The outcome of the evaluation of the pilot project was very positive. Therefore, the collaboration between the TLV and MPA will continue and offer the pharmaceutical industry the possibility of applying for joint scientific advice meetings from 1 January 2011.
The TLV and the MPA have received inquiries from the pharmaceutical industry regarding the possibility of arranging joint scientific advice meetings. In the light of these inquiries and the outcome of the evaluation, it has been decided by both Agencies to continue offering joint scientific advice meetings.
The aim of providing joint scientific advice is to fulfil the Government’s instructions to the agencies to contribute to a rational and cost-effective use of pharmaceutical products as well as meeting inquiries from the pharmaceutical industry.
The application procedure is in principal the same as for regular scientific advice meetings at the MPA. The application form at the MPA website for scientific advice meetings has been updated with a section to request the participation of the TLV in the meeting. Specific questions directed to the MPA and the TLV respectively should be included in the application and it is of importance that it is clearly stated which questions are directed to which authority.
The meetings are held at the premises of the MPA and are 1 hour and 30 minutes long. Representatives from both the MPA and the TLV will be present. The meetings are organized by a specific administrator at the MPA. For further information see the routine for scientific advice at the MPA.
As usual a fee is charged for scientific advice from the MPA. The additional scientific advice provided by the TLV is free of extra charge. The fee per scientific advice meeting is 45,000 Skr. An invoice will be sent to the applicant after the meeting has taken place, with a liability to pay within 30 days.
The advice given is not binding either for the MPA, the TLV or the company.