CHAPTER IIMARKETING AUTHORISATIONS – GENERAL PROVISIONS AND RULES ON APPLICATIONS
Article 16Package leaflet of registered homeopathic veterinary medicinal products
By way of derogation from Article 14(1), the package leaflet of homeopathic veterinary medicinal products registered in accordance with Article 86 shall contain at least the following information:
- (a)
the scientific name of the stock or stocks followed by the degree of dilution, using the symbols of the European Pharmacopoeia or, in the absence thereof, of the pharmacopoeias used officially in Member States;
- (b)
name or company name and permanent address or registered place of business of the registration holder and, where appropriate, of the manufacturer;
- (c)
method of administration and, if necessary, route of administration;
- (d)
pharmaceutical form;
- (e)
special storage precautions, if any;
- (f)
the target species and, where appropriate, dosage for each such species;
- (g)
a special warning, if necessary, for the homeopathic veterinary medicinal product;
- (h)
registration number;
- (i)
withdrawal period, if applicable;
- (j)
the statement ‘homeopathic veterinary medicinal product’.