Pharmaceutical Product Licensing: Requirements For Europe by A. C. Cartwright

By A. C. Cartwright

Presents a scientific account of the foremost technical, administrative and criminal requisites for registering a product in any of the nationwide markets in the EEC, utilizing the present systems, with information as to how those approaches are inclined to switch after 1992.

Show description

Read Online or Download Pharmaceutical Product Licensing: Requirements For Europe (Ellis Horwood Books in the Biological Sciences) PDF

Similar administrative law books

Reforming the French Law of Obligations: Comparative Reflections on the Avant-Projet De Reforme Du Droit Des Obligations Et De La Prescription, ('the Avant-projet ... Institute of European and Comparative Law)

The 2005 Avant-projet de r? forme du droit des responsibilities et de l. a. prescription — additionally dubbed the Avant-projet Catala — indicates the main far-reaching reform of the French Civil Code because it got here into strength in 1804. It stories important facets of agreement legislations, the legislation of delict, and the legislation of unjustified enrichment.

NGOs in International Law: Efficiency in Flexibility?

The expanding function that NGOs play at varied degrees of felony relevance - from treaty-making to rule implementation, and from help to judges to help supply - demands reconsideration of the overseas felony prestige of these firms. This ebook exhibits that the measure of flexibleness presently loved by way of NGOs in fields as diversified as human rights, the surroundings and the eu Union improvement cooperation coverage constitutes the simplest enviornment for all actors concerned, with the implications that the cases the place extra strict law of NGOs participation is fascinating are very restricted.

European Competition Law Annual 2000: The Modernisation of EU Competition Law

The ecu festival legislation Annual 2000 is 5th in a chain of volumes following the once a year Workshops on european pageant legislations and coverage held on the Robert Schuman Centre of the eu college in Florence. the current quantity reproduces the fabrics of a roundtable debate that happened on the EUI in June 2000 between senior representatives of ecu associations, well known lecturers and overseas felony specialists within the box of antitrust at the proposals made by way of the eu fee for the reform and decentralization of EC antitrust enforcement.

Public Secrets: A Study in the Development of Government Secrecy

W 0000000000000 0000000000 0000000000000

Extra info for Pharmaceutical Product Licensing: Requirements For Europe (Ellis Horwood Books in the Biological Sciences)

Example text

Volume I is the text of the Directives. For convenience these have been collated so that the texts of the later amendments replaces the original texts. An unofficial Addendum has been published in October 1989 containing the texts of the socalled ‘extension Directives’. These are described in Chapter 21. This five-volume set of texts forms part of the essential library for the researcher, the research and development pharmacist, the toxicologist, the pharmacologist, and the clinician engaged in organising clinical trials.

In other EC Member States (such as the UK) the registration committees (such as the CSM) are advisory, although in practice their advice is very seldom disregarded. In the Federal Republic of Germany the first German Drug Law of 1961 (AMG 1961) set up the Federal Health Office (Bundesgesundhheitsamt), made manufacture of products approvable by the authorities in the Länder (local authorities), and made registration of proprietary products obligatory. SchmittRau (1988) summarised the changes made by the Drug Law of 1976.

Any new medicinal product (such as the Massengill sulfanilamide elixir) could not be marketed until the FDA approved it as safe. 4 Thalidomide In 1946, the West German soap and cosmetic company of Dalli-Werke, Mäurer, and Wirtz formed a new pharmaceutical subsidiary named Chemie Grünenthal. In 1956 Grünenthal test marketed a combination product called Grippex containing thalidomide in Hamburg. This product was indicated for the treatment of respiratory infections. In 1957 thalidomide tablets were marketed in West Germany under the trade mark Contergan.

Download PDF sample

Rated 4.05 of 5 – based on 13 votes