Product information

For new applications, renewals and variations, revised product information needs to be submitted to the MPA in Word format for text documents and in PDF format for mock-ups. Here you will find more information about the guidelines and templates to use, and how you go about it when you submit.

Information regarding Submission of Product Information

For new applications, renewals and variations, electronic versions of the product information need to be submitted to the MPA via RIC@lakemedelsverket.se . Product information refers to the Summary of Product Characteristics (SmPC), package leaflet (PL), labelling text and mock ups. Always refer to the procedure number/reference number in any correspondence.

For the submission of Swedish product information see ”Checklist for Swedish product information” under Templates and Forms in right margin.

Please also see CMDh och CMDv ”Best practice guide on the submission of high quality national translations" under Related information.

New Applications

For new applications clean versions of SmPC, PL and labelling text should be submitted to the MPA with the application. Mock-ups should be submitted in PDF format version 1.4 or later.

Variations and renewals

Revisions to the approved SmPC, PL and labelling text should be clearly marked out using the Word function "Track changes".

Please use the by the MPA currently approved Word-version of the product information when making revisions to the text.

If the mock-ups are affected by the changes in the text you are requested to submit updated mock-ups accordingly.

Please note that for the IA and IB variations and applications referred to in article 61 (3) in the Mutual Recognition Procedure, both English and Swedish texts are to be submitted with the application.

Response

Always refer to the procedure number/reference number in any correspondence relating to a specific procedure. When revisions have been made to the SmPC, PL or labelling text electronic versions, with changes made with the Word function "Track changes", are to be submitted to the MPA via RIC@lakemedelsverket.se.

National Phase for the Mutual Recognition Procedure and Decentralised Procedure

For new applications, renewals and type II variations the applicant is responsible to submit the Swedish Product information to the MPA within seven calendar days after the end of the procedure. Always refer to the procedure number in all correspondence relating to a specific application.

For all new applications clean versions of the Swedish product information (SmPC, PL, labelling text and mock-ups) should be submitted. If no product information, or other communication, is received by the MPA within the above mentioned seven calendar days, the MPA will assume that the product will not be marketed in Sweden and a marketing authorisation will be issued without Swedish product information. Please refer to the heading The product is not to be marketed below for further information of what this entails.

For renewals and type II variations all revisions from day 0 to end of procedure should be marked out with the Word function "Track changes".

Please note that for the IA and IB variations and applications referred to in article 61 (3) in the Mutual Recognition Procedure, both English and Swedish texts are to be submitted with the application.

In cases where the change affects mock-ups, updated versions of mock-ups should also be included.

For renewals, where no revisions have been made in product information during the procedure, no texts or mock-ups are needed to be submitted again upon end of the procedure. The MPA, however, requests a confirmation that the product information remains unchanged.

The Swedish product information should follow the same version of the QRD template as the English product information.

Double correspondence

It should be clearly stated in the correspondence with the MPA if a letter sent by post is also sent electronically.
Please also state if the product information is sent in separately to the application.

Mock-ups

Mock-ups which are to be submitted shall be in PDF-format version 1.4 or later. Submit one PDF-file per mock-up.

Request for common Nordic assessment for mock-ups, please use the form ”Request for a Nordic mock- up cooperation” under Templates and Forms in right margin.

The product is not to be marketed

Please clearly state in the cover letter if you do not intend to market the product at this time. In these cases you do not have to submit the Swedish product information. However, any issues regarding the product name must be solved prior to granting of marketing authorisation. Also, please be informed that in this case the product will be approved with Rx status even if you have applied for OTC status. OTC status will be assessed when the Swedish product information is submitted to the MPA. If you applied for OTC status at the time of the original application you will not be charged for this assessment; it is included in the fee for the original application.

Before marketing of the product the proposed product information including mock-ups should be sent to the MPA for evaluation and approval. The evaluation time for the MPA is three months. If an OTC application is also included, the assessment time is up to four months. When mock-ups are submitted for approval, please take into account any possible lead time in the company's own production.

If variation procedures have been approved since the first marketing authorisation, the changes should be implemented in the Swedish product information. Please state in your cover letter a list of the variation procedure numbers, the approval dates and the sections in the SmPC which are concerned.

Assessment Time for Products in the National Procedure according to Article 61 (3)

The authorisation through the national procedure according to Council Directive 2001/83/EC article 61 (3) take up to three months. When mock-ups are submitted for approval, please take into account any possible lead time in the company's own production.

Design of product information

SmPC, PL and labelling

Use the current QRD template. In the annotated QRD-template you will find useful help text and guidance for how the text is to be drawn up. In the QRD-template you will also find the implementation plans for the latest versions of the QRD templates. It is important that all of the text in your document is formatted in line with the format of the template. Please also consider this when you copy information from another document into the text.

The current SmPC-guideline is to be used for all applications.

SmPC, PL and labelling text should maintain a high quality throughout and have good readability, see the "Guideline on the readability of the labelling and package leaflet of medicinal products for human use" under Related information in the right margin.

For veterinary products the language of the PL should be adapted for animal owners, see "annotated QRD-template" for veterinary products.

The information in the labelling text document, as agreed upon within the mutual recognition procedure /decentralised procedure, should appear as agreed in the Swedish labelling text. Avoid including too much information in the labelling text because this can affect the readability in a negative way when trying to fit all the information from the labeling text on to the mock-ups. This should be taken into account already before submitting the application.

The Swedish product information, within the mutual recognition procedure /decentralised procedure, should follow the same version of the QRD template as the English product information, maintain high quality and have good readability. See "Best practice guide on the submission of high quality national translations" for human products and "Best practice guide for the submission of high quality national translations for veterinary medicines" for veterinary products under Related information.
Any update of the adverse advent reporting in the SmPC and PL is done according to the current QRD-template. For information about how the address is to be implemented nationally, see “Reporting of side effects in SmPC and PL” under Related information.

For additional instructions regarding content in PL, labelling text and mock-ups, please see the “Swedish Medical Products Agency's Provision (LVFS 2005:11) on Labelling and Package Leaflets for Medicinal Products” and the "Guideline Concerning the Swedish Medical Products Agency's Provision (LVFS 2005:11) on Labelling and Package Leaflets for Medicinal Products".

For Nordic product information, see also "Guideline on Nordic packages" and "Questions & Answers" concerning Nordic packages. Links to all these documents can be found under Related information

Mock-ups

The information in the labelling text document, as agreed upon within the mutual recognition procedure/decentralized procedure, should appear as agreed on the mock-ups. Avoid including too much information in the labelling text because this can affect the readability in a negative way when trying to fit all the information from the labeling text on to the mock-ups. This should be taken into account before submitting the application. Mock-ups shall have good readability. See the "Guideline on the readability of the labelling and package leaflet of medicinal products for human use" under Related information.

For Nordic product information, see also "Guideline on Nordic packages", "Questions & Answers" concerning Nordic packages and the form ”Request for a Nordic mock- up cooperation”.

For information regarding Braille on pharmaceutical packs, see “Guideline for Braille in labeling and package leaflet (Swedish)” under Related information.

Further information regarding mock-ups

 
 

Contact us

 

Related information

 Medical Products Agency’s Provision (LVFS 2005:11) on Labelling and Package Leaflets for Medicinal Products (Swedish)

 Medical Products Agency’s Provision (LVFS 2005:11) on Labelling and Package Leaflets for Medicinal Products (English)

 Guideline concerning the Medical Products Agency’s Provision (LVFS 2005:11) on Labelling and Package Leaflets for Medicinal Products (Swedish)

 Guideline concerning the Medical Products Agency’s Provision (LVFS 2005:11) on Labelling and Package Leaflets for Medicinal Products (English)

 Changed LVFS 2009:23 (Swedish)

 Guideline on Summary of Product Characteristics - SmPC (September 2009)

 Quality Review of Documents human product-information annotated template (English) version 9

 Quality Review of Documents veterinary product-information annotated template (English) version 8

 EudraLex - Volume 2 - Pharmaceutical Legislation Notice to applicants and regulatory guidelines medicinal products for human use

 Guideline on the readability of the labelling and package leaflet of medicinal products for human use

 Best practice guide for submission of high quality national translations (human)

 Best practice guide for submission of high-quality national translations for veterinary medicines

 Excipient list

 Reporting of side effects in SmPC and PL

 Guideline for Braille in labelling and package leaflet (Swedish)

 Change in labelling for information only (Swedish)

 Guideline on Nordic packages

 Q&A Nordic packages

 Further information regarding mock-ups

 Information regarding QR-codes

 

 

Templates and forms

   
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information