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EudraLex consists of 10 volumes: Concerning Medicinal Products for Human use: Volume 1 - Pharmaceutical Legislation. Volume 2 - Notice to Applicants. Volume 2A deals with procedures for marketing authorisation. Volume 2B deals with the presentation and content of the application dossier. Volume 2C deals with Guidelines. Volume 3 - Guidelines.
The Clinical Trials Directive (Officially Directive 2001/20/EC of 4 April 2001, of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use) is a European Union directive that aimed at ...
The requirement for QP oversight has been extended to material for use in clinical trials since the introduction of EU Directive 2001/20/EC. In countries that are part of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), the same role may be termed responsible person ( RP ) or authorized person ...
While each document (and each language version) is an individual part of the database, the content is grouped into sectors. There are currently 12 sectors, each represented by a number or a letter: [10] 1 - Treaties; 2 – International agreements; 3 – Legal acts; 4 – Complementary legislation; 5 – Preparatory documents; 6 – Case-law
The Poisons Standard organises substances into 10 schedules (and unscheduled substances), [10] therapeutic goods are generally organised only into schedules 2, 3, 4 and 8: unscheduled substances: unscheduled substances are available for purchase at any retailer. schedule 1 (S1) - Blank: this schedule is left intentionally blank.
A 1:20 solution is isotonic with body fluids. 1:4 dilution is used for wound management applications; this contains 0.25% (w/v) available chlorine and has a pH of 10.5–11.2 . [ 1 ] [ 2 ] The fluid has been used in endodontics , for example to irrigate an infected root canal , although it is not medically licensed for use in the mouth.
A regulation is a legal act of the European Union [1] which becomes immediately enforceable as law in all member states simultaneously. [ 2 ] [ 3 ] Regulations can be distinguished from directives which, at least in principle, need to be transposed into national law .
Neutrolin is an anti-microbial catheter lock solution developed by Cormedix/Cormedix GmbH. Neutrolin contains heparin and citrate (1000 U/mL and 3.5% respectively [1]), two compounds commonly used to prevent thrombosis and maintain catheter patency. Other brand names include Citra-Lock and Taurolock.