Guidance for the pharmaceutical industry on how to submit applications, data packages and company responses for proposed or existing authorisations in the UK.
This guidance applies to marketing authorisations, veterinary homeopathic registrations, animal test certificates, specific batch control, autogenous vaccines, non-food animal blood banks and equine stem cell centres.
Applications and responses must be submitted electronically.
Submission slots for Biological and Bio-Pharm new MA applications
Applicants should obtain a submission slot in advance of submitting new or extension variation applications for Biological or Bio-Pharm Marketing Authorisations. Meetings should be requested at least 3 months (7 months for applications involving centralised procedure) prior to your planned submission.
Please contact firstname.lastname@example.org to arrange a meeting.
All other application types do not require a submission slot.
Submission of Pharmaceutical application types
Pharmaceutical application types do not require a submission slot agreement.
However, applicants should provide the VMD with a minimum 6-month forewarning of any applications intended to be submitted under Article 12(3) (full) or 13a (well-established use/bibliographic). Please send the notification to email@example.com with the following minimum information:
- Article 12(3) (full) or 13a (well-established use)
- Active substance
- Pharmaceutical form
- Brief summary of indication sought
- Phase II ERA, if applicable
Veterinary Medicines Digital Service
The Veterinary Medicines Digital Service (VMDS) is the UK submission and communication system to apply for new national authorisations, or to vary or renew existing ones and to submit information in support of other licensing activities, such as mock-ups and animal test certificates.
National applications and responses to questions that we ask you during the application must be submitted through the VMDS.
The VMDS system works using Marketing Authorisation Holder (MAH) company numbers to assign the right lists of products to the right companies. Therefore, you will only see those MAs listed for your company. If you would like to act on behalf of another MAH, perhaps an EU counterpart, they can then invite you to use their account. You can switch between company profiles using one set of log-in details.
Common European Submission Portal (CESP)
EU applications and responses to questions for mutual recognition and decentralised procedures where NI is a CMS should be submitted via CESP or Eudralink.
If using Eudralink, the package should be sent to firstname.lastname@example.org. The subject line should identify that it is a submission of an application or a response and provide the VMD application number or EU reference number.
Applications for centrally authorised procedures and responses to questions should continue to be submitted via the EMA eSubmission Gateway. You will also need to send us a copy of the Centralised submission via the VMDS, and any subsequent procedural communications you submit to the EMA such as responses to lists of questions and requests for additional information during validation.
The VNeeS guidelines published by the Veterinary Harmonisation Group should be followed in all cases, where possible. Although the application structure for national-only schemes do not completely fit within the VNeeS guidelines, you should use as many of the principles laid out in the guidelines as possible, such as file size, naming conventions, and indexing. This applies to the following:
- marketing authorisations for parallel import (MAPI)
- exceptional marketing authorisations
- specific batch control
- animal test certificates (ATC)
Some areas of the VNeeS guidelines to note:
|Page numbering||Each document in the dossier must contain page numbers but these do not need to be sequential throughout the whole dossier|
|Naming conventions||You should follow the naming conventions for the folder and files set out in the VNeeS guidelines. For some software programmes using anything other than lower case letters, or numbers 0 to 9, can cause problems and you run the risk of your submission failing technical validation|
|Root folders||A root folder is part of the VNeeS structure and should be the first folder you create when preparing your submission|
|Technical validation||For MA applications, you must prove technical validity before submission of the electronic dossier and should include the validation report in the add-info folder of the VNeeS submission.|
Submission routes for new MAs, variations and renewals
The table below shows the submission routes per MA type which applies to the initial application, active substance master files in support of the application and any subsequent provision of information and responses to questions.
If you are submitting an MA application using the new online form, you must add a placeholder file in the dossier where you would have previously included an application form. Without this placeholder file, your application will fail the automatic technical validation process.
|National MA in GB only – new, variations and renewals||VMDS: online application; select GB option|
|National MA in NI only – new, variations and renewals||VMDS: online application; select NI option|
|National MA in GB and NI (submitted in parallel) – new, variations and renewals||VMDS: online application; select the GB and NI option; provide only one data package|
|UK wide MA (national in both GB and NI) - variations and renewals||VMDS: online application|
|UK wide MA (national in GB, but EU in NI (NI is a CMS)) - variations and renewals||CESP or Eudralink for the NI element; Plus, within two working days of the EU submission, VMDS: online application for the GB element. In the ‘other information’ section in the form, tell us the CESP submission number or date of the Eudralink for the corresponding EU application|
|EU MA in NI - MRP / DCP where NI is CMS – new, variations and renewals||CESP or Eudralink|
|EU MA in NI (MRP / DCP where NI is a CMS) and national MA in GB - submitted in parallel – new, variations and renewals||CESP or Eudralink for the NI MA. Plus within two working days of EU submission, VMDS: online application for the GB MA; select GB option. In the ‘other information’ section in the form, tell us the CESP submission number or date of the Eudralink for the corresponding EU application.|
|EU MA in NI (Centralised) – new, variations and renewals and EU MRL||EMA eSubmission Gateway. Plus within two working days of EU submission VMDS: Use the ‘other’ application submission type and upload the application form and dossier or send via secure message and attach the application form and dossier. During the procedure you must also provide to us any additional information submitted to the EMA during validation, any procedural timetables provided by the EMA, questions asked during the procedure and your responses to lists of questions|
|EU MA in NI (Centralised) and new national MA in GB – submitted in parallel – new, variations and renewals||EMA eSubmission Gateway. Plus, within two working days of EU submission, VMDS: online application for the GB MA; select GB option. In the ‘other information’ section in the form, tell us the date of the EMA submission. You should include a copy of the EU application form in the dossier and must include both variants of all differences between the data packages, for example both sets of MA holder details if these are different for the proposed Centralised and GB MAs. During the procedure you must also provide to us any additional information submitted to the EMA during validation, any procedural timetables provided by the EMA, responses to lists of questions|
Active substance master files (ASMF)
ASMFs may be submitted electronically and in Common Technical Document (CTD) or Notice to Applicants (NTA) format, however CTD format is preferred. You should ensure that the proposed active substance manufacturer has submitted the full ASMF to us before submitting your application. A full ASMF includes the open and restricted parts, including Expert Reports, or Quality Overall Summary, if submitted in CTD format.
The ASMF should be submitted via the same method as the application.
The active substance manufacturer needs to register as a manufacturer to use the VMDS, so they can submit ASMFs and use the secure messaging part of the service to receive and respond to questions during national applications.
Other application types
Veterinary homeopathic registrations, maximum residue limits, animal test certificates, specific batch control, autogenous vaccines, non-food animal blood banks and equine stem cell centre applications should be submitted via the VMDS using the ‘other’ application type or via secure message.
Validation and additional information
Most types of applications are validated upon receipt to check that everything has been provided in order to begin the assessment. If you are submitting an MA application using the new online form, you must add a placeholder file in the dossier where you would have previously included an application form. Without this placeholder file, your application will fail the automatic technical validation process.
It is up to you to identify and submit all the necessary information in support of your application. If the submission is incomplete, we may not be able to progress your application.
We will contact you if further information is needed.
For information or queries email email@example.com