Search results with tag "Human use"
The Medicines for Human Use (Clinical Trials) Regulations …
www.legislation.gov.ukThese Regulations may be cited as the Medicines for Human Use (Clinical Trials) Regulations 2004 and shall come into force on 1st May 2004. 4 Interpretation 2.—(1) In these Regulations— “the Act” means the Medicines Act 1968(a); “adult” means a …
Medicines for Human Use: POM, P, GSL & General …
www.psni.org.uk1 Medicines for Human Use: POM, P, GSL & General Pharmacy Regulations General Legal Requirements A guide for pharmacists in Northern Ireland 2010 Edition
The Medicines for Human Use (Clinical Trials) Regulations …
www.legislation.gov.ukSTATUTORY INSTRUMENTS 2004 No. 1031 MEDICINES The Medicines for Human Use (Clinical Trials) Regulations 2004 Made - - - - 31st March 2004 Laid before Parliament 1st April 2004
The Medicines for Human Use (Clinical Trials) Amendment ...
www.legislation.gov.ukSTATUTORY INSTRUMENTS 2006 No. 1928 MEDICINES The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 Made - - - - 13th July 2006
Detailed guidance on the application format and ...
ec.europa.eumedicinal product for human use to the competent authorities in the European Union, notification of substantial amendments and the declaration of the end of a clinical trial’2, in several cases. The application form for the request for the start of the clinical trials, the notification of the
REGULATION (EU) No 536/•2014 OF THE EUROPEAN …
ec.europa.euadministrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34).
European Medicines Agency Policy Publication Clinical Data ...
www.ema.europa.eu3 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. European Medicines Agency policy on publication of
Annex 2 Recommendations for inactivated rabies …
www.who.int84 Introduction The last revision of the requirements for rabies vaccines for human use was in 1980 (1).However, an additional document, WHO Requirements