Guideline on labelling, package leaflets and naming of veterinary medicinal products
- Published: May 13, 2024
- Last updated: December 31, 2023
- Topics: Package leaflet, Veterinary medicinal products, Labelling
Guideline concerning the Swedish Medical Products Agency’s Provisions (HSLF-FS 2021:97) on labelling, package leaflets and naming of veterinary medicinal products.
Introduction
The purpose of this guideline is to promote the consistent application of the Regulation (EU) 2019/6 of the European Parliament and of the council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC and to promote the consistent application of the Swedish Medical Products Agency's provisions (HSLF-FS 2021:97) on labelling and package leaflets for medicinal products for veterinary use and a consistent application on the naming of medicinal products for veterinary use.
- The guideline includes labelling and package leaflets for medicinal products for veterinary use in centralised, mutual, decentralised, subsequent recognition and national procedures.
- The guideline includes naming of medicinal products for veterinary use in mutual, decentralised, subsequent recognition and national (but not centralised) procedures.
The guideline is intended for companies who are preparing labelling and package leaflets and the naming of veterinary medicinal products. The aim of the guideline is to describe and interpret the content of the applicable legislation in order to make labelling and information to the animal owner 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, 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 of the Regulation (EU) 2019/6 of the European Parliament on veterinary medicinal products and the Swedish Medical Products Agency’s Provisions and not as an independent document. The sections in this guideline refer to the corresponding section in the provisions and the articles refer to the corresponding article in the Regulation (EU) 2019/6.
Special medicinal product categories
Homeopathic medicinal products
For labelling and package leaflets of homeopathic medicinal products intended for animals, refer to the Swedish Medical Products Agency’s provisions (HSLF-FS 2022:10) on registration of homeopathic veterinary medicinal products.
Provision in Swedish
Medicinal products for clinical trials
Provisions regarding the labelling of medicinal products for animal use in clinical trials, refer to the Swedish Medical Products Agency’s provisions (HSLF-FS 2021:110) on supplementary provisions to the Veterinary Medicinal Products Regulation (EU) 2019/6, which entered into application on 28 January 2022.
Provision in Swedish
Veterinary medicinal products subject to parallel trade
In addition to what is stated in this guideline, the Swedish Medical Products Agency’s provisions (HSLF-FS 2022:9) on parallel trade in veterinary medicinal products shall be applied in the design of labelling and package leaflets for veterinary medicinal products subject to parallel trade.
Provision in Swedish
Abbreviations and other terms
Abbreviations
CMD(v)
Cooperation Group for Mutual and Decentralised Procedures (veterinary) - Group for the coordination within the EU of approval procedures for medicinal products for veterinary use.
EMA
European Medicines Agency
MAH
Marketing Authorisation Holder - In this document, the MAH also indicates the wholesale distributor licenced to sell a veterinary medicinal product subject to parallel trade in accordance with Article 102 in the Regulation (EU) 2019/6 of the European Parliament and of the Council.
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.1).
ref. Reference
SPC
Summary of Product Characteristics – applies to medicinal products for veterinary use
UPD
The Union Product Database on veterinary medicinal products
Other terms
”X”
Is used to indicate the product's name, i.e. relevant use of name or substance.
<…>
Indicates the proposed standard wording.
Multiple package
Packaging size approved to contain several smaller packaging units and where the individual packages may not be sold separately.
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 veterinary medicinal products
- Published: May 13, 2024
- Last updated: December 31, 2023
- Topics: Package leaflet, Veterinary medicinal products, Labelling
Guideline concerning the Swedish Medical Products Agency’s Provisions (HSLF-FS 2021:97) on labelling, package leaflets and naming of veterinary medicinal products.
Introduction
The purpose of this guideline is to promote the consistent application of the Regulation (EU) 2019/6 of the European Parliament and of the council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC and to promote the consistent application of the Swedish Medical Products Agency's provisions (HSLF-FS 2021:97) on labelling and package leaflets for medicinal products for veterinary use and a consistent application on the naming of medicinal products for veterinary use.
- The guideline includes labelling and package leaflets for medicinal products for veterinary use in centralised, mutual, decentralised, subsequent recognition and national procedures.
- The guideline includes naming of medicinal products for veterinary use in mutual, decentralised, subsequent recognition and national (but not centralised) procedures.
The guideline is intended for companies who are preparing labelling and package leaflets and the naming of veterinary medicinal products. The aim of the guideline is to describe and interpret the content of the applicable legislation in order to make labelling and information to the animal owner 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, 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 of the Regulation (EU) 2019/6 of the European Parliament on veterinary medicinal products and the Swedish Medical Products Agency’s Provisions and not as an independent document. The sections in this guideline refer to the corresponding section in the provisions and the articles refer to the corresponding article in the Regulation (EU) 2019/6.
Special medicinal product categories
Homeopathic medicinal products
For labelling and package leaflets of homeopathic medicinal products intended for animals, refer to the Swedish Medical Products Agency’s provisions (HSLF-FS 2022:10) on registration of homeopathic veterinary medicinal products.
Provision in Swedish
Medicinal products for clinical trials
Provisions regarding the labelling of medicinal products for animal use in clinical trials, refer to the Swedish Medical Products Agency’s provisions (HSLF-FS 2021:110) on supplementary provisions to the Veterinary Medicinal Products Regulation (EU) 2019/6, which entered into application on 28 January 2022.
Provision in Swedish
Veterinary medicinal products subject to parallel trade
In addition to what is stated in this guideline, the Swedish Medical Products Agency’s provisions (HSLF-FS 2022:9) on parallel trade in veterinary medicinal products shall be applied in the design of labelling and package leaflets for veterinary medicinal products subject to parallel trade.
Provision in Swedish
Abbreviations and other terms
Abbreviations
CMD(v)
Cooperation Group for Mutual and Decentralised Procedures (veterinary) - Group for the coordination within the EU of approval procedures for medicinal products for veterinary use.
EMA
European Medicines Agency
MAH
Marketing Authorisation Holder - In this document, the MAH also indicates the wholesale distributor licenced to sell a veterinary medicinal product subject to parallel trade in accordance with Article 102 in the Regulation (EU) 2019/6 of the European Parliament and of the Council.
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.1).
ref. Reference
SPC
Summary of Product Characteristics – applies to medicinal products for veterinary use
UPD
The Union Product Database on veterinary medicinal products
Other terms
”X”
Is used to indicate the product's name, i.e. relevant use of name or substance.
<…>
Indicates the proposed standard wording.
Multiple package
Packaging size approved to contain several smaller packaging units and where the individual packages may not be sold separately.
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)