Practical guidance for submission of applications for
registration of Traditional Herbal Medicinal Products and
approval of Natural Remedies
Applications for registration of Traditional Herbal Medicinal Products or approval of Natural
Remedies should be submitted to:
Medical Products Agency
Department of Herbal Medicinal Products
Dag Hammarskjölds väg 42
SE-751 03 Uppsala
SWEDEN
Structure of the dossier
It is strongly recommended that the documentation is put in binders with solid backs. On the
spine and front of the binders it should be clearly stated the name of the product, its
pharmaceutical form, strength and, where appropriate, the procedure number. As stated in Annex
I to Directive 2001/83/EC, implemented trough LVFS 2003:7, the Common Technical Document
(CTD) format is mandatory for all new applications for approval of human medicinal products,
including traditional herbal medicinal products and natural remedies. Applicants are requested to
adhere to the recommendations given in Notice to Applicants Volume 2B.
A table of content should always be included. In case a specific annex listed in the table of
contents is not applicable to the dossier, please indicate this by adding “N/A” in the
corresponding space in the table.
The binders should only contain paper, i.e. the documents should not be put in plastic covers.
Dossier format – paper and electronic versions
The MPA still requires all applications in paper format, but to facilitate the assessment, we would
also appreciate electronic copies (CD ROM) of the summaries and overviews (module 2.3-2.7)
and module 3, submitted in Word format.
An electronic copy (CD ROM) of the suggested product information (SPC, Package Leaflet (PL)
and labelling) in Word format should always be submitted with the application. Please, refer to
our web site (www.lakemedelsverket.se ) for templates. For MRP and DCP the product information
should be in English only, but for national procedures product information in Swedish is
required.
Questions concerning specific submissions should be sent to the Department of Herbal Medicinal
Products’ E-mail address, vbl.central@mpa.se
Number of copies requested
Only one copy of the application should be submitted.
Duplicate application
For duplicate applications, there is a specific statement to fill in and enclose with the application
in order to simplify the validation of the application. Please find the template on our web site. A
duplicate application is defined by reference to the first application or marketing authorisation as
follows:
• Same legal basis
• Same dossier (photocopy)
• Different trade name
• Same or different 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.
The MPA experience is that quite a lot of applications include for example different batch release
sites or package sizes, even if applied for as duplicates. In these cases, the applications should be
handled as non-duplicates and invoiced accordingly. So please, make sure that the correct
reference is made in the statement.
Product samples
Samples of the finished product need not be submitted with the application. Finished product,
active substance and impurities for analysis purposes should be available on request.