Regulation 29 Amendment to paragraph 3

For paragraph 3 (summary of product characteristics) substitute—

“Summary of product characteristics

3.

(1)

Subject to sub-paragraph (2), the summary of product characteristics required under paragraph 2(2)(h) must include the following information in the order indicated below—

1. Name of the veterinary medicinal product, followed by its strength and pharmaceutical form.
2. Qualitative and quantitative composition of the active substances and qualitative composition of excipients and other constituents stating their common name or their chemical description and their quantitative composition, if that information is essential for proper administration of the veterinary medicinal product.
3. Clinical information as regards—
3.1 target species;
3.2 indications for use for each target species;
3.3 contra-indications;
3.4 special warnings;
3.5 special precautions for use, including in particular special precautions for safe use in the target species, special precautions to be taken by the person administering the veterinary medicinal product to the animals and special precautions for the protection of the environment;
3.6 frequency and seriousness of adverse events;
3.7 use during pregnancy, lactation or lay;
3.8 interaction with other medicinal products and other forms of interaction;
3.9 administration route and dosage;
3.10 symptoms of overdose and, where applicable, emergency procedures and antidotes in the event of overdose;
3.11 special restrictions for use;
3.12 special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance;
3.13 if applicable, withdrawal periods, even if such periods are zero.
4. Pharmacological information as regards—
4.1 the ATCvet Code;
4.2 pharmacodynamics;
4.3 pharmacokinetics.
5. Pharmaceutical particulars as regards—
5.1 major incompatibilities;
5.2 shelf-life, where applicable after reconstitution of the medicinal product or after the immediate packaging has been opened for the first time;
5.3 special precautions for storage;
5.4 nature and composition of immediate packaging;
5.5 requirement to use take-back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products and, if appropriate, additional precautions regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products.
6. Name of the holder of the marketing authorisation.
7. Marketing authorisation number or numbers.
8. Date of the first marketing authorisation.
9. Date of the last revision of the summary of product characteristics.
10. If applicable, the statement—
10.1 “marketing authorisation granted for a limited market and therefore assessment based on customised requirements for documentation”; or
10.2 “marketing authorisation in exceptional circumstances and therefore assessment based on customised requirements for documentation”.
11. Information on the take-back schemes referred to in point 5.5 applicable to the veterinary medicinal product concerned.
12. Classification of the veterinary medicinal product.

(2)

In the case of an immunological veterinary medicinal product or a biological veterinary medicinal product that is not immunological, in place of the information at points 4, 4.1, 4.2 and 4.3, the summary of product characteristics must include immunological information.”.

1.		Name of the veterinary medicinal product, followed by its strength and pharmaceutical form.
2.		Qualitative and quantitative composition of the active substances and qualitative composition of excipients and other constituents stating their common name or their chemical description and their quantitative composition, if that information is essential for proper administration of the veterinary medicinal product.
3.		Clinical information as regards—
	3.1	target species;
	3.2	indications for use for each target species;
	3.3	contra-indications;
	3.4	special warnings;
	3.5	special precautions for use, including in particular special precautions for safe use in the target species, special precautions to be taken by the person administering the veterinary medicinal product to the animals and special precautions for the protection of the environment;
	3.6	frequency and seriousness of adverse events;
	3.7	use during pregnancy, lactation or lay;
	3.8	interaction with other medicinal products and other forms of interaction;
	3.9	administration route and dosage;
	3.10	symptoms of overdose and, where applicable, emergency procedures and antidotes in the event of overdose;
	3.11	special restrictions for use;
	3.12	special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance;
	3.13	if applicable, withdrawal periods, even if such periods are zero.
4.		Pharmacological information as regards—
	4.1	the ATCvet Code;
	4.2	pharmacodynamics;
	4.3	pharmacokinetics.
5.		Pharmaceutical particulars as regards—
	5.1	major incompatibilities;
	5.2	shelf-life, where applicable after reconstitution of the medicinal product or after the immediate packaging has been opened for the first time;
	5.3	special precautions for storage;
	5.4	nature and composition of immediate packaging;
	5.5	requirement to use take-back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products and, if appropriate, additional precautions regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products.
6.		Name of the holder of the marketing authorisation.
7.		Marketing authorisation number or numbers.
8.		Date of the first marketing authorisation.
9.		Date of the last revision of the summary of product characteristics.
10.		If applicable, the statement—
	10.1	“marketing authorisation granted for a limited market and therefore assessment based on customised requirements for documentation”; or
	10.2	“marketing authorisation in exceptional circumstances and therefore assessment based on customised requirements for documentation”.
11.		Information on the take-back schemes referred to in point 5.5 applicable to the veterinary medicinal product concerned.
12.		Classification of the veterinary medicinal product.