Ben Smith, Author at JensonR+ Ltd - Your Strategic Solution

International Recognition Procedure
International Recognition Procedure

International Recognition Procedure

Ben Smith2023-09-05T14:08:47+01:00September 5th, 2023|

From 1st January 2024, the MHRA will be introducing new International Recognition Procedures (IRP) for marketing authorisations in the UK for both new and generic medicines. These recognition procedures will absorb the existing EU recognition procedures; the EC Decision Reliance Procedure (ECDRP) and the Mutual Recognition/Decentralised Reliance Procedure (MRDCRP), as well as introduce new recognition procedures for medicines authorised by the MHRA’s specified Reference Regulators (RR).

JensonR+ team attending Nicholas Hall European Conference
JensonR+ team attending Nicholas Hall European Conference

JensonR+ team attending Nicholas Hall European Conference

Ben Smith2023-06-09T10:34:37+01:00April 12th, 2022|

Janet Worrell and Ben Smith from our Regulatory team are looking forward to participating in Nicholas Hall’s 32nd European CHC Conference to be held in Athens on 5th & 6th May.

Supply of Medicines into Northern Ireland – new guidance part 1
Supply of Medicines into Northern Ireland – new guidance part 1

Supply of Medicines into Northern Ireland – new guidance part 1

Ben Smith2023-06-09T10:39:07+01:00February 15th, 2022|

Following the MHRA Medicines Supply to Northern Ireland Webinar at the start of February, the JensonR+ team have created a summary of the key changes and impacts for industry for medicinal products.

Nutraceuticals, a new product sector for the UK?
Nutraceuticals, a new product sector for the UK?

Nutraceuticals, a new product sector for the UK?

Ben Smith2023-06-09T10:51:29+01:00July 9th, 2021|

Last month, the Taskforce on Innovation, Growth and Regulatory Reform (TIGRR) report was published, giving its recommendations to the Prime Minister on how the UK can reshape its approach to regulation and seize new opportunities from Brexit.

Overview of the latest MHRA Post-Transition Guidance
Overview of the latest MHRA Post-Transition Guidance

Overview of the latest MHRA Post-Transition Guidance

Ben Smith2023-06-09T11:00:20+01:00October 20th, 2020|

JensonR+ Regulatory Officer, Ben Smith talks through a bitesize overview of the latest MHRA Post-Transition Guidance in this helpful video.

A year at JensonR+
A year at JensonR+

A year at JensonR+

Ben Smith2023-06-09T11:01:23+01:00October 13th, 2020|

It's been a year since Ben Smith, our Regulatory Officer joined the JensonR+ team and we thought it would be interesting to have a catch up with him and see how his work life has evolved over the last 12 months.

CAP Grandfathering
CAP Grandfathering

CAP Grandfathering

Ben Smith2023-06-09T11:01:52+01:00October 1st, 2020|

BREXIT will affect the pharmaceutically industry greatly and with an exit date of 31/12/2020 it is important that you are aware of all the changes that will take place - there are a lot of important dates and pressure points that you need to be aware of.

150 Days to the End of the Transition Period: A Focus on Centrally Authorised Products
150 Days to the End of the Transition Period: A Focus on Centrally Authorised Products

150 Days to the End of the Transition Period: A Focus on Centrally Authorised Products

Ben Smith2021-01-12T13:46:14+00:00August 3rd, 2020|

150 Days to the End of the Transition Period: A Focus on Centrally Authorised Products Today marks 150 days until the end of the UK-EU transition period; on the 1st January 2021 the UK will no longer be in the EU single market and customs union. Following on from our post about the possible [...]

EMA soon to publish updated guidance on Nitrosamine Impurities
EMA soon to publish updated guidance on Nitrosamine Impurities

EMA soon to publish updated guidance on Nitrosamine Impurities

Ben Smith2021-01-12T13:46:21+00:00July 20th, 2020|

EMA soon to publish updated guidance on Nitrosamine Impurities The EMA’s human medicines committee (CHMP) has now issued an opinion regarding the maximum limits of nitrosamines in medicines and the measures required by pharmaceutical companies to reduce the presence of these carcinogenic impurities. As captured in our 2019 posts regarding nitrosamines and the considerations [...]

Deadline Looms for the Safe Labelling of Excipients in Medicines
Deadline Looms for the Safe Labelling of Excipients in Medicines

Deadline Looms for the Safe Labelling of Excipients in Medicines

Ben Smith2021-01-12T13:46:35+00:00July 10th, 2020|

Deadline Looms for the Safe Labelling of Excipients in Medicines In October 2017, the EMA and European Commission updated the annex to excipient guidelines for new safety advice of 15 excipients and the three-year timeline to implement the change is nearly over. Excipients are considered to be the ‘inactive’ [...]

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