14 January 2020, London. EMMAC Life Sciences Group, Europe’s leading independent cannabis company, is pleased to announce its wholly owned subsidiary, Rokshaw Laboratories, a leading UK based manufacturer of medicinal specials, has secured regulatory approval for a Manufacturer’s Authorisation for Investigational Medicinal Products MIA (IMP) license from the Medicines and Healthcare Products Regulatory Agency (MHRA).
The Manufacturer’s Authorisation for IMPs is an EU requirement for the production of material for patient use in clinical trials. The license enables Rokshaw to manufacture, import and label investigational medicinal products for use in clinical trials.
The requirements and procedures for clinical trials in the UK are set out in the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended). These regulations require all interventional clinical trials to be authorised by the MHRA and ethically approved. They also include requirements for the application and assessment of each trial, the supply of investigational medicinal products (IMPs), the conduct of clinical trials in accordance with Good Clinical Practice and safety reporting.
Barbara Pacchetti, Chief Scientific Officer of EMMAC, commented: “As a company committed to scientific research in the field of medicinal cannabinoids we are extremely pleased that Rokshaw continues to develop its capabilities in line with our objective to deliver clinical data around cannabis based medicines. Furthermore the IMP approval allows Rokshaw to supply products to Imperial College whom we are partnered with to conduct clinical research on the effects of cannabinoids in post-operative pain, nausea and vomiting, as part of our research program to advance the understanding of the medical benefits of cannabis.”
About EMMAC Life Sciences Group
EMMAC Life Sciences Group is Europe’s leading independent cannabis company, bringing together pioneering science and research with cutting-edge cultivation, extraction and production. With a unique supply and distribution network throughout Europe, EMMAC’s vision is to bring the life-enhancing potential of cannabis to the people who need it.
All statements, other than statements of historical fact, in this news release are forward-looking statements that involve various risks and uncertainties, including, without limitation, statements regarding potential values, the future plans and objectives of EMMAC Life Sciences Group. There can be no assurance that such statements will prove to be accurate, achievable or recognisable in the near term.
Actual results and future events could differ materially from those anticipated in such statements. These and all subsequent written and oral forward-looking statements are based on the estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. EMMAC Life Sciences Group assumes no obligation to update forward-looking statements should circumstances or management’s estimates or opinions change.