VO-Checklist
Formal control Application
authorisation veterinary medicines Art.13, TPA
For Swissmedic use onlyAuthorisation no.:…… / Application ID: / ……
To be completed by the applicant and submitted together with the form "Application for authorisation / variation Veterinary medicines" (with, in addition, "Application requesting that the assessment results by foreign authorities (Art. 13, TPA) be taken into consideration"
(only complete this checklist for applications for first authorisation and major variations):
Product name:
…… / Dosage strength:
…… / Pharmaceutical form:
……
Applicant:
……
Reference authority whose assessment results form the basis of the application for authorisation in Switzerland:
☐EMA
☐ EU MRP / Reference authority: ……
☐ EU DCP / Reference authority: ……
☐ EU / EFTA- Member State / Reference authority: ……
☐ FDA / USA
☐ Canada
☐ Singapore
☐ Japan
☐ Australia
☐New Zealand
Submitted?
Yes / No[1] / n.a.[2] / Comments
General administrative documentation
Cover letter / ☐ / ☐ / ☐ / ……
Forms / ☐ / ☐ / ☐ / ……
Form: Application for authorisation / Variation / ☐ / ☐ / ☐ / ……
Form: Full declaration / ☐ / ☐ / ☐ / ……
Form: Manufacturer information / ☐ / ☐ / ☐ / ……
Form: Status marketing authorisations abroad / ☐ / ☐ / ☐ / ……
Form: Substances of animal and human origin / ☐ / ☐ / ☐ / ……
Form: DMF/ASMF first authorisations / Variation / ☐ / ☐ / ☐ / ……
Form: Quality information, if request for Art 13, TPA / ☐ / ☐ / ☐ / ……
Other forms
…… / ☐ / ☐ / ☐ / ……
Documents on quality
DMF/ASMF Letter(s) of Access (signed original) / ☐ / ☐ / ☐ / ……
Ph. Eur. Certificate of Suitability for active pharmaceutical ingredient / ☐ / ☐ / ☐ / ……
Ph. Eur. Certificate of Suitability for TSE / ☐ / ☐ / ☐ / ……
Manufacturing
GMP certificate(s) (dated < 3 years previously) / ☐ / ☐ / ☐ / ……
Manufacturing licence(s) / ☐ / ☐ / ☐ / ……
Form Responsible Person Declaration (RP Declaration) for foreign manufacturer / ☐ / ☐ / ☐ / ……
Other appendices
…… / ☐ / ☐ / ☐ / ……
Information for healthcare professionals and packaging material
Information for healthcare professionals / ☐ / ☐ / ☐ / ……
Folding box / ☐ / ☐ / ☐ / ……
Label, blister, tube, vial, etc. / ☐ / ☐ / ☐ / ……
Approved EuSmPC or information for healthcare professionals of the reference country in the original language and translation into German, French or English. Approved on: ……. / ☐ / ☐ / ☐ / ……
Expert Reports and information on the experts
Quality Expert Report, CV, signature and date / ☐ / ☐ / ☐ / ……
Safety and Residues Expert Report, CV, signature and date / ☐ / ☐ / ☐ / ……
Efficacy Expert Report, CV, signature and date / ☐ / ☐ / ☐ / ……
Presentation, in tabular form, of the comparability of the foreign reference product with the Swiss original product / reference product / ☐ / ☐ / ☐ / ……
Environmental Risk Assessment / ☐ / ☐ / ☐ / ……
Decisions by foreign authorities
Responses to Questions (always incl. LoQ) / ☐ / ☐ / ☐ / ……
EMA
CP: / Answer to day 180 LoOI (incl. day 180 LoOI) / ☐ / ☐ / ☐ / ……
Answer to day 120 LoQ (incl. day 120 LoQ) / ☐ / ☐ / ☐ / ……
All other countries: Answer to LoQ (incl. LoQ) / ☐ / ☐ / ☐ / ……
Assessment Reports (=AR) / ☐ / ☐ / ☐ / ……
EMA
CP / Day 210 AR / ☐ / ☐ / …… / ……
Day 80 AR / ☐ / ☐ / ☐ / ……
EU DCP/MRP / Day 70 Preliminary AR (for DCP) / ☐ / ☐ / ☐ / ……
Day 90 RMS AR (for MRP) / ☐ / ☐ / ☐ / ……
EU DCP/MRP / Final AR (MRP = day 90, DCP ≥ day 105) / ☐ / ☐ / ☐ / ……
If arbitration to CHMP-> Opinion of the EMA / ☐ / ☐ / ☐ / ……
EU/EFTA / Final AR / ☐ / ☐ / ☐ / ……
Assessment report / ☐ / ☐ / ☐ / ……
All other countries: Final AR (translatedif applicable) / ☐ / ☐ / ☐ / ……
Decisionby reference authority
EMA
CP / CVMP Opinion / ☐ / ☐ / ☐ / ……
Decision by the EU Commission (submit as soon as available) / ☐ / ☐ / ☐ / ……
EU DCP/MRP: Marketing Authorisation by the RMS / ☐ / ☐ / ☐ / ……
EU/EFTA: Marketing Authorisation / ☐ / ☐ / ☐ / ……
Decision by other foreign authorities:
…… / ☐ / ☐ / ☐ / ……
Information on pharmacovigilance
Has a procedure been initiated as a result of a current safety signal? (submit the letter to initiate the procedure, LoQ communication, experts' reports, interim results, final reports) / ☐ / ☐ / ☐ / ……
Have any safety signals been completed since an authorisation granted in a foreign country came into force? (Submit final report) / ☐ / ☐ / ☐ / ……
Submitted?
Yes / No1 / n.a.2 / Comments
Other information
Compare the changes (previous / current) (by means of a tracking table or overview table) / ☐ / ☐ / ☐ / ……
…… / ☐ / ☐ / ☐ / ……
Reference dossier
(for eNTA, it is always necessary to also submit a paper version) / Submitted?
Yes / No1 / n.a.2 / Comments
Part I (Administrative information) / ☐ / ☐ / ☐ / ……
Part II (Quality) / ☐ / ☐ / ☐ / ……
Part III (Safety and residues) / ☐ / ☐ / ☐ / ……
Part IV: (Effectiveness) / ☐ / ☐ / ☐ / ……
Additional information on products with known active pharmaceutical ingredients / Submitted?
Yes / No1 / n.a.2 / Comments
Confirmation in accordance with Art. 17, 1a, VAM if API of the originator product is under first applicant protection (FAP) / ☐ / ☐ / ☐FAP expired
Information on the Swiss reference product for products with known active pharmaceutical ingredients
Name of the Swiss reference product: / ……
Swissmedic Authorisation number: / ……
Information concerning the foreign comparator product for products with known active pharmaceutical ingredients
Name of the foreign comparator product: / ……
Name and address of foreign authorisation holder / ……
Country of authorisation / ……
Authorisation no. / ……
LOT / EXP / LOT: ……
EXP: ……
Country of origin / Supplier / ……
Tabulated summary of comparing the foreign comparator product with the Swiss reference product / Submitted?
Yes / No1 / n.a. 2 / Comments
☐ / ☐ / ☐ / ……
Annexes / Submitted?
Yes / No[3] / Comments
Product information / ☐ / ☐ / ……
Overall documentation / Submitted?
Yes / No / Comments
Status of the documents corresponds to Swissmedic requirements (Ease of finding references, readability, file indexes, file dividers) / ☐ / ☐ / ……
The documentation is available in an official language of Switzerland or in English. / ☐ / ☐ / ……
For e-documentation; Basis NTA structure, and it must be possible to open the files / ☐ / ☐ / ……
Forms submitted in the original, and signed / ☐ / ☐ / ……
QM-Ident: ZL000_00_013e_CL / V04 / lac, cis / ps / 25.07.20161 / 7
Swissmedic • Hallerstrasse 7 • CH-3000 Berne 9 • • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
VO-Checklist
Formal control Application
authorisation veterinary medicines Art.13, TPA
For the authorisation of medicinal products already authorised in foreign countries in accordance with Art. 13, TPA in connection with Arts. 5a to 5d, VAM, the corresponding documentation must be provided to Swissmedic. The following points must be confirmed by the applicant.
Divergences or missing documentation must be stated under the comments, and described, justified, or if appropriate documented in the cover letter.
Requirements for authorisation in accordance with Art. 13, TPA in connection with Arts. 5a to 5d, VAM that must be met by the authorisation holder:Yes[4] / Comment
The product is identical with that submitted and authorised in a foreign country. (The exceptions being divergences as described in the information sheet Authorisation of veterinary medicines already authorised in a foreign countries (Art. 13 TPA). These must be justified, critically assessed, and documented.) / ☐ / ……
The documentation submitted, including additions, is identical to that based on which the reference authority granted the authorisation.
Additions can be integrated within the dossier or appended separately. A list of the additions, including the Assessment Report, must be attached to the cover letter.
(The exceptions being divergences as described in the information sheet Authorisation of veterinary medicines already authorised in a foreign countries (Art. 13 TPA). These must be justified, critically assessed, and documented.) / ☐ / ……
Any variations since the authorisation by the reference authority are submitted with a comparison (previous / current) and mentioned in the cover letter.
An additional Assessment Report is provided for the variations submitted. The variations must, where applicable, be justified, critically assessed, and documented. / ☐ / ……
The foreign authorisation or its approved revision must not be more than 5 years old. (Date of official decision) / ☐ / ……
All of the documents listed the information sheet Authorisation of veterinary medicines already authorised in a foreign countries (Art. 13 TPA) are submitted. Where applicable: the DMF Holder has been informed that the Assessment Report of the Restricted Part, LoQ and the company's answers to the Restricted Part must be submitted to Swissmedic. / ☐ / ……
The current requirements of the Ph.Eur. / Ph.Helv. were met and the corresponding proof is submitted.
(If the methods of the Ph.Eur. / Ph.Helv. were not used, equivalence must be proved.) / ☐ / ……
The applicant hereby confirms that all the information provided is correct and complete.
The applicant confirms that he / she will inform Swissmedic immediately of all changes or conditions imposed by foreign authorities (such as suspension or deletion of the authorisation, restriction of the indication, inclusion of new warnings in the information for healthcare professionals or patient information, changed dosage, batch recalls and similar).
(Company stamp of the applicant / authorisation holder (distributing company))
……
……
……
Compulsory / Optional (additional signature)
Place, date……
Signature......
Responsible person
Name……
First name……
Job title……
Tel.……
E-Mail…… / Place, date……
Signature......
Responsible person
Name……
First name……
Job title……
Please send this application to:
SwissmedicSwiss Agency for Therapeutic Products
P.O. Box, Hallerstrasse 7, 3000 Bern 9
Switzerland /
For enquiries:
Tel.+41 58 462 02 11Fax +41 58 462 02 12
This page will be completed by Swissmedic:
Checklist known API products with the reference product: prior to formal control(If the application is for a known API with the reference product, the questions below must be answered prior to the formal control.)
Product applied for:…… / Authorisation no: ……
Reference product:…… / Authorisation no: ……
Existing first applicant protection for the active pharmaceutical ingredient / ☐No Formal control can be carried out
☐Yes, until (date): ……
☐Confirmation in accordance with Art 17, para. 1, lettera), VAM provided
☐Yes Formal control can be carried out
☐No Official decision not to process the application
Existing first applicant protection for therapeutic combination with a different medicinal product for which the first applicant protection is still valid / ☐No Formal control can be carried out
☐Yes, until (date): ……
☐Confirmation in accordance with Art. 17, para. 1, lettera), VAM submitted
☐Yes Formal control can be carried out
☐No Official decision not to process the application
Date: …… / Visum CM: ……
eDoc:
Status of the documents, Part 2-4 / Comments
Documents can be opened (random samples) / ☐OK☐not OK / ……
Evaluation of formal control:
Yes / No / Date / Initials CM
Will the documents be accepted?
Yes. (In line with current practice, however, no "formal control completed" letter will be sent to the company.)
If no: CB "formal objection to the company" / ☐ / ☐ / …… / ……
Second formal control: Will the documents be accepted?
Yes: CB “formal control completed” to the company
No: CB “Verfügung Nichteintreten” to the company / ☐ / ☐ / …… / ……
QM-Ident: ZL000_00_013e_CL / V04 / lac, cis / ps / 25.07.20161 / 7
Swissmedic • Hallerstrasse 7 • CH-3000 Berne 9 • • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
VO-Checklist
Formal control Application
authorisation veterinary medicines Art.13, TPA
Change history
Version / Valid and binding as of: / Modified without version change / Description, comments (by author) / Author’s initials29.07.16 / Duplication to new form RP Declaration deleted. / cis
04 / 25.07.16 / Adaptation following the introduction of a template for RP declaration for foreign manufacturer. Simplified submission of GMP certificates / lac
03 / 30.05.16 / Alignment with current practice (example: formal control of major applications by Case Manager) / lac
02 / 11.11.15 / More detailed instructions on page 5 regarding submission of the LoQ and the Assessment Report of the DMF Restricted Part. / cis
21.05.15 / Clarification on page 3, Rubric “Reference dossier”; Customized of terminology / cas
01.04.15 / Point Manufacturing: Harmonization of terminology / its
09.01.15 / Document technically adapted for internet publication. / cis
01 / 01.01.15 / New Document / Process attribution of the document has changed
Old: SU000_00_009e_CL_Formal_control_Art13TPA_TAM
New: ZL000_00_013e_CL_Formal_control_Art13TPA_TAM / its
13.10.14 / The telephone and fax numbers within the document have been updated in line with those in the footer. / sel
04 / 01.09.14 / Information on the reference product and foreign reference product harmonised and wording edited for greater clarity. / apk
QM-Ident: ZL000_00_013e_CL
Swissmedic • Hallerstrasse 7 • CH-3000 Berne 9 • • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
[1]Please justify the reason for not submitting this documentation
[2]Not applicable
[3]Please justify the reason for not submitting this documentation
[4]Please justify the reason for not submitting this documentation