As the first year of GB being outside of the European regulatory system, draws to a close, we wish to remind our clients and holders of Centrally Authorised Products (CAP, also known as grandfathered MAs) that action is required before 31 Dec 2021.
The deadline for submitting the initiating sequence is fast approaching, as all marketing authorisation holders have until the 31st December 2021 to submit the data for converted EU licences valid in Great Britain. Our Regulatory team have captured the key changes and that need to be taken and the associated timelines in a helpful video.
A regulatory submission is the process through which your company provides information to the regulatory authorities for review, whether this is for a new product you want to launch or for maintenance of an existing one.
The development of your regulatory strategy, aligned to your commercial strategy, is the principle activity you need to establish to deliver the business goals for your company. It is the glue that binds together development, commercial and regulatory aspiration.
JensonR+ Ltd Head of Regulatory, Janet Worrell shares some of her team's collective thoughts on sustainability and their efforts to help make the place we live in, a little better.
The Regulatory team at JensonR+ have been considering the changes to European MR/DC Procedures for medicines following the end of transition period and offer some guidance in this helpful video
The Regulatory team at JensonR+ present details on important information concerning the end of the transition period on the 31st December in this video.
Thank you - This is a very short post to say thank you to Medilink EM colleagues for making our virtual networking event fun and forcing the technology to bend to our will rather than cause chaos.
Medicines Management in Professional Sport One aspect of taking the plunge and being a freelance regulatory consultant, is the opportunity to explore new ideas and concepts. Especially when you decide to decide to run 3 networking events a year and need to embrace and use all of your networking skills repeatedly. I am pleased [...]
CBD and the latest developments. Our last Special interest Group (SIG) of the year is all about Cannabidiol (CBD). Its been an explosive new kid on the block. Within the space of a couple of years, CBD ingestibles have transitioned from a lightly regulated consumer product to potentially being classified as a narcotic and [...]
