Pharmaceutical production, Europe

Applications. These materials are stiU in developmental infancy. Current production is limited to one commercial process in Europe and a demonstration-scale process in North America. The lignins produced in these processes have potential appHcation in wood adhesives, as flame retardants (qv), as slow-release agents for agricultural and pharmaceutical products, as surfactants (qv), as antioxidants (qv), as asphalt extenders, and as a raw material source for lignin-derived chemicals. 

Uses of oxalic acid ia each region are summarized in Table 5 (58). The demand for agrochemical/pharmaceutical production and for separation/recovery of rare-earth elements in each region has been increasing. The use for marble polishing in western Europe is unique to the region. 

Cartwright AC. Introduction and history of pharmaceutical regulation. In Cartwright AC, Matthews BR, eds. Pharmaceutical Product Licensing. Requirements for Europe. Chichester EUis Horwood, 1991 29 5. 

FIGURE 9 Simulation network for distributed pharmaceutical manufacturing systems and their warehouses in U.S., Europe, India, and Asia. Model focuses on information and data management, the way the servers can cope with the task of tracking pharmaceutical product, and RFID data on a world wide basis. As a modeling tool we use OPNET, a professional network simulation tool. 

Cartwright Matthews PHARMACEUTICAL PRODUCT LICENSING Requirements for Europe... 

In Europe, regulatory exclusivity is more complex. More specifically, the countries may choose between a 10 year or 6 year period. According to European Community Directive 87/21, the national states can protect pharmaceutical products for 6 or 10 years from first marketing approval in the European Community. An exception to this is biotech products for which a 10 year period applies for all European countries. The countries that have chosen 10 or 6 years are presented in Table 3. 

In subsequent years, a number of guidance documents related to stability of pharmaceutical products have been issued. The guidance documents are based on the concept of climatic zones (1). There are four zones based on Mean Kinetic Temperature and Mean Annual Relative Humidity (RH) Zone I (temperate climate), e.g., Canada and Northern European, Zone 11 (subtropical), e.g., the United States and Southern Europe, Zone III (hot and dry), e.g.. Egypt and Zone IV (hot and humid), e.g., Brazil. The United States, Europe, and Japan are all in Zones I and II so the ICH guidelines are applicable for these zones. 

The vinylpyrrohdone-vinyl acetate copolymer has been used by the pharmaceutical industry in Europe for decades [101,114,231,409]. Up to about 1975, it was sold in this sector under tradenames, which are now used exclusively for the techni-cal/cosmetic grade of this copolymer. This is why many older publications often mention one of these tradenames (e.g. Luviskol VA64) for use in pharmaceutical products. 

An auxiliary such as povidone, crospovidone or copovidone cannot be registered as such by the authorities for use in pharmaceutical products. In Europe, Japan or America, it is always only possible to register a finished drug. There is no general positive or negative list of auxiliaries used in pharmaceuticals. It is only possible to state in which countries pharmaceuticals that contain povidone, copovidone and/or crospovidone are registered. 

Aluminum toxicity has also been linked with oral exposure as a result of Al-containing pharmaceutical products such as Al-based phosphate binders or antacid intake. As over-the-counter antacids are an important source for human Al exposure from a quantitative point of view, patient information leaflets in Europe contain warnings of possible Al toxicity. ... 

At the national level within Europe, the situation becomes yet more complicated for both regulatory and less tangible, cultural reasons. Each member state has a National Competent Authority (NCA) regulating pharmaceutical product price, label and distribution. Each NCA can mandate product withdrawal within its boundaries, and notify others about its concerns. But such a decision is never binding in any other part of the EEA, and there is certainly no obligation for one member state to implement a risk management program that has been mandated at the national level elsewhere. 

Examples of International disharmony. The examples of diacetylmorphine and thalidomide (see above) are examples of pharmaceutical products that are available either only in Europe or only in the United States, respectively. Within Europe, the existence of National Competent Authorities provides further scope for nonuniform risk management plans. 

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. 

It was through this series of, now codified, Directives that a Europe-wide Committee for Proprietary Medicinal Products was created, now known as the Committee for Medicinal Products for Human Use (CHMP). Its role is significant. In conjunction with the European Medicines Agency (EMEA) established in February 1995, which it advises, it is responsible for overseeing the procedures established for the regulatory harmonization of pharmaceutical products throughout Europe, namely ... 

Pharmaceuticals (Directive 65/65/EEC). The EMEA in Europe is responsible for the registration of new pharmaceutical products placed on the market after 1993. In England and Wales the Medicines Control Agency is responsible for licensing... 

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