Life sciences glossary O–P

The following Life Sciences practice note provides comprehensive and up to date legal information covering:

  • Life sciences glossary O–P
  • Officinal formula
  • Off-label
  • Originator
  • Orphan drug
  • Orphan medicinal product (OMP)
  • Over the counter (OTC) medicine
  • Periodic safety update report (PSUR)
  • Personalised medicine
  • Pharmaceutical Research and Manufacturers of America (PhRMA)
  • More...

Life sciences glossary O–P

IP COMPLETION DAY: 11pm (GMT) on 31 December 2020 marks the end of the Brexit transition/implementation period entered into following the UK’s withdrawal from the EU. At this point in time (referred to in UK law as ‘IP completion day’), key transitional arrangements come to an end and significant changes begin to take effect across the UK’s legal regime. This document contains guidance on subjects impacted by these changes. Before continuing your research, see Practice Note: What does IP completion day mean for Life Sciences?

A–B | C–D | E–H | I–N | Q–U.

Officinal formula

There are exceptions to the requirement that medicinal products must have obtained a marketing authorisation (MA) before being placed on the market. Medicinal products prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and intended to be supplied directly to patients served by the pharmacy constitute an exception to the requirement for MA. This is known as the officinal formulae. See also the definition of Magistral formula.

Off-label

The use of a medicinal product or a medical device respectively outside the terms of its marketing authorisation (for example, by indication, dose or patient population) or differently from what the manufacturer has instructed.

See also medical device, medicinal product and marketing authorisation.

Originator

An originator pharmaceutical product is the product that was first authorised worldwide for marketing, normally as a patented

Related documents:

Popular documents