Over the course of August 2018, Biotherapy Services Ltd. (BTS) were awarded an MIA : IMP License. This was granted by the Medicines & Healthcare products Regulatory Agency (MHRA) as a recognition of the RAPID1-DFU Trial. Being the recipient of this prestigious license was a great motivator to pursue the work we are doing!


At the same time, the MHRA also awarded BTS with a Specials (MS) license, for the manufacture of Unlicensed Medicines. With RAPID Gel being an Investigational Medicinal Product in a Stage 2b development phase, its application is limited within the scope of the Clinical Trial. However, due to the high, unmet “special” clinical need surrounding Chronic Wounds, the MHRA recognised the potential of RAPID Gel and therefore approved its use As a response to an unsolicited order.


MIA : IMP License


All Clinical Trials conducted in the UK need ethical approval and authorisation from the MHRA.

The stamp of approval comes in the form of a Manufacturer’s / Importation Authorisation (MIA). An additional layer of control is added when dealing with Investigational Medicinal Products (IMP). This is to ensure that the investigational trial is conducted to Good Clinical Practices (GCP) throughout the entire process.

The manufacture and import of IMPs is detailed in the following regulatory documents:

  • EudraLex Vol. 4: Good Manufacturing Practice (GMP) guidelines.
  • EudraLex Vol. 10: Clinical Trial guidelines.

On the 08th November 2018, the MHRA and the Research Ethics Committee (REC) gave BTS their approval to commence the RAPID1-DFU Trial.

MS License


Unless exempt, a medicinal product must be the subject of a marketing authorisation or product licence before being placed on the market.

Regulation 167 of the Human Medicines Regulations 2012 provides an exemption from the need for a marketing authorisation for a medicinal product which is supplied:

  • in response to an unsolicited order;
  • manufactured and assembled in accordance with the specification of a person who is a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber;
  • for use by a patient for whose treatment that person is directly responsible in order to fulfil the special needs of that patient; and meets the conditions specified in regulation 167(2)-(8).

The approval of an MS to the RAPID Gel gave BTS the authority to treat patients who may not qualify for the RAPID-1DFU Trial. For a treatment to happen, as mentioned above, a registered and approved Healthcare Professional needs to prescribe a course of RAPID Gel therapy.