A public consultation was conducted in October 2007 - January 2008 on the
comitology aspects of the review of the Variations Regulations. The European
Commission has proposed this regulation with the aim to harmonise the differing
regulatory requirements regarding variations among Member States so that all
changes or variations to pharmaceutical marketing authorisations are subject to
the same criteria in the EU. It should also provide a simpler, clear and
flexible regime for the handling of licence variations which continues to
maintain high levels of public health protection.
Comments from stakeholders were published on 15 January 2008. Contributions were
sent in by 16 Member States which are in general positive towards the
preliminary proposal. They also welcome the principle of work sharing.
However some of the Member State's agencies fear additional administrative
workload for example by grouping variations. Concerns were also raised on the
integration of Design Space in the regulation: such an introduction should be
accompanied by detailed definitions and guidance in order to obtain a common
understanding of the concept.
Twenty-five pharmaceutical companies and industry representatives/ associations
have also sent in comments to the respective regulation. Industry strongly
supports the Commission's proposal for the revised Variation Regulation and
broadly agrees with its objectives and suggested concepts. They appreciate their
increased responsibility for change implementation. However, industry is looking
for further improvements to the legal drafting to ensure that it fully reflects
the Commission's strategy paper and the needs of the pharmaceutical industry.
In general, most comments were made on how to further reduce the need for
post-authorisation changes. The proposal that a change within an approved
'design space' does not require a Variations application is welcomed. A "do and
tell" approach would be appreciated and supported by both the industry and the
authorities of the Member States.
Also, CMD(h), EDQM and EMEA have made detailed contributions. EMEA welcomes the
overall streamlining of the handling of variations. However, the agency "is
concerned that the flexible and simplified submission requirements are not
associated with a simplification of administrative processing and
decision-making to the same extent at the level of the regulatory authorities."
Various comments were made on the text as such which is seen complicated and not
easy to read. Definitions on type of variations should be defined more precisely
and stated as such.
The contributions can be found here:
A summary of the outcome of this consultation will be published soon.