VO-Form

Application for recognition of Orphan Drug Status

Company stamp
(or if in electronic form, company name, street, no., postal code / location)
°°°°°
°°°°°
°°°°°
Product name
…… / Authorisation no.……
Application ID……
(Attributed when application is first submitted)
Dosage form……
Active substance(s)
……
Dosage strengths
…… / …… / …… / …… / ……
Pharmaco-therapeutic group
ATC code……
IT no.…… / Area of application
(precise wording of the indication)*
……
*if based on recognition of the ODS from a foreign country, provide the precise wording of the decision, translated into an official language of Switzerland.
Status of application
Orphan Drug status is applied for on the following grounds
☐VAZV Art. 4 para. 1 letter a (Documentation)
☐VAZV Art. 4 para. 1 letter b (Status abroad), Country: ……
Submission of authorisation application
☐Simultaneously with application for recognition of status
☐Later, expected by ……
☐Time of submission not yet known
Applicant / authorisation holder
Name……
Street……
Postal code/location……
Tel.……
Fax……
E-mail……

Orphan Drug Status abroad**

☐ / Status obtained / Country:
…… / Date of recognition**:
Date of authorisation (Marketing authorisation): / ……
…… / Trade name:
……
☐ / Status applied for / Country:
…… / Date of application: / …… / Trade name:
……
☐ / Status withdrawn / Country:
…… / Date of withdrawal / …… / Trade name:
……
☐ / Status rejected / Country:
…… / Date of reject / …… / Trade name:
……

**Status abroad must be stated at least for EU countries and countries according to article 13 TPA

***Annexe: Copy of the official decision / decree / ordinance confirming recognition of orphan drug status issued by the foreign authorities plus a signed, dated self declaration confirming that the foreign product is identical to the one that is applied for (this confirmation / self-declaration can be integrated in the cover letter).

Documents submitted
/
yes
/
no
Accompanying letter to application for recognition of Orphan Drug Status / ☐ / ☐
ZL102_00_002e_FO_Application_recognition_orphan_drug_Status / ☐ / ☐
ZL000_00_005d_FO_Full_Declaration (optional) / ☐ / ☐
ZL000_00_013e_FO_GMO_substance_confirmation (optional) / ☐ / ☐
ZL000_00_006d_FO_Declaration_Radiopharmaceuticals / ☐ / ☐
Information for healthcare professionals (optional) / ☐ / ☐
Patient information (PI) (optional) / ☐ / ☐
SmPC (EU version) / (optional)
When yes:☐Date of approval Datum?☐Draft / ☐ / ☐
Other documents (e.g. other specialised information from foreign countries) / ☐ / ☐
If ODS recognised in a foreign country: confirmation of identity / self declaration (***) / ☐ / ☐
Documentation for the application
/ No. binders:/ folders: / …… / No. CDs / ……
For eCTD applications
/ Sequence / ……
The undersigned confirms that this information is complete and accurate:
(Company stamp of applicant / authorisation holder (distributing firm))
°°°°°
°°°°°
°°°°°
Compulsory / Optional (additional signature)
Place, date ……
Signature ......
Person responsible
Surname……
First name……
Job title……
Telephone……
E-mail…… / Place, date ……
Signature ......
Additional person
Surname……
First name……
Job title……
Please return the application to:
Swissmedic, Swiss Agency for Therapeutic Products
P.O. Box, Hallerstrasse 7, 3000 Berne 9 /
For further questions:
Tel.+41 58 462 02 11
Fax+41 58 462 02 12

QM-Ident: ZL102_00_002e_FO / V04 / rc, apk, cas / dts / 19.05.20141 / 2

Swissmedic • Hallerstrasse 7 • CH-3000 Berne 9 • • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12

VO-Form

Application for recognition of Orphan Drug Status

Change history

Version / Valid and binding as of: / Modified without version change / Description, comments (by author) / Author’s initials
20.11.14 / Telephone and fax numbers within the document updated, telephone and fax number in the footer updated, new change history inserted in the document, document name modified in the header. / cis
04 / 19.05.14 / Adjustment of regulatory documents relating to authorisation as a result of the Guidance Document Formal requirements / apk

QM-Ident: ZL102_00_002e_FO

Swissmedic • Hallerstrasse 7 • CH-3000 Berne 9 • • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12