VO-Form
Meeting with applicants
Company stamp(or, electronically, company name; street, no.; postcode/city)
……Applicant / Authorisation holder
Contact……
Phone……
Fax……
E-mail……
A. Type of requested meeting
☐Scientific Advice Meeting (in the development phase)see Section C
☐Presubmission Meeting (before application submission)see Section D
☐Clarification Meeting (after LoQ)see Section E
B. Details of the medicinal product
Name of active substance / active substances (preferably INN): ……
Preparation name: ……
Dosage form: ……
Administration route: ……
(Planned) therapeutic indication: ……
Therapeutic classification (Group / ATC code): ……
Authorisation status of the medicinal product in Switzerland:
☐not authorised
☐previously rejected by Swissmedic
☐application withdrawn
☐authorised
Preparation name: ……
Authorisation number: ……
Authorisation status of the medicinal product in other countries:
☐authorised in ……
☐rejected / revoked in …………
☐application pending in ……
☐application withdrawn in ……
Note: For the requested meeting please submit relevant details on the authorisation status in other countries in an enclosure with this application form.
C. Subject of the Scientific Advice Meeting in the development phase
Subject areas(according to the enclosed list of questions)
☐Pharmaceutical quality
☐Biological quality
☐Biotechnological quality
☐Preclinical
☐Clinical
☐Biometrics
☐Pharmacovigilance, Risk Management Plan
☐Procedural issues
☐other (please specify) ……
Reason for the application:
……
D. Subject of the Presubmission Meeting before application submission
Scheduled application:
Application type: ……
Planned submission date: ……
Subject areas (according to the enclosed list of questions)
☐Legal basis for the application
☐Dossier structure and content
☐Aspects of the Information for healthcare professionals and Patient information / packaging elements (labelling)
☐Procedure and timetable
☐Technical aspects of submission
☐other (please specify) ……
Reason for the application:
……
E. Subject of the Clarification Meeting after receipt of the LoQ (justified need for clarification in the event of major objections)
Relates to the LoQ letter dated ……Concerning the preparation ……
Subject areas (according to the enclosed list of questions)
☐Scientific rationale in the event of major objections that are not clearly understood
☐Clarification of questions on the applicant's scheduled response strategy
☐other (please specify) ……
Reason for the application:
……
F. Enclosures
☐Covering letter
☐List of questions
(Note: The applicant must state its position, with reasons, on each question. Any additionally submitted documentation should be structured in accordance with this list of questions.)
☐Documentation and background information
☐Records of advice procedures with other authorities
☐Relevant details on authorisation status in other countries
☐List of scheduled participants at the requested meeting
☐Proposal with meeting dates
☐Agenda with the points to be discussed
The scientific and procedural advice provided by Swissmedic in Scientific Advice Meetings, Presubmission Meetings and Clarification Meetings is subject to fees, and in certain cases the applicants must meet specific conditions. The invoice will be issued on completion of the advice procedure. The fees are based on the Therapeutic Products Fees Ordinance (FeeO; SR 812.214.5).
☐I hereby confirm my awareness of this fact and agree to pay the costs associated with the procedure
The undersigned confirms that this information is complete and correct: (or, electronically, company name; street, no.; postcode/city)……
Obligatory
/Optional (additional signature)
Place, date ……Signature …………………………
Responsible Person
Surname ……
First name……
Function ……
Phone ……
E-mail …… / Place, date ……
Signature …………………………
Additional person
Surname ……
First name……
Function……
The application must be sent to
Swissmedic, Swiss Agency for Therapeutic Products
P.O. Box, Hallerstrasse 7, 3000 Bern 9 / For enquiries contact
Telephone+41 58 462 02 11
Fax +41 58 462 02 12
QM-Ident: ZL105_00_001e_FO / V04 / mc, cas / dts / 19.05.20141 / 3
Swissmedic • Hallerstrasse 7 •CH-3000 Berne 9 • • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
VO-Form
Meeting with applicants
Change history
Version / Valid and binding as of / Modified without version change / Description, comments (by author) / Author’s initials20.11.14 / Telephone and fax numbers in the document updated, telephone and fax numbers in the footer updated, new change history inserted in the document, document name modified in the header. / cis
04 / 19.05.14 / Specification documents for authorisation adapted to the guidance document on "Formal requirements" / cas
QM-Ident: ZL105_00_001e_FO
Swissmedic • Hallerstrasse 7 • CH-3000 Berne 9• •Tel. +41 58 462 02 11 • Fax +41 58 462 02 12