The Medicines and Healthcare product Regulatory Agency (MHRA) has launched a public consultation on European Commission proposals to harmonise the handling of variations to national medicine licenses.
The current European Union (EU) rules governing the handling of variations are recognised by regulators and industry as unduly burdensome, says the MHRA. Moreover, the legislation only applies to products authorized under the EU harmonising provisions, generally products authorised in more than one EU member state since 1995. A company wanting to change an aspect of a medicine authorised nationally in a number of member states may have to comply with different procedures in each of them, adding to the complexity of the procedure for industry and the administrative burden.
The review of these arrangements seeks to streamline them and reduce the burden, while also ensuring that the procedures continue to deliver appropriate standards of public health protection. It is also the Commission’s key pharmaceutical initiative in support of the Better Regulation agenda.
There are three aspects to the review; first, a technical examination of the current Variations Regulation, then a negotiated amendment to the legislation (Directive 2001/83/EC) and, if these are successful, a proposal to extend the Regulation ensure that all future variations, regardless of the procedure under which the medicine has been authorised, are subject to the same criteria for evaluation, approval and administration. The first two stages involve technical discussions and are not, therefore, subject to formal consultation exercises.
The MHRA says it has worked closely with the European Commission in developing these overall proposals, mainly because it has, over the past years, been working with the UK industry on the Better Regulation of Medicines Initiative (BROMI). This was originally set up to look at how unnecessary regulatory burdens, primarily in relation to over-the-counter (OTC) medicines, could be eased, whilst maintaining safeguards to protect public health, but its scope was subsequently extended to the entire pharmaceutical industry.
BROMI has been highly successful and many of its procedures have been incorporated into the Commission initiative which will, says the MHRA, impact directly on companies (especially the UK industry which has already benefited extensively from BROMI) and regulators. The agency adds that it has consulted the industry in a number of face-to-face meetings and that both these main interest groups have expressed wwidespread support for the proposals.
Specifically, the consultation will ask stakeholders if they support the Commission’s initiative and if they believe the potential changes to the Variations Regulation can reduce the administrative burden placed on companies for national Marketing Authorizations (MAs). If they do, they are asked to quantify these savings, and whether they would then support extending the Regulation’s scope to variations to purely national MAs.
“Any quantification of the impact of the Commission’s proposals that stakeholders can provide would be very helpful, particularly in relation to any administrative savings that can be achieved or costs incurred,” says the MHRA, which is asking for responses to be received by September 17.
