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Contacts


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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: 

    1. a signed cover letter indicating CESP number,
    2. a signed application form for marketing authorisation, renewal or variations,
    3. a power of attorney, if not submitted to the Agency previously,
    4. 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