OTC regulations to be streamlined
pharmafile | June 2, 2006 | News story | Sales and Marketing |
The rules governing the way over-the-counter medicines are regulated are set to change as the government strives to reduce the red tape surrounding the sector.
The MHRA is to allow manufacturers to make minor changes to the labelling of their products without having to resubmit them to the regulator.
Patient information leaflets will also be covered by the new system, which the MHRA says will make the rules more proportionate and targeted.
Companies wanting to make small labelling changes can now do so under a new 'self-certification' scheme, which will allow them to confirm that they remain within the current guidelines.
The amendment comes with the launch of the first report from the Better Regulation of Over-the-Counter Initiative (BROMI) group, whose members include the Proprietary Association of Great Britain and the National Pharmacy Association.
BROMI's report makes a series of recommendations to streamline the way the OTC market is regulated.
UK Health Minister Andy Burnham said: "The BROMI initiative can deliver change for patients and industry.
"The initiative also 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."
Companies will still need to submit changes to the MHRA, which will then audit a sample of the filings it receives.
MHRA chief executive Prof Kent Woods said: "OTC medicines contain well-established ingredients whose risks and benefits are well known. It is therefore suitable to introduce new ways of regulating OTC products that are proportionate, targeted, accountable, consistent and transparent."
Any breaches of the rules will face a variety of sanctions, ranging from the requirement for future changes to be submitted for approval, 'naming and shaming' the company or, in serious cases, withdrawing a product's marketing authorisation.
