Pharmaceutical legislation

EU Pharmaceutical legislation on CD http //ec.europa.eu/enterprise/pharmaceuticals/eudralex/homecd.htm... 

With respect to development pharmaceutics data, the requirements stated in Directive 75/318/EEC (as amended) are included in the Annex to that document at Part 2 A 4 (page 20 of the Rules Governing Medicinal Products in the European Union, Volume 1, Pharmaceutical Legislation Medicinal Products for Human Use). With respect to the general requirement for pharmaceutical products this states 4.1 An explanation should be provided with regard to the choice of composition, constituents and container and the intended function of the excipients in the finished product. This explanation shall be supported by scientific data on development pharmaceutics. The overage, with justification thereof, should be stated. This, then, is the legal requirement. Needless to say, there is a... 

Rules Governing Medicinal Products in the European Union, Volume 1, Pharmaceutical legislation— Medicinal products for human use Commission of the European Communities, Luxembourg, 1998... 

Devolution of the implementation of pharmaceutical legislation to several autonomous communities (Catalonia, Navarre, Canaries, Galicia, and Castile and Leon)... 

The foundation of European pharmaceutical legislation is Directive 65/65/EEC [1], which, when it was promulgated in 1965, applied only to the initial six member states. In this directive, the definition of a medicinal product is given and the data required to obtain approval are described. This original directive has been continually updated, amended, and supplemented with subsequent legislation, but remains the basis of pharmaceutical legislation. 

Further modifications to advertising. Articles 86-100 of the EU Pharmaceutical Legislation Review 2001, now consolidated, do not even mention the internet. Should the proposals be accepted, the term advertising of medicinal products will in future include the phrase awareness of the availability of such products. This will, by implication, include the internet. The MHRA has published advice on advertising... 

It is now a well-known theme in European pharmaceuticals legislation that the use of animals should be minimised as far as possible ... 

After a product has been authorised, the regulatory system operates to keep the quality, safety and efficacy of that product under review and to control the way in which it is manufactured, marketed and distributed. The pharmaceutical legislation in Europe has recently been consolidated and, pursuant to Commission consultation and review, amended. The majority of the amendments are due to come into effect in November 2005. What follows, reflects the state of legislation as at close of 2004. 

For the marketing authorisation ( MA ) holder, there are numerous obligations and conditions attaching to the authorisation and, as with all authorisations held under pharmaceutical legislation, failure to comply will give rise to the imposition of regulatory sanctions. Enforcement measures are pursued at local level. 

As a matter of law, there is very little in the European pharmaceutical legislation... 

Volume 1 Pharmaceutical Legislation Volume 2 Notice to Applicants... 

The definition of a medicinal product has been changed following the recent review of the EU pharmaceutical legislation (Directive 2004/27/EC). The new definition states that to be a medicine a product must be ... 

As will be discussed later, following a comprehensive review of European pharmaceutical legislation. Directive 2001/83/EC was further amended extensively by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004. 

Following extensive discussions among aU interested parties, such as the national authorities, the EC and the European Federation of Pharmaceutical Industries and Associations (EFPIA), the EC proposed comprehensive reform of the EU pharmaceutical legislation. The amending legislations are ... 

The reader may be interested to know that it is possible to create one s own CD with the whole pharmaceutical legislation (human and veterinary) and an integrated search engine. The CD is similar to the EudraLex section of the web site, but clearly has the advantage of off-hne use. All the documents are in PDF format and without protection. 

Richmond, Lesley, Julie Stevenson and Alison Turton, eds. The Pharmaceutical Industry A Guide to Historical Records. Aldershot, Hampshire, England Ashgate, 2003. This guide facilitates the study of the pharmaceutical industry in Britain by providing information on the location of archives and company records. Few will want to examine the archives, but the book also includes brief histories of some companies, a chronology of pharmaceutical legislation, and essays by experts on the history of the industry. The material on Britain shows both similarities and differences to the history of the pharmaceutical industry in the United States. 

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