EEC states that this directive must be brought into force by the member states within three years. 

Basic directives (type A). The basic directives apply to all manufacturers of products and address trade, enforcement, liability, and other issues. It is important to understand the implication of these directives, especially concerning enforcement against product manufacturers. Examples of the basic directives are CE Marking, Conformity Assessment, General Product Safety, and Product Liability. Products, components, and materials not covered by Type B or C directives must still be safe according to the General Product Safety Directive (e.g., comply with standards). 

Any decision taken by virtue of this directive shall be without prejudice to Product Liability directive 85/374/EEC and without prejudice to the assessment of the liability of the party concerned, in the light of the national criminal law applying in the case in question (see Product Liability). 

Since the Product Liability Directive was implemented, a trend toward American-style liability has resulted and civil lawsuits are on the rise in Europe. 

Directive 85/374/EEC concerning Liability for Defective Products (Product Liability Directive) was enacted in 1987 to protect consumers from defective... 

---