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GUIDELINE FOR THE UNIFICATION OF THE LABELING SYSTEMS USED IN VETERINARY MEDICINES

GUIDELINE FOR THE UNIFICATION OF THE LABELING SYSTEMS USED IN VETERINARY MEDICINES (1)

Purpose

A basic criterion is needed in order to harmonize the characteristics and directions included in the labeling and packaging materials for veterinary products, in order to assure their precise identification and the principal concern for its correct usage, in benefit of its therapeutical use, and essentially to provide its traceability through the international trade.

The unification of the criteria used in the labeling of veterinary products is an essential aspect in order to harmonize the technical mechanisms which will allow their correct identification and make possible an appropriate use in their source countries as in the worldwide trade. 

I. Aim and scope

Categorize the contents which must be present on the labeling and packaging materials in the “necessary” and “indispensable” classes, based on their relevance, and according to each product category, size and kind of packaging materials.

Regulate the contents and its layout on the packaging materials for pharmacological and biological products used in Veterinary Medicine.

II. Terms and Definitions

a. General

Packaging: Containing material, which can be removable, and intended to contain, pack, and protect a product.

Packaging material: Any material being part of the labeling of a product.

Presentation form: Mode in which a product is featured for its commercialization

Retail sale unit: Unit in which a product is marketed for its final usage.

Logo-Brand: Mixed brand, formed by the logotype and the marketer company name, which allows the consumer and the official representatives to trace and identify the manufacturer, owner or legal responsible for the product.

Product name: Trademark (Brand name) plus supplement

b. Components of the packaging material

Label: Printed or litographied identification, as printed or engraved by heat, pressure, or any other method, securely applied on containers, packages, packings or wrappers or any other protective component.

Label-leaflet: Label containing all of the text needed for the correct usage of the product.

Instructive, Insert, Prospect, or leaflet: printed matter accompanying a product, containing the information defined as necessary and indispensable for its usage.

Box: Package made of paper, cardboard or another material holding the primary package.

Caja: empaque de papel, cartón u otro material que acondiciona al empaque primario.

Box – Insert: Package made of paper, cardboard or another material holding the primary package and containing all of the information included in the insert. 

Blister: Molded wrapping containing a finished product

Sachet (or pouch): Primary package, made of paper or another material, containing a product.

III. Categorization for the classes of information contained

Indispensable information: Applies to the information that must be included in all of the components of the packaging material, according to the distribution indicated in this regulation.

Necessary information: Applies to the information that must be included at least in one of the components of the packaging material, according to the distribution indicated in this regulation.

IV: Manufacture stages

Semi-Finished Product: Product which has not finished all the stages of the manufacturing process

Bulk product: Product which has finished all the stages of the manufacturing process, excepting final packaging.

Finished Product: product which has finished all the stages of the manufacturing process

V. Basic criteria for the application of the technical information

1. As for the application of this regulation, text included in the packaging materials should be classified in indispensable and necessary information categories.

2. The following information shall be considered as indispensable

2.1.  Brand name of the product – generic name – Dosage form 

2.2.  Volume, net weight, number of doses and/or units 

2.3.  Logo-Brand of the manufacturer  – name of the producer and country of manufacture

2.4.  License number – Name of the licensing agency (information for different countries can be included). 

2.5. Route of administration

2.6. Storage conditions

2.7.  The phrase “sale under prescription”, or sales category (For controlled substances)

2.8. Name and address for the importer in the marketing country

2.9. Lot/Batch number

2.10. Manufacture date

2.11.  Expiry date 

2.12.  The phrase “For veterinary use” 

2.13.  The phrase “Read the insert before using this product”

3. The following items could be excluded from the inserts:

3.1.  Name and address for the importer in the marketing country 

3.2. Lot number

3.3. Manufacture date

3.4. Expiry date

3.5. The phrase “For veterinary use”

3.6. The phrase “Read the insert before using this product” 

4. Items 2.4 (License number) and 2.8 (Name and address for the importer in the country) may be excluded when its inclusion in the label should not be possible due to the lack of available printing space.

5. Ampoules, small containers and other packaging materials whose technical characteristics or storage conditions could not allow the inclusion of indispensable information should include the name of the product and the lot number, as other information must be included on another component of the packaging materials.

6. Packaging material for diluents for injectable products, stabilizers or similar products should contain the indispensable information. In the case of distilled or bidistilled water, only the expression “water for injection” shall be needed..

7. The following information shall be considered as necessary:

7.1. Quali-quantitative formula / Strain used

7.1.1. For pharmacological products: Indicating the concentration of the active ingredients

7.1.2. For biological products: Indicating the antigens constituting the product and the strain used. In all of the cases, it should be stated if live or inactivated biological agents are used.

7.2.  Pharmacological function (principal feature of the product)

7.3.  Indications of use

7.4. Species for which the product is intended

7.5. Dosage (specified by animal species)

7.6. Method and route of administration

7.7. Warnings and precautions – “See additional information on the insert”

7.8. Adverse effects - “See additional information on the insert”

7.9. Contraindications and restrictions of use - “See additional information on the insert”

7.10. Adverse reactions - “See additional information on the insert”

7.11. Antidotes (If any) - “See additional information on the insert”

7.12. Withdrawal time

7.13. The phrase “Keep out of reach of children and domestic animals”

7.14. Customer attention phone number (optional)

7.15. Name and identification of the representative, owner and manufacturer for the product.

7.16. Name of the Technical Responsibles

8. Distribution of necessary information shall be performed as detailed in the Annex of the present regulation. In all of the cases, the inclusion of the necessary items shall be priorized for the box above the insert.

9. Packaging materials for bulk or unfinished products shall contain the following information, written in the language used in the importer country:

9.1. Name of the product 

9.2. License number for the destination country

9.3. Volume, net weight, or number of doses

9.4.  Lot number

9.5.  Expiry date

9.6.  Storage conditions

9.7.  The phrase “For veterinary use”

9.8.  Name and address of the importer 

9.9. Country of origin 

10. The requirements for the labeling of bulk or unfinished products shall also apply to pharmochemicals and raw materials imported for the manufacture of veterinary products.

11. For contract manufacturing, packaging material shall include the name of the proprietary company as the manufacturer contracted for its production. This requirement does not apply for the process of packaging or labeling the finished product.

12. For packages including multiple units for retail sale, inserts shall be provided for each retail unit included in the package. The retailer shall provide an insert for each unit sold separately.

13. Printing of lot number and expiry date (or their abbreviation) shall be made in an unerasable and easy to read manner, not being allowed the use of additional labels for that purpose.

14. Texts included in the packaging material shall be presented in the official language, and expressions in other languages could be accepted in case of technical considerations due to translation accuracy.

15. For bilingual packaging materials, texts shall not contradict those approved in the official language, excepting the use of specific information for a given country and due to technical reasons.

16. The approval of the texts included in packaging materials in languages different from the official language is responsibility of the legal representative in the destination country.

17. Characters used on packaging materials shall be printed using sizes which allow its easy reading. Minimum character size accepted for printing shall be of four points. 

18. Vaccines intended exclusively for use on dogs, cats and exotic species shall include easily detachable self-adhesive labels in order to be attached to the animal´s sanitary documentation. 

VI. Responsibility for veterinary pharmaceutical industries

Based on the license of the product, industry holds the responsibility to harmonize all of the information defined as indispensable and necessary under the present regulation, in order to asset the best understanding for the correct usage of the product in the national and international trade.

VII. Responsibility for the regulatory authorities 

Regulatory authorities shall control that licenses granted for products keep in accordance with the information regarding the usage of the product, and respecting the necessary and indispensable information, which shall be adequately laid out according to the product characteristics and presentation form

VIII: Responsibility for the veterinary products retailers 

Indications regarding storage and distribution conditions shall be identified and applied by the retailers and distributors according to specific indications detailed on the label, insert or packaging material in order to assure the proper keeping of the product during its shelf life.

IX: Responsibility for the veterinarian

The professionals prescribing or administering the veterinary product shall attend to the indications described for the indispensable and necessary categories included in the labels and packaging material, in order to adequate its usage according to the conditions of the prescription.

ANNEXES

Table 1. Layout schema for indispensable information

 Point Item LABEL BOX INSERT

2.1 Brand name of the product – generic name – Dosage form X X X

2.2 Volume, net weight, number of doses and/or units X X X

2.3 Logo-Brand of the manufacturer  – name of the producer and country of manufacture X X X

2.4 License number – Name of the licensing agency (information for different countries can be included) T X X

2.5 Route of administration X X X

2.6 Storage conditions X X X

2.7 The phrase “sale under prescription”, or sales category (For controlled substances) X X X

 

3.1 Name and address for the importer in the marketing country T X  

3.2 Lot/Batch number X X

3.3 Manufacture date X X

3.4 Expiry date X X

3.5 The phrase “For veterinary use” X X  

3.7 The phrase “Read the insert before using this product” X X  

Notes:

All of the items detailed in the present Table belong to the information defined as indispensable, and shall be included in all of the individual components marked with “X” 

Items marked with “T” may be excluded from the individual components when its inclusion should not be possible due to the lack of available printing space

Table 2. Layout schema for necessary information

 Point Item LABEL BOX INSERT

7.1 Quali-quantitative formula / Strain used X X

7.1.1 Pharmacological products: Concentration of the active ingredients X X

7.1.2   Biological products: Antigens constituting the product and the strain used. Indication on live or inactivated biological agents used X X

7.2 Pharmacological function (principal feature of the product) X X

7.3 Indications of use X X

7.4 Species for which the product is intended X X

7.5 Dosage (specified by animal species) X X

7.6 Method and route of administration X X

7.7 Warnings and precautions – “See additional information on the insert” X X

7.8 Adverse effects - “See additional information on the insert” X

7.9

Contraindications and restrictions of use - “See additional information on the insert” X

7.10 Adverse reactions - “See additional information on the insert” X

7.11 Antidotes (If any) - “See additional information on the insert” X

7.12 Withdrawal time X X

7.13 The phrase “Keep out of reach of children and domestic animals” T X X

7.14 Customer attention phone number (optional) X

7.15 Name and identification of the representative, owner and manufacturer for the product X

7.16 Name of the Technical Responsibles T X

Notes:

All of the items detailed in the present Table belong to the information defined as necessary, which could be included on any of the individual components marked with “X”. Inclusion of the necessary items shall be priorized for the box above the insert

Items marked with “T” may be excluded from the individual components when its inclusion should not be possible due to the lack of available printing space

(1) References

? Sindicato Nacional da Indústria de Produtos para Saúde Animal (SINDAN)

? X Seminario de armonización de Normas de Registro y Control de Medicamentos Veterinarios - Brasilia, Brasil, 9 al 12 de Agosto de 2004: Approval of the text (Step VI)

? XI Seminario de armonización de Normas de Registro y Control de Medicamentos Veterinarios - Montevideo, Uruguay, 12 al 14 de Septiembre de 2005: Approval of Tables I & II, layout schema for contants (Step VI)

? Mayo 2006: Review and approved text unification. Step VII.