Submission of product information
- Published: November 17, 2020
- Last updated: May 11, 2023
It is preferred by the Swedish Medical Products Agency to have all submissions received in electronic format. For new authorisations, renewals and variations the product information text documents should be submitted in MS Word-format and mock-ups in PDF-format.
Information about requirements and guidelines for submission of product information is available at EU-related websites:
Swedish translations for product information within the mutual, subsequent or decentral procedure should be sent to RIC@lakemedelsverket.se.
Always refer to the procedure number/reference number in all correspondence.
New authorisations
For new authorisations clean versions of Summary of Products Characteristics, package leaflet and labelling text in MS Word-format should be submitted to the Swedish MPA. In the response the updates should be shown with the MS Word-function “Tracked changes”.
Mock-ups should be submitted in PDF-format version 1.4 or higher (one PDF for each mock-up). For assessment of Nordic packages the form “Request for a Nordic mock-up cooperation” should be enclosed with the submission.
Request for a Nordic mock-up cooperation
Variations and renewals
For updates of product information the approved SmPC, PL and labelling text should be submitted clearly marking out he revisions of the text using the Word function “Tracked changes”. Always use the currently approved version of the product information when making revisions of the text.
If the changes of the product information affect mock-ups, updated mock-ups should be submitted in PDF-format version 1.4 or higher (one PDF for each mock-up). For assessment of Nordic packages the form “Request for a Nordic mock-up cooperation” should be enclosed with the submission.
For IA- and IB-variations in the mutual recognition procedure and for Art 61(3)-notifications (for human medicines) both English and Swedish versions of the product information should be submitted.
For VNRAs – variations not requiring assessment – (for veterinary medicines) both English and Swedish product information is uploaded to the Union Product database (UPD) when the variation is registered.
National phase of the mutual, subsequent and decentral procedure
After the end of procedure for new authorisations, renewals and type II-variations the applicant is responsible for submitting Swedish product information to the Swedish MPA within seven calender days after the end of procedure.
Email: RIC@lakemedelsverket.se
Always refer to the procedure number in all correspondence.
New authorisations
For new authorisations clean versions in MS Word-format of the Swedish product information (Summary of Products Characteristics, package leaflet and labelling text) and mock-ups in PDF-format version 1.4 or higher (one PDF for each mock-up) should be submitted. For assessment of Nordic packages the English version of the form “Request for a Nordic mock-up cooperation” should be enclosed with the submission.
If no product information, or any other message is received by the Swedish MPA within 7 calendar days, it will be assumed that the product is not going to be marketed in Sweden and the Swedish MPA will make an authorisation without Swedish product information.
Renewals and type II-variations
For renewals and type II-variations for which the product information has been changed relevant Swedish product information should be submitted. All changes should be clearly marked out using the MS Word-function “Tracked changes”. Always use the currently approved version of the product information when making revisions of the text.
When no changes to the product information has been made during a renewal procedure there is no need to submit Swedish texts or mock-ups again after the procedure has finished. The Swedish MPA just need to have a confirmation that the product information has not been changed.
Article 61(3)-notifications, IA- and IB variations
For Art 61(3)-notifications, IA- and IB variations both English and Swedish product information is submitted with the application.
Checklist for Swedish product information
Guideline for translations
Notification of change in labelling and/or package leaflet – national change
Products that are not marketed
- Always specify in the cover letter if you do not intend to market the product in Sweden. In that case there is no need to submit Swedish product information.
- All issues regarding the product name must be solved before a marketing authorisation can be granted. The product will in these cases be authorised with prescription status although it has been applied for non-prescription status.
- The application for non-prescription status will be continued when the Swedish product information has been submitted to the Swedish MPA.
Prior to marketing
- Before a product can be marketed the proposed Swedish product information including mock-ups has to be submitted for assessment and approval as an Article 61(3)-notification.
- Assessment of an article 61 (3)-notification takes 90 days. If the submission includes an application for non-prescription the handling of the case can be up to four months.
- If a non-prescription application is included in an application for a new authorisation there will be no extra fee for the non-prescription assessment.
- If any changes to the product information has been made after the first authorisation they should be included in the Swedish product information. A list of procedure number, authorisation date and which sections of the SmPC that is concerned should be included in the cover letter.
- When mock-ups are submitted for assessment, please also consider eventual long lead times for the production for the company.
National phase of the mutual and decentral procedure – veterinary medicines
After the end of procedure for new authorisations the applicant is responsible for submitting Swedish product information to the Swedish MPA within 6 monts after the end of procedure. For VRA applications (variations requiring assessment) the timeframe is seven calendar days after the end of the procedure.
Email: RIC@lakemedelsverket.se
Always refer to the procedure number in all correspondence.
New authorisations
For new authorisations clean versions in MS Word-format of the Swedish product information (Summary of Products Characteristics, package leaflet and labelling text) and mock-ups in PDF-format version 1.4 or higher (one PDF for each mock-up) should be submitted. For assessment of Nordic packages the English version of the form “Request for a Nordic mock-up cooperation” should be enclosed with the submission.
VRA applications
For VRA applications for which the product information has been changed relevant Swedish product information should be submitted. All changes should be clearly marked out using the MS Word-function “Tracked changes”. Always use the currently approved version of the product information when making revisions of the text.
VNRA applications
For VNRA applications both English and Swedish product information is registered in the Union Product Database (UPD) with the application. For preparing Swedish product information translations, see checklist and guidelines:
Checklist for Swedish product information
Guideline for translations
Products without approved Swedish translation
- Before the product is marketed, proposals for Swedish product information including mock-ups shall be submitted for assessment and approval as a VRA application.
- The time period for our review is 30 days. If an application for OTC status is included the time period is up to 4 months.
- If application for OTC status was included in the application for a new medicinal product, there will be no separate fee for the assessment of OTC as that is included in the fee for the initial application.
- If variations have been approved after the initial marketing authorisation was issued, those changes shall be included in the Swedish product information.
- A list with procedure numbers, approval dates and which sections of the SmPC are affected should be included in the cover letter.
- When mock-ups are submitted for approval, possible long internal production times should be taken into consideration by the company when planning.
Mock-ups
- Before a product can be marketed in Sweden mock-ups (information and layout of the package) must be approved.
- Mock-ups for national, mutual and decentral procedures are authorised by the Swedish MPA.
- Mock-ups for the central procedure are authorised by the European Medicines Agency, EMA.
- Mock-ups should be submitted in PDF-format version 1.4 or higher (one PDF for each mock-up). For assessment of Nordic packages the form “Request for a Nordic mock-up cooperation” should be enclosed with the submission.
- Mock-ups may be submitted to the Medical Products Agency as a 61(3) application for medicines for human use and as a VRA application for medicines for animals respectively. In case the amendment of a mock-up fulfills the conditions for a VNRA notification such could be registered in the UPD database.
Generally about mock-ups
- The smallest pack size intended to be marketed for each strength and type of packaging should be submitted for assessment by the MPA. Larger pack sizes that are confirmed to follow the same design (layout and colour, the same text content with identical location and the same font size (or larger)) are automatically accepted.
- Mock-ups shall be submitted in life-size (1:1 scale). The pack size shall be indicated on the mock-up.
- Information regarding what updates have been made should be clear and the current approved mock-ups should be enclosed.
- For variations the mock-ups submitted should be based on the currently approved mock-ups. For new pack size or new product, a completely new mock-up is submitted.
- "Dummies" of mock-ups are not accepted. Final mock-ups with all changes implemented should be submitted, i.e. all technical details such as dimensions, production codes, location of Braille (including translation of Braille), current colour codes and QR codes should be listed on the mock-up.
Safety features for packages for human medicinal products
To implement safety features on the package a form should be used.
For further information:
Form for notification on anti-tampering device
Naming PDF-files containing mock-ups
- One mock-up per PDF-file
- Name the files as follows: <product name> <strength> <complete pharmaceutical form> <type of package> (<package size>).
- Strength, pharmaceutical form and package size should be given in English.
- Please use the suffix "CURRENT" if the mock-up in the file already has been approved by the Swedish Medical Products Agency and is submitted only for comparison.
- Files containing mock-ups submitted in the formats eCTD, NeeS or VNeeS need not to be named according to the above description.
Examples
Medicin 3 mg, film-coated tablets, blister (10 pcs).pdf
Medicin 3 mg, film-coated tablets, carton for blister (30 pcs).pdf
Medicin 3 mg, hard capsules, label for bottle (100 pcs).pdf
Medicin 3 mg, hard capsules, carton for bottle (100 pcs).pdf
Medicin 100 mg/ml, powder for oral suspension, label for bottle (60 ml).pdf
Medicin 100 mg/ml, powder for oral suspension, carton for bottle (60 ml).pdf
Medicin 25 microg/0.5 ml, suspension for injection in prefilled syringe, label for syringe with needle (1 dose).pdf
Medicin 25 microg /0.5 ml, suspension for injection in prefilled syringe, carton for syringes with needles (5 doses).pdf
Medicin 25 microg/0.5 ml, suspension for injection in prefilled syringe, label for syringe with needle (1 dose) CURRENT.pdf
Medicin 25 microg/0.5 ml, suspension for injection in prefilled syringe, carton for syringes with needles (5 doses) CURRENT.pdf
Contact
Questions regarding specific applications can be sent to
ric@lakemedelsverket.se.
Always refer to the procedure number/reference number in all correspondence.
General questions regarding mock-ups can be sent to registrator@lakemedelsverket.se.
Please state “Mock-up question” in the subject line.
Labelling changes as a notification or for information only
According to Directive 2001/83/EC the marketing authorisation holder (MAH) must notify the authority about all changes of labelling that are not based on changes of the Summary of Product Characteristics (article 61:3). The Swedish MPA are handling these cases. Even though the authority does not oppose to the changes that the MAH has to notify, the MAH still has the legal responsibility for the information on the package material (article 61:4).
The Swedish MPA has made it possible to submit a change in labelling for human medicinal products “for information” to the Swedish MPA.
Criteria for changes of the labelling to be submitted “for information”
It must be clearly stated in the cover letter if the submission is a change of labelling “for information”. The applicant should confirm that all the criteria are fulfilled and refer to relevant paragraphs given below.
Example of how to write in the application:
Change of labelling “for information”
The change concerns removal of text for another market and fulfils the criteria necessary according to Changes of labelling that can be sent to the Swedish MPA as a notification for information only paragraph 3.
No other changes should have been made as compared to currently approved labelling.
Both currently approved and new labelling should be enclosed as mock-ups in colour.
Assessment of changes “for information”
The labelling with changes for information only will not be assessed, the authorisation is based on the confirmation from the applicant that all criteria for an authorisation are fulfilled and that supporting information has been enclosed. The Swedish MPA will however make random assessments, so that deviations from the requirements can be revealed.
Assessment of variations that are not fulfilling the criteria for “for information only” notifications
Changes of the labelling that are not, or only partly fulfils the criteria for a notification for information only, should be submitted to the Swedish MPA for assessment and approval. Standard timetables are in that case applied, and the changes are should not be introduced until a letter of approval has been received from the Swedish MPA.
Date of approval
Changes to the labelling that are made as a notification for information only is valid when is has been submitted to the Swedish MPA and can therefore be implemented immediately.
Changes of labelling that can be sent to the Swedish MPA as a notification for information only
The following changes of labelling can be submitted “for information only” if currently approved Swedish labelling text is not affected.
It is sufficient to only submit the labelling for the smallest package to be marketed for each strength and packaging type (e.g. bottle, carton, label for bottle etc).
Larger packaging sizes with the same design, i.e. the same layout, colour, the same text with identical placing and with the same font size (or larger) will automatically be approved and will not need to be submitted to the MPA.
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Removal of text that is intended for other markets.
- Only information that are intended for a market outside Sweden can be removed.
- All other information on the labelling is identical with the approved version regarding placing, font and size.
- Packaging design, layout and colours are in all respects identical to the approved labelling. -
Addition of Braille.
- The complete product name should be given in Braille. If the medicinal product has several different strengths, the strength should also be given in Braille.
- The Braille should be placed on one panel or continue on a direct adjacent panel.
- All other information on the labelling is identical with the approved labelling regarding placing, font and size.
- Packaging design, layout and colours are in all respects identical to the approved labelling. - Changed placing of Braille.
- The Braille should be placed on one panel or continue on a direct adjacent panel.
- All other information on the labelling is identical with the approved labelling regarding placing, font and size.
- Packaging design, layout and colours are in all respects identical to the approved labelling. -
Correction of spelling/typing error in the labelling information
- The changed text/word is easy to identify and all other information on the labelling is identical with the approved labelling regarding placement, font and size.
- Packaging design, layout and colours are in all respects identical to the approved labelling. -
Change of the dimensions of the package.
- All information on the labelling is identical with the approved version regarding placement, font and size.
- Packaging design, layout and colours are in all respects identical to the approved labelling. - Addition of excipients with known effect according to the guideline from the Commission: NTA Volume 3B,” Excipients in the label and package leaflet of medicinal products for human use”.
- The actual composition is unchanged.
- All other information on the labelling is identical with the approved labelling regarding placement, font and size.
- Packaging design, layout and colours are in all respects identical to the approved labelling.
- The added text has the same font and size as other approved mandatory information. - Removal of excipients which are not considered to have any known effect according to the guideline from the Commission: NTA Volume 3B,” Excipients in the label and package leaflet of medicinal products for human use”.
- The actual composition is unchanged.
- All other information on the labelling is identical with the approved version regarding placement, font and size.
- Packaging design, layout and colours are in all respects identical to the approved labelling. -
Change of Nordic Product Number.
- The new Nordic Product Number has the same placement on the package as the previous one and the font size or colour has not been changed.
- All other information on the labelling is identical with the approved labelling regarding placement, font and size.
- Packaging design, layout and colours are in all respects identical to the approved labelling. -
Update of pre-existing bar code and data matrix code.
- All other information on the labelling is identical with the approved labelling regarding placement, font and size.
- Packaging design, layout and colours are in all respects identical to the approved labelling. - Update the address to MAH and/or local representative in line with earlier approved notification.
- All other information on the labelling is identical with the approved labelling regarding placing, font and size.
- Packaging design, layout and colours are in all respects identical to the approved labelling. - Decrease the size or removing the logo for MAH and/or local representative.
- All other information on the labelling is identical with the approved labelling regarding placing, font and size.
- Packaging design, layout and colours are in all respects identical to the approved labelling. -
Changed placing of batch number and/or expiry date.
- Abbreviations for batch number and expiry date are not changed compared to the ones already approved.
- All other information on the labelling is identical with the approved labelling regarding placement, font and size.
- Packaging design, layout and colours are in all respects identical to the approved labelling. - Update of the abbreviation for expiry date from “Anv. Före” to “Utg. Dat.” or ”Exp”.
- There is already an abbreviation on the labelling, font and size is not changed.
- All other information on the labelling is identical with the approved labelling regarding placement, font and size.
- Packaging design, layout and colours are in all respects identical to the approved labelling. - Update of the abbreviation for batch number to “Sats”, “Batch” or ”Lot”.
- There is already an abbreviation on the labelling, font and size is not changed.
- All other information on the labelling is identical with the approved labelling regarding placement, font and size.
- Packaging design, layout and colours are in all respects identical to the approved labelling. - For POM: removing the pre-existing bar code in case the labelling has a data matrix code containing safety features.
- All other information on the labelling is identical with the approved labelling regarding placement, font and size.
- Packaging design, layout and colours are in all respects identical to the approved labelling. -
Update of storage conditions provided that the content is the same (e.g. “Store at 2-8 ºC (in a refrigerator” to “Store in a refrigerator”).
- The precautions for storage are in line with the information of the SmPC section 6.4 and follows the appendix III (to QRD template for human medicinal products).
- The changed text is identical with the corresponding approved text regarding placing, font and size.
- All other information on the labelling is identical with the approved labelling regarding placement, font and size.
- Packaging design, layout and colours are in all respects identical to the approved labelling. -
Update of storage conditions in line with the SmPC section 6.4
- Please note that update of labelling concerning changes of storage conditions should normally be submitted with the original variation procedure of changed storage conditions, so that all parts of the product information is updated at the same time.
- The precautions for storage are in line with the information of the SmPC section 6.4 and follows the appendix III (to QRD template for human medicinal products).
- The changed text is identical with the corresponding approved text regarding placement, font and size.
- All other information on the labelling is identical with the approved version regarding placement, font and size.
- Packaging design, layout and colours are in all respects identical to the approved labelling. -
Removal of obsolete notes indicating new information 12 months after introducing the new presentation (e.g. “new flavour” or “new design”).
- Only the information about the “news” should be removed.
- All other information on the labelling is identical with the approved labelling regarding placement, font and size.
- Packaging design, layout and colours are in all respects identical to the approved labelling.