MHRA issued guidelines on Reference Medicinal Products (RMPs) from 1 January 2021

Reference Medicinal Products (RMPs) from 1 January 2021

From 1 January 2021 reference medicinal products will have to fall within the definition in regulation 48 of the Human Medicines Regulations 2012. It is our intention to update these Regulations to reflect the change of implementation dates following the Transition Period. Data and market exclusivity period entitlements for reference medicinal products approved before 1 January 2021 will continue to apply in the UK.

This guidance will apply from 1 January 2021 in line with the Human Medicines Regulations (Amendment etc.) (EU Exit) Regulations 2019. For Northern Ireland, the definition of a RMP in regulation 48 of the Human Medicines Regulations 2012 should comply with relevant EU legislation. Applicants seeking UK-wide marketing authorisations will be required to comply with requirements applicable in Northern Ireland.

Source: MHRA guideline on Reference Medicinal Products (RMPs) from 1 January 2021

What our Clients Say?

We have had a good impression of Freyr and feel more than comfortable telling our partners that we are engaging with Freyr for our Regulatory needs. The project went very smoothly, and at a reasonable pace. The team was knowledgeable, friendly and accommodating. Rapid response appreciated. Keep up the good work.

Director, Regulatory Affairs,

US based leading precision medicine company

Speed of service, responsiveness, attention to our needs, quality of product, and price are all very important and I felt they were very good in our work with Freyr. Service was delivered appropriately and in a timely fashion. Thankful to Freyr’s responsive team because of which we could comprehend our unusual needs. I thought the support was very good and met with expectations. In addition, found the price reasonable given the workload.

Director, Regulatory Affairs,

US based leading precision medicine company

You have exceeded our expectations as a team and individuals! Special thanks for all the prepared technical documentation!! What an effort team! Again, many thanks for all the work and efforts put into this, moving forward positively. Thank you for your consistency, perseverance, and amazing teamwork at Freyr. we would like to express our gratitude to the Freyr team for all the great work and expertise that they have brought to the project to make it a success!

Regulatory Affairs Officer

A Global Industry Leader in Medical Device Design and Manufacturing

Thank you so much Freyr team for your support on the way in registering 3 of our medical devices in Philippines.
I hope this achievement will open numerous business opportunities for both Freyr and our company to work in synergy.

Associate, Regulatory Affairs Team II,

Clinical & Regulatory Affairs Center,
A Korean Chemical Company

Thank you very much for the support. A regulatory requirement to submit a safety report and obtain an accession number was a totally new process for us and we had plenty of doubts especially when having strong comments from other internal departments.
Freyr has successfully obtained the accession number within a short timeline. That’s what is really important and gratifying. Thank you again and keep up the excellent work!

Manager, Regulatory Affairs

A Spanish Medical Devices Manufacturer

The team has always been very professional and supportive with our projects and inquiries. Communication was always timely. Knowledge of regulations, open communication, timely follow ups with my team and professionalism. What I wanted to add as a strength yet did not; was the ability to work without sleep. I feel you all work around the clock as you are very responsive on our questions any time of day ?

Director, Regulatory Affairs

US based top Sterilization company

Reference Medicinal Products (RMPs) from 1 January 2021

Insights

Blogs

White Papers

Case Studies

What our Clients Say?

Director, Regulatory Affairs,

Director, Regulatory Affairs,

Regulatory Affairs Officer

Associate, Regulatory Affairs Team II,

Manager, Regulatory Affairs

Director, Regulatory Affairs

Get in Touch

USA

UK

GERMANY

INDIA

More Locations

Quick Inquiry

Reference Medicinal Products (RMPs) from 1 January 2021

Insights

Blogs

White Papers

Case Studies

What our Clients Say?

Director, Regulatory Affairs,

Director, Regulatory Affairs,

Regulatory Affairs Officer

Associate, Regulatory Affairs Team II,

Manager, Regulatory Affairs

Director, Regulatory Affairs

Subscribe to Our Newsletter

Get in Touch

USA

UK

GERMANY

INDIA

More Locations

Quick Inquiry