http://www.legislation.gov.uk/uksi/1995/2808/schedule/2/paragraph/5/made
The Medicines (Exemption from Licences) (Clinical Trials) Order 1995
Medical research
Health care services and specialisms
King's Printer of Acts of Parliament
2017-05-04
MEDICINES
This Order and the Medicines (Exemption from Licences and Certificates) (Clinical Trials) Order 1995 (S.I.1995/2809), which comes into force immediately after this Order came into force, together effect the revocation and replacement of the Medicines (Exemption from Licences) (Clinical Trials) Order 1981 (“the 1981 Order”). The 1981 Order granted, in respect of medicinal products for use in clinical trials, exemption from restrictions imposed by Part II of the Medicines Act 1968 (“the Act”) on certain dealings in medicinal products without product licences or clinical trial certificates. The 1981 Order specified conditions subject to which the exemption applied, and provided for the termination of the exemption in specified circumstances.
The Medicines (Exemption from Licences) (Clinical Trials) Order 1995
Order
The Medicines for Human Use (Clinical Trials) Regulations 2004
Sch. 11
reg. 1
SCHEDULE 2INFORMATION TO BE CONTAINED IN USAGE GUIDELINE
5
A description of how safety will be monitored during the clinical trial.