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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.
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relates to medicinal products for human use in mainly countries that are part of the European Union. [1]
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
EudraGMP is the database of the European Community of manufacturing authorisations and of certificates of good manufacturing practice.The EudraGMP system was launched in April 2007, for use by European Medicines Regulators.
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 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.
Dakin's solution is a dilute solution of sodium hypochlorite (0.4% to 0.5%) and other stabilizing ingredients, traditionally used as an antiseptic, e.g. to cleanse wounds in order to prevent infection. [1] The preparation was for a time called also Carrel–Dakin solution or Carrel–Dakin fluid. [2]