Minor label changes made easier
Regulators will focus on safety rather than packaging |
Manufacturers of over-the-counter medicines are now allowed to make technical changes to their packaging, labelling and patient information leaflets without having to get detailed approval from the Medicines and Healthcare products Regulatory Agency first.
The aim is to minimise administrative hurdles to simple changes like
removing the word “new” from packaging once a product variant
has been on the market for a year or making amendments across a range
of pack sizes without having them individually approved. Any changes
to be made must be in accordance with a previously approved summary of
product characteristics.
The newly relaxed regulatory regime is the first substantive outcome
of the MHRA’s better
regulation of over-the-counter medicines initiative (BROMI). Organisations
involved in BROMI include the MHRA, the Proprietary Association of Great
Britain, the National Pharmacy Association, the Department of Health,
the Cabinet Office and representatives of the non-proprietary sector.
The new system, announced this week, came into immediate effect.
PAGB president John Harold said that the MHRA’s volume of administrative
work means backlogs and delays are not uncommon. “At worst seasonal
products can lose a whole year’s marketing as a result,” he
said. “The recommendations will have a huge impact on backlogs
and delays and will cut red tape, allowing the OTC industry to be innovative
in its product development.”
Health minister Andy Burnham added: “The initiative has the potential
to have a big impact on public health by enabling regulators to focus
their time on medicine safety, rather than carrying out lengthy administrative
processes.” |
The
Pharmaceutical Journal
Acrobat
Reader