How to prepare the product information for submission
- Published: November 17, 2020
- Last updated: January 10, 2024
The product information documents – Summary of Product Characteristics, package leaflet and labelling texts – are prepared according to special regulations and are based on so called QRD (Quality Review of Documents) templates.
Summary of Product Characteristics (SmPC), package leaflet (PL) and labelling text (LAB)
Current QRD templates and SmPC guideline should be used for the preparation of product information. Guiding information on how the texts should be written is available in a commented version of the template, “annotated QRD template”.
- Guideline on Summary of Product Characteristics - SmPC - medicinal products for humans (pdf-dokument, öppnas i ny flik)
- Guideline on Summary of Product Characteristics – pharmaceuticals – medicinal products for animals (pdf-dokument, öppnas i ny flik)
- Guideline on Summary of Product Characteristics – immunologicals – medicinal products for animals (pdf-dokument, öppnas i ny flik)
- Guideline on Summary of Product Characteristics – antimicrobials – medicinal products for animals (pdf-dokument, öppnas i ny flik)
- EudraLex - Volume 2 - Pharmaceutical legislation on notice to applicants and regulatory guidelines for medicinal products for human use (extern länk, öppnas i ny flik)
- Product information templates – human medicines (extern länk, öppnas i ny flik)
- Product information templates – veterinary medicines (extern länk, öppnas i ny flik)
- QRD convention to be followed for the EMA-QRD templates (pdf-dokument, öppnas i ny flik)
Swedish Medical Products Agency’s provisions on labelling and package leaflets
The language in the package leaflet shall be suitable for the user and for the animal owner if it is a medicinal product for animals.
Medicinal products for humans
HSLF-FS 2021:96 (in Swedish):
Guideline:
Medicinal products for animals
HSLF-FS 2021:96 (in Swedish):
Guideline:
Swedish Medical Products Agency’s provisions on parallel importations
Parallel import of human medicines (in Swedish)
Parallel trade in veterinary medicines (in Swedish)
Swedish Medical Products Agency’s provisions on registration of homeopathic medicinal products
Medicinal products for humans (in Swedish)
Medicinal products for animals (in Swedish)
The guidance documents of the provisions are being updated. Meanwhile, information may still be used from the previous guidance documents (in Swedish):
Other guidance
The Swedish translation of the product information should follow the same version of the QRD template as the English product information.
Nordic multilingual packages might need adjustment as the information should be identical in all languages to have a good readability.
Excipients in the SmPC and package leaflet for medicinal products for humans should be written in line with:
The source document "Blue box requirements" specifies which Blue box texts are to be used in Swedish product information for medicinal products for humans.
Add addresses for reporting adverse reactions for medicinal products for humans
To encourage health care professionals and consumers to report suspected adverse reactions there should be information in the SmPC and PL about where to send the report.
English SmPC, central procedure (electronic version)
(during the procedure and when published at the EMA and European Commission website)
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
English PL, central procedure (electronic version)
(during the procedure and when published at the EMA and European Commission website)
Reporting of side effects
If you get any side effects, talk to your <doctor> <or> <,> <pharmacist> <or nurse>. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Swedish SmPC, central procedure (electronic version)
(for the linguistic review and when published at the EMA and European Commission website)
Rapportering av misstänkta biverkningar
Det är viktigt att rapportera misstänkta biverkningar efter att läkemedlet godkänts. Det gör det möjligt att kontinuerligt övervaka läkemedlets nytta-riskförhållande. Hälso- och sjukvårdspersonal uppmanas att rapportera varje misstänkt biverkning via det nationella rapporteringssystemet listat i bilaga V.
Swedish PL, central procedure (electronic version)
(for the linguistic review and when published at the EMA and European Commission website)
Rapportering av biverkningar
Om du får biverkningar, tala med <läkare> <eller> <,> <apotekspersonal> <eller sjuksköterska>. Detta gäller även biverkningar som inte nämns i denna information. Du kan också rapportera biverkningar direkt via det nationella rapporteringssystemet listat i bilaga V. Genom att rapportera biverkningar kan du bidra till att öka informationen om läkemedels säkerhet.
List of addresses of the national reporting systems
Swedish SmPC, central procedure (printed version)
(when printed)
Rapportering av misstänkta biverkningar
Det är viktigt att rapportera misstänkta biverkningar efter att läkemedlet godkänts. Det gör det möjligt att kontinuerligt övervaka läkemedlets nytta-riskförhållande. Hälso- och sjukvårdspersonal uppmanas att rapportera varje misstänkt biverkning till:
Läkemedelsverket
Box 26
751 03 Uppsala
www.lakemedelsverket.se
Swedish PL, central procedure (printed version)
(when printed)
Rapportering av biverkningar
Om du får biverkningar, tala med <läkare> <eller> <,> <apotekspersonal> <eller sjuksköterska>. Detta gäller även biverkningar som inte nämns i denna information. Du kan också rapportera biverkningar direkt (se detaljer nedan). Genom att rapportera biverkningar kan du bidra till att öka informationen om läkemedels säkerhet.
Läkemedelsverket
Box 26
751 03 Uppsala
www.lakemedelsverket.se
English SmPC with SE as RMS (electronic version)
(during the procedure and when published at the Swedish MPA website)
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system
[To be completed nationally]
English PL, with SE as RMS (printed version)
(during the procedure and when published at the Swedish MPA website)
Reporting of side effects
If you get any side effects, talk to your <doctor> <or> <,> <pharmacist> <or nurse>. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
[To be completed nationally]
Swedish SmPC for the MRP/DCP/national procedure
(during the procedure, when published at the Swedish MPA website and when printed)
Rapportering av misstänkta biverkningar
Det är viktigt att rapportera misstänkta biverkningar efter att läkemedlet godkänts. Det gör det möjligt att kontinuerligt övervaka läkemedlets nytta-riskförhållande. Hälso- och sjukvårdspersonal uppmanas att rapportera varje misstänkt biverkning till
Läkemedelsverket
Box 26
751 03 Uppsala
www.lakemedelsverket.se
Swedish PL for the MRP/DCP/national procedure
(during the procedure, when published at the Swedish MPA website and when printed)
Rapportering av biverkningar
Om du får biverkningar, tala med <läkare> <eller> <,> <apotekspersonal> <eller sjuksköterska>. Detta gäller även biverkningar som inte nämns i denna information. Du kan också rapportera biverkningar direkt (se detaljer nedan). Genom att rapportera biverkningar kan du bidra till att öka informationen om läkemedels säkerhet.
Läkemedelsverket
Box 26
751 03 Uppsala
www.lakemedelsverket.se
Add addresses for reporting adverse reaction for veterinary medicinal products
The general public can submit reports of adverse reactions for veterinary medicinal products directly to the responsible authority, therefore there is a standard text in the package leaflet template for these medicinal products.
For the Swedish PL it is recommended to have a specific reference to the Swedish MPA for medicinal products approved by mutual- (MRP), SRP (Subsequent Recognition Procedure), decentrallised (DCP) or national procedure.
The reference should not be included for medicinal products approved according to the central procedure. It is the European Medicines Agency (EMA) that are responsible for these medicinal products and they are not yet providing the possibility of reporting directly to the responsible authority.
Addition to Swedish PL for MRP/SRP/DCP/national procedure
The following text should be added in section 7:
"Det är viktigt att rapportera biverkningar. Det möjliggör fortlöpande säkerhetsövervakning av ett läkemedel. Om du observerar biverkningar, även sådana som inte nämns i denna bipacksedel, eller om du tror att läkemedlet inte har fungerat, meddela i första hand din veterinär. Du kan också rapportera eventuella biverkningar till <innehavaren av godkännande för försäljning> <eller den lokala företrädaren för innehavaren av godkännandet för försäljning> genom att använda kontaktuppgifterna i slutet av denna bipacksedel, eller via ditt nationella rapporteringssystem:
www.lakemedelsverket.se"
The requirements for Swedish package leaflet and labelling are described in the Medical Products Agency’s Provisions on labelling and package leaflets for naming of medicinal products. See links in the section "Summary of Product Characteristics (SmPC), package leaflet (PL) and labelling text (LAB)" above.
Name of medicinal products
A medicinal product should have an acceptable and unique distinguishable name. The name of the medicinal product may be either an invented name or a generic name (common/scientific name followed by the company name). A guideline is available for companies naming medicinal products and it is based on the guideline applied by EMA regarding invented names for human medicinal products processed through the central procedure.
Guidance for naming
Non-prescription medicinal products (OTC)
General requirements for the design and production of package leaflets and packaging for OTC products are set out in the guidance.
More information about Sweden's position on OTC status for certain substances, and on criteria for medicinal products that may be sold outside pharmacies: