Information relevant to the sending of Electronic Files to the AEMPS
The possibility of making electronic applications is assuming a change in the communication and exchange of data between the industry of veterinary laboratories and regulatory authorities such as the AEMPS.
Instructions for the preparation and submission of electronic files
- The following steps will be followed:
- Prepare the electronic file on CD/DVD according to the specifications of the "European Guide v2.6» for electronic referral of veterinary medicines dossiers.The electronic media will store the information following a certain standard folder structure (VNeeS format) that is set out in the "European Guide v2.6«.
You can download the template model of such a VNeeS structure
(version 2.3).In this normalized folder structure, the information files will be located. The names of the information files will be standardized. In the «European Guide v2.6» The file names to be used are clearly displayed.
Important Note: Once a request for a drug has been made using the electronic channel, all requests for modification relating to the drug must also be made electronically.
- Register the applications in RAEVET.Applications that are part of the shipment must be registered with RAEVET, both for shipments of new authorizations and for shipments of variations. To connect to RAEVET, the digital certificate, user and password will be used, in the same way as is already the case today.How to obtain a Digital Certificate?
The Application Number assigned to RAEVET must appear both on the CD or DVD label and on the cover letter. If multiple medications are presented on the CD or DVD (e.g. 100 mg, 150 mg and 300 mg) the different application numbers for each drug must appear on the cover letter and on the labels of CD’s and DVD’s.
- Submit the electronic file on CD/DVD together with paper-based documentation in the AEMPS Registry.The CD or DVD, made according to the «European Guide v2.6» must be submitted to the AEMPS register together with the following paper documents:
3.1 Delivery in face-to-face registration.
- Cover letter signed handwritten.
- Depending on the type of application, the following will be submitted:
- For New Drugs. For each application included in the shipment, the first sheet of the application form (section 1.a) signed in manuscript will be presented.
- For Variations. For each variation request included in the submission, the complete hand-signed application form will be submitted.
- Documents accrediting the payment of the fees corresponding to the requests contained in the shipment (variations or authorizations).
Important Note: If additional information is provided, it will only be accompanied by a cover letter.
3.2 Telematic submission of documentation.
WARNING
New VNees Validation Rules since October 1, 2015.
Applicants are reminded that they must validate VNeeS telematic shipments by means of the “VNeeS checker” before making the shipment.
The documentation in VNeeS format can be sent telematically through RAEVET, the paper documentation detailed in the previous section should be included in the corresponding folders of the VNeeS shipment in electronic or scanned format, it being not necessary to present any paper document.
The appropriate method for telematic shipping is by compressing the root folder of the shipment, as shown in:
https://sinaem.agemed.es/documentacionraefar/Recursos/Ayuda_es.swf.These zip or rar files will be attached in the Cover Letters.
The remediation documentation, answers to questions, additional information, which generates a VNeeS sequence, can also be sent telematically through RAEVET, compressing the root folder of the sent in various zip files, following the same guidelines expressed in the previous paragraph.
- Guide “Sending electronic files to the AEMPS”. Sending and tracking by electronic records laboratories to the AEMPS
(v3.0 – August 2017)
“The CESP portal (Single European Platform for Submission of Registration Applications and Variations) is scheduled to be launched on 1 October 2012. The participation of the Spanish Agency will be announced through an information note of the AEMPS».
Submissions of MRP and DCP procedures.
They will be carried out via CESP or through the National Portal (Raevet).
Shipments of national procedures.
They will be done through the National Portal, and if these are greater than 40 MB it is recommended to send them via CESP.
Link to the portal and informationhttp://cesp.hma.eu/.
- Prepare the electronic file on CD/DVD according to the specifications of the "European Guide v2.6» for electronic referral of veterinary medicines dossiers.The electronic media will store the information following a certain standard folder structure (VNeeS format) that is set out in the "European Guide v2.6«.
Frequently asked questions and answers
- In the document ofFrequently Asked Questions (FAQs)They respond to the usual doubts for the construction and referral of the electronic file. The email address is also enablededossierv@aemps.esto resolve possible queries
Links of Interest
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Related documentation can be found at the following addresses:
- Documentation EMA, European Medicines Agency:
- Website of the TIGes Vet. EMA subgroup for electronic submission of documentation in the context of procedures relating to the approval of veterinary medicinal products:
- VNeeS Checker: Program to validate whether or not a shipment is compatible with the European Guide.
- “Notice to Applicants” and regulatory references for veterinary medical products.
- General aspects to take into account on the transition to the Electronic Dossier.
- Link to the Notice to Applicants – Frequently Asked Questions about the CTD.
- eSubmission Roadmap v.2.0 (24 February 2017)
- Final HMA eSubmission Roadmap (adopted)
Contacts and suggestions
For more information, contact the AEMPS:
E-mail address:edossierv@aemps.es.