Applications for marketing authorisations

The pan-European application platform, CESP, should normally be used to send application documents to the Swedish MPA, but other paths may be used in special cases. Only use one of the paths listed below, as duplications cause additional work and risk extending the processing time.

1. CESP – mandatory for all applications under MRP/DCP and also strongly recommended in national procedures. The files must be zipped.
2. EudraLink – must not be used for eCTD sequences and VNeeS, unless there are special reasons. The files must be zipped.
3. Ordinary ‘open’ email – must not be used for eCTD sequences and VNeeS, unless there are special reasons. Max. 20 MB. The files must be zipped.
4. CD/DVD – may be used for national applications, but CESP is strongly recommended.

We recommend that you use the cover letter template published by CDMh and CMDv for MRP/DCP applications (see link to HMA’s template page). The template is also recommended for national applications to the Swedish MPA.

Neither an original signature nor scanned signatures are required on the application form or the cover letter to the Swedish MPA.

However, applicants must always lock their eAF by inserting what is known as a ‘signature’.

The electronic application form (eAF) must always be sent in locked format, with a ‘signature’. Always use the current version. This form can be found on the EMA’s website, which also provides information on the eAF and how to lock the form, as well as regulatory and technical guidance documents.

PDF files should normally be created, where possible, from electronic text documents (Word or similar). To facilitate the work on the investigation, please ensure that PDF files copied into electronic text documents result in a format that is fully editable after copying, so that they can easily be used when we create our investigation reports.

Product information (SMPC, PL and labelling) must always be attached as Word copies (with the ‘Track Changes’ function enabled, where relevant).

Word copies of documents in Module 2 are also requested for applications under the national procedure or when Sweden acts as RMS in DCP/MRP, where a lot of texts and tables are copied to the investigation report.

These Word files are only working copies and should be placed outside the structure of the electronic application, in a separate folder called ‘xxxx-working documents’.

All electronic applications (eCTD and VNeeS) must comply with the applicable ICH and/or EU requirements, and must pass the technical validation process carried out by the MPA with respect to the applicable validation requirements.

In order to be accepted, all Pass/Fail criteria must be met.

Guides and criteria for validation for each format can be found on EMA website.

According to the CMDh Guide, strictly national applications in the following areas do not need to be submitted in eCTD format:

• change in MAH
• change of agent
• dose dispensation
• sunset Clause
• change in the design of the label
• national additions to packaging sizes already approved in the MRP
• addition/deletion of indications due to patent protection.

In these cases, documentation may be sent to the Swedish MPA as ‘loose’ PDF documents, but they must still meet the technical requirements for files, i.e. PDF version 1.4 or higher, and have no security settings. The Swedish MPA also accepts the same procedure for VNeeS.

It should be noted that national translations of product information must always be sent in a separate folder called ‘xxxx-workingdocuments’ together with an application. When sent as loose Word files by email or Eudralink, there must be a clear reference to the application.

The single European application portal, CESP, is mandatory for applications under the MRP and DCP, and is also strongly recommended for national applications. There is no nominal size limit, but zipping is a requirement in order to minimise bandwidth.

It should be noted that ‘PSUR single assessment’ and ‘referrals’ coordinated by EMA should not be submitted.

You can access CESP via HMA’s website CESP. To use CESP, you must first register on the website.

The portal has a self-service function, which means that each undertaking must appoint its own administrator to set up and ensure that the undertaking’s employees have access to CESP.

To register the undertaking’s administrator, a specific form must be completed. This can be accessed via the registration link on the same website.

The Swedish MPA recommends that all new users participate in the free webinars provided on a regular basis.

Avoid sending duplicates. If, for any reason, you submit documentation which has already been submitted, the remarks field should therefore always be used to explain why the documentation is being submitted again. Include a clear reference to the previous CESP submission.

If documentation for an MRP product in any position is only to be sent to a specific CMS, RMS ‘zz’ must be stated, to ensure that the RMS does not receive an unwanted copy of the documentation.

All documentation for human and veterinary medicinal products in the Central Procedure, for PSURs which are being assessed under the EU Single Assessment, as well as the referrals coordinated by the EMA, must be submitted only via eSubmission Gateway/Web Client. Such documentation must be sent to the MPA by other means, as we retrieve relevant documentation from the Common Repository/PSUR Repository.

The Swedish MPA wishes to receive only one copy of each disc when you submit documentation on CD/DVD. Discs must be clearly marked in accordance with the applicable EU guidelines for electronic applications. If multiple applications (regulatory activities) are submitted at the same time for the same product, these should, as far as possible, be placed together on the same CD/DVD. However, each application must have its own separate folder structure, and the disc must be clearly marked with all constituent applications.

If the documentation for a product is still handled in paper or NeeS format, the change in format to eCTD and VNeeS must be made when, for example, a new amendment application or a response document for an ongoing procedure is submitted.

The change in format is always assumed to cover all strengths and forms of a medicinal product with the same product name, even if the current application concerns only single strengths/forms.

For ongoing procedures, there is support for a change in format to eCTD in the document entitled ‘Q&A on how to handle ongoing procedures in relation to mandatory eCTD format’ on the EMA’s website. ‘Questions and answers concerning mandatory eCTD in the National Procedure’ is also available on the same website.

When switching to electronic format, there is no requirement for product documentation which has previously been submitted in paper format to be re-submitted in electronic format. However, to facilitate the investigation, the MPA recommends that undertakings switching to eCTD format submit the relevant documentation in Module 3 as a baseline dossier. In this case, it should be sent as a separate sequence (normally sequence 0000) with confirmation in the cover letter that only the format has changed, not its content.

A baseline can also be submitted later in the life cycle in order to supplement the dossier with valid documentation that has not yet been submitted electronically. Even in these cases, the documentation must be submitted as a separate sequence (with the next available sequence number in the current life cycle) and information in the cover letter.

More information on baselines in the EU Harmonised Technical eCTD Guidance on the EMA’s eSubmission website, under eCTD 3.2.

ASMF documentation must always be submitted in eCTD or VNeeS format.

ASMF documentation sent electronically is technically validated based on the applicable EU criteria. If it is not technically valid, a technically revised ASMF will be required.

More information on how to handle ASMF documentation in eCTD format can be found on the EMA’s eSubmission page, under the eASMF tab.