Guideline on labelling, package leaflets and naming of human medicinal products
- Published: May 13, 2024
- Last updated: December 31, 2023
- Topics: Package leaflet, Labelling
Guideline concerning the Swedish Medical Products Agency’s Provisions (HSLF-FS 2021:96) on labelling, package leaflets and naming of human medicinal products.
Introduction
The purpose of this guideline is to promote the consistent application of the Swedish Medical Products Agency's provisions (HSLF-FS 2021:96) on labelling and package leaflets for medicinal products for human use and a consistent application on the naming of medicinal products for human use.
- The guideline includes labelling and package leaflets for medicinal products for human use in centralised, mutual recognition, decentralised and national procedures.
- The guideline includes naming of medicinal products for human use in mutual recognition, decentralised and national (but not centralised) procedures.
The guideline is intended for companies who are preparing labelling and package leaflets and the naming of human medicinal products. The aim of the guideline is to describe and interpret the content of the applicable legislation in order to make labelling and patient information clear and user-friendly, as well as to reduce the risk of mix ups and incorrect use.
Guidelines may contain additional information that is not included in the legislation, the aim of which is to improve understanding of the legislative requirements.
Guidelines are not legally binding, rather they contain examples and recommendations that can be helpful in the interpretation and application of legislative provisions. This guideline does not exclude other methods of achieving the results intended in the legislation, instead it represents the Swedish Medical Products Agency's interpretation.
The most recent QRD template for medicinal products, approved via centralised, mutual recognition, decentralised and national procedures, with the associated standard wording determined by the EMA should be used.
The guideline should be regarded as a complement to the provision and not as an independent document. The paragraphs in this guideline refer to the corresponding paragraphs in the provisions.
Related information
Special medicinal product categories
Medicinal products for clinical trials
Provisions regarding the labelling of medicinal products for human use in clinical trials are found in the Clinical Trials Regulation (Regulation (EU) No 536/2014), which entered into application on 31 January 2022, and in the Swedish Medical Products Agency’s provisions (HSLF-FS 2021:109) on supplementary provisions to the Clinical Trials Regulation.
Provision in Swedish
Homeopathic medicinal products
For labelling of homeopathic medicinal products intended for humans, refer to the Swedish Medical Products Agency’s provisions (HSLF-FS 2022:11) on homeopathic medicinal products for human use.
Provision in Swedish
Parallel imported human medicinal products
In addition to what is stated in this guideline, the Swedish Medical Products Agency’s provisions (HSLF-FS 2022:8) on parallel imported human medicinal products shall be applied in the design of labelling and package leaflets for parallel imported human medicinal products.
Provision in Swedish
Traditional herbal medicinal products
In addition to what is stated in this guideline, the Swedish Medical Products Agency’s provisions (LVFS 2006:3) on traditional herbal medicinal products for human use shall be applied in the labelling of traditional herbal medicinal products.
Provision in Swedish
Abbreviations and other terms
Abbreviations
CMD(h)
Cooperation Group for Mutual and Decentralised Procedures (human) Group for the coordination within the EU of approval procedures for medicinal products for human use.
EMA
European Medicines Agency
MAH
Marketing Authorisation Holder
In this document, the MAH also indicates those who have permission to market a parallel-imported medicinal product or a registered traditional herbal medicinal product.
QRD
Quality Review of Documents
Working group within the EU for improving the structure and quality of product information (publishes e.g. product information templates).
QRD template
Product information document template
ref.
Reference
SmPC
Summary of Product Characteristics – applies to medicinal products for human use.
Other terms
”X”
Is used to indicate the product's name, i.e. relevant use of name or substance.
Words within {…}
Are replaced with the relevant text.
<…>
Indicates the proposed standard wording.
[…]
English explanatory text to Swedish wording.
Blue Box
Further information (not included in the QRD template) that may be required at the national level. These special requirements are published on the website of the CMDh (ref. 2). The Blue Box concept is not applicable to the centralised procedure.
Directly distributed medicinal product
Medicinal product that the parallel imported medicinal product refers to in its licence application
Generic name, common name
HSLF-FS 2021:96 states that the common name means the international generic name recommended by the World Health Organisation or, if none exists, the usual common name (INN, pharmacopoeia name or commonly used name)
Multiple package
Packaging size approved to contain several smaller packaging units and where the individual packages may not be sold separately
Mock-up
Electronic 2D model of outer or immediate packaging showing the labelling on the packaging and the package layout
Labelling
Labelling text and mock-up
Labelling text
Labelling text document according to QRD template
Provisions
In Swedish.
Related information
- QRD templates for medicinal products for human use - EMA (extern länk, öppnas i ny flik)
- QRD templates for medicinal products for human use - HMA (extern länk, öppnas i ny flik)
- Blue Box requirements (pdf-dokument, öppnas i ny flik)
- EDQM Standard Terms (extern länk, öppnas i ny flik)
- Appendices to QRD templates for medicinal products for human use (extern länk, öppnas i ny flik)
- OTC substance reports
- EMA List of medicines under additional monitoring (extern länk, öppnas i ny flik)
- Excipients and information for the package leaflet (extern länk, öppnas i ny flik)
- Alternatives for how to indicate reporting of adverse reactions
- EMA Guideline on invented names (pdf-dokument, öppnas i ny flik)
- EMA’s scientific committee CHMP - 31/7/2019 (extern länk, öppnas i ny flik)
- EMA’s scientific committee CHMP - 26/9/2019 (extern länk, öppnas i ny flik)
- The WHO naming guidelines (extern länk, öppnas i ny flik)
Guideline in pdf-format
Guideline on labelling, package leaflets and naming of human medicinal products
- Published: May 13, 2024
- Last updated: December 31, 2023
- Topics: Package leaflet, Labelling
Guideline concerning the Swedish Medical Products Agency’s Provisions (HSLF-FS 2021:96) on labelling, package leaflets and naming of human medicinal products.
Introduction
The purpose of this guideline is to promote the consistent application of the Swedish Medical Products Agency's provisions (HSLF-FS 2021:96) on labelling and package leaflets for medicinal products for human use and a consistent application on the naming of medicinal products for human use.
- The guideline includes labelling and package leaflets for medicinal products for human use in centralised, mutual recognition, decentralised and national procedures.
- The guideline includes naming of medicinal products for human use in mutual recognition, decentralised and national (but not centralised) procedures.
The guideline is intended for companies who are preparing labelling and package leaflets and the naming of human medicinal products. The aim of the guideline is to describe and interpret the content of the applicable legislation in order to make labelling and patient information clear and user-friendly, as well as to reduce the risk of mix ups and incorrect use.
Guidelines may contain additional information that is not included in the legislation, the aim of which is to improve understanding of the legislative requirements.
Guidelines are not legally binding, rather they contain examples and recommendations that can be helpful in the interpretation and application of legislative provisions. This guideline does not exclude other methods of achieving the results intended in the legislation, instead it represents the Swedish Medical Products Agency's interpretation.
The most recent QRD template for medicinal products, approved via centralised, mutual recognition, decentralised and national procedures, with the associated standard wording determined by the EMA should be used.
The guideline should be regarded as a complement to the provision and not as an independent document. The paragraphs in this guideline refer to the corresponding paragraphs in the provisions.
Related information
Special medicinal product categories
Medicinal products for clinical trials
Provisions regarding the labelling of medicinal products for human use in clinical trials are found in the Clinical Trials Regulation (Regulation (EU) No 536/2014), which entered into application on 31 January 2022, and in the Swedish Medical Products Agency’s provisions (HSLF-FS 2021:109) on supplementary provisions to the Clinical Trials Regulation.
Provision in Swedish
Homeopathic medicinal products
For labelling of homeopathic medicinal products intended for humans, refer to the Swedish Medical Products Agency’s provisions (HSLF-FS 2022:11) on homeopathic medicinal products for human use.
Provision in Swedish
Parallel imported human medicinal products
In addition to what is stated in this guideline, the Swedish Medical Products Agency’s provisions (HSLF-FS 2022:8) on parallel imported human medicinal products shall be applied in the design of labelling and package leaflets for parallel imported human medicinal products.
Provision in Swedish
Traditional herbal medicinal products
In addition to what is stated in this guideline, the Swedish Medical Products Agency’s provisions (LVFS 2006:3) on traditional herbal medicinal products for human use shall be applied in the labelling of traditional herbal medicinal products.
Provision in Swedish
Abbreviations and other terms
Abbreviations
CMD(h)
Cooperation Group for Mutual and Decentralised Procedures (human) Group for the coordination within the EU of approval procedures for medicinal products for human use.
EMA
European Medicines Agency
MAH
Marketing Authorisation Holder
In this document, the MAH also indicates those who have permission to market a parallel-imported medicinal product or a registered traditional herbal medicinal product.
QRD
Quality Review of Documents
Working group within the EU for improving the structure and quality of product information (publishes e.g. product information templates).
QRD template
Product information document template
ref.
Reference
SmPC
Summary of Product Characteristics – applies to medicinal products for human use.
Other terms
”X”
Is used to indicate the product's name, i.e. relevant use of name or substance.
Words within {…}
Are replaced with the relevant text.
<…>
Indicates the proposed standard wording.
[…]
English explanatory text to Swedish wording.
Blue Box
Further information (not included in the QRD template) that may be required at the national level. These special requirements are published on the website of the CMDh (ref. 2). The Blue Box concept is not applicable to the centralised procedure.
Directly distributed medicinal product
Medicinal product that the parallel imported medicinal product refers to in its licence application
Generic name, common name
HSLF-FS 2021:96 states that the common name means the international generic name recommended by the World Health Organisation or, if none exists, the usual common name (INN, pharmacopoeia name or commonly used name)
Multiple package
Packaging size approved to contain several smaller packaging units and where the individual packages may not be sold separately
Mock-up
Electronic 2D model of outer or immediate packaging showing the labelling on the packaging and the package layout
Labelling
Labelling text and mock-up
Labelling text
Labelling text document according to QRD template
Provisions
In Swedish.
Related information
- QRD templates for medicinal products for human use - EMA (extern länk, öppnas i ny flik)
- QRD templates for medicinal products for human use - HMA (extern länk, öppnas i ny flik)
- Blue Box requirements (pdf-dokument, öppnas i ny flik)
- EDQM Standard Terms (extern länk, öppnas i ny flik)
- Appendices to QRD templates for medicinal products for human use (extern länk, öppnas i ny flik)
- OTC substance reports
- EMA List of medicines under additional monitoring (extern länk, öppnas i ny flik)
- Excipients and information for the package leaflet (extern länk, öppnas i ny flik)
- Alternatives for how to indicate reporting of adverse reactions
- EMA Guideline on invented names (pdf-dokument, öppnas i ny flik)
- EMA’s scientific committee CHMP - 31/7/2019 (extern länk, öppnas i ny flik)
- EMA’s scientific committee CHMP - 26/9/2019 (extern länk, öppnas i ny flik)
- The WHO naming guidelines (extern länk, öppnas i ny flik)