European Union, licensing

The company has a legal obligation to report all suspected serious ADRs occurring in the European Union to the Licensing Authority within 15 days of the receipt from any health professional. Serious and unexpected suspected ADRs are required to be reported from outside the EU within 15 days of receipt from health professionals. All other ADRs should be reported in the periodic safety updates. 

Hemp is the common name for Cannabis sativa cultivated for industrial (nondrug) use. Licenses for hemp cultivation are issued in the European Union and... 

In the European Union, drugs may be licensed in three ways ... 

Patents and the patenting system represent the orderly system of public documents used in most parts of the world to handle much of this kind of information. Patent protection is of substantial importance to chemical as well as other companies. Patents must be applied for in each country or region (e.g., the European Union) for which protection is desired. Otherwise, the subject of a patent may be practiced and the product sold without license in any country in which this precaution has not been taken. Composition of matter patents, which relate primarily to newly discovered chemical compounds, are issued on successful application by an inventor (individual or company). Utility (i.e., some type of useful function of the compound) must be demonstrated before a patent application of this type can be filed. In return this class of patent provides the best kind of protection for a new compound because the compound itself is protected from its sale by others for the 17- to 20-year life of a patent, regardless of the synthetic route developed to produce it. 

There is reasonable similarity across the countries of the European Union (EU), and these labels are collated into national compendia such as the Rotte Liste in Germany or the Data Sheet Compendium in the UK, to which the reader is referred. Consistency between countries is likely to increase now that drug licensing has been centralized at the European Medicines Evaluation Agency (EMEA). Many of the headings within European labeling correspond to those shown for Japan (Table 31.1, above), and the USA. 

The Council of the European Union, 2004, Directive 2004/49/EC of the European Parliament and of the Council of 29 April 2004 on safety on the Community s railways and amending Council Directive 95/18/EiC on the licensing of railway undertakings and Directive 2001/14/EC on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety certification (Railway Safety Directive) . 

Compassionate use is a treatment option that allows the use of an unlicensed medicine. Compassionate use programmes are for patients in the European Union (EU) who have a disease with no satisfactory authorised therapies or cannot enter a clinical trial. They are intended to facilitate the availability to patients of new treatment options under development. To qualify for a compassionate use programme, the manufacturer calls on the national authorities for permission. The manufacturer must submit a request for the granting of a marketing authorisation or he must perform research in the context of a research programme with a cohort. Compassionate use procedures are also applicable for unlicensed medicines withdrawn from the market or for off-label use of licensed medicines. 

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