We are living in a fast moving regulatory environment which has to address advances in products & technology, changing practices, safety issues, global markets and much more.
Not keeping up with these changes can present a threat to the compliancy of your organisation.
Below are just a few new documents that are now available, f you need help with compliance or just a better understanding of their content and how you are affected, PCL can help. Please call +44(0) 1252 302 342
4th July, 2014
2014 – Updated guidance notes 5 & 6
The issue of two MHRA updated guidance notes have followed the consolidation of the Human Medicines Regulations and the Falsified
Medicines Directive. These notes are aimed at existing and new Manufacturers, Distributors and Brokers of medicinal products.
Guidance note 5: Notes for applicants and holders of a manufacturer’s licence
Guidance note 6: Notes for applicants and holders of a wholesale dealer’s licence (WDA(H)) or broker registration
10th June, 2014
2014 – Reclassification of Tramadol
The reclassification of Lisdexamfetamine, Tramadol, Zaleplon, Zopiclone and Ketamine came into force. Companies who possess, supply
or produce these products or products containing these substances now need to obtain the correct licences from the Home Office
http://www.legislation.gov.uk/uksi/2014/1106/contents/made
May 27th, 2014
2014 – EU Clinical Trials Regulation
New EU Clinical Trials Regulation published and will apply from 28th May 2016 (unless the IT infrastructure that underpins it
is not ready) and will replace the current EU Clinical Trials Directive
http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1401366187088&uri=OJ:JOL_2014_158_R_0001
6TH May, 2014
2014 – Updated guidance note 14
The issue of the updated MHRA guidance (Guidance note 14) on the supply of unlicensed medicines (specials). The guidance note provides
advice on the manufacture, importation, distribution and supply of specials.
http://www.mhra.gov.uk/home/groups/is-lic/documents/publication/con413520.pdf