Informed consent application in accordance with article 10c of directive 2001/83/EC
DRAFT corapporteur preliminary assessment report
<Product name>
International non proprietary name: <INN
Procedure no. EMEA/H/C/<XXX>
Applicant:
CHMP Rapporteur: /CHMP Co-Rapporteur:
PRAC Rapporteur
EMA EPL:
EMA PM:
Start of the procedure:
Date of this report:
Table of contents
1. Recommendation 8
1.1. Executive summary 8
1.2. Introduction 8
1.3. Compliance with GLP, GMP, GCP 8
2. Assessment of Module 1 8
3. Quality 8
3.1.1. Introduction 8
3.1.2. Active Substance 8
3.1.3. Finished Medicinal Product 8
3.1.4. Discussion on chemical, pharmaceutical and biological aspects 9
3.1.5. Conclusions on the chemical, pharmaceutical and biological aspects 9
3.1.6. Recommendation(s) for future quality development 9
4. Non clinical 9
5. Clinical 9
6. Pharmacovigilance system 9
7. Risk management plan 9
8. Summary of product characteristics (SmPC) 9
9. Labelling 9
10. Package leaflet (PL) 9
11. Overall conclusion and risk benefit assessment 9
12. List of questions as proposed by the rapporteur 9
13. Recommendation conditions for marketing authorisation and product information 9
13.1. Proposed list of post-authorisation measures* 9
13.2. Summary of product characteristics (SmPC) 10
13.3. Labelling 10
13.4. Package leaflet (PL) 10
Administrative information
CHMP Co-Rapporteur contact person:
PRAC Rapporteur contact person:
EMA Product Lead:
EMA Procedure Manager: / Name
Tel:
Fax:
Email:
Name
Tel:
Fax:
Email:
Name
Tel:
Fax:
Email:
Name
Tel:
Fax:
Email:
Name
Tel:
Fax:
Email:
Names of the CHMP Rapporteur assessors
(internal and external):
Names of the CHMP Co-Rapporteur assessors
(internal and external):
Names of the PRAC Rapporteur assessors
(internal and external): / Quality
Name(s)
Tel:
Fax:
Email:
Non-clinical
Name(s)
Tel:
Fax:
Email:
Clinical
Name(s)
Tel:
Fax:
Email:
Quality
Name(s)
Tel:
Fax:
Email:
Non-clinical
Name(s)
Tel:
Fax:
Email:
Clinical
Name(s)
Tel:
Fax:
Email:
Name(s)
Tel:
Fax:
Email:
Administrative information
mARKETING AUTHORISATION APPLICATION
Name of the medicinal product:Applicant:
Active substance:
International Non-proprietary Name:
Pharmaco-therapeutic group
(ATC Code):
Therapeutic indication(s):
Pharmaceutical form(s):
Strength(s):
Route(s) of administration:
Packaging:
Package size(s):
rEFERENCE MEDICINAL PRODUCT
Name of the medicinal product:Marketing Authorisation Holder:
Active substance:
International Non-proprietary Name:
Therapeutic indication(s):
Pharmaceutical form(s):
Strength(s):
Route(s) of administration:
Authorised in MS/Community:
Date of initial MA in the EU:
Declarations
The assessor confirms that proprietary information on, or reference to, third parties (e.g. ASMF holder) or products are not included in this assessment, unless there are previous contracts and/or agreements with the third party(ies).
The assessor confirms that reference to ongoing assessments or development plans for other products is not included in this assessment report.
Whenever the above box is un-ticked please indicate section and page where confidential information is located here:
List of abbreviations
1. Recommendation
1.1. Executive summary
1.2. Introduction
1.3. Compliance with GLP, GMP, GCP
2. Assessment of Module 1
Product information
Consultation with target patient groups
Braille
Environmental risk assessment
Pharmacovigilance
Risk management plan
3. Quality
3.1.1. Introduction
3.1.2. Active Substance
General Information
Manufacture, characterisation and process controls
Specification
Stability
Comparability exercise for Active Substance
3.1.3. Finished Medicinal Product
Description of the product and Pharmaceutical Development
Manufacture of the product and process controls
Product specification
Stability of the product
Comparability exercise for Finished Medicinal Drug Product
Adventitious agents
GMO
3.1.4. Discussion on chemical, pharmaceutical and biological aspects
3.1.5. Conclusions on the chemical, pharmaceutical and biological aspects
3.1.6. Recommendation(s) for future quality development
4. Non clinical
5. Clinical
6. Pharmacovigilance system
7. Risk management plan
8. Summary of product characteristics (SmPC)
9. Labelling
10. Package leaflet (PL)
11. Overall conclusion and risk benefit assessment
12. List of questions as proposed by the rapporteur
1.
13. Recommendation conditions for marketing authorisation and product information
13.1. Proposed list of post-authorisation measures*
Post-authorisation measure(s) / Motivation /Proposed post-authorisation measure 1 with proposed classification: / Motivation/Background information on measure, including due date:
1.
Proposed post-authorisation measure 2 with proposed classification: / Motivation/Background information on measure, including due date:
2.
Proposed post-authorisation measure 3 with proposed classification: / Motivation/Background information on measure, including due date:
3.
Proposed post-authorisation measure X with proposed classification: / Motivation/Background information on measure, including due date:
X.
* Classification: Annex II (specific obligations; obligations), RMP
Proposed list of recommendations:
Description of post-authorisation measure(s) /1.
2.
13.2. Summary of product characteristics (SmPC)
13.3. Labelling
13.4. Package leaflet (PL)
Informed consent application in accordance with article 10c of directive 2001/83/ECRev 10.16 / Page 6/6