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Countdown to the End of the 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 UK eCTD publishing requirements in a post-Brexit world, our next regulatory topic is the anticipated post-transitional arrangements of medicinal products approved via

By |2020-12-10T11:11:49+00:00August 3rd, 2020|Compliance and QMS Services|0 Comments

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’ substances in the medicinal product that are added in addition the drug substance

By |2021-08-04T10:25:11+00:00July 10th, 2020|Compliance and QMS Services|0 Comments

Brexit Strategy Legal Presence Requirements in UK

Legal presence requirements in UK The transition period was not extended at five minutes to midnight on 30 June 2020. In theory the UK and EU may negotiate an agreement which means that all the previously published MHRA requirements listed for a “no deal” Brexit may not be needed at the end of the

By |2021-08-04T10:25:54+00:00July 2nd, 2020|Compliance and QMS Services|0 Comments

Making sense of the regulatory landscape in the UK and Europe

This year marks the 10-year anniversary since eCTD became mandatory for all submissions to the EMA for Centrally Authorised Products, meaning all these products have eCTDs hosted by the EMA. After the transition period on the 31st December 2020, the MHRA will not be able to access these eCTDs anymore, meaning new baseline sequences will

By |2021-08-04T10:26:47+00:00June 23rd, 2020|Compliance and QMS Services|0 Comments