1. Application for marketing authorisation
Please consider the CMDh recommendations for the cover letter and preferably use the published template (see link to the right).
1.1. Electronic submissions on CD/DVD
Electronic-only submissions (eCTD, NeeS or VNeeS format) are strongly encouraged. A filled “Confirmation of transition to electronic-only submissions” should be submitted together with extension applications to clarify that all future submissions also for other strengths and forms of the product applied for will be submitted electronic only.
The criteria for accepting electronic submissions as originals in all procedures are that the current ICH and EU specifications and the EU eCTD harmonised guidance or the EU NeeS harmonised guidance are followed. The submissions have to pass the technical validation at the MPA.
If the submission requires more than one CD, a DVD is preferred. The CD/DVD should be packed adequately to prevent damage. Each CD/DVD should be properly labelled in accordance with current EU guidance.
The applicant is responsible for checking the CD/DVD for viruses.
Avoid submitting documents in several different formats, unless they are so called working documents which should be submitted in MS Word in a separate folder.
All submissions, whether entirely on paper or on CD/DVD, should have a paper cover letter with submission subject clearly stated. Original signature is not needed. If in electronic format, the cover letter should also be included on the CD/DVD.
1.2. Paper submissions
If the submission cannot be submitted in eCTD, NeeS or VNeeS format, paper submissions are still accepted by the MPA.
It is strongly recommended that the documentation is put in binders with solid backs. The name of the product, the pharmaceutical form, strength and, where applicable, the procedure number should be clearly stated on the spine and front of the binders. For health and safety reasons, the application dossier should be packed in boxes weighing no more than 15 kilos each. All boxes should be numbered and the module numbers should be stated on the boxes. The box containing the Cover Letter should be easily identified.
If one or more modules are common for multiple strengths/pharmaceutical forms or for duplicate applications, a reference to these modules in the “first” application should be given in the Cover Letter instead of submitting all these copies.
An electronic copy of the submission in any format is still appreciated. This copy will not be technically validated.
1.3. Product samples
An application for a Marketing Authorisation in Sweden should be accompanied by a sample of the finished product (one package per medicinal product/strength/pharmaceutical form). The sample should be presented as the product in its intended package, but does not need to have the final labelling. The purpose of the sample is not to perform any laboratory analyses or to evaluate the labelling but rather to assure user friendly packages. Placebo samples rather than drug containing samples should be submitted:
- if the drug substance is classified as a narcotic substance in Sweden
- if the drug substance is cytostatic or otherwise particularly toxic
Placebo samples rather than drug containing samples may be submitted:
- if the originators patent is still in force and prohibit samples containing the drug to be sent
- if the price of the drug substance is particularly high
If justified, an empty sample of the package can be sufficient, for example if the filled package is very large. Finished product, active substance and impurities should be available on request for analysis purposes.
1.4. Duplicate applications
For duplicate applications, there is a specific form, “Statement for duplicate applications” to fill in and enclose with the application. A duplicate application is defined by reference to the first application or marketing authorisation as follows:
- same dossier (copy of modules 1, 2, 3, 4 and 5)
- same legal basis according to Directive 2001/83/EC, as amended
- different trade name
- same or different applicant/marketing authorisation holder
In other words, the product name and the Marketing Authorisation Holder are the only things that may differ from the first application referred to. In addition, the documentation for the first application referred to has to be in line with the current legislation before a duplicate application can be submitted.
Only module one is required for the duplicate allocation.
2. Other submission types (e.g. variations and PSURs)
2.1. Electronic submissions via e-mail
Submissions concerning mock-ups/PL, change of local representative, MAH transfer and Type IA/IB variations are accepted by e-mail. Any documentation submitted should either be accompanied by an application or as amendment to an existing application. Documentation submitted that does not refer to any application will not be saved.
Submissions should have their subject stated clearly in the subject line or early in the e-mail. Product name, Aspnr and/or procedure number (where relevant) should be included. Use accepted standard terms.
Submissions concerning products that are still considered “paper submissions”, and therefore have to be printed out by the agency, should not exceed 100 pages.
Avoid submitting both by e-mail and by regular mail. This might slow the processing of the submission and is time consuming, since we need to make sure that both submissions do concern the same application(s).
If anyhow needed (e.g. for large responses to questions (>100 pages) sent by e-mail due to time limits for products that are still “paper-based” and paper copies are required), it should be clearly stated in the e-mail that the documentation will also be submitted by regular mail to the MPA.
PSUR: PSUR submissions should not be combined with other types of submissions, except if they are submitted together with a renewal application.
PSUR submissions can be made electronically (either by e-mail or CD/DVD), also for product where you normally submit the documentation on paper.
If you normally submit documentation for the product(s) in question only on eCTD:s, PSURs should also be submitted in eCTD format.
For all the above listed submission types, please use the e-mail address RIC@mpa.se.
2.2. Transfer from paper to electronic
The MPA strongly encourage companies to change from paper to electronic-only submissions for all authorised products within DCP, MRP and NP. A so called “Baseline submission” is not required to do this. However, the change should normally be made for all strengths and forms of that particular product (trade name). Please refer to text on “Electronic submissions”.
The first time the company submits an application in electronic format only for a particular product ("trade name ") within MRP, DCP or the national procedure, it must submit in connection with the start of a so-called regulatory activity, such as a new application for approval, a PSUR or a variation application (preferebly not IA variations). A completed "Confirmation for electronic-only submissions" should be submitted with the application, but does not need be included in the electronic application. The MPA strongly recommend that all strengths and forms of the same name are handled the same way. The regulatory activity that initiates the transfer does not have to cover all strengths and forms that are covered by the transfer to electronic-only.