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Austrian Agency for Health and Food Safety

Austria

Areas: Human Medicines Veterinary Medicines

Updated: 06 November 2015

National Requirements:

No requirement for CD/DVD and PAPER documents for submissions through CESP. NCA may request CD/DVD, PAPER documents in the event of an issue with the CESP submission. If DVDs/CDs, PAPER documents are sent although the dossier was submitted through CESP please mark these with the relevant CESP-submission number. For your notice: these CD/DVDs and PAPER documents will not be processed or archived.

Contact Details:

General Contact

Regulatory Contact (Primary)

E-mail: cesp@ages.at

Website: www.basg.gv.at
Federal Agency for Medicines and Health Products

Belgium

Areas: Human Medicines Medical Devices Veterinary Medicines

Updated: 02 February 2018

National Requirements:

From the 1st of July 2013, the allowed regulatory activities or in other words, the allowed dossier types for CESP submissions to the FAMHP are:

For Human and Veterinary Medicines : Initial Marketing Authorisation Application, Extension, Variation Type IA, Variation Type IB, Variation Type II, PSUR, renewal, ASMF, Transfer of a marketing authorization, National variations, PASS, Homeopathic MP application, Herbal MP application

Only for Human Medicines: Notification 61 (3), National notification

Only for Veterinary Medicines: Authorisation for temporary use, Follow-up Measures (includes post-approval commitments for national MAs)

Answers to Questions for any accepted dossier type listed above are also allowed.

Any other dossier type is actually not allowed via CESP. For more information, please refer to FAMHP’s website.

As the xml is used to upload your file automatically into our Agency, please don’t change or rename it, since this will block the transfer from the CESP server to our Agency.

When submitting via CESP, parallel submission on CD, DVD, or via eudralink is no longer allowed.

Please note that FAMHP (Belgium) has special requirements for electronic submissions. Please refer to FAMHP’s website.

CAP via CESP: Human - No

Veterinary - Yes

.

Contact Details:

Els Verschaeren

Regulatory Contact (Primary)

E-mail: els.verschaeren@fagg.be

Els Verschaeren

New Registrations (Human)

E-mail: els.verschaeren@fagg.be

Katelijne Vankeymeulen

New Registrations (Human)

E-mail: katelijne.vankeymeulen@fagg.be

Iris Geussens

Variations/renewals (Human)

E-mail: iris.geussens@fagg.be

Roselien Poppe

Variations/renewals (Human)

E-mail: roselien.poppe@fagg.be

Katrien Bernaert

PSURs (Human)

E-mail: katrien.bernaert@fagg.be

Lesley Verley

PSURs (Human)

E-mail: lesley.verley@fagg.be

Dries Minne

Veterinary submissions: (pre- and post-authorisation)

E-mail: dries.minne@fagg.be

Valerie Vanmerris

Veterinary submissions: (pre- and post-authorisation):

E-mail: valerie.vanmerris@fagg.be

Wim Huygh

HOMEO-PHYTO

E-mail: wim.huygh@fagg.be

Jamila Bazza

HOMEO-PHYTO

E-mail: jamila.bazza@fagg.be

Website: www.fagg-afmps.be
Bulgarian Drug Agency

Bulgaria

Areas: Human Medicines

Updated: 18 August 2022
National Requirements:

Bulgarian Drug Agency

Please, be informed that due to unexpected situation related to technical issue Bulgarian Drug Agency (BDA) has stopped accepting variation AFs and dossier for a month.

Now, we are happy to announce that BDA resumes accepting all types of applications and documents through the CESP, except clinical trials.

Please, be kindly informed that as of 9/11 BDA will not require a CD/DVD for the procedures submitted via CESP.

Important:
1. A signed paper copy of the eAF and Cover Letter.
2. Annex 5.4 Letter of authorisation for communication on behalf of the applicant/MAH(the signatures must be officially authenticated by a notary or Administrative official).
3. Annex 5.22 with original signature (QP declaration)
must be provided with each submission.

Submission of these documents to the BDA may be delayed within a reasonable period of time.

Additionally, we still require hard copies of national translations of Product Information in order to finalise the procedures and issue a national MA. The hard copies can be submitted and received at the Agency using licensed postal operator as DHL for instance (or others).

Clinical trials via CESP: NO

Contact details:

Lyubina Todorova, MD, PhD

lyubina.todorova@bda.bg

Please, be kindly informed that due to Easter holidays BDA will be closed till 4th May.

All submissions via CESP will be accepted and considered chronologically, according to the date and order of the submission.

Contact Details:

General Contact

Regulatory Contact (Primary)

E-mail: cesp@bda.bg

Website: www.bda.bg
Bulgarian Food Safety Agency

Bulgaria

Areas: Veterinary Medicines

Updated: 17 May 2020

National Requirements:

No specific national requirements and No requirement for CD/DVD for submissions through CESP, NCA may request CD/DVD in the event of an issue with the CESP submission.

Contact Details:

Dr. Lilia Asenova

Regulatory Contact (Primary)

E-mail: l_asenova@bfsa.bg

Phone: 00359-882 469 283

Website: http://www.babh.government.bg
European Directorate for the Quality of Medicines & Healthcare

Council of Europe

Areas: EDQM

Updated: 03 May 2019

National Requirements:

Contact Details:

General Contact

Regulatory Contact (Primary)

E-mail: cep@edqm.eu

Website: www.edqm.eu
Agency for Medicinal Products and Medical Devices (HALMED)

Croatia

Areas: Human Medicines Medical Devices

Updated: 07 June 2018

National Requirements:

No requirement for CD/DVD for submissions through CESP, NCA may request CD/DVD in the event of an issue with the CESP submission..

For details on specific regulatory national requirements please refer to http://www.halmed.hr/en/Lijekovi/Upute-za-podnositelje-zahtjeva/MRP-i-DCP-postupci-specificni-nacionalni-zahtjevi/

CAP via CESP : No (Submission via EMA eSubmission Gateway)
Clinical Trials via CESP: No

Contact Details:

Maja Lovrek Romcevic

Regulatory Contact (Primary)

E-mail: maja.lovrek@halmed.hr

Website: www.halmed.hr
MINISTRY OF AGRICULTURE - Veterinary and Food Safety Directorate

Croatia

Areas: Veterinary Medicines

Updated: 05 September 2022

National Requirements:

NCA may request CD/DVD in the event of an issue with the CESP submission.

Contact Details:

Boris Fabijanic;

Regulatory Contact (Primary)

E-mail: boris.fabijanic@mps.hr

Phone: 00385-385 1 6443 822

Irena Žarkovic

Veterinary

E-mail: andrisic@veinst.hr

Phone: 00385-385 1 6443 822

Website: www.veterinarstvo.hr
Pharmaceutical Services/Ministry of Health

Cyprus

Areas: Human Medicines

Updated: 17 November 2021
National Requirements:

Submissions through CESP are mandatory for all types of regulatory activities and the CESP portal must be used as the only channel for submissions. Additional submission via other channels such as CD/DVDs, are not allowed and will not be accepted. Note that a scanned copy of the signed Cover Letter should be included in the submission.

Cyprus accepts the following types of applications through CESP :
1. Initial Marketing Authorisation Application (DCP/MRP/National/Exceptional MA/Parallel Imports/Herbal/Homeopathic)
2. Variation Type IA /IB/II (MRP/National)
3. Line Extension of a MA
4. Renewal (MPR/National/Exceptional MA/Parallel Imports/Homeopathic)
5. Notification (Art.61(3) or national notifications)
6. ASMF
CAP via CESP : No

The relevant circulars have been published on our website

https://www.moh.gov.cy/moh/phs/phs.nsf/circulars_table_en/circulars_table_en?openform

Contact Details:

Mrs Natasa Kiza

Regulatory Contact (Primary)

E-mail: nkiza@phs.moh.gov.cy

Mrs. Athina Koutsoventi

Human Medicines

E-mail: akoutsoventi@phs.moh.gov.cy

Website: www.moh.gov.cy/phs
VETERINARY SERVICES - VMP Section

Cyprus

Areas: Veterinary Medicines

Updated: 12 July 2022

National Requirements:

During the initial two months of the mandatory use, the paper, CD/DVD forms will continue to be accepted. Note that, the documents that need to be signed will continue to be issued in hard copy and in their original form. Additionally, NCA may request CD/DVD in the event of an issue with the CESP submission.

Contact Details:

General

Regulatory Contact (Primary)

E-mail: vmpsection@vs.moa.gov.cy

Stavroula Themistocleous

Regulatory Contact

E-mail: sthemistocleous@vs.moa.gov.cy

Phone: 00357-22805158

Website: www.moa.gov.cy/moa/vs/vs.nsf/index_gr/index_gr?opendocument#
Czech State Institute for Drug Control

Czech Republic

Areas: Human Medicines Medical Devices

Updated: 13 May 2022

National Requirements:

The Institute accepts all types of authorisation applications and related documents submitted through the CESP.

In addition to the documentation sent via CESP, it is required to deliver powers of attorney containing an authorisation for an unspecified number of a particular subject - related proceedings that will be initiated in future, with the original signature by post or courier, the grantor’s signature must be officially certified.

For more information, please visit:

http://www.sukl.eu/medicines/submission-of-documentation-via-the-cesp-portal

Clinical Trials Via Cesp: Yes

Contact Details:

Ing. Hana Nemcova

Regulatory Contact (Primary)

E-mail: hana.nemcova@sukl.cz

MUDr. Alice Nemcova

Clinical trials

E-mail: alice.nemcova@sukl.cz

Website: www.sukl.cz
Institute for State Control of Veterinary Biologicals and Medicines

Czech Republic

Areas: Veterinary Medicines

Updated: 06 November 2015

National Requirements:

No specific national requirements and No requirement for CD/DVD for submissions through CESP, NCA may request CD/DVD in the event of an issue with the CESP submission.

CAP Via CESP : Yes
CLINICAL TRIALS Via CESP: Yes

Contact Details:

Daniel Dušek

Regulatory Contact (Primary)

E-mail: dusek@uskvbl.cz

Website: www.uskvbl.cz
Danish Medicines Agency

Denmark

Areas: Human Medicines Medical Devices Veterinary Medicines

Updated: 26 October 2022

National Requirements:

None - No CD/DVD or other submission (paper, Eudralink…) if submission is made through CESP. NCA may request CD/DVD in the event of an issue with the CESP submission.

Clinical Trials submissions to DKMA are not accepted through CESP. Instead we encourage the use of DKMAnet. Please see DKMA website<laegemiddelstyrelsen.dk/en/licensing/clinical-trials/trials-in-humans/applying-via-dkmanet> for guidance.

CAP via CESP : No
CLINICAL TRIAL via CESP: No

Contact Details:

General Contact

Regulatory Contact (Primary)

E-mail: esubmission@dkma.dk

Phone: 0045-4488 9214

Website: www.dkma.dk
State Agency of Medicines

Estonia

Areas: Human Medicines Veterinary Medicines

Updated: 19 October 2022

National Requirements:

No requirement for CD/DVD for submissions through CESP, NCA may request CD/DVD in the event of an issue with the CESP submission.

CAP (human or veterinary) via CESP: No (only submitted to EMA, submissions retrieved using the Common Repository for Centralised Procedure)
Clinical Trials Via CESP: Yes

Contact Details:

Kerli Ülper

Regulatory Contact (Primary)

E-mail: documentation@ravimiamet.ee

Website: www.ravimiamet.ee
DG Sanco

European Commission

Areas: Currently In Testing

Updated: 24 May 2022

National Requirements:

Currently in Pilot

Contact Details:

Test

Regulatory Contact (Primary)

E-mail: test@test.com

Website: ec.europa.eu/food/fvo/index_en.cfm
Finnish Medicines Agency

Finland

Areas: Human Medicines Veterinary Medicines

Updated: 18 October 2019
National Requirements:

ASMF/DMF submissions in eCTD and VNeeS format are accepted via CESP.

DSUR submissions will be accepted starting from November 1st 2019 ( Other clinical trials related submissions later in 2019, update will follow)
- All PSURs for human medicines and related supplemental information must be submitted to the PSUR Repository, NOT via CESP
- Human Referral submission must be submitted to the Common Repository NOT via CESP. (Starting from September 15th 2017)
CAP via CESP : NO

No other specific national requirements and No requirement for CD/DVD for submissions through CESP

Contact Details:

General Contact

Regulatory Contact (Primary)

E-mail: esubmission-info@fimea.fi

Website: www.fimea.fi
ANSM - Agence nationale de sécurité du médicament et des produits de santé

France

Areas: Human Medicines

Updated: 30 November 2022

National Requirements:

ANSM accepts e-submissions via the CESP within a pilot phase starting 1st October 2013.

Following the step four of this pilot phase where only type IA,IB and II variations submissions were accepted (of all kind of products), the step four bis has started 01 june 2015.

Please note that during this step four bis, which still applies to all kind of products, when using the CESP to submit applications to ANSM:

1. Only the following submissions are accepted by ANSM:

- All regulatory activities of all kind of procedures: national submissions (France), MRP, DCP.

-For centralised procedure, send the eCTD to the EMA eSubmission Gateway

-For PSURs, can you send us the submission through CESP and in parallel to EMA eSubmission Gateway

Submissions that do not follow these criteria:

- will be rejected and will have to be resubmitted via paper or CD/DVD format;

- will consequently slow down the process.

2. No parallel submission (paper or CD/DVD) is required for France.

3. Zipped files are accepted (Winzip or Microsoft Compressed Folders) – 1 zipped folder per submission.

4. Only one activity per submission – Only one procedure per submission will be accepted.

5. Only NeeS and eCTD submissions will be accepted.

For more detailed information regarding ANSM e-submission requirements via the CESP and the pilot phase, please refer to the ANSM note to applicants that applies to this pilot phase (updated version: “CESP – Pilot phase – Note to applicants – Version 6.1”) available on the ANSM website:

http://ansm.sante.fr/Activites/Autorisations-de-Mise-sur-le-Marche-AMM/Constitution-de-dossier-d-AMM/%28offset%29/1

Contact Details:

General Contact

Regulatory Contact (Primary)

E-mail: e-recevabilite@ansm.sante.fr

Website: www.ansm.sante.fr
Agence Nationale du Médicament Vétérinaire

France

Areas: GxP Scientific Establishments Veterinary Medicines

Updated: 29 April 2019

National Requirements:

None - Avoid duplication of submission: No CD/DVD or other submission (paper, Eudralink…) if submission is made through CESP.

Regulatory activities acceptable via CESP : all for Veterinary Medicinal Products.

CAP Via CESP : Yes
CLINICAL Trials Via Cesp: Yes

Contact Details:

Laurent Moallic

Regulatory Contact (Primary)

E-mail: laurent.moallic@anses.fr

Website: www.anses.fr
Paul-Ehrlich-Institut

Germany

Areas: Human Medicines Veterinary Medicines

Updated: 15 November 2021

National Requirements:

No requirement for CD/DVD for submissions through CESP, NCA may request CD/DVD in the event of an issue with the CESP submission. A signed copy of the cover letter or the application form should be provided for certain applications. Please refer to PEI’s website.

www.pei.de/elektronische-einreichung or www.pei.de/esubmission

CAP (human or veterinary) via CESP: No, via eSubmission Gateway / Common Repository

NAP via CESP: Yes, except Referrals (via eSubmission Gateway / Common Repository)

Contact Details:

Angelina Burcea

Regulatory Contact (Primary)

E-mail: esubmission@pei.de

Website: www.pei.de
Bundesinstituts für Arzneimittel und Medizinprodukte

Germany

Areas: Human Medicines Medical Devices

Updated: 31 March 2020

National Requirements:

Please note that BfArM (Germany) have special requirements for electronic submissions please refer to BfArM's website.

Please do notice the following exemptions from submitting via CESP:
CAP via CESP : No. Please submit using the EMA eSubmission Gateway and eSubmission Web Client.
CHMP & PRAC Referrals: No. Please submit using the EMA eSubmission Gateway and eSubmission Web Client.

Contact Details:

Dino Soumpasis

Regulatory Contact (Primary)

E-mail: Dino.Soumpasis@bfarm.de

Website: www.bfarm.de
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL) Federal Office of Consumer Protection and Food Safety

Germany

Areas: Veterinary Medicines

Updated: 06 January 2022

National Requirements:

The BVL accepts and encourages submissions for all procedures through CESP. The submission of paper copies is not necessary.

For further information please refer to the BVL website BVL_eSubmission

CAP via CESP: No, via eSubmission Gateway / Common Repository

Contact Details:

General Contact

Regulatory Contact (Primary)

E-mail: Tamreg@bvl.bund.de

Website: www.bvl.bund.de
Greek National Organization for Medicines

Greece

Areas: Cosmetics Food and Nutrition Human Medicines Medical Devices Veterinary Medicines

Updated: 17 June 2022

National Requirements:

1/2/2017: The transitional phase is extended till the end of March 2017, thus the requirement for the optical disc applies till 31/3/2017. The signed copy of the cover letter and the application form remain as valid documentation.

27/06/2016: The transitional phase is extended till the end of 2016, thus the above requirement for the optical disc applies till 31/12/2016.

A signed copy of the cover letter should be provided in paper together with the CD/DVD.
A signed copy of the application form should be provided in paper together with the CD/DVD.
An optical disc (CD/DVD) with the entire documentation is required until the end of 2Q 2016 for all submissions through CESP (transitional phase).

CAP via CESP: ΝΟ
CLINICAL TRIALS via CESP: ΝΟ

Contact Details:

Afroditi Neokosmidi

Regulatory Contact (Primary)

E-mail: aneokosm@eof.gr

Phone: 0030-2132040232

Functional Mailbox

Validation of Applications Division

E-mail: esubmission@eof.gr

Phone: 0030-2132040208

Website: www.eof.gr
NÉBIH ÁTI

Hungary

Areas: Veterinary Medicines

Updated: 18 April 2019

National Requirements:

For new applications product samples should be submitted during validation phase.

CAPS through CESP : Yes

Contact Details:

Dóra Földesi

Regulatory Contact (Primary)

E-mail: foldesid@nebih.gov.hu

Website: https://portal.nebih.gov.hu/adatbazisok-allat
National Institute of Pharmacy and Nutrition

Hungary

Areas: Human Medicines

Updated: 26 November 2019

National Requirements:

Please be informed that the Hungarian National Institue of Pharmacy and Nutrition (OGYÉI) is starting a CESP Pilot Phase on 4th January 2016.
In the pilot phase the allowed dossier types for CESP are the Initial Marketing Authorisation Applications in MR/DC Procedures and National Procedures for Human Medicines only. Other procedure types will not be accepted.
All the documents, previously needed originally hand signed, now will be acknowledged with certified electronic signature.
Please note, that as before, paper documentation, as well as CD/DVD submissions are allowed. Although there is a strong emphasis not to mix up the CESP way and the standard way of submission.
For more information please refer to the OGYÉI site.
Please be aware that this is still a Pilot Phase. Therefore, anytime submitting new documentation, please check for changes here.

Contact Details:

General

Regulatory Contact (Primary)

E-mail: mrp-dcp-new-cms@ogyei.gov.hu

Website: www.ogyei.gov.hu
Icelandic Medicines Agency

Iceland

Areas: Human Medicines Medical Devices Veterinary Medicines

Updated: 08 July 2022

National Requirements:

No specific national requirements and No requirement for CD/DVD for submissions through CESP, NCA may request CD/DVD in the event of an issue with the CESP submission.

CAP via CESP : Human - No (only submitted to EMA)
Veterinary - Yes

Contact Details:

General Contact

Regulatory Contact (Primary)

E-mail: esubmissions@ima.is

Website: www.ima.is
Health Products Regulatory Authority

Ireland

Areas: GxP Human Medicines Medical Devices Scientific Establishments Veterinary Medicines

Updated: 10 March 2022

National Requirements:

No specific national requirements and No requirement for CD/DVD for submissions through CESP, NCA may request CD/DVD in the event of an issue with the CESP submission.

CAP via CESP: Yes (Veterinary only)
Clinical Trial via CESP : Yes

Contact Details:

Linda Brophy

Regulatory Contact (Primary)

E-mail: linda.brophy@hpra.ie

Phone: 00353-16343302

Website: www.hpra.ie
Agenzia Italiana del Farmaco

Italy

Areas: Human Medicines

Updated: 12 June 2019

National Requirements:

CAP (human) via CESP: no

Referral submission must be received via Common Repository.

MR/DC/National procedures: for marketing authorization applications, variation applications, MAH transfers submitted through MR/DC/National procedures as well as any response document concerning these applications, ASMF deposits or ASMF amendments only submission through standard channels is considered official submission and will be taken into consideration for the purpose of defining the date of submission (e.g. for the start the validation phase and for acceptability of fees in accordance with the applicable National rules). Submissions received through the actual CESP are considered only as supportive. As soon as the integration with the national systems is be completed CESP submission will be accepted.

Marketing authorization applications, variation applications, MAH transfers and ASMF deposits or ASMF amendments should be submitted in paper accompanied by complete documentation on CD/DVD. Application form and cover letter should bear original signature. For procedures where Italy is CMS only application form and cover letter should be submitted in paper accompanied by CD/DVD containing the whole dossier. As regards variations applications submission through the national portal is strongly encouraged.

Clinical Trials submissions are not accepted through CESP: new applications and related substantial amendments applications should be submitted to the National Competent Authority (Italian Medicines Agency – AIFA) and the concerned Ethics Committees through the platform “Osservatorio Nazionale sulla Sperimentazione Clinica dei Medicinali (OsSC)” (https://servizionline.aifa.gov.it/jam/UI/Login?goto=https://servizionline.aifa.gov.it%2Fportale%2F%23/ossc/home) according to the communication published on the AIFA portal (http://www.aifa.gov.it/content/attivazione-nuova-piattaforma-ossc-e-progetto-%E2%80%9Cfast-track%E2%80%9D-17072018).

Contact Details:

General Contact

Regulatory Contact (Primary)

E-mail: cesp@aifa.gov.it

Maurizio Trapanese

ICT Sector

E-mail: settoreict@aifa.gov.it

Website: www.agenziafarmaco.gov.it/en
Direction General for Animal Health and Veterinary Medicinal Products

Italy

Areas: Veterinary Medicines

Updated: 24 March 2021

National Requirements:

Italy: Ministry of Health - DGSAF

National Requirements:
Ministry of Health – DGSAF

The Directorate General for Animal Health and Veterinary Medicinal Products started implementing CESP for the submission of applications for authorization, variations, transfer of ownership for Centralized procedures, including any responses to the above-mentioned applications, on September 4th, 2017.

The second phase of implementation began on April 16th, 2018: In addition to Centralised procedures, it concerned the MAA acceptance through CESP of Mutual Recognition procedures and Decentralised procedures, both authorizations and variations.

The technical documentation (dossier) shall be submitted in VNeeS format. A signed copy of the cover letter should be provided.

For ongoing MR and DC procedures, any further documentation required to complete the assessment must be sent via the previous channel (Cover letter + CD-ROM).

PSURs should be preferably sent via CESP.

Starting from April 2020, the third phase of implementation started: marketing authorization applications, variation applications, MAH transfers concerning purely National procedures, ASMF deposits or ASMF amendments must also be submitted through the CESP.

Details on procedures are available on the Ministry of Health website:
http://www.salute.gov.it/portale/temi/p2_5.jsp?lingua=italiano&area=veterinari&menu=immissione

Specific requests for clarifications/information can be sent to cesp@sanita.it

Contact Details:

General Contact

Regulatory Contact (Primary)

E-mail: cesp@sanita.it

Website: http://www.salute.gov.it

State Agency of Medicines of Latvia

Latvia

Areas: Human Medicines

Updated: 17 July 2019

National Requirements:

No specific National Requirements if a mutual agreement on the acceptance of documentation submission via CESP without an original signature is signed (please follow the link for further details)

National Requirements if a mutual agreement on the acceptance of documentation submission via CESP without an original signature is not signed:
Document submission through CESP is not mandatory, other options for submission of documents may still be used (also within the life cycle of a medicinal product).
The Agency accepts documents through CESP: (if documents are submitted through CESP, duplications are not allowed by submission of documents in CD/DVD format or through Eudralink)

Mutual Recognition Procedure (MRP), Decentralised Procedure (DCP), National Authorisation Procedure (NP)

Only for marketing authorisation, renewal,variation or response documentation upon request and additionaldocumentation
Only eCTD/Non-eCTD format
In addition to the documentation submitted through CESP the following original documents must be submitted separately

For a new application:

a signed cover letter indicating CESP number,
a signed application form for marketing authorisation, renewal or variations,
a power of attorney, if not submitted to the Agency previously,
a copy of SAM invoice and a payment confirmation containing the number of the invoice issued by the Agency.

· When submitting additional documentation it is not necessary to submit a signed cover letter.

· The Agency shall begin review of documentation only after receiving the original documents and advance payment!

The original documents shall be submitted in accordance with the normative acts in force in the Republic of Latvia, therefore, they have to be signed with a secure electronic signature or signed in paper format:

Option No 1
A letter sent via e-mail info@zva.gov.lv must be signed with a secure electronic signature (created using a secure electronic signature formation method and confirmed with a quality certificate). Size limit of one e-mail is 10 MB.

Option No 2
The signed documentation in paper format may be submitted in the Agency in person or it may be sent via mail to Zalu valsts agentura, Jersikas iela 15, Riga LV-1003, Latvija

Clinical Trials via CESP: Acceptable

Contact Details:

Maija Cirkina

Regulatory Contact (Primary)

E-mail: Maija.Cirkina@zva.gov.lv

Website: www.zva.gov.lv/

Food and Veterinary Service of the Republic of Latvia

Latvia

Areas: Veterinary Medicines

Updated: 10 February 2020

National Requirements:

No specific national requirements and No requirement for CD/DVD for submissions through CESP, NCA may request CD/DVD in the event of an issue with the CESP submission.

Contact Details:

Anete Šulce

Regulatory Contact (Primary)

E-mail: vzr@pvd.gov.lv

Phone: 00371-67084618

Website: http://www.pvd.gov.lv/
State Medicines Control Agency of Lithuania

Lithuania

Areas: Human Medicines

Updated: 07 January 2020
National Requirements:

ASMF/DMF via CESP: YES
CAP (Human) via CESP: NO
Clinical Trials via CESP: YES

National Requirements:

Starting from the 1st of January, 2019, State Medicines Control Agency (SMCA) switches to e-submission (e-dossier) in eCTD only. All applications for marketing authorization, renewal, all types of variations (under national, decentralized or mutual recognition procedures) need to be submitted as e-dossier via CESP (Common European Submission Portal) or written on CD/DVD.

To facilitate the administrative processes all regulatory activities (including MAH transfer, Change of local representative, Sunset Clause and etc.) need to be submitted as correspondent eCTD sequence.

If Common Repository for EMA coordinated submissions is used correspondent official cover letter with such information must be sent to SMCA simultaneously.

Clinical Trials:

In order to simplify the submission process of applications for clinical trials on medicinal products and to waive the submission of paper documents, The State Medicines Control Agency (SMCA) will now accept all documentation related to clinical trial applications through CESP portal.

The documentation submitted via the CESP portal shall be provided in one compressed ZIP file.

In addition, in order to speed the process please make sure your ZIP file is readable and clearly named according to the submission type, for example:
- Clinical Trial Application - Protocol No. XXX - EudraCT No. XXX - Initial application
- Clinical Trial Application - Protocol No. XXX - EudraCT No. XXX - Substantial amendment
- Clinical Trial Application - Protocol No. XXX - EudraCT No. XXX - DSUR
- Clinical Trial Application - Protocol No. XXX - EudraCT No. XXX - End of trial declaration
- Clinical Trial Application - Protocol No. XXX - EudraCT No. XXX - Other trial related documents
Contact Details:

Ausra Masiukaite

Regulatory Contact (Primary)

E-mail: AusraMasiukaite@vvkt.lt

Website: www.vvkt.lt
State Food and Veterinary Service

Lithuania

Areas: Veterinary Medicines

Updated: 21 October 2020

National Requirements:

Contact Details:

Jurgita Bazariene

Regulatory Contact (Primary)

E-mail: vaistu.registracija@vmvt.lt

Phone: 00370-37 268129

Website: https://vmvt.lt/
Ministère de la Santé – Division de la Pharmacie et des Médicaments

Luxembourg

Areas: Human Medicines Veterinary Medicines

Updated: 17 August 2022

National Requirements:

The submission of CD/DVD/Mail/Eudralink in parallel is not required.

Please note that the Ministère de la Santé has special requirements, see the website for more information.

CAP via CESP:

Human use: No (LU retrieves CAP related dossiers via the C.R.)
Veterinary Use: Yes

Clinical Trials Via Cesp: Yes

Contact Details:

Mylene Ferrier

Regulatory Contact (Primary)

E-mail: maa.hum@ms.etat.lu

Marc Schmit

Veterinary Medicines

E-mail: luxvet@ms.etat.lu

Website: https://sante.public.lu/fr/espace-professionnel/domaines/pharmacies-et-medicaments.html
Medicines Authority

Malta

Areas: Human Medicines

Updated: 06 November 2015

National Requirements:

Please refer to document 'Requirements for submission of applications for National and European procedures' on this link http://www.medicinesauthority.gov.mt/requirementssubmission.

No requirement for CD/DVD for submissions through CESP. NCA may request CD/DVD in the event of an issue with the CESP submission CAP Via CESP : No

Contact Details:

Helen Vella

Regulatory Contact (Primary)

E-mail: helen.vella@gov.mt

Website: www.medicinesauthority.gov.mt
Medicines Evaluation Board

Netherlands

Areas: Human Medicines Medical Devices Veterinary Medicines

Updated: 19 September 2018

National Requirements:

No specific national requirements. If an application is transferred over CESP, parallel submission of paper documents like the cover letter or application forms, CDs or DVDs is NOT allowed. MEB may request CD/DVD in the event of an issue with the CESP submission.

Contact Details:

General Contact

Regulatory Contact (Primary)

E-mail: infocesp@cbg-meb.nl

Website: www.cbg-meb.nl
Statens legemiddelverk, NoMA

Norway

Areas: Human Medicines Veterinary Medicines

Updated: 30 April 2019

National Requirements:

No specific national requirements and No requirement for CD/DVD for submissions through CESP, NCA may request CD/DVD in the event of an issue with the CESP submission.

CAP via CESP: Human - No
Veterinary - Yes

Contact Details:

General Contact

Regulatory Contact (Primary)

E-mail: CESP@legemiddelverket.no

Website: www.legemiddelverket.no
The Office for Registration of Medicinal Products Medical Devices and Biocidal Products

Poland

Areas: Human Medicines Medical Devices Veterinary Medicines

Updated: 08 March 2021
National Requirements:

From the 3rd of April 2017, the allowed dossier types for CESP submissions to the URPL are:

For Human and Veterinary Medicines: Initial Marketing Authorisation Application (national, MRP, DCP), Extension, Variation, Renewal.

Only eCTD, NeeS and VNees submissions will be accepted.

No requirement for CD/DVD for submissions through CESP, The Office may request CD/DVD in the event of an issue with the CESP submission.

The original documents shall be signed by an qualified electronic signature based on a qualified certificate for electronic signatures issued within the EU (in accordance with Regulation of the European Parliament and of the council on electronic identification and trust services for electronic transactions in the internal market) or ''wet-ink'' hand-signed and sent in parallel with the CESP submission in physical form (the cover letter should contain this information)

In reference to the above, in case of lack an electronic signature on the required documents to variations in the MRP/DCP procedures, the designation of the calendar for these procedures will be made after the documents with original signatures have been submitted to The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

Not accepted via CESP:
- draft response documents submitted for pre-assessment when Poland is acting as RMS. These should be submitted directly to the case coordinator via e-mail or EudraLink.
- Clinical Trials
- ASMF submitted in NeeS, PDF and other formats
The applicant/Marketing Authorisation Holder will not receive the information that a submission not acceptable via CESP is ignored.

As all the URPL will accept other forms of submission documentation: CD/DVD or in paper version.

CAP via CESP: No
Clinical Trial Submission through CESP : No

ASMF: Yes (only eCTD)

Contact Details:

Albert Biernacki

Regulatory Contact (Primary)

E-mail: albert.biernacki@urpl.gov.pl

Website: www.urpl.gov.pl/
INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P

Portugal

Areas: Human Medicines

Updated: 05 September 2018
National Requirements:

In case of National and MR/DC MAA, CESP submissions should be sent only after completion of the pre-submission of the MAA in INFARMED, I.P. online portal, available at http://www.infarmed.pt/web/infarmed/entidades/medicamentos-uso-humano and confirmation of valid payment of fee to INFARMED, I.P. in the portal. For MR/DC MAA ; pre-submission in the online portal is only mandatory after November, 4th 2013.

No requirement for CD/DVD for submissions through CESP, PT may request CD/DVD in the event of an issue with the CESP submission.

In case of national and MR/DC variation application (type IA, IAIN, IB, II, grouping or worksharing procedures) or Renewal applications, submission must be made through INFARMED, I.P. online portal (more information on the National Portal available at http://www.infarmed.pt/web/infarmed/entidades/medicamentos-uso-humano/autorizacao-de-introducao-no-mercado/alteracoes_transferencia_titular_aim (PT) / http://www.infarmed.pt/web/infarmed-en/human-medicines/marketing-authorisation (EN) )

For applications exceeding 10MB, the documentation may be sent to INFARMED, I.P. via CESP, however parallel submission in the online national portal (with reference to CESP submission number) is mandatory.

The submission of Active Substance Master File only through CESP is mandatory.

Submissions not accepted through CESP:
- Plasma Master File
CAP Via CESP: No (submissions retrieved using the Common Repository for Centralised Procedure).

Contact Details:

General Contact

Regulatory Contact (Primary)

E-mail: cimi@infarmed.pt

Website: www.infarmed.pt
Directorate-General of Food and Veterinary Medicine

Portugal

Areas: Veterinary Medicines

Updated: 21 November 2018

National Requirements:

No Specific Requirement

Contact Details:

Regulatory Contact

Regulatory Contact (Primary)

E-mail: cesp@dgav.pt

Phone: 00351-217808253

Website: www.dgav.pt
Institute for Control of Biological Products and Veterinary Medicines

Romania

Areas: Veterinary Medicines

Updated: 24 April 2019

National Requirements:

No CD/DVD or other submission (Paper, Eudralink...) if submission is made through CESP. NCA may request CD/DVD in the event of an issue with the CESP submission.

Contact Details:

Dr. Rena Dorofte

Regulatory Contact (Primary)

E-mail: cesp@icbmv.ro

Phone: 0040-212202112

Website: www.icbmv.ro
National Agency for Medicines and Medical Devices

Romania

Areas: Human Medicines Medical Devices

Updated: 04 January 2022

National Requirements:

No specific national requirements and No requirement for CD/DVD for submissions through CESP, NCA may request CD/DVD in the event of an issue with the CESP submission.

CAP via CESP: No
Clinical Trial Submission through CESP : No

Contact Details:

Ms. Nicoleta Diana Rosioru

Regulatory Contact (Primary)

E-mail: diana.rosioru@anm.ro

Ms. Madalina Minescu

General Contact – Coordinator of the Registry and Archive Service

E-mail: madalina.minescu@anm.ro

Website: https://www.anm.ro/.
Štátny ústav pre kontrolu lieciv - State Institute for Drug Control

Slovak Republic

Areas: Human Medicines

Updated: 20 December 2022

National Requirements:

The State Institute for Drug Control will update the procedures from 1 January 2023 with the aim of speeding up and streamlining the processes in the area of ??submitting applications.

The update concerns the cancellation of the Slovak application (SK form) in the case of eAF applications (Electronic Application Forms) and documentation submitted in eCTD format via the CESP portal.

You can find more information here and here

The Institute accepts all types of authorisation applications and related documents submitted through the CESP.

Notification of the receipt of applications and the allocation of a registration number will be sent to the e-mail address of the contact person for the Slovak Republic, which is listed in eAF, or of the person who submitted the application or whose authorization (original or notarized copy) was delivered to SIDC.

According to the Act. 362/2011 Coll on medicinal products and medical devices § 60 par. 1 letters x) and on the amendment of certain laws, we ask you a designate a natural person with permanent residence or a legal entity based in the territory of the Slovak Republic authorized to represent the marketing authoriasation holder or act on its behalf. The Power of Attorney authorisation is necessary dolivered with the original signature by post or courier.

For submission ASMF please see here

Contact Details:

Katarina Flaskova

Regulatory Contact (Primary)

E-mail: katarina.flaskova@sukl.sk

Danka Rochovska

Registry and Administration Support Department

E-mail: danka.rochovska@sukl.sk

Website: www.sukl.sk
Institute for State Control of Veterinary Biologicals and Medicines

Slovak Republic

Areas: Veterinary Medicines

Updated: 17 July 2017

National Requirements:

No specific national requirements.

Contact Details:

Katarína Thomová

Regulatory Contact (Primary)

E-mail: cesp@uskvbl.sk

Phone: 00421-376575385

Website: www.uskvbl.sk
Javna agencija Republike Slovenije za zdravila in medicinske pripomocke

Slovenia

Areas: Human Medicines Veterinary Medicines

Updated: 02 December 2021

National Requirements:

There are no specific national requirements.

JAZMP may request CD/DVD in the event of an issue with the CESP submission.

CAP via CESP : No (using the common repository for centralised submissions)

Contact Details:

Aljaž Bolta

Regulatory Contact (Primary)

E-mail: Aljaz.Bolta@jazmp.si

Website: www.jazmp.si
La Agencia Espanola De Medicamentos Y Productos Sanitarios

Spain

Areas: Human Medicines Veterinary Medicines

Updated: 31 March 2022

National Requirements:

Accepted formats for electronic submissions are eCTD, NeeS and VNeeS.

Only one way of submission should be used

"National Application Number" field is mandatory for addtitional submissions (Not Initial) in National procedures about new MA, Variations or Renewals ( The National Application Number will be provided by the AEMPS)

PSURs for Human Medicines are not accepted.

All Human Referral Submissions must be submitted via Common Repository from the next 1st of December 2017.

Please note that Spanish Agency for Medicines and Health Products (AEMPS), has special requirements for electronic submissions.

Refer to AEMPS website for further info.

Contact Details:

General Contact

Regulatory Contact (Primary)

E-mail: soporte_aplicaciones@aemps.es

Website: www.aemps.gob.es
Medical Products Agency

Sweden

Areas: Human Medicines Medical Devices Veterinary Medicines

Updated: 12 December 2019

National Requirements:

Accepted formats for electronic submissions are eCTD and VNeeS. Only one way of submission should be used (CESP, email/EudraLink or CD/DVD). No specific national requirements.

CAP via CESP : Human - No

Veterinary - No

Contact Details:

General Contact

Regulatory Contact (Primary)

E-mail: eSubmission@lakemedelsverket.se

Website: www.lakemedelsverket.se
Medicines and Healthcare products Regulatory Agency

United Kingdom

Areas: Human Medicines Medical Devices

Updated: 26 July 2021

National Requirements:

**WORKSHARING PROCEDURES: If the documentation is relevant for the same regulatory activity, please submit all documentation in the same CESP submission. Work-sharing procedures submitted on separate CESP submissions causes internal processing issues and potential delays.

For details on submissions to the MHRA please refer to the MHRA Submissions guidance web pages on the MHRA website.

CD/DVDs not required or accepted.

CAP via CESP: Yes
Clinical Trials Via CESP: Yes - Please visit our blog for faster approval times

Visit the MedRegs blog for expert insight on the latest regulatory thinking and all aspects of medicines regulation

Email Queries: Please include ‘CESP QUERY’ in the subject details along with the CESP Reference and the submission type e.g. “CESP QUERY Ref. 5000000 Type 1B Variation”

Resubmissions: Please select the following Sub Activity Text for resubmissions: ‘Initials’. Selecting ‘Answer to Questions during validation’ will cause delays with your application.

Sub Activity text - Answer to Questions during validation: Please use this category only when it relates to a Request for further information.

Sub Activity text - Not applicable: If possible, please avoid this Sub Activity text and choose the most appropriate text to avoid delays with your application.

Contact Details:

General Contact

Regulatory Contact (Primary)

E-mail: IPUenquiries@mhra.gov.uk

Website: gov.uk/mhra
Veterinary Medicines Directorate

United Kingdom

Areas: Veterinary Medicines

Updated: 26 January 2022

National Requirements:

No specific national requirements and No requirement for CD/DVD for submissions through CESP, NCA may request CD/DVD in the event of an issue with the CESP submission.

CAP via CESP : Yes

Contact Details:

Licensing Administration Branch

Regulatory Contact (Primary)

E-mail: s.response@vmd.gov.uk

Website: https://www.gov.uk/government/organisations/veterinary-medicines-directorate

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Contacts

Austrian Agency for Health and Food Safety

Austria

Areas: Human Medicines Veterinary Medicines

Updated: 06 November 2015

National Requirements:

Contact Details:

General Contact

Federal Agency for Medicines and Health Products

Belgium

Areas: Human Medicines Medical Devices Veterinary Medicines

Updated: 02 February 2018

National Requirements:

Contact Details:

Els Verschaeren

Els Verschaeren

Katelijne Vankeymeulen

Iris Geussens

Roselien Poppe

Katrien Bernaert

Lesley Verley

Dries Minne

Valerie Vanmerris

Wim Huygh

Jamila Bazza

Bulgarian Drug Agency

Bulgaria

Areas: Human Medicines

Updated: 18 August 2022

National Requirements:

Contact Details:

General Contact

Bulgarian Food Safety Agency

Bulgaria

Areas: Veterinary Medicines

Updated: 17 May 2020

National Requirements:

Contact Details:

Dr. Lilia Asenova

European Directorate for the Quality of Medicines & Healthcare

Council of Europe

Areas: EDQM

Updated: 03 May 2019

National Requirements:

Contact Details:

General Contact

Agency for Medicinal Products and Medical Devices (HALMED)

Croatia

Areas: Human Medicines Medical Devices

Updated: 07 June 2018

National Requirements:

Contact Details:

Maja Lovrek Romcevic

MINISTRY OF AGRICULTURE - Veterinary and Food Safety Directorate

Croatia

Areas: Veterinary Medicines

Updated: 05 September 2022

National Requirements:

Contact Details:

Boris Fabijanic;

Irena Žarkovic

Pharmaceutical Services/Ministry of Health

Cyprus

Areas: Human Medicines

Updated: 17 November 2021

National Requirements:

Contact Details:

Mrs Natasa Kiza

Mrs. Athina Koutsoventi

VETERINARY SERVICES - VMP Section

Cyprus

Areas: Veterinary Medicines

Updated: 12 July 2022

National Requirements:

Contact Details:

General

Stavroula Themistocleous

Czech State Institute for Drug Control