WHOPAR Guidance for Applicants
(2004; 140 pages)
Table of Contents
View the documentGuidance note to Applicants (Manufacturers) on the compilation of the WHO Public Assessment Report version 1.0 - December 2004
View the documentAppendix 1 - Characteristics of WHOPAR Parts
View the documentAppendix 2 - Documentation to submit together with the initial submission
Close this folderAppendix 3 - Guidance on Package Leaflet, Summary of Product Characteristics and Labelling
View the documentANNEX I - Summary of product characteristics - Word Templates
View the documentANNEX III - Labelling and package leaflet - Word Templates
View the documentANNEX I - Summary of product characteristics - annotated
View the documentANNEX III - Labelling and package leaflet
View the documentAPPENDIX I - Statements for use in Section 4.6 "Pregnancy and lactation" of SPC
View the documentAPPENDIX II - MedDRA terminology to be used in Section 4.8 "Undesirable effects" of SPC
View the documentAPPENDIX III - Standards for required storage standards
View the documentAPPENDIX IV - Terms for batch number & expiry date to be used on outer and/or inner labelling
View the documentConvention to be followed for EMEA-QRD templates
View the documentCompilation of QRD decisions on the use of terms
View the documentCompilation of QRD decisions on stylistic matters in product information
View the documentTables of non-standard abbreviations
View the documentAppendix 4 - Format of the Summary of Product Safety and Efficacy
 

ANNEX I - Summary of product characteristics - annotated

[NOTE: the following are those items of information required by Article 11 of Directive 2001/83/EC, as amended, and current practice in the centralised procedure. This guidance should be read in conjunction with the relevant guidelines that can be found on the EMEA website (See also "Convention" for format and layout): <http://www.emea.eu.int/htms/human/qrd/qrdplt/qrdconventionv6.pdf> in particular the "Guideline on Summary of Product Characteristics" as published by the EC in December 1999:

<http://pharmacos.eudra.org/F2/eudralex/vol-2/C/SPCGuidRev0-Dec99.pdf>

During the evaluation process, applicants may present SPCs for different strengths in one document, clearly indicating with gray shaded titles the strength or presentation to which alternative text elements refer. However, a separate SPC per strength and per pharmaceutical form, containing all pack-sizes related to the strength and pharmaceutical form concerned will have to be provided by the applicant as follows:

-English language version: immediately after adoption of the opinion
-All other language versions: at the latest 40 days after adoption of the opinion (i.e. at the latest after incorporation of Member States comments)]


See also: The new Product Information linguistic review process for new applications in the Centralised Procedure - <http://www.emea.eu.int/pdfs/human/regaffair/554202en.pdf>

1. NAME OF THE MEDICINAL PRODUCT

{(Invented) name of product <strength> <pharmaceutical form>}

[no ® ™ symbols attached here and throughout the text. "tablets" and "capsules" in the plural]

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

[Name of the active substance(s) in the language of the text]

For excipients, see section 6.1.

3. PHARMACEUTICAL FORM

[Include here a description of the visual appearance of the product pharmaceutical form as marketed. Information on appearance of reconstituted parental solution should appear under section 6.6]

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

[Specify, if appropriate, <This medicinal product is for diagnostic use only.> If applicable, results of clinical trials to appear under section 5.1]

4.2 Posology and method of administration

[In case of restricted medical prescription start this section by specifying the conditions. Method of administration: directions for proper use by healthcare professionals or by the patient. Practical details for the patient can be included in the package leaflet, e.g. in the case of inhalers, subcutaneous self-injection. Instructions for preparation are to be placed under section 6.6]

4.3 Contraindications

<Hypersensitivity to the active substance(s) or to any of the excipients <or {residues}>.>

4.4 Special warnings and special precautions for use

4.5 Interaction with other medicinal products and other forms of interaction

4.6 Pregnancy and lactation

[Results from reproduction toxicology to be included under section 5.3 and cross-referenced here, if necessary.]
[For Pregnancy and lactation statements see Appendix I.]

4.7 Effects on ability to drive and use machines

<{Invented name} has <no or negligible influence> <minor or moderate influence> <major influence> on the ability to drive and use machines.> [describe effects where applicable] <No studies on the effects on the ability to drive and use machines have been performed.>
<Not relevant>

4.8 Undesirable effects

[MedDRA frequency convention and system organ class database, see Appendix II ]

4.9 Overdose

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

<No case of overdose has been reported.>

Pharmacotherapeutic group: {group [lowest available level]}, ATC code: {code}

5.2 Pharmacokinetic properties

5.3 Preclinical safety data

<Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction>

<Preclinical effects were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.>

<Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows.>

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

[Each to be listed on a separate line according to the different parts of the product] [Name of the excipient(s) in the language of the text]

6.2 Incompatibilities

<Not applicable> [if appropriate, e.g. for solid oral pharmaceutical forms] <In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.> [e.g. for parenterals]

<This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.>

6.3 Shelf life

6.4 Special precautions for storage

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

[For Storage condition statements see Appendix III ]

6.5 Nature and contents of container

[All pack sizes must be listed. If applicable, add:]

<Not all pack sizes may be marketed.>

6.6 Instructions for use and handling < and disposal>

<No special requirements>

<Any unused product or waste material should be disposed of in accordance with local requirements.> [if applicable, e.g. radiopharmaceuticals, cytostatics.]

7. MARKETING AUTHORISATION HOLDER

{Name and address} [Country name in the language of the text. Telephone, fax numbers, e-mail addresses or websites are not allowed.]

8. MARKETING AUTHORISATION NUMBER(S)

[Item to be completed by the Marketing Authorisation Holder once the Marketing Authorisation has been granted.]

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

[Item to be completed by the Marketing Authorisation Holder once the Marketing Authorisation has been granted or renewed.

The date should correspond to the initial authorisation of the medicinal product concerned. It should not reflect individual presentation approvals introduced via subsequent variations and/or extensions.

Both the date of first authorisation and, if the authorisation has been renewed, the date of the (last) renewal should be stated in the format given in the following example:

Date of first authorisation: 3 April 1985.
Date of last renewal: 3 April 2000.]


10. DATE OF REVISION OF THE TEXT

ANNEX II

A. <MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND>MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE

B. CONDITIONS OF THE MARKETING AUTHORISATION

C. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER >

[Annex II will be completed in English by the EMEA at the time of adoption of the Opinion, and will reflect the manufacturing site(s), legal status, specific obligations and other conditions (if any) as agreed by the CHMP. Therefore, applicants are not to provide the Annex II in the English version of the Annexes as part of a new product application.

Translations of the adopted Annex II in all languages are however to be included in the full set of translated Annexes as provided by the Applicant after Opinion, reflecting the adopted English Annex II. Section C of Annex II is only applicable to Opinions adopted by the CHMP under 'Exceptional Circumstances' and for which Specific Obligations are to be fulfilled by the MAH.]

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND> MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer of the biological active substance(s)

{Name of the manufacturer of the biological active substance(s)}
{Address}

Name and address of the manufacturer responsible for batch release

{Name of the manufacturer responsible for batch release in the EEA}
{Address}

<[In cases where more than 1 manufacturer responsible for batch release is designated: list all and add the following statement:]

The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch>

B. CONDITIONS OF THE MARKETING AUTHORISATION

CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER

<Medicinal product subject to medical prescription.>
<Medicinal product not subject to medical prescription.>
<Medicinal product subject to special medical prescription.>
<Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, 4.2)>

<OTHER CONDITIONS

The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.

[PSURs: Specify requirements only if different from the normal PSUR cycle]

[Vaccines] <Official batch release: in accordance with Article 114 Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.>

[Blood products] <Official batch release: in accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose>

C. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER

The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/risk profile.

<Chemical, pharmaceutical and biological aspects>
<Toxicological and pharmacological aspects>
<Clinical aspects>>

to previous section
to next section
 
 
The WHO Essential Medicines and Health Products Information Portal was designed and is maintained by Human Info NGO. Last updated: December 1, 2019