|
On 31 July 2007 the EU Commission published a summary record of the 62nd
meeting which was held on 21 May 2007. Different legislatives issues were
presented at this meeting, among others the next steps of the Variations
Regulations. The following text is taken from the summary record:
"The Commission presented results of a stakeholder
consultation on a concept paper, which ended on 20 December 2006. In total
28 written responses were submitted, which expressed a broad support
for all five key items of the proposal, although some concerns were also
expressed:
- Harmonisation to national authorisation: outcome
of the revision should be a simple
Procedure
- The incorporation of new concepts established or in
development at ICH level (Q8, Q9 and Q10): voluntary character should
be maintained and a transitional period should be introduced
- "Do and tell" procedure as regards certain minor
changes: the scope of the annual report, any changes should not
increase workload
- Work sharing between Member States; some
delegations considered that the previous pilot projects were not fully
successful
- Introduction of the Type IB procedure as the
default procedure: comments focused on practical details
In the discussion it was stressed by certain Member States'
delegations, that the revision of the Variations Regulations should be
mirrored in the corresponding national legislation governing pricing and
reimbursement procedures. In conclusion, the Commission representatives
outlined the next steps, in particular the objective to have a round of
open public consultation on the basis of a draft Regulation in the course of
2007. An impact assessment of proposed revisions is currently ongoing."
|
