Definitions and application
- Published: May 13, 2024
- Last updated: May 13, 2024
- Topics: Package leaflet, Veterinary medicinal products, Labelling
About definitions and application.
Section 1 These provisions apply to labelling and package leaflets for veterinary medicinal products. The regulations are a complement to 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. The regulations shall not apply to veterinary medicinal products manufactured in pharmacies. The expressions and terms used in the Regulation (EU) 2019/6 of the European Parliament have the same meaning in the present provisions.
Article 4 of Regulation (EU) 2019/6
Active substance: means any substance or mixture of substances intended to be used in the manufacture of a veterinary medicinal product that, when used in its production, becomes an active ingredient of that product.
Excipient: means any constituent of a veterinary medicinal product other than an active substance or packaging material.
Common name: means the international non-proprietary name recommended by the World Health Organization (WHO) for a substance or, if one does not exist, the name generally used.
Guideline
Common name has previously been used as “generic name”.
Name of the veterinary medicinal product: means either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trademark or the name of the marketing authorisation holder.
Guideline
For guidance, see section Naming of veterinary medicinal products.
Strength: means the content of active substances in a veterinary medicinal product, expressed quantitatively per dosage unit, per unit of volume or per unit of weight according to the pharmaceutical form.
Labelling: means information on the immediate packaging or the outer packaging.
Guideline
Labelling text - Labelling text document according to QRD template.
Mock-up - Electronic 2D model of outer or immediate packaging showing the labelling on the packaging and the package layout.
Labelling refers to both labelling text and mock-up.
Information about labelling applies to both the labelling text and the package layout (mock-up), unless otherwise stated.
Immediate packaging: means the container or any other form of packaging that is in direct contact with the veterinary medicinal product.
Outer packaging: means packaging in which the immediate packaging is placed.
Package leaflet: means a documentation leaflet on a veterinary medicinal product which contains information to ensure its safe and efficacious use.
Withdrawal period: means the minimum period between the last administration of a veterinary medicinal product to an animal and the production of foodstuffs from that animal which under normal conditions of use is necessary to ensure that such foodstuffs do not contain residues in quantities harmful to public health.
Definitions and application
- Published: May 13, 2024
- Last updated: May 13, 2024
- Topics: Package leaflet, Veterinary medicinal products, Labelling
About definitions and application.
Section 1 These provisions apply to labelling and package leaflets for veterinary medicinal products. The regulations are a complement to 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. The regulations shall not apply to veterinary medicinal products manufactured in pharmacies. The expressions and terms used in the Regulation (EU) 2019/6 of the European Parliament have the same meaning in the present provisions.
Article 4 of Regulation (EU) 2019/6
Active substance: means any substance or mixture of substances intended to be used in the manufacture of a veterinary medicinal product that, when used in its production, becomes an active ingredient of that product.
Excipient: means any constituent of a veterinary medicinal product other than an active substance or packaging material.
Common name: means the international non-proprietary name recommended by the World Health Organization (WHO) for a substance or, if one does not exist, the name generally used.
Guideline
Common name has previously been used as “generic name”.
Name of the veterinary medicinal product: means either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trademark or the name of the marketing authorisation holder.
Guideline
For guidance, see section Naming of veterinary medicinal products.
Strength: means the content of active substances in a veterinary medicinal product, expressed quantitatively per dosage unit, per unit of volume or per unit of weight according to the pharmaceutical form.
Labelling: means information on the immediate packaging or the outer packaging.
Guideline
Labelling text - Labelling text document according to QRD template.
Mock-up - Electronic 2D model of outer or immediate packaging showing the labelling on the packaging and the package layout.
Labelling refers to both labelling text and mock-up.
Information about labelling applies to both the labelling text and the package layout (mock-up), unless otherwise stated.
Immediate packaging: means the container or any other form of packaging that is in direct contact with the veterinary medicinal product.
Outer packaging: means packaging in which the immediate packaging is placed.
Package leaflet: means a documentation leaflet on a veterinary medicinal product which contains information to ensure its safe and efficacious use.
Withdrawal period: means the minimum period between the last administration of a veterinary medicinal product to an animal and the production of foodstuffs from that animal which under normal conditions of use is necessary to ensure that such foodstuffs do not contain residues in quantities harmful to public health.