guidance for presenting the spc, package leaflet and

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Draft

Guidance for Presenting the SPC, Package Leaflet and Labeling Information for Veterinary Products

Version 1

Date issued 08/02/2012

Date of implementation 08/08/2012

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Guidance for Presenting the SPC,

Package Leaflet and Labeling

Information for Veterinary Products Version 1

Drug Sector

Saudi Food & Drug Authority

Kingdom of Saudi Arabia

Please visit SFDA’s website at http://www.sfda.gov.sa/En/Drug

for the latest update

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Document Control

Version Date Author(s) Comments

1.0 8/03/2012 Product Evaluation and Standards

Setting Department

Draft

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Contents Introduction: ................................................................................................................................ 6 Summary of Product Characteristics (SPC)................................................................................... 7 A. SPC – For Pharmaceutical and Immunological Veterinary Medicinal Products ..................... 8

1. Name of the veterinary medicinal product ......................................................................... 8

2. Qualitative and quantitative composition........................................................................... 9

3. Pharmaceutical form ....................................................................................................... 12

4. Clinical particulars .......................................................................................................... 12

4.1 Target species ............................................................................................................. 12

4.2 Indications for use, specifying the target species.......................................................... 13

4.3 Contraindications ........................................................................................................ 13

4.4 Special warnings for each target species ...................................................................... 14

4.5 Special precautions for use .......................................................................................... 16

4.6 Adverse reactions (frequency and seriousness) ............................................................ 20

4.7 Use during pregnancy, lactation or lay......................................................................... 23

4.8 Interaction with other medicinal products and other forms of interaction ..................... 25

4.9 Amount(s) to be administered and administration route ............................................... 26

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary ......................... 27

4.11 Withdrawal period(s) .................................................................................................. 28

5. Pharmacological properties ............................................................................................. 29

5.1 Pharmacodynamic properties [not applicable for immunologicals] .............................. 29

5.2 Pharmacokinetic particulars [not applicable for immunologicals] ................................ 29

Immunological properties [applicable for immunologicals] ..................................................... 31

6. Pharmaceutical particulars .............................................................................................. 31

6.1 List of excipients......................................................................................................... 31

6.2 Incompatibilities ......................................................................................................... 32

6.3 Shelf-life ..................................................................................................................... 33

6.4 Special precautions for storage .................................................................................... 33

6.5 Nature and composition of immediate packaging ........................................................ 34

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, [if any] ......................................................... 34

7. Marketing authorization holder ....................................................................................... 35

8. Marketing authorization number(s) ................................................................................. 35

9. Date of first authorization / renewal of the authorization ................................................. 35

10. Date of revision of the text .......................................................................................... 35

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Package Leaflet - For Veterinary Medicinal Products ................................................................. 36 1. Name and address of the marketing authorization holder ................................................. 37

2. Name of the veterinary medicinal product ....................................................................... 37

3. Statement of the active substance (s) and other ingredients .............................................. 37

4. Indication(s) ................................................................................................................... 38

5. Contraindications ............................................................................................................ 38

6. Adverse reactions ........................................................................................................... 38

7. Target species ................................................................................................................. 38

8. Dosage for each species, route(s) and method of administration ...................................... 38

9. Advice on correct administration .................................................................................... 39

10. Withdrawal period ...................................................................................................... 39

11. Special storage precautions ......................................................................................... 39

12. Special warning(s) ...................................................................................................... 39

13. Special precautions for the disposal of unused product or waste materials, if any ......... 40

14. Date on which the package leaflet was last approved ................................................... 40

15. < Other information> .................................................................................................. 40

Labeling ..................................................................................................................................... 41 1. Requirments to appear on the <outer packaging> <and> < immediate packaging> ......... 42

2. Minimum requirments to appear on small immediate packaging units ............................. 45

3. Minimum requirments to appear on blisters or strips ....................................................... 47

Appendix 1: Recommended labeling statements ......................................................................... 48 Appendix 2: Additional information that are required to be translated into Arabic language ........ 49 A. Information on the outer package (in addition to the information that is provided in the guidance): .................................................................................................................................. 49 B. Blister information (in addition to the information that is provided in the guidance): ........... 49 C. Information on the outer package of small containers (less than 100 mL) (in addition to the information that is provided in the guidance): ............................................................................. 49 Appendix 3: Readability of the label and package leaflet ............................................................ 50 References ................................................................................................................................. 59

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Introduction:

This guideline is adapted from the EMEA Notice to applicants veterinary medicinal products, volume 6C.

The document is intended to guide the applicants on how to present the required information for:

• Summary of Product Characteristics (SPC); • Package Leaflet; • Labeling.

The SPC is the basis of information for veterinary professionals on how to use the medicinal product safely and effectively. Package Leaflet shall be drawn up in accordance with the SPC.

This guideline provides advice on the principles of presenting information. Applicants should maintain the integrity of each section of the document by only including information in each section, which is relevant to the section heading. However, some issues may need to be addressed in more than one section and in such situations the individual statements may cross refer to other sections when these contain relevant additional information.

When submitting a new application for registration, renewal or variation, the information presented by the applicant regarding the SPC, Package Leaflet and labeling must follow this guidance.

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Summary of Product Characteristics (SPC)

General considerations for the preparation of the SPC

When preparing an SPC, it should be noted that the SPC is intended to provide detailed

objective information on the conditions of authorization of a veterinary medicinal product.

The SPC is not a promotional document, nor is it intended to constitute a summary of the

evaluation of the medicinal product by the SFDA.

It follows that all the statements contained in the SPC must be justified by the contents of

the application dossier which is submitted to the SFDA. Statements of a promotional

nature such as “xx is the treatment of choice for y” are not acceptable. Moreover,

extraneous information such as the results of toxicity studies should not be included unless

necessary to enable the practitioner to assess the benefits and risks of the use of the

product in a particular case.

Particular care should be taken to ensure that clear and unambiguous language is used

throughout the SPC. Attention should be given to the clear definition of the scope of the

indications, contraindications, precautions for use and warning statements to ensure that

these clearly identify the groups or sub-groups of animals concerned.

Applicants should maintain the integrity of each section of the document by only

including information in each section, which is relevant to the section heading. However,

some issues may need to be addressed in more than one section of the SPC (e.g.

contraindications plus interactions). In such situations, the individual statements may

cross-refer to other sections when these contain relevant additional information.

A separate SPC should be completed per pharmaceutical form, including all strengths of

each pharmaceutical form, if appropriate, and containing all pack-sizes related to the

strength(s) and pharmaceutical form concerned.

Standard statements are given in the template which must be used whenever they are

applicable. If the applicant can justify the need to deviate from these statements to

accommodate product-specific requirements, alternative or additional statements will be

considered on a case-by-case basis.

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Bracketing convention:

{text}: Information to be filled in.

<text>: Text to be selected or deleted as appropriate.

A. SPC – For Pharmaceutical and Immunological Veterinary Medicinal

Products

1. Name of the veterinary medicinal product

{(Invented) name of veterinary medicinal product strength pharmaceutical form

<target species>}

Given in the following order: (invented) name (no ® ™ symbols attached here or

throughout the text), strength (consistent with section 2 of the SPC), pharmaceutical

form “tablets” and “capsules” in the plural) and target animal species, if necessary , in

order to avoid any confusion

E.g. {(Invented) name} 10 mg tablets for dogs

{(Invented) name} 20 mg/ml solution for injection for dogs

For mock-ups and specimens, this information may be presented on different lines of

text or in different font sizes if necessary, provided that the appearance of the name is

preserved as an integrated item.

When selecting invented names, care should be taken to avoid the use of words or

abbreviations, which may give rise to confusion.

In those sections of the SPC in which full information on the name of the medicinal

product is specifically required, the name should include both the strength and

pharmaceutical form, even if there is only one strength and/or pharmaceutical form.

However, when otherwise referring to the medicinal product throughout the text of the

SPC, strength and pharmaceutical form do not have to be mentioned in the name. The

International Non-proprietary Name (INN) or the usual common name of the active

substance should be used when referring to properties of the active substance(s) rather

than those of the product. The use of pronouns is encouraged where it improves the

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readability of the text.

It must be noted that there are some situations where the expression of the strength or

pharmaceutical form is not straightforward, e.g. fixed combination products containing

more than two active substances and biotechnological medicinal products. In such

cases, it may be acceptable not to include the strength and/or the pharmaceutical form.

Different strengths of the same medicinal product should be stated in the same way,

for example 250 mg, 500 mg, 750 mg.

For vaccines and other biological, biotechnological medicinal products where the

expression of the pharmaceutical form is not straightforward, it may be acceptable not

to include the pharmaceutical form. To avoid confusion qualifiers such as strain

contained in the vaccine, target species, number of doses in the vial, etc may be added.

In addition, for immunological the strength might not be feasible to be include in the

name of the product.

2. Qualitative and quantitative composition

The qualitative and quantitative composition should be stated for the active

substance(s) and those excipients, where the knowledge is essential for the safe

administration of the medicinal product. For example, preservatives should always be

mentioned with their «E» numbers. Other excipients should not be mentioned here. A

standard statement should be included at the end of the section: “For full list of

excipients, see section 6.1”.

For immunological, the qualitative and quantitative composition of the adjuvant(s)

should be stated, where knowledge of this is essential for the safe administration of the

medicinal product. Adjuvants must always be mentioned at least by name. Traces of

antibiotics and/or other substances used in production of vaccines, but not present in

sufficient quantities to have a pharmacological effect should not be included in the

SPC.

If a diluent is part of the medicinal product, information should be included in the

relevant sections, usually sections 3 (pharmaceutical form), 4.9 (Amounts to be

administered), 6.1 (List of excipients) and 6.5 (composition of packaging).

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Qualitative composition

The international non-proprietary name (INN) recommended by the World Health

Organization should be used, accompanied by its salt, derivative or hydrate form if

relevant. If no INN exists, the Pharmacopoeial name should be used. If the substance

is not in the Pharmacopoeia, the usual common name should be used. In the absence of

a common name, the exact scientific designation should be given. Substances without

an INN or an exact scientific designation should be described by a statement of how

and from what they were prepared. References to a pharmacopoeial quality should not

be included.

Where the active substance is present in the form of the parent molecule, the standard

terminology should be used (e.g. dexamethasone).

Where the active substance is present as a salt, derivative or hydrate, this should be

clearly stated (e.g. dexamethasone acetate).

For immunologicals, where the active substance is of a particular quality standard, for

example selected mutants or marker virus, this should be indicated. Excipients should

be referred to by their recommended INN if one exists or by their Pharmacopoeial

name.

Quantitative composition

The quantity of the active substance must be expressed per dosage, per unit volume, or

per unit of weight.

Where the active substance is present in the form of a salt or hydrate, the quantitative

composition should be expressed in terms of the mass (or biological activity in

International (or other) Units where appropriate) of the active entity or entities (base,

acid or anhydrous material) in the molecule (e.g. X mg levamisole as levamisole

sulphate).

However, in the cases of older compounds which have traditionally been expressed in

the form of a salt or hydrate, it may in some cases be appropriate to indicate the

quantitative composition in terms of both the parent molecule and the salt (e.g. X mg

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levamisole equivalent to Y mg levamisole sulfate)

In the case of unit dose preparations, the quantitative composition should be stated per

unit dose (e.g. X mg per tablet; Y mg per ampoule). In other cases, the quantitative

composition should be stated in terms of mg per g or mg per ml. When the product is a

powder to be reconstituted prior to administration, the quantity per ml after

reconstitution should be stated.

For immunologicals, the biological activity, the titre or the potency of the active

substance should be described in international or other units and expressed per dose. In

inactivated vaccines the titre before inactivation is not acceptable. The composition

should be given in terms of minimum quantities per dose and, if appropriate with

maximum quantities per dose and an indication of the nature of a single dose (e.g. vol-

ume).

Active substance<s>:

Full details of the qualitative and quantitative composition in terms of active

substances should be provided. Expressed per dosage unit or according to the form of

administration for a given volume or weight, using their INN or common names. The

use of “%”, ppm or ppb as a strength should be avoided.]

For salt/ester: {quantity of active moiety} as {salt/ester}

or

{quantity of active moiety} equivalent to {quantity of salt/ester}

E.g.: 5 mg {X} as {Y}

8 mg {X} equivalent to 10 mg {Y}

<Adjuvant(s) :>

[E.g. Aluminum gels or salts, mineral or vegetable oil]

<Excipient(s):>

Knowledge of which is essential for proper administration of the veterinary medicinal

product, e.g . Preservatives such as formaldehyde or thiomersal.]

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[For immunologicals, traces of antibiotics and/or other substances used in production

of vaccines not present in sufficient quantities to have a pharmacological effect should

not be included in the SPC]

3. Pharmaceutical form

The term used in this section should be the same as the term used in section 1.

[Include here a description of the visual appearance of the product pharmaceutical

form as marketed e.g. shape, texture, colour, imprint, including information on pH and

osmolarity as required. In case of vaccines intended for reconstitution, the appearance

of the product before reconstitution should be stated here]

Examples:

-‘Tablet.

White, circular flat bevelled-edge tablets marked ‘100’ on one side.’

-“Solution for injection.

Pale yellow, clear solution for injection, pH 7.0”

If the product is not presented in the final pharmaceutical form intended for

administration to animals, the final pharmaceutical form should also be stated, e.g.

“powder and solvent for solution for injection”.

In case of tablets, designed with a score line, a statement should be given whether or

not reproducible halfing of the tablets has been shown.

Examples:

-“The tablets can be divided into equal halves”.

-“The scoreline is intended to facilitate ease of swallowing and not to divide into

equal doses.”

4. Clinical particulars

4.1 Target species

[Including any sub-category; indicate species in singular or plural]

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4.2 Indications for use, specifying the target species

The indications should be clearly defined for the target species. It should be clearly

stated whether the treatment is for prophylactic, therapeutic or diagnostic purposes.

[For immunologicals, the indications should be clearly defined for the target species

and should be substantiated by data in the dossier.

The indications may be considered as the general claims for the immunological

veterinary medicinal products. It gives the intention of the use of the immunological

veterinary medicinal product. One or more of the following standard text and wording

should be used, as appropriate.

For active immunization or passive immunization of target species to:

- Prevent mortality, clinical signs and/or lesions of the disease;

- Prevent infection;

- Reduce mortality, clinical signs and/or lesions of the disease;

- Reduce infection.

In addition to the indications, the onset and duration of immunity of the

immunological veterinary medicinal product should be specified, if appropriate.

Where appropriate, further information on the protection that can be expected from the

use of the immunological veterinary medicinal product may be included.

4.3 Contraindications

[Do not specify species which are not included in the target species, unless studies or

knowledge indicate severe toxicity; non-indications (e.g. “this veterinary medicinal

product is not indicated for...”) should not be mentioned]

Situations, which arise from a set of circumstances where the veterinary medicinal

product must not be used for target animal safety reasons, i.e. absolute

contraindications, are the subject of this section. Contraindications may be linked with

a target species or a sub-group of the target species, the administration of the product

by a particular route or with administration in conjunction with other products.

Furthermore, particular clinical diagnoses, concomitant diseases, age or sex may

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constitute contraindications. Other veterinary medicines or classes of medicine, which

should be specifically avoided (i.e. contraindicated) for concomitant or consecutive

use, should only be stated here, if such use has serious consequences (e.g. fatalities).

Otherwise, this information should be mentioned under section 4.8 (Interactions).

Absolute contraindications must be unambiguously, comprehensively and clearly

worded. It is not necessary to contraindicate species that are not included in the target

species, unless studies indicate a particular risk with off-label use in a non-target

species. Cross-reference to other sections may be made, if necessary e.g. to sections

4.7 (Use during pregnancy, lactation or lay) and 4.8. (Interactions).

Non-indications (e.g. ‘this veterinary medicinal product is not indicated for...’) should

not be mentioned. Relative contraindications should be listed in section 4.5 (Special

precautions for use).

Contraindications arising from hypersensitivity reactions in the target species to any of

the excipients, residues from the manufacturing process or the presence of certain

excipients should be included. Possible hypersensitivity reactions in the user should

not be addressed here, but in section 4.6 (Adverse Reactions).

Additionally, all information relating to consumer safety should only be given in 4.11

(withdrawal period).

The following standard phrases to be used in listing of contraindication are:

<None>

<Do not use in ….>

<Do not use in case of hypersensitivity to the active substance(s) or to any of the

excipient(s).>

4.4 Special warnings for each target species

<None.>

[Warnings to ensure the effective use of the veterinary medicinal product.]

The purpose of this section is to provide clear information on how to ensure the

effective use of the product in target animals.

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Information could include recommendations on the handling of animals, the proper

use of the product or any other impact on the efficacy of the product.

Additionally it is to warn prescribers of possibilities of modifications of the efficacy

profile of the product, which may arise in particular situations such as very old or very

young animals.

Description should be made under which conditions the veterinary medicinal product

may be recommended for use in such groups provided the special precautions are

followed. Situations in which use of the medicinal product is absolutely

contraindicated should be mentioned under section 4.3. only and is not to be repeated

in this section.

Descriptions of warning and precautions regarding pregnancy, lactation or lay and

other aspects of interactions should be dealt with in sections 4.7 and 4.8 respectively.

Examples:

- Limitations of use, if adequate:

“Although the product may be safely administered to… with …, it has no

therapeutic effect against …; or

“The efficacy of … has not been established in dogs weighing less than … or

under …of age”.

- Information about dose or duration:

“A second injection must not be given, even if clinical signs recur…”.

- General recommendations for the proper use and about handling, if appropriate:

“Animals with acute infections and severely reduced feed intake should be treated

with a suitable injection product first”.

- Impact on efficacy:

“Frequent shampooing or immersion of the animal in water after treatment may

reduce the efficacy of the product” or

“Animals may be bathed xx hours after treatment without loss of efficacy”.

Information on resistance should be included in this section, if applicable.

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4.5 Special precautions for use

[including special precautions to be taken by the person administering the medicinal

product to animals]

i. Special precautions for use in animals

[Precaution(s) relating to particular sub-groups such as animals with renal, hepatic or

cardiac failure, or use in young or old animals, or certain specific breeds.]

The purpose of this section is to provide clear information on how to ensure the safe

use of the product in animals. The section should include information on relative

contraindications. It should also contain information on class or drug-related effects in

particular conditions such as renal, hepatic or cardiac failure, or in particular groups

such as very old or very young animals or sensitive subpopulations.

Possible hypersensitivity reactions in the target species to any of the excipients,

residues from the manufacturing process or the presence of certain excipients should

be included.

Relative contraindications should be mentioned first. Situations in which use of the

product is absolutely contraindicated should be mentioned under section 4.3

(Contraindications) only.

The information should include the following:

- The conditions under which the product could be used provided that special

conditions for use are fulfilled (for example, relative contraindications).

Examples:

- “The safety of … has not been established in dogs weighing less than … or

under …of age”,

- “The safety of the product has not been tested under certain conditions e.g. ….”

(Limitations of use, if adequate such as information on use in certain subgroups

of animals).

- Special animal groups likely to experience product or class related adverse

reactions when the product is used as recommended e.g. specified age groups,

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animals with renal or hepatic impairment (including the degree of impairment,

such as mild, moderate or severe) or cardiac disease (including the severity of the

condition) or sensitive sub-populations e.g. ivermectin sensitive collies.

Examples:

- “Special care should be taken when administering the product to animals with

<condition or disease>, since ….”

- “Treated animals should be monitored for <clinical signs or analytical

parameters>…”

- “<Adverse effect> may occur when administering the product to <animals or

specific condition>, in this case treatments should be < discontinued or dose

should be reduced>.

- Any measures which can be taken to identify animals at risk and to prevent the

occurrence, or to detect early the onset or worsening of conditions. Also, any

safety measures to minimize impact of the treatment to untreated animals should

be mentioned.

- Where appropriate, information may also be provided about possible risks

resulting from the off-label use of the product.

Descriptions of warning and precautions regarding pregnancy and lactation and other

aspects of interactions should be dealt with in sections 4.7 (Use during pregnancy,

lactation or lay) and 4.8 (Interactions) respectively.

Descriptions on general information for instance on handling and directions for proper

use concerning the mode of administration should be dealt with in section 4.9

(Amounts to be administered) with cross reference to section 4.4 (Special warnings)

e.g. “Do not administer more than 10 ml in each site of injection”.

Do not use chlorinated water” for immunologicals.

[Actions necessary to avoid pathogenic agents spreading from the vaccinate to either

non-target categories of the same species or non-target species (for immunologicals.).]

<Not applicable>

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<Vaccinated {species} may excrete the vaccine strain up to {x days/weeks} following

vaccination.

During this time, the contact of immunodepressed and unvaccinated {species} with

vaccinated

{species} should be avoided. >

<The vaccinal strain can spread to {species}.

Special precautions should be taken to avoid spreading of the vaccine strain to

{species}.>

<Appropriate veterinary and husbandry measures should be taken to avoid spread to

susceptible

species.>

< {Species} and unvaccinated {species} in contact with vaccinated {species} may

react to the vaccine strain, presenting clinical signs such as ….>

[Any warnings necessary for excipients or residues from the manufacturing process.]

ii. Special precautions to be taken by the person administering the medicinal

product to animals

Risks resulting from the nature of the product, its preparation and use and of any risks

resulting from the particular characteristics of the user should be stated here.

Possible hypersensitivity reactions in the user to any of the excipients or residues from

the manufacturing process should be included.

Example:

- People with known hypersensitivity to xx should <avoid contact with the product>

If applicable, information should also be given for persons in close contact to the

treated animal e.g. animal owner, children, immuno-compromised persons, and

pregnant women.

Example:

- Women of child-bearing potential should avoid contact with, or wear disposable

gloves when administering, the product.

Recommendations should be given to minimize the exposure of the user during

administration or preparation of the product for administration.

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Safety phrases given in international legislation should be used where possible.

Guidance on action to be taken following accidental contact should also be given,

where necessary.

<Not applicable.>

<Do not eat, drink or smoke while handling the product>.

<In case of accidental <self-administration> <self-injection> <ingestion> <spillage

onto skin>, seek medical advice immediately and show the package leaflet or the label

to the physician.>

<People with known hypersensitivity to {INN} should <avoid contact with the

veterinary medicinal product.>

<Should administer the product with caution.>

<Personal protective equipment consisting of {specify} should be worn when handling

the veterinary medicinal product.>

<The product should not be administered by pregnant women.>

<The vaccine can be pathogenic for humans. Since this vaccine has been prepared

with live, attenuated microorganisms, appropriate measures should be taken to prevent

contamination of the handler and other people that collaborate in the process.>

<Vaccinated {species} may excrete the vaccine strain up to {x days/weeks} following

vaccination. Immunocompromised persons are advised to avoid contact with the

vaccine and vaccinated animals during {period}.>>

<The vaccine strain can be found in the environment for up to {x days/weeks}.

Personnel involved in attending vaccinated {species} should follow general hygiene

principles (changing clothes, wearing gloves, cleaning and disinfection of boots) and

take particular care in handling litter from recently vaccinated {species}.>

[If the product contains mineral oil:]

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<To the user:

This product contains mineral oil. Accidental injection/self injection may result in

severe pain and swelling, particularly if injected into a joint or finger, and in rare cases

could result in the loss of the affected finger if prompt medical attention is not given.

If you are accidentally injected with this product, seek prompt medical advice even if

only a very small amount is injected and take the package leaflet with you.

If pain persists for more than 12 hours after medical examination, seek medical advice

again.

iii. < Other precautions>

[Other precautions regarding impact on the environment, or chemical reactions of

the product with furniture or clothes.]

Examples:

- This product is highly flammable. Keep away from heat, sparks, open flame or

other sources of ignition.

- Do not allow treated animals to swim in water courses until at least … hours/days

after administration.

[The following statements, which are relevant only for the product label and package

leaflet, should not be included in the SPC:

‘For veterinary use only.’

‘Keep out of reach and sight of children.’]

4.6 Adverse reactions (frequency and seriousness)

[By target species if more than one. Only include the adverse drug reactions (ADRs),

which are those effects where a direct causal relationship between the effects and the

treatment has been established]

This section should include information on adverse drug reactions attributed to the

product when used as recommended. The reactions listed should be based on an

assessment of all observed adverse events and all facts relevant to their causality,

severity and frequency. The main adverse reactions in the target species should be

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included in the SPC, if they are at least possibly causally related, based for example on

their comparative incidence in clinical trials, or on findings from epidemiological

studies and/or on an evaluation of causality from individual reports. Adverse events,

without at least a suspected causal relationship, should not be listed in the SPC. Data

can be derived either from data submitted in an application dossier or from post-

authorization pharmacovigilance reports.

This section should also include information about any action that may be taken by the

animal owner or the veterinarian in case of adverse reactions, for example immediate

cessation of treatment or emergency resuscitation. If there is a need for awareness of

clinical signs representing early warning of a serious adverse reaction, a statement

should be included. Any need for specific clinical or laboratory monitoring should be

stated.

Claims regarding the absence of specific adverse reactions, statements on lack of proof

of causal association or comparative frequency statements other than those described

below should not be included in this section.

In order to provide clear and readily accessed information, the section should be

structured according to the following recommendations:

a) Description of the adverse reaction(s)

The information in this section must be consistent with the figures presented and

should not contain general statements such as "well tolerated".

The following information should be provided for each adverse reaction: a brief

description of the nature of the reaction, the duration, reversibility and intensity of

the reactions, the frequency of the reaction experienced in treated animals and any

effect on the general state of health of the animal. In addition, it should be

indicated whether certain species or breeds or types of individual are more

susceptible to the undesirable effect concerned, or whether it is more frequent

under certain types of husbandry conditions.

All adverse reactions should be ranked in “frequency groupings” with the most

frequently occurring reactions listed first, using the following convention:

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Adverse reaction Incidence

Very common more than 1 in 10 animals displaying adverse reaction(s)

during the course of one treatment

Common more than 1 but less than 10 animals in 100 animals

Uncommon more than 1 but less than 10 animals in 1,000 animals

Rare more than 1 but less than 10 animals in 10,000 animals

Very rare less than 1 animal in 10,000 animals, including isolated reports

More precise figures on the frequency of adverse reactions from clinical trials, e.g.

XX% animals, are generally of limited value under conditions of market use and

should only be included when it is of particular relevance to the animal owner or

user of the product and/or prescriber to be informed of certain risks. In these cases

it is preferable that the data should be based on pooled study results and/or large

studies performed under actual market conditions and should refer to adverse

reactions, not to unrelated adverse events.

This information can be presented in tabular format. Examples of acceptable

statements are given below:

- “Commonly reported adverse reactions are gastrointestinal signs such as

diarrhoea”.

- “Adverse reactions are rare (<1/1,000). At the beginning of therapy, colic,

diarrhoea, or tremors may occur”.

b) Measures to be taken to avoid specific adverse reactions should be mentioned

under 4.5 (Special precautions) and cross-referenced here. Any adverse reactions

resulting directly from an interaction should be mentioned here and cross-

referenced to section 4.8 (Interactions).

c) Adverse reactions, which have been described for the active ingredient(s) or their

pharmacological class and which are very rare or occur with delayed onset of

clinical signs. These reactions may not have been observed in relation to the

product, but are generally accepted as being attributable to the pharmacological

class. The fact that this is a class attribution should be mentioned .

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4.7 Use during pregnancy, lactation or lay

<The safety of the veterinary medicinal product has not been established during

<pregnancy>

<lactation> <lay>.>

In order to ensure the safe use of the product, the user must be informed of the

recommendations regarding the use of the product in pregnant/lactating animals or

laying birds. Information about use of the product during pregnancy or lactation may

have been provided in the sections dealing with contraindications or special

precautions for use. In such cases, a cross-reference to the relevant section will be

sufficient. Information on the reasons for the relevant recommendation should always

be given.

In the absence of data, the use of this veterinary products is not recommended.

<Pregnancy>

In the case where reproductive toxicity studies have shown evidence of teratogenic,

foetotoxic or maternotoxic effects in the target species or in other animal species, the

applicant should give further information.

Examples

< Can be used during pregnancy> (if the safety on pregnant animals has been shown in

the target species).

<The use is not recommended (during the whole or part of the pregnancy).>

<Do not use (during the whole or part of the pregnancy).> because…” (if adverse

reactions have been shown during pregnancy with the recommended dose in the target

species, a case by case evaluation is needed and depending on the type of reaction).

<Use only accordingly to the benefit/risk assessment by the responsible veterinarian.>

<Laboratory studies in <species> have shown evidence of teratogenic, foetotoxic,

maternotoxic effects.>

<Laboratory studies in {species} have shown evidence of teratogenic, foetotoxic,

maternotoxic

effects.>

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<Lactation>

<Not applicable>

The tolerance of the product in lactating animals and suckling off-spring should be

addressed here. Information in relation to consumer safety i.e. consequences of residues

for the use of milk for human consumption should be given in section 4.11 (Withdrawal

period).

Where possible, information on excretion of the active substance and/or its metabolite(s)

in milk should be given. Where relevant, recommendation as to whether to stop or

continue to feed (new-born) animals with milk obtained from the mother should be given,

and the reason for the recommendation should be stated.

Examples:

<Can be used during lactation> (If the safe consumption of milk obtained from treated

animals has been shown in the off spring in the target animal).

<Do not use during lactation>, because” or “New born calves..<species> should not be

fed with milk from the treated animals, because…” (If adverse reactions have been shown

in the off spring consuming milk from treated animals).

<Laying birds>

<Do not use in birds in lay <breeding birds> and/or within 4 weeks before the onset of the

laying

period.>

For chicken/avian products, it should be indicated if the product is unsuitable for laying

birds.

Example:

- “Do not use in breeding birds and/or within xx weeks before the onset of the laying

period”.

If the product is not for use in laying birds the prohibition of use is given in section

4.4. Information about the consequences of residues for the use of eggs for human

consumption should be given in section 4.11. Withdrawal period.

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<Fertility>

The following standard phrase should be used when applicable:“Do not use in

breeding animals”.

Information regarding fertility in both males and females should be given in sections

4.3 (Contraindications), 4.4 (Special warnings) or 4.6 (Adverse reactions), as

appropriate.

4.8 Interaction with other medicinal products and other forms of interaction

<None known.> [if appropriate]

<No data available.> [if appropriate. For pharmaceuticals]

<No information is available on the safety and efficacy of this vaccine when used with

any other veterinary medicinal product. A decision to use this vaccine before or after

any other veterinary medicinal product therefore needs to be made on a case by case

basis.> [For immunologicals]

[Where safety and efficacy data are available for use of the products with others the

following statements are applicable:

When the vaccines can be used on the same day:

<Safety <and> efficacy data are available which demonstrate that this vaccine can be

administered on the same day but not mixed with {description of tested product(s).}>

[For immunologicals]

[In the case of products administered parenterally, the products should be given at

different sites].

When the vaccines can be used concurrently but not on the same day:


administered at least {X number of} <days> <weeks> <before> <after> the

administration of {description of tested product(s).}> [For immunologicals]

[The X number of days/weeks and the references to before or after are based on the

data presented by the applicant in the marketing authorization file. They correspond to

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the minimum time between administrations for which compatibility data have been

submitted].

[In addition to the above statements, to reflect the absence of information on the safety

and efficacy of the association with any other vaccines, the following wording should

also be included:]

<No information is available on the safety and efficacy of this vaccine when used with

any other veterinary medicinal product except the products mentioned above. A

decision to use this vaccine before or after any other veterinary medicinal product

therefore needs to be made on a case by case basis.> [For immunologicals]

4.9 Amount(s) to be administered and administration route

Include information on the posology and method of administration. Posology: target

groups to be specified, e.g. cattle less than 1 year of age. Method of administration:

directions for proper use by healthcare professionals or by the farmer or owner and

mixing instructions, if appropriate. Further practical details for the farmer or owner

can be included in the package leaflet or, in its absence, on the label.]

The dosage has to be specified for each target species, route of administration and

indication.

The dosage should be given per kg bodyweight (BW) in the first place, where

appropriate, as well as in terms of the amount to be administered to the animal (e.g. ml

or mg/xx kg BW).

The dosage should be expressed in terms of a veterinary medicinal product (e.g. by

unit doses or by a volume of solution administered to the animal). Whenever a titre is

expressed in terms of infectious dose the wording should be cell culture infectious

dose (CCID 50%) and egg infectious dose. Other terms can be added in order to guide

for proper use of the product. International System (SI) units should be used. The

frequency/interval and duration of administration should be specified in hours, days,

weeks or months. [For immunologicals].

The method, including route and site of administration and directions for proper use by

the veterinarian, farmer or owner should be given. Any special equipment needed for

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administration of the product should be mentioned. Where the product is to be

administered via the feed or water, any dosage adjustment for inappetent animals

should be specified, if justified from the data available.

Other terms can be added in order to provide guidance on the proper use of the

product. International System (SI) units should be used. The frequency and duration of

treatment should be specified in hours, days or weeks.

For products to be administered via drinking water, important additional information

should be added here:

- “Medicated drinking water should be refreshed or replaced every “xx” hours.”

For premixes for medicated feeding stuff, clear instructions for the proper preparation

of the medicated feed e.g. pelleting instructions and mixing equipment, and the amount

of premix for the incorporation should be provided. Also, information on the feeding

stuff(s) to be used should be included. If necessary, the use of a pre-mixture should be

recommended.

For products to be reconstituted, information on the solvent to use and its volume

should be given.

[In case of vaccines intended for reconstitution, a visual description of the reconstituted

vaccine should be included here, e.g.: ]

<The vaccine should not be used if {description of the visible signs of deterioration}.>

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

The purpose of overdose studies is to detect signs of possible adverse reactions and to

identify the dose at which they occur, in order to establish a safety margin.

Signs observed at higher dose levels than the recommended one should be mentioned.

If no clinical signs were observed this should be mentioned as well. The following

information should be provided, if available:

- Clinical signs, nature, evolution, seriousness, duration. It should also be indicated

at what doses the overdosage signs were observed.

- Available symptomatic treatments.

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- Emergency procedures.

- Antidote(s).

4.11 Withdrawal period(s)

The withdrawal period is defined as the period between the last administration of the

veterinary medicinal product to animals and the production of foodstuffs from such

animals. Where all foodstuffs may be used for human consumption during the

treatment period and immediately after the last administration of a veterinary

medicinal product, a withdrawal of “zero days” should be indicated.

If necessary, withdrawal periods should be stated for meat and offal, milk, or eggs.

Withdrawal periods should be indicated in whole days, using Arabic numerals, except

for milk withdrawal periods, which may be more appropriately expressed in whole

hours. A zero withdrawal period should be expressed as ‘Zero hours/days’.

However, for fish, the withdrawal period should be stated in degree-days. The number

of degree-days is divided by the average water temperature, in °C, to give the

withdrawal period in days.

When expressing the withdrawal period, the method of treatment must be taken into

account:

- In the case of single administration only, the withdrawal period starts from the

time of treatment.

- In the case of two or more administrations, the time of the last treatment is defined

as the start of the withdrawal period.

- If a product is removed at the end of the treatment (e.g. implants), the time of the

removal of the product is defined as the start of the withdrawal period.

- In the case of intra-mammary products administered during the dry period, the

withdrawal period for animal slaughter for meat starts from the date of treatment;

for milk the withdrawal period is determined by the date of subsequent calving.

For veterinary medicinal products for food producing species, which contain

pharmacologically active substances without MRLs (e.g. for milk/eggs), relevant

information should be given.

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For a majority of immunological products the concern is in respect of live zoonotic

organisms, adjuvants and preservatives. It is not anticipated that animals will be likely

to be slaughtered for human consumption within a few days of being vaccinated, how-

ever this possibility should be addressed if relevant.

Examples:

< Not applicable” (For non-food producing species). >

< Zero days” (For food producing species where no withdrawal period is necessary). >

< xx hours, days or degree-days” (For food producing species where a withdrawal

period is necessary). >

<Not authorised for use in lactating animals producing milk for human consumption.>

[for milk producing animals]

< Do not use in pregnant animals, which are intended to produce milk for human

consumption, within xx months of expected parturition (For milk food producing

animals species where no MRL exists for milk). >

<Not authorised for use in laying birds producing eggs for human consumption.> [for

laying birds]

<Do not use within xx weeks of onset of the laying” (For food producing species where

no MRL exists for eggs). >

5. Pharmacological properties

The therapeutic group (according to the ATCvet classification system) and the ATCvet

code should be stated at the beginning of this section.

5.1 Pharmacodynamic properties [not applicable for immunologicals]

The pharmacodynamic activity of the active substance(s) should be specified, together

with the mechanism of the action, on the basis of the information contained in the

application dossier. Also, information on resistance should be included in this section,

if appropriate.

5.2 Pharmacokinetic particulars [not applicable for immunologicals]

Information, relevant for the proposed use of the product should be provided on the

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absorption, distribution, biotransformation and elimination of the active substance in

each of the -target species, for example:

Absorption

- Percentage of the dose absorbed by the recommended route of administration, e.g.

oral or dermal route;

- Time necessary to obtain the maximum concentration (Tmax);

- The maximum concentration (Cmax);

- Influence of feeding regime for absorption by the oral route;

- Quantity or percentage of the dose applied absorbed after topical administration.

Distribution

- Existence of possible linearity between the concentrations obtained and the dose

administered;

- Degree of protein binding;

- Tissue distribution;

- Apparent volume of distribution.

Biotransformation

- Information relating to metabolism;

- Activity of metabolites;

- Percentage of the substance metabolized if known.

Elimination

- Half-life;

- Principal routes of excretion. Also, if relevant from an environmental point of

view, information on secondary excretion routes might be included (e.g. main

excretion route via urine; however, some active metabolites with impact on the

environment might also be excreted via faeces).

For products intended for multiple administrations information on kinetic properties

after repeated dosage should be given. Additionally, information on steady state levels,

possible changes in absorption, distribution, metabolism and elimination between the

pharmacokinetic particulars after a single administration and those after multiple

administrations should be taken into consideration.

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Immunological properties [applicable for immunologicals]

A brief description of the immunological properties, characteristics of the active

substance(s) and the ATC vet code should be included in this section. For example:

- To stimulate active immunity against (……).

- To provide passive immunity against (……).

- To affect the physiological function of <target species> through immunological

mechanism(s).

To modulate the function of the immune system of <target species>.

<Environmental properties> [if not applicable delete this section]

For products, which might enter the environment directly e.g. medicines for fish or via

manure, general information on environmental effects should be provided. The impact

of the active substance or relevant metabolites excreted into the environment should be

addressed. Information on degradation and factors influencing this (e.g. light, pH,

temperature) and other ways of deactivation (e.g. binding to organic matter) should be

given. Possible accumulation in the environment should be addressed.

6. Pharmaceutical particulars

6.1 List of excipients

[Each excipient to be listed on a separate line according to the different parts of the

product][A qualitative list (not quantitative) should be provided]

[Name of the excipient(s) in the language of the text]

A list should be given of the excipients, expressed qualitatively only. All excipients,

which are present in the product, even those present in small amounts, should be

included. The active substance itself, residues of substances used during manufacture

of the finished product (e.g. solvents or head-space gases), and lubricants for prefilled

syringes should not be included. Excipients that should usually be included on the

product literature include preservatives, colorants and premix carriers.

Excipients should be referred to by their recommended INN, if one exists,

accompanied by the salt or hydrate form, if relevant, or by their Pharmacopoeial name.

If an excipient has neither an INN nor a Pharmacopoeial name, it should be described

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by its usual common name. References to the pharmacopoeial quality should not be

included.

E numbers should be given where they exist if the excipient has a recognized action or

effect, for example preservatives and coloring matters, along with the common name

of the excipient.

Flavors or fragrances may be declared in general terms (e.g. ‘orange flavor’, ‘citrus

per-fume’). However, any of the components, which have a recognized action or

effect, must be included.

Modified excipients should be declared in such a way as to avoid confusion with the

unmodified excipients (e.g. pregelatinised starch).

For clarity, it is recommended that each excipient be listed on a separate line and no

abbreviations should be used.

Ingredients that may or may not be added for pH-adjustment should be followed by

the parenthesis “(for pH adjustment)”.

In the case of premixes for medicated feeding-stuffs, the main carriers in brackets

should be indicated.

6.2 Incompatibilities

[Information should be given about major physical or chemical incompatibilities of the

product with other products with which it is likely to be diluted, mixed or co-

administered. Major incompatibilities observed from compatibility studies should be

included here]

<Not applicable.> [if incompatibility is not a concern due to the pharmaceutical form

of the product, e.g. for solid oral pharmaceutical forms]

<In the absence of compatibility studies, this veterinary medicinal product must not be

mixed with other veterinary medicinal products.> [e.g. for parenterals, premixes for

medicated feeding stuffs]

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[It is not permitted to mix immunological products with other products, except other

components or the recommended diluent, unless compatibility data have been

provided. In the absence of this data the following statement should be used]

<Do not mix with any other veterinary medicinal product <, except diluent or other

component <recommended> <supplied> for use with the product.> >

[If applicant has demonstrated that mixing of products (simultaneous administration)

is possible and if it is accepted by SFDA, the following statement should be used:]


mixed and administered with {description of tested product(s)}.>

<None known.>

6.3 Shelf-life

This section should include:

<Shelf life of the veterinary medicinal product as packaged for sale>

<Shelf life after first opening the immediate packaging>

<Shelf life after dilution or reconstitution according to directions>

The shelf-life should be expressed in Arabic numerals as :

<6 months> <...> <1 year> <18 months> <2 years> <30 months> <3 years>

In the case of multi-dose preparations presented in sealed containers, the shelf-life of

the broached or opened container should also be stated. Similarly, in the case of

premixes for medicated feeding-stuffs, the shelf-life should be indicated for the

premix. For medicated drinking water, the shelf life should be stated and may not

exceed 24 hours.

No storage conditions should be included here. They are given in section 6.4 (Special

precautions for storage).

6.4 Special precautions for storage

This section contains the information necessary for the correct storage of the product:

temperature, light and humidity. If no storage warning is required, the following

phrase should be used <No special precautions for storage>.

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Storage conditions for veterinary medicinal products should be made according to the

recommended labeling statements, see Appendix 1.

6.5 Nature and composition of immediate packaging

[Include full information about contents of the packaging, such as type(s) of the

immediate and outer containers (e.g. glass vial in a cardboard box), material (e.g. glass

type, type of plastic) in contact with the veterinary medicinal product, package size(s)

for the particular pharmaceutical form and strength(s), and devices supplied. Include

the fill-volume/weight of the container, if appropriate.

All pack sizes must be listed. If more than 1 pack size applicable, add:] <Not all pack

sizes may be marketed.>

6.6 Special precautions for the disposal of unused veterinary medicinal product

or waste materials derived from the use of such products, [if any]

This section should include information necessary for the safe disposal of unused

product, and the equipment used for the administration of the product to animals. In

addition, reference should be made to any restrictions on the disposal of waste

products from treated animals.

In particular cases there may be a need for specific warnings due to the environmental

features of the active substance/metabolites, for example:

<Not applicable.>

<Any unused veterinary medicinal product or waste materials derived from such

veterinary medicinal product should be disposed of in accordance with local

requirements.> [e.g. pharmaceuticals and inactivated immunologicals]

<Dispose of waste material by boiling, incineration or immersion in an appropriate

disinfectant approved for use by the competent authorities.> [live immunologicals]

<{Invented name} should not enter water courses as this may be dangerous for fish

and other aquatic organisms.> [if applicable]

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7. Marketing authorization holder

Name, address and contact details of the marketing authorization holder (including

electronic mail address, if appropriate) should be included. However, references to

web-sites on the internet should not be included.

{Name and address}

<{tel}>

<{fax}>

<{e-mail}>

8. Marketing authorization number(s)

[Item to be completed by the Marketing Authorisation Holder once the Marketing

Authorisation has been granted.]

9. Date of first authorization / renewal of the authorization


Authorisation has been granted or renewed.]

The date of first authorization and the date of renewal, if applicable, should be

indicated.

Date of first authorization <{DD/MM/YYYY}> <{DD month YYYY}>

Date of renewal <{DD/MM/YYYY}> <{DD month YYYY}>

10. Date of revision of the text

Leave blank in case of a first authorization. In case of changes to the SPC, the date of

approval by the SFDA should be indicated.

{MM/YYYY}

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Package Leaflet - For Veterinary Medicinal Products

[NOTE: the inclusion of a package leaflet in the packaging of veterinary medicinal

products shall be obligatory unless all the information required can be conveyed on the

container and the outer package].

The applicant should provide package leaflet by both arabic and english languages. A

separate package leaflet should be provided per strength and per pharmaceutical form. The

package leaflet must be easily readable for the healthcare professionals, farmer or animal

owner.

It is important that the package leaflet can easily be tracked for updates and review. Each

package leaflet should be given a reference number along with the date the leaflet was

issued and a suitable review date. Each package leaflet should be reviewed every 5 years

or when necessary.

The following items must appear in the package leaflet as required by this guidance. In

exceptional cases, alternative headings may be acceptable. This should not in any case

affect the content required for the section concerned. Applicants should justify the use of

alternative headings. For certain products not all items may be relevant, in this case the

corresponding heading should not be included.


{text}: Information to be filled in.

<text>: Text to be selected or deleted as appropriate.

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Package leaflet for: {(Invented) name of veterinary medicinal product strength pharmaceutical form

<target

species>} [as it appears in the SPC under section 1.]

1. Name and address of the marketing authorization holder

Name, address and contact details of the marketing authorization holder (Including town,

postal code (if available) and country name (Telephone, fax numbers, email addresses

may be included (no websites or e-mails linking to websites allowed).

<Marketing authorisation holder <and manufacturer>:

<Manufacturer for the batch release:>

{Name and address}

<{tel}>

<{fax}>

<{e-mail}>

2. Name of the veterinary medicinal product

[as it appears in the SPC under section 1. Name of the veterinary medicinal

product followed by its strength and pharmaceutical form. The common name

shall appear if the product contains only one active substance and its name is an

invented name.]

{(Invented) name of veterinary medicinal product strength pharmaceutical form <target

species>}

{active substance(s)}

3. Statement of the active substance (s) and other ingredients


• The composition should be stated for the active substance(s) (expressed

qualitatively and quantitatively) and excipients (expressed qualitatively).

• Information on the description of the pharmaceutical form, e.g. “xx is a white

powder containing …mg (active substance)”.

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• Information on the appearance of the product before reconstitution/dilution, if

applicable.

4. Indication(s)


• Clearly defined indications for the target species.

• A short section describing the benefits of the product and the purpose of the

treatment.

5. Contraindications

This section should include information under section 4.3 of the SPC, if appropriate.

6. Adverse reactions

This section should include information on adverse drug reactions attributed to the

product when used as recommended. The reactions listed should be based on an

assessment of all observed adverse events and all facts relevant to their causality,

severity and frequency.

This section should also include information about any action that may be taken by the

animal owner or the veterinarian in case of adverse reactions, for example immediate

cessation of treatment or emergency resuscitation.

7. Target species

The target species, and sub-categories, when appropriate, should be indicated.

Dosage for each species, route(s) and method of administration.

8. Dosage for each species, route(s) and method of administration

The dosage should be given per kg bodyweight (BW) in the first place, where

appropriate, as well as in terms of the amount to be administered to each species (e.g.

ml or mg /xx kg BW).

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The method, route and site of administration of the veterinary medicinal product

should be given.

[Method of administration: directions for proper use of the veterinary medicinal

product; e.g. “Shake well before use”.]

9. Advice on correct administration

[Directions for proper use by healthcare professionals, farmer or animal owner;

including practical details such as mixing instructions. A description of appearance

after reconstitution, if applicable]

10. Withdrawal period

This section should include information under section 4.11 of the SPC.

11. Special storage precautions


- Keep out of the reach and sight of children.

- A statement of the recommended labeling statements (see Appendix 1).

Note: storage conditions in Arabic language should be added.

- Shelf-life of the veterinary medicinal product as packaged for sale.

- Shelf-life after first opening of the immediate packaging (where relevant).

- Shelf-life after dilution or reconstitution (where relevant).

- Shelf life after incorporation into feed (where relevant).

- Use immediately, do not store (where relevant).

- Warning against certain visible signs of deterioration (where relevant).

e.g. <Do not use {name} if you notice {description of the visible signs of

deterioration}.>

12. Special warning(s)

This section should include warnings from relevant sections 4.4, 4.5, 4.7, 4.8, 4.10 or

6.2 from the SPC should be included as appropriate in user-friendly wording.

<None.>

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13. Special precautions for the disposal of unused product or waste materials, if

any

This section should include information from section 6.6 of the SPC in user-friendly

wording.

e.g. <Medicines should not be disposed of via wastewater or household waste.>

<Ask your veterinary surgeon how to dispose of medicines no longer required.

These measures should help to protect the environment>

14. Date on which the package leaflet was last approved

Leave blank in case of a first authorization. In case of changes to the package leaflet,

the date of approval by the SFDA should be indicated.

{MM/YYYY}

15. < Other information>


- Package size(s). All pack sizes should be listed. If appropriate, a standard

statement, ‘Not all pack sizes may be marketed’, should be included.

- To report any side effect(s):

− National Pharmacovigilance Center (NPC)

o Fax: +966-1-2057662

o E-mail: [email protected]

o Website: www.sfda.gov.sa/npc

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Labeling

The data should be presented according to the template below, irrespectively of their

sequence on the actual labeling and their position and possible repetition on the individual

sides/flaps of the packaging (e.g. top flap, front, back etc.).

A separate text for the labeling of the outer and immediate packaging should be provided.

Separate labeling documents should be prepared for each strength and pharmaceutical

form. However, different pack sizes of the same strength can be presented in one

document. Where the same text for outer and immediate packaging is used, this should be

clearly indicated in the heading.

Standard statements are given in the template, which must be used whenever they are

applicable. If the applicant needs to deviate from these statements to accommodate

product-specific requirements, alternative or additional statements will be considered on a

case-by-case basis.

Boxed headings are provided to help applicants when completing the template. However,

they are not to appear in the final printed packaging materials (mock-ups/specimens).


{text}:Information to be filled in.

<text>:Text to be selected or deleted as appropriate.

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1. Requirments to appear on the <outer packaging> <and> < immediate packaging>

a.Name of the veterinary medicinal product

{(Invented) name of the product Strength Pharmaceutical form <Target species>}


[Name of the veterinary medicinal product, followed by its strength and pharmaceutical

form. The common name shall appear if the medicinal product contains only one active

substance and its name is an invented name, as it appears in the SPC under section 1.]

• Note: The invented (trade) name in Arabic language should be added.

b. Statement of active and other substance(s)

Expressed qualitatively and quantitatively per dosage unit or according to the form of

administration for a given volume or weight, using the common names. Where the active

substance is present as a salt, this should be clearly indicated.

e.g.: “mg X” or “mg Y-hydrochloride (equivalent to mg Y)”.

Express qualitatively those excipients known to have a recognized action or effect.

However, where justified for space considerations, abbreviations for excipient names

may appear on the labeling, on condition that these abbreviations together with the full

name are also included in section (6.1) of the SPC and section (3) of the package leaflet.

c. Pharmaceutical form

The pharmaceutical form has to be mentioned on the outer package.

d. Package Size

Contents by weight, by volume or by number of doses of the veterinary medicinal

product (i.e. content of bottle; pack size, including a reference to any ancillary items

included in the pack such as needles, swabs etc…).

In case of a combined labeling text covering different pack-sizes of the same strength,

further pack-size(s) should be included in grey shading.

e.g. 28 tablets

56 tablets

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e. Target species

The target species should be mentioned if not already included in the name.

In addition to the wording, a pictogram can be used.

f. Indication(s)

Information to be included for immunologicals only.

In case of space restriction and if the indication is clear from the name of the product, the

indication should not be repeated.

g.Method and route(s) of administration

This section should include information on directions for proper use of the veterinary

medicinal product (e.g. “shake well before use”).

In all cases, and especially if full details cannot be included on the outer packaging itself,

a reference to the package leaflet must be included (read the package leaflet before use).

h. Withdrawal period

[Withdrawal period for veterinary medicinal products to be administered to food-

producing species ,for all the species concerned and for the various foodstuffs concerned

(meat and offal, eggs, milk ,honey), including those for which the withdrawal period is

zero]

[Not applicable for non-food producing animals.

Present by species and/or food components.]

<Withdrawal period:>[as in SPC]

i. Special warning(s), if necessary

[Indicate any particulars essential for safety or health protection, including any special

precautions relating to use and any other warnings.]

<Read the package leaflet before use.> [Unless already included under method and

route(s) of administration or in case of space limitation.]

[For certain products e.g. injectables containing mineral oil or live vaccines, the

following statement should be included:]

<Accidental injection is dangerous – read package leaflet before use>

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<Accidental administration> <contact with the mucosa> is dangerous – see package

leaflet before use>

j. Manufacturing and Expiry dates

Dates should be expressed with the month given as 2 digits or 3 characters and the year

as 4 digits, e.g.: 02/2010, Feb 2010.

Where applicable, the shelf life after reconstitution, dilution or after first opening the

container should be included.

k. Special storage conditions

This section should include a statement of the recommended labeling statements (see

Appendix 1).

• Note: Storage conditions in Arabic language should be added.

l. Specific precautions for the disposal of unused products or waste materials, if any

This section is not required on the immediate label and should include information from

section 6.6 of the SPC in user-friendly wording, e.g. <xx should not be disposed of via

wastewater or household waste.> or <disposal: read package leaflet>.

m. The words “veterinary use only” and the general classification for supply, if

applicable

This section should include the following phrases, if applicable:

- <for veterinary use only> this phrase should be written in RED color.

• <xx to be supplied only on veterinary prescription.>

n. The words “keep out of the reach and sight of children”

This section should include the following phrase “keep out of the reach and sight of

children”. However, this section is not required on the immediate label.

o.Name and address of the marketing authorisation holder

This section should include the town, postal code (if available) and country name of the

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marketing authorization holder (telephone, fax numbers or e-mail addresses may be

included).

{Name and address}

<{tel}>

<{fax}>

<{e-mail}>

p. Marketing authorization number(s)


Authorisation has been granted.]

q. Name and address of the Agent in K.S.A (If any)

This section should include telephone, fax numbers (e-mail addresses may be included) of the

agent

{Name and address}

<{tel}>

<{fax}>

<{e-mail}>

r. Manufacturer’s batch number

<Batch> <Lot> <BN> {number}

2. Minimum requirments to appear on small immediate packaging units

Ampoules, small single-dose containers other than ampoules.

On a case-by-case basis, the minimum particulars could be considered for containers

where it is not feasible to include all the information. Such exceptional cases have to

be justified, discussed and agreed with the SFDA. In case where the space is not

enough to hold the minimum requirments , the information should be provided as a

folded label.

a. Name of the veterinary medicinal product

{(Invented) name of the product Strength Pharmaceutical form <Target

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species>}{active substance(s)}

A clear pictogram of the target animal species might be used to replace mentioning

the target species on the packaging (to be discussed case-by-case).

b. Quantity of the active substance(s)

The active substance(s) should be expressed qualitatively and quantitatively.

c. Contents by weight, by volume or by number of doses

d. Route(s) of administration

e. Withdrawal period

f. Batch number


g. Manufacturing and Expiry dates

Dates should be expressed with the month given as 2 digits or 3 characters and the

year as 4 digits, e.g.: 02/2010, Feb 2010.

Where applicable, the shelf life after reconstitution, dilution or after first opening

the container should be included.

h. The words “veterinary use only”

“veterinary use only” > this phrase should be written in RED color.

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3. Minimum requirments to appear on blisters or strips

a. Name of the veterinary medicinal product

{(Invented) name of the product Strength Pharmaceutical form <Target

species>}


b. Name of the marketing authorization holder

{Name} [Full/short name of the Marketing Authorization Holder]

c. Manufacturing and Expiry dates

Dates should be expressed with the month given as 2 digits or 3 characters and the

year as 4 digits, e.g.: 02/2010, Feb 2010.

d. Batch number


e. The words “for veterinary use only”

“veterinary use only” > this phrase should be written in RED color.

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Appendix 1: Recommended labeling statements

• The statements that should be used if supported by the stability studies for finished

pharmaceutical products (FPPs) are listed in Table 1.

Table 1: Recommended labeling statements for finished pharmaceutical products (FPPs)

Testing condition under which the stability

of the FPP has been demonstrated Recommended labeling statement

30 °C/65% RH (long-term)

40 °C/75% RH (accelerated) “Do not store above 30 °C” *

5 °C ± 3 °C ”Store in a refrigerator (2 °C to 8 °C)”

-20 °C ± 5 °C “Store in freezer”

* “Protect from moisture” should be added as applicable.

• Additional labeling statements that could be used in cases where the result of the

stability testing demonstrates limiting factors are listed in Table 2.

Table 2: Additional labeling statements for use where the result of the stability testing

demonstrates limiting factors

Limiting factors Additional labeling statements, where

relevant

FPPs that cannot tolerate refrigeration “Do not refrigerate or freeze” a

FPPs that cannot tolerate freezing “Do not freeze” a

Light-sensitive FPPs “Protect from light”

FPPs that cannot tolerate excessive heat, e.g.

suppositories “Store and transport not above 30 °C”

Hygroscopic FPPs “Store in dry condition”

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Appendix 2: Additional information that are required to be translated

into Arabic language

A. Information on the outer package (in addition to the information that is provided in the

guidance):

1. Name of the veterinary medicinal product and strength

2. Special storage condition.

3. Only for veterinary use (this phrase should be written in red color).

B. Blister information (in addition to the information that is provided in the guidance):


2. Only for veterinary use (this phrase should be written in red color).

C. Information on the outer package of small containers (less than 100 mL) (in addition to

the information that is provided in the guidance):


2. Special storage condition.

3. Only for veterinary use (this phrase should be written in RED COLOR).

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Appendix 3: Readability of the label and package leaflet

Introduction

The main purpose of this document is to provide guidance on how to ensure that the

information on the labelling and package leaflet is accessible to and can be understood by

users.

This document is written to assist applicants and marketing authorizations holders when

drawing up the labeling and package leaflet and preparing the mock-ups or specimens of

the sales presentations.

A. Recommendations for the package leaflet

General considerations

The package leaflet is intended for the user. If the package leaflet is well designed and

clearly worded, this maximizes the number of people who can use the information.

Companies are encouraged to seek advice from specialists in information design when

devising their house style for the package leaflet to ensure that the design facilitates

navigation and access to information.

The following guidance sets out recommendations on various aspects related to the

preparation of package leaflets. It is aimed at helping applicants/marketing authorization

holders to fully comply with the legal requirements and is based on experience where it

has been shown that using these techniques optimizes the usability of the package leaflet.

1. Type size and font

Choose a font which is easy to read. Stylized fonts which are difficult to read should not

be used. It is important to choose a font in which similar letters/numbers, such as “i”, “l”

and “1” can be easily distinguished from each other. The type size should be as large as

possible to aid readers. A type size of 9 points, as measured in font ‘Times New Roman’,

not narrowed, with a space between lines of at least 3 mm, should be considered as a

minimum.

Consideration should be given to using different text sizes to enable key information to

stand out and to facilitate navigation in the text (e.g., for headings).

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The widespread use of capitals should not be used. The brain recognizes words in written

documents by the word shape, so choose lower case text for large blocks of text. However,

capitals may be useful for emphasis.

Do not use italics and underlining as they make it more difficult for the reader to

recognize the word-shape. Italics, however, may be considered when using Latin terms.

2. Design and layout of the information

The use of “justified” text (that is text aligned to both left hand and right hand margins)

should in principle not be used.

Line spaces should be kept clear. The space between lines is an important factor

influencing the clarity of the text. As a general rule the space between one line and the

next should be at least 1.5 times the space between words on a line, where practical.

Contrast between the text and the background is important. Factors like paper weight,

color of the paper, size and weight of the type, color of the type and the paper itself should

be considered. Too little contrast between the text and the background adversely affects

the accessibility of the information. Therefore, background images should in principle not

be placed behind the text since they may interfere with the clarity of the information

making it harder to read.

A column format for the text can help the reader navigate the information. The margin

between the columns should be large enough to adequately separate the text. If space is

limited a vertical line to separate the text may be used. Related information should be kept

together so the text flows easily from one column to the next. Consideration should be

given to using a landscape layout which can be helpful to users. Where a multi-lingual

package leaflet is proposed there should be a clear demarcation between the different

languages used; all the information provided in each language should be assembled.

3. Headings

Headings are important and can help users navigate the text if used well. Therefore, bold

type face for the heading or a different color, may help make this information stand out.

The spacing above and below the headings should be consistently applied throughout the

leaflet. Same level headings should appear consistently (numbering, bulleting, color,

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indentation, font and size) to aid the reader.

The use of multiple levels of headings should be considered carefully, as more than two

levels may make it difficult for readers to find their way around the leaflet. However,

where complex information has to be communicated multiple levels of headings may be

needed.

Using lines to separate the different sections within the text can also be helpful as a

navigational tool.

4. Print color

Accessibility is not only determined by print size. Characters may be printed in one or

several colors allowing them to be clearly distinguished from the background. A different

type size or color is one way of making headings or other important information clearly

recognizable.

The relationship between the colors used is as important as the colors themselves. As a

general rule dark text should be printed on a light background. But there may be occasions

when reverse type (light text on a dark background) could be considered to highlight for

instance particular warnings. In such circumstances the quality of the print will need

careful consideration and may require the use of a larger type size or bold text. Similar

colors should not be used for the text and background as legibility is impaired.

5. Syntax

Some people may have poor reading skills, and some may have poor health literacy. Aim

to use simple words of few syllables.

Long sentences should not be used. It is better to use a couple of sentences rather than one

longer sentence, especially for new information.

Long paragraphs can confuse readers, particularly where lists of side effects are included.

The use of bullet points for such lists is considered more appropriate. Where possible, no

more than five or six bullet points in a list are recommended.

When setting out the side effects it is particularly important to consider the order in which

they are given so the users may maximize the use of the information. In general, setting

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out the side effects by frequency of occurrence, starting with the highest frequency, is

recommended to help communicate the level of risk to individuals. Frequency terms

should be explained in a way users can understand – for example “very common” (more

than 1 in 10 animals). However, where a serious side effect exists which would require the

user to take urgent action this should be afforded greater prominence and appear at the

start of the section. Setting side effects by organ/system/class is not recommended since

users are in general not familiar with these classifications.

6. Style

When writing, an active style should be used, instead of passive. For example:

-'take 2 tablets' instead of '2 tablet should be taken','

-'you must....' is better than 'it is necessary ...'

When telling users what action to take, reasons should be provided. Instructions should

come first, followed by the reasoning.

“This medicine,…etc.” should be used rather than repeating the name of the product, as

long as the context makes clear what is being referred to.

Abbreviations and acronyms should not usually be used unless these are appropriate.

When first used in the text, the meaning should be spelled out in full. Similarly scientific

symbols (e.g. > or <) are not well understood and should not be used.

Medical terms should be translated into language which users can understand. Consistency

should be assured in how translations are explained by giving the lay term with a

description first and the detailed medical term immediately after. On a case by case basis

the most appropriate term (lay or medical) may then be used thereafter throughout the

package leaflet in order to achieve a readable text. Make sure that the language used alerts

the reader to all relevant information, and gives sufficient detail on how to recognize

possible side effects and understand any action which may be necessary.

7. Paper

The paper weight chosen should be such that the paper is sufficiently thick to reduce

transparency which makes reading difficult, particularly where the text size is small.

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Glossy paper reflects light making the information difficult to read, so the use of uncoated

paper should be considered.

Make sure that when the package leaflet is folded the creases do not interfere with the

readability of the information.

8. Use of symbols and pictograms

The images, pictograms and other graphics can be used to aid comprehension of the

information, but these exclude any element of a promotional nature. Symbols and

pictograms can be useful provided the meaning of the symbol is clear and the size of the

graphic makes it easily legible. They should only be used to aid navigation, clarify or

highlight certain aspects of the text and should not replace the actual text. Evidence may

be required to ensure that their meaning is generally understood and not misleading or

confusing. If there is any doubt about the meaning of a particular pictogram it will be

considered inappropriate.

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B. Recommendations for the labeling

General considerations

Labeling covers both outer packaging and inner packaging. Although inner packaging

may include a lesser set of particulars, many of the principles outlined in relation to outer

packaging will apply equally to the labeling of blister packs or other small package units.

Labeling ensures that the critical information necessary for the safe use of the medicine is

legible, easily accessible and that users of medicines are assisted in assimilating this

information so that confusion and error are minimized.

Those involved in the design of labeling should consider the following sections prior to

submission to the SFDA. The recommendations given in relation to the package leaflet

(section A) may be applicable to labeling and should be borne in mind in designing and

laying out the required information on labels. The particulars appearing on the label of all

medicinal products should be printed in characters of at least 7 points (or of a size where

the lower case "x" is at least 1.4 mm in height), leaving a space between lines of at least 3

mm.

In particular the information presented on small packs will need careful consideration so

that the text is presented in as large a type size as possible to reduce the likelihood of

medication error.

1. Name of the medicine

The full name of the medicinal product, with its strength and its pharmaceutical form, and

the target species should appear on the outer packaging and on the immediate packaging

to aid accurate identification of the medicinal product.

Where the medicinal product contains up to three active ingredients, the international non-

proprietary name (INN)/common name(s) of these active ingredient(s) should be stated

after the full name on the outer packaging and the immediate packaging, unless the

INN/common name(s) is part of the name. The INN should be afforded due prominence

for safety reasons.

2. Strength and total content

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Different strengths of the same medicinal product should be expressed in the same

manner: for example 250 mg, 500 mg, 750 mg, 1000 mg and NOT 1 g. Trailing zeros

should not appear (2.5 mg and NOT 2.50 mg). The use of decimal points (or comma)

should be avoided where these can be removed (i.e. 250 mg is acceptable whereas 0.25 g

is not). For safety reasons it is important that micrograms is spelt out in full and not

abbreviated. However, in certain instances where this poses a practical problem which

cannot be solved by using a smaller type size then abbreviated forms may be used, if

justified and if there are no safety concerns.

3. Route(s) of administration

This should be as stated in the summary of product characteristics (SPC). Negative

statements should not be used: for example “Not for intravenous use”. In principle only

standard abbreviations may be acceptable (i.v., i.m., s.c.).

Other nonstandard routes of administration should be spelled out in full. Some routes of

administration will be unfamiliar to users and may need to be explained within the

package leaflet.

4. Design and layout

Applicants and marketing authorization holders should make best use of the space

available to ensure that the important information is clearly mentioned on prime spaces on

the outer and immediate packaging, presented in a sufficiently large type size. Company

logos and pictograms may be presented, where space permits, on the outer packaging and

on immediate packaging, provided they do not interfere with the legibility of the

mandatory information.

Use of a large type size will be appropriate, although other factors may also be important

in making the information legible. Consideration should be given to the line-spacing and

use of white space to enhance the legibility of the information provided. For some small

packs it may not be possible to present all the critical information in the same field of

view. The use of any innovative technique in packaging design to aid in the identification

and selection of the medicinal product is encouraged. It is also encouraged where space is

at a premium.

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Colors should be chosen to ensure a good contrast between the text and the background to

assure maximum legibility and accessibility of the information. Highly glossy, metallic or

reflective packaging should be avoided, as this affects the legibility of the information.

Different colors in the name of the product are discouraged since they may negatively

impact on the correct identification of the product name. The use of different colors to

distinguish different strengths is strongly recommended.

Similarity in packaging which contributes to medication error can be reduced by the

judicious use of color on the pack. The number of colors used on packs will need careful

consideration as too many colors could confuse. Where color is used on the outer pack it is

recommended that it is carried onto primary packaging to aid identification of the

medicine.

Where a multi-lingual outer and/or immediate packaging is proposed there should be a

clear demarcation between different languages where space permits.

5. Blister pack presentations

For blister pack presentations it is important that the particulars remain available to the

user up to the point at which the last dose is removed. Often it will not be possible to

apply all the information over each blister pocket, consequently where a random display

of the information is proposed it should frequently appear across the pack. In all cases it

will be acceptable to apply the batch number, manufacturing and expiry dates to the end of

the blister strip. If technically possible, applying this information to both ends of each strip

should be considered.

In addition, blister foils should be printed to ensure maximum legibility of the information

using a sufficiently large font.

Color for the text and the font style, should be chosen carefully as the legibility of the text

on the foil is already impaired due to the nature of the material. Where possible, non-

reflective material or colored foils should be considered to enhance the readability of the

information presented and the correct identification of the medicine.

Small containers

Where the labeling particulars cannot be applied in full to the labeling of small containers,

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the minimum particulars could be considered. Other factors may need to be taken into

account such as the amount of information which has to be included and the font size

necessary to ensure the legibility of the information.The criteria for small container status

would normally apply to containers of nominal capacity of 100 ml or less.

Innovative pack design is encouraged where space is at a premium (e.g. the use of wrap-

around or concertina labels). Paper labels are recommended to increase the legibility of the

information applied to, for example, ampoules.

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References

• Guideline on preparation of Summary of Product Characteristics SPC -

Pharmaceuticals for veterinary medicinal products (revision 2 - 07/2006).

• Guideline on preparation of Summary of Product Characteristics SPC -

Immunologicals for veterinary medicinal products (revision 3 - 06/2007).

• Annex III: labelling and package leaflet, European Commission, Version 7.3,

2010.

• Guideline on the readability of the label and package leaflet of medicinal products

for human use, European Commission, 12 January 2009.

http://ec.europa.eu/health/files/eudralex/vol-6/c/spcpharmaceuticals_10-07-2006_en.pdf

http://ec.europa.eu/health/files/eudralex/vol-6/c/spc_immunologicals_rev3_08-06-2007_en.pdf

guidance for presenting the spc, package leaflet and

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