Ministry of Health
Central Administration for
Pharmaceutical Affairs
General Registration Department
Department of Biological
Products Registration
‫وزارة الصحة‬
‫اإلدارة المركزية للشئون الصيدلية‬
‫اإلدارة العامة للتسجيل‬
‫إدارة تسجيل المستحضرات الحيوية‬
Code No. CL-RBP-01
Check List for Documents Submit for Registration Dossier
Date of Submission:
Product Name:
Applicant Name:
Applicant Representative:
Biological Registration Specialist:
Prepare 5 separate dossiers as follows
Check
Notes
Dossier I: Core Registration Dossier
First: Administrative data
1
5
Index
Covering letter on applicant head letter signed and stamped by
the registration general manager
Copy of Box approval
Copy of pricing certificate
Copy of Preliminary approval
6
C.D containing all content of the
2
3
4
7
8
9
10
five
dossiers
A certification that all data in the file is true and accurate and
identical to the CD
Authorization letter for the person responsible for
communication on behalf of applicant during the procedure and
this letter should be certified as truly signed
Payment receipt 10000 L.E
Application form for registration of biological medicinal
products.
Signed by the Applicant
Stamped by the applicant
11
(each page)
Composition Certificate
On license holder letter head
Signed by the license holder
Stamped by the license holder
Notarized and Authenticated
Trade name of the product is specified
Dosage form of the product is specified
Page 1 of 13
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Ext.:1330
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Email: biologicals@eda.mohp.gov.eg
Ministry of Health
Central Administration for
Pharmaceutical Affairs
General Registration Department
Department of Biological
Products Registration
‫وزارة الصحة‬
‫اإلدارة المركزية للشئون الصيدلية‬
‫اإلدارة العامة للتسجيل‬
‫إدارة تسجيل المستحضرات الحيوية‬
Code No. CL-RBP-01
Active ingredient (s) with its (their) quantity (ies) per unit dose is (are) specified
inactive ingredient (s) with its (their) quantity (ies) per unit dose is (are) specified
Active & inactive ingredient is specified (in house specification , USP ,EU ,JP ,British pharmacopeia)
The overage should be mentioned
API name is specified (the INN, scientific, pharmacopoeia, common name accompanied by its salt or
hydrate form (if any))
API Manufacturer’s name + Country + City are specified
API manufacturing site address is specified
12
Reference:
The latest version(BNF ,Swiss compendium Rote list, Vidal)
WHO prequalification, FDA, EMA
13
Free sale certificate or CPP issued by Competent Authorities in
Country of Origin
Authenticated
Valid
The Arab Republic of Egypt is mentioned as Importing Country (Optional)
Number of product license is specified
Date of issue is specified
Trade name of the Product is specified (in COO and A.R.E)
Dosage form (s) and Strength (s) are specified.
License Holder (address, city, country) is specified
Role of License Holder is specified
Product marketed in the COO (if not, explain why marketing is lacking?)
Manufacturing site(s) is/are specified, registration for other manufacturing, packing & batch release
site(s) involved in the manufacturing of the product is available (If any)
Good Manufacturing Practice (GMP) of the manufacturer is specified (or in separated certificate if
manufacturing site is not in the same country, it must by valid and authenticated)
Pack Presentation and pack size(s) of the Product is (are) specified (could be as attachment)
Inner leaflet recent modification (could be as attachment)
Active Ingredient(s) by its salt or hydrate form (if any) with its (their) quantity (ies) per unit dose is (are)
specified
Inactive Ingredient(s) with its (their) quantity (ies) per unit dose is (are) specified (could be as
attachment)
Shelf-life of the Product is specified (could be as attachment)
Storage Conditions of the Product is specified (could be as attachment)
SPC or package insert of the product is attached
If the Name of the product may change in Egypt it must by noted or clarified by other letter.
If there are two manufacturing site in the COO it must be clarified which site will be the supplier.
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Ministry of Health
Central Administration for
Pharmaceutical Affairs
General Registration Department
Department of Biological
Products Registration
14
‫وزارة الصحة‬
‫اإلدارة المركزية للشئون الصيدلية‬
‫اإلدارة العامة للتسجيل‬
‫إدارة تسجيل المستحضرات الحيوية‬
Code No. CL-RBP-01
GMP of all the manufacturers involved in the production process
(Manufacturer of active substance, Manufacturer of finished, Manufacturer of solvent, Batch
releaser, primary packager,…….)
Authenticated
Valid
The name of plant by its address should be specified
The date of the last inspection should be specified
The invalidation date should be mentioned
The production lines are specified
15
16
Manufacturing license indicating production lines or equivalent
TSE free certificate (if the product contains magnesium stearate,
lactose, or gelatin derived from animal source)
Original letter from the company mentioning that Product is TSE free and mentioning Countries of
origin of source materials
17
18
19
20
21
22
Copy(s) of the Supplier company letter(s) stating the safety of
substance supplied to the concerned company available
Notarized copy of the certificate of suitability from the concerned
authorities in the country of origin (e.g.: Certification of
Suitability of Monographs of the European Pharmacopoeia)
available
List of the countries where the product is registered & sold,
notarized from the chamber of commerce or its equivalent in the country of origin and certified from the
Egyptian embassy abroad
Company profile (applied once for each company) recieval letter
from CAPA.
Certificates clarifying the relationship between the
manufacturing company, the importing company & the
distributor (for imported products)
i.e Authorization letter or Agency agreement
Certificate of the scientific office ( if scientific office is the
applicant)
mentioning the name of the companies affiliating the scientific office
23
A letter from the manufacturing company in the country of
origin authorizing packaging & registration of product in Egypt
(for bulk products)
24
25
27
Tax Card
Commercial register
Certificate of importers register
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Ext.:1330
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Email: biologicals@eda.mohp.gov.eg
Ministry of Health
Central Administration for
Pharmaceutical Affairs
General Registration Department
Department of Biological
Products Registration
‫وزارة الصحة‬
‫اإلدارة المركزية للشئون الصيدلية‬
‫اإلدارة العامة للتسجيل‬
‫إدارة تسجيل المستحضرات الحيوية‬
Code No. CL-RBP-01
28
Certificate of approval of chamber of medicinal industries (for
local products)
29
Outer label of the Product (for the COO product and the
proposed A.R.E product) 3 original packs and 4 layouts
Trade Name is typed in the same way and style, identical to the CPP or the approved one.
The Pharmaceutical Form is identical to the CPP or the approved one
The Pack Size is identical to the approved by pricing committee
Active ingredients with their quantities are mentioned on the Outer pack, are identical to the CPP or the
approved one, under the trade name
Manufacturer, license holder or any other participant in the manufacturing process, the name, address,
city, country, (phone, Fax, web site) must maintained in addition to the specific logo or trade mark.
The brief indication or the therapeutic class is maintained
Route of administration (in case of (IV, IM. SC, Ia, infusion…) injection, vaginal supp., Rectal supp.,
eye only, ear only, eye/ ear, vaginal or external cream/ ointment)
Special precaution for handling (if any, as Shaking, dilution…)
If the dosage form or the product related to special population (infant, Children, adults)
Different concentration should have different printing color for easier identification
Unit of the dosage form present in the container or box (the priced unit)
The legalized price / unit
Registration Number of Egyptian ministry of health / Year of registration
Batch number is mentioned on the Outer pack
Manufacturing date is mentioned on the Outer pack
Expiry date is mentioned on the Outer pack
In case, the product submitted for export only , export and tender, hospital use (must maintained)
Storage conditions are mentioned on the Outer pack
Contains the warning/ presence of some ingredients (for exp.: Aspartame. Sunset yellow, Benzalkonium
chloride and others) if not mentioned in the package insert (leaflet)
A clarification letter stating that the submitted samples are the COO or for registration purpose only, if
these samples are not intended for the Egyptian market use.
30
Inner Label of the product 3 original labels and 4 layouts
The manufacturer and / or the license holder by their logo should specified
The trade name and strength are specified
Batch number is specified
Manufacturing date is specified
Expire date is specified
31
Package Insert (leaflet) of the Product (for the COO product and
the proposed A.R.E product) 2 original and 2 word copies
On Company letter-head
Page 4 of 13
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Email: biologicals@eda.mohp.gov.eg
Ministry of Health
Central Administration for
Pharmaceutical Affairs
General Registration Department
Department of Biological
Products Registration
‫وزارة الصحة‬
‫اإلدارة المركزية للشئون الصيدلية‬
‫اإلدارة العامة للتسجيل‬
‫إدارة تسجيل المستحضرات الحيوية‬
Code No. CL-RBP-01
Contains the Composition of the product {Active ingredient(s) with quantity(ies) }
Contains list of the Inactive ingredient(s)
Contains the Pharmaceutical Form (s)
Contains Storage Conditions
The Storage Conditions are identical to the one available in the file & identical to the one mentioned on
the outer pack and inner pack
Powder for reconstitution: The Storage Conditions before reconstitution and after reconstitution are
mentioned in the insert.
All Pack size (s) is (are) mentioned
Manufacturer and License holder full name and address are mentioned
Package insert reference no. and date of issue/revision are available
32
33
Reference for the insert (innovator insert)
Declaration letter that the submitted insert is the most updated
and is the one marketed in the COO
Second: Ingredients & packaging materials
34
A) Active ingredients:
Specifications of the active ingredients and the relevant tests.
Justification of Specification
35
Certificate of Analysis
Original & Signed by the Company or the concerned center or laboratory that held the analysis
Stamped by the Company or the concerned center or laboratory that held the analysis
Product name, strength and form are specified
Manufacturing date is specified
Expiry date is specified
Batch number is specified
36
37
38
39
Methods of analysis and validation (soft copy only)
Supplier name & origin
b) Excipients:
Specifications of the inactive ingredients and the relevant tests.
Certificate of Analysis
Signed by the Company or the concerned center or laboratory that held the analysis
Stamped by the Company or the concerned center or laboratory that held the analysis
Product name, strength and form are specified
Manufacturing date is specified
Expiry date is specified
Batch number is specified
40
41
Methods of analysis and validation (soft copy only)
Supplier name & origin
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Email: biologicals@eda.mohp.gov.eg
Ministry of Health
Central Administration for
Pharmaceutical Affairs
General Registration Department
Department of Biological
Products Registration
42
‫وزارة الصحة‬
‫اإلدارة المركزية للشئون الصيدلية‬
‫اإلدارة العامة للتسجيل‬
‫إدارة تسجيل المستحضرات الحيوية‬
Code No. CL-RBP-01
d)Packaging material:
Type of packaging materials.
Specifications of packaging materials.
Supplier name & origin
43
44
Third: Finished product
Specifications of the finished product and the relevant tests
Certificate of Analysis of finished products
Signed by the Company or the concerned center or laboratory that held the analysis ( Authenticated
and Notarized)
Stamped by the Company or the concerned center or laboratory that held the analysis
Product name, strength and form are specified
Manufacturing date is specified
Expiry date is specified
Batch number is specified
45
46
49
Methods of analysis and validation (soft copy only)
Supplier name & origin of finished products
If the materials entering in the product formulation are from
blood derivatives , the following will be presented besides the
previous: (47-50)
Official certificates declaring plasma source
HV-1,HV-2,HBsAG,HCV freedom certificate for the plasma
Flow chart indicating sites and steps of product manufacture.
50
Certificate of release from Health authority
51
Method of manufacture including in process control & validation
(soft copy only)
47
48
Manufacturing Process Development
Manufacturer (s) (Name, address, responsibility of each manufacturer including contractors, and each
proposed production site or facility involved in manufacturing and testing should be provided)
Information should be provided on the manufacturing process, which typically starts with a vial(s) of the
cell bank, and includes cell culture, harvest(s), purification and modification reactions, filling, storage
and shipping conditions.
Controls of critical steps and intermediates (Tests and acceptance criteria performed at critical steps of
the manufacturing process to ensure that the process is controlled should be provided)
52
53
Site master file (soft copy only)
Description of cold chain maintenance procedure
Page 6 of 13
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Ext.:1330
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Email: biologicals@eda.mohp.gov.eg
Ministry of Health
Central Administration for
Pharmaceutical Affairs
General Registration Department
Department of Biological
Products Registration
‫وزارة الصحة‬
‫اإلدارة المركزية للشئون الصيدلية‬
‫اإلدارة العامة للتسجيل‬
‫إدارة تسجيل المستحضرات الحيوية‬
Code No. CL-RBP-01
Dossier II: Stability Studies of The Finished
Product
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
Submitted to stability
department
Authorization letter for the person responsible for
communication on behalf of applicant during the procedure and
this letter should be certified as truly signed
Copy of the Preliminary approval
Composition Certificate (5 copies)
Copy of the Free sale certificate or CPP issued by Competent
Authorities in Country of Origin
Stability summary sheet (on website in stability committee)
Stability report
Certificate of Analysis of finished product
Stability decision (3 copies) (on website in stability committee)
stability report (on website in stability committee)
Certificate of the lab where the stability studies id done ( for local
products)
Declaration of responsibility on the storage conditions
C.D containing all content of the stability dossiers
Letter (on company head letter) confirm the all the documents
inside the C.D is identical to stability dossier (use the form on the
website)
NORCB analysis report (if issued)
stability study (every paper should be stamped)
M.O.A of active substance in the finished product
Validation of the M.O.A of active substance in the finished
product
Declaration if the product is multi or single dose i.e immediate
use or there is stability after opening
Description of the packaging material
Dossier III: Inspection Dossier
1
Site master file (stamp each paper)
Covering letter from the License holder declaring that the submitted SMF is the most updated and
approved signed, stamped and Authorized
2
Active substance master file
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Ministry of Health
Central Administration for
Pharmaceutical Affairs
General Registration Department
Department of Biological
Products Registration
3
4
5
6
7
‫وزارة الصحة‬
‫اإلدارة المركزية للشئون الصيدلية‬
‫اإلدارة العامة للتسجيل‬
‫إدارة تسجيل المستحضرات الحيوية‬
Code No. CL-RBP-01
GMP of all the manufacturers involved in the production process
(Active substance, Manufacturer of finished, Manufacturer of solvent, Batch releaser, primary
packager,…….)
Manufacturing license indicating production lines
Copy of CPP of the product
Manufacturing process for Active substance and Finished
product
CD contains all contents the Inspection dossier
Dossier IV: Quality Dossier
1
Copy of application form for biological products
2
Copy of composition
Copy of Preliminary approval
a)Active ingredients:
Specifications of the active ingredients and the relevant tests.
3
4
Justification of Specification
5
Certificate of Analysis
Signed by the Company or the concerned center or laboratory that held the analysis
Stamped by the Company or the concerned center or laboratory that held the analysis
Product name, strength and form are specified
Manufacturing date is specified
Expiry date is specified
Batch number is specified
6
7
8
9
Methods of analysis and validation
Supplier name & origin
b)Excipients:
Specifications of the Excipients and the relevant tests.
Certificate of Analysis
Signed by the Company or the concerned center or laboratory that held the analysis
Stamped by the Company or the concerned center or laboratory that held the analysis
Product name, strength and form are specified
Manufacturing date is specified
Expiry date is specified
Batch number is specified
10
11
12
Methods of analysis and validation
Supplier name & origin
c)Packaging material:
Type of packaging materials.
Page 8 of 13
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Ext.:1330
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Email: biologicals@eda.mohp.gov.eg
Ministry of Health
Central Administration for
Pharmaceutical Affairs
General Registration Department
Department of Biological
Products Registration
‫وزارة الصحة‬
‫اإلدارة المركزية للشئون الصيدلية‬
‫اإلدارة العامة للتسجيل‬
‫إدارة تسجيل المستحضرات الحيوية‬
Code No. CL-RBP-01
Specifications of packaging materials.
Supplier name & origin
13
d)Finished product:
General Information
Nomenclature (as INN, compendial name if relevant, chemical Name,…)
Structure (Structural formula, relative & absolute stereochemistry, Molecular formula,..).
Biotech :
The schematic amino acid sequence indicating glycosylation sited or post translational modifications.
General Properties (Physicochemical and other relevant properties)
14
15
Specifications of the finished product and the relevant tests
Certificate of Analysis of finished products
Signed by the Company or the concerned center or laboratory that held the analysis
Stamped by the Company or the concerned center or laboratory that held the analysis
Product name, strength and form are specified
Manufacturing date is specified
Expiry date is specified
Batch number is specified
16
Methods of analysis and validation of finished product
Validation information including experimental data used to test drug substance)
17
18
Supplier name & origin of finished products
Summary protocol
19
Pre-clinical data (soft copy only)
20
Clinical data (Soft copy only)
21
CD contains all contents the Quality dossier
Submitted to
biologicals
scientific
committee team
Dossier V: Scientific Committee Dossier
1
2
3
4
5
6
Covering Letter to Biological Manager (signed and stamped on
company Letter head)
List of countries where the product is being registered and
marketed indicating the registration number & date in each
country
Copy of CPP in addition to SPC
Copy of reference(BNF 61,Vidal,Swiss Compendium, Rote liste)
Copy of certificate of composition
Product insert
Page 9 of 13
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Ext.:1330
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Ministry of Health
Central Administration for
Pharmaceutical Affairs
General Registration Department
Department of Biological
Products Registration
7
8
9
10
11
12
‫وزارة الصحة‬
‫اإلدارة المركزية للشئون الصيدلية‬
‫اإلدارة العامة للتسجيل‬
‫إدارة تسجيل المستحضرات الحيوية‬
Code No. CL-RBP-01
Box Approval
Approved or suggested price (signed and stamped on company
letter head)
Plasma Master file, PMF approval from health authority and
viral inactivation,certificate of release from health
authority,certificate of analysis (plasma derived product as active
or excipient)
Clinical overview (Hard copy)
Pharmacoeconomic studies for new active substances
CD containing Module 2,Module4,Module5 and contents of all
the Scientific dossier
PV requirements (2CD containing the following)
13
14
15
16
17
18
Covering letter to EPVC manager (signed and stamped on
company letter head)
The latest periodic safety update report (PSUR) in PBRER
format covering at least the last 3 years,separate PSURs covering
at least the last 3 years or addendum to clinical overview
The Most Updated "EU-Risk Management plan=Global RMP"
of the product –in case of imported products
The Egyptian display of EU-EMP
Pharmacovigillence System Master file (PSMF)/Summary PSMF
of the global MAH-in case of imported products
Pharmacovigillence system of the applicant in Egypt in case of
- If Applicant is the MAH local office submit
(PSSF/summary PSSF)
- If Applicant is an agent submit (PSMF/summary PSMF)
Quality Overall Summary
Introduction
Drug substance
General Information
Manufacture
Characterization
Control of Drug Substance
Reference Standards or Materials
Container/Closure System
Stability
Drug Product
Page 10 of 13
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Ext.:1330
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Email: biologicals@eda.mohp.gov.eg
Ministry of Health
Central Administration for
Pharmaceutical Affairs
General Registration Department
Department of Biological
Products Registration
‫وزارة الصحة‬
‫اإلدارة المركزية للشئون الصيدلية‬
‫اإلدارة العامة للتسجيل‬
‫إدارة تسجيل المستحضرات الحيوية‬
Code No. CL-RBP-01
Description and Composition of the Drug Product
Pharmaceutical Development
Manufacture
Control of Excipients
Control of Drug Product
Reference Standards or Materials
Container/Closure System
Stability
Appendices
Facilities and Equipment
Adventitious Agents Safety Evaluation
Novel Excipients
Regional Information
Nonclinical Overview
Overview of the Nonclinical Testing Strategy
Product Development Rationale
Overview of Biopharmaceutics
Overview of Clinical Pharmacology
Overview of Efficacy
Overview of Safety
Benefits and Risks Conclusions
References
Non clinical written and tabulated summaries: Pharmacology, pharmacokinetics, Toxicology
Introduction
Pharmacology Written Summary
Brief Summary
Primary Pharmacodynamics
Secondary Pharmacodynamics
Safety Pharmacology
Pharmacodynamic Drug Interactions
Discussion and Conclusions
Tables and Figures
Pharmacology Tabulated Summary
Pharmacokinetics Written Summary
Brief Summary
Methods of Analysis
Absorption
Page 11 of 13
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Ext.:1330
Fax: +202 - 23684194
Email: biologicals@eda.mohp.gov.eg
Ministry of Health
Central Administration for
Pharmaceutical Affairs
General Registration Department
Department of Biological
Products Registration
‫وزارة الصحة‬
‫اإلدارة المركزية للشئون الصيدلية‬
‫اإلدارة العامة للتسجيل‬
‫إدارة تسجيل المستحضرات الحيوية‬
Code No. CL-RBP-01
Distribution
Metabolism (interspecies comparison)
Excretion
Pharmacokinetic Drug Interactions
Other Pharmacokinetic Studies
Discussion and Conclusions
Tables and Figures
Pharmacokinetics Tabulated Summary
Toxicology Written Summary
Brief Summary
Single-Dose Toxicity
Repeat-Dose Toxicity
Genotoxicity
Carcinogenicity
Reproductive and Developmental Toxicity
Local Tolerance
Other Toxicity Studies (if available)
Discussion and Conclusions
References
Toxicology Tabulated Summary
Clinical Summary
Summary of Biopharmaceutic and Associated Analytical Methods
Background and Overview
Summary of Results of Individual Studies
Comparison and Analyses of Results Across Studies
Appendix
Summary of Clinical Pharmacology Studies
Background and Overview
Summary of Results of Individual Studies
Comparison and Analyses of Results Across Studies
Special Studies
Appendix
Summary of Clinical Efficacy
Background and Overview of Clinical Efficacy
Summary of Results of Individual Studies
Comparison and Analyses of Results Across Studies
Study Populations
Page 12 of 13
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Ext.:1330
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Email: biologicals@eda.mohp.gov.eg
Ministry of Health
Central Administration for
Pharmaceutical Affairs
General Registration Department
Department of Biological
Products Registration
‫وزارة الصحة‬
‫اإلدارة المركزية للشئون الصيدلية‬
‫اإلدارة العامة للتسجيل‬
‫إدارة تسجيل المستحضرات الحيوية‬
Code No. CL-RBP-01
Comparison of Efficacy Results Across All Studies
Comparison of Results in Sub-Populations
Analysis of Clinical Information Relevant to Dosing Recommendations
Persistence of Efficacy and/or Tolerance Effects
Appendix
Summary of Clinical Safety
Exposure to the Drug
Overall Safety Evaluation Plan and Narratives of Safety Studies
Overall Extent of Exposure
Demographic and Other Characteristics of Study Population
Adverse Events
Analysis of Adverse Events by Organ System or Syndrome
Narratives
Clinical Laboratory Evaluations
Vital Signs, Physical Findings, Observations Related to Safety
Safety in Special Groups and Situations
Intrinsic Factors
Extrinsic Factors
Drug Interactions
Use in Pregnancy and Lactation
Overdose
Drug Abuse
Withdrawal and Rebound
Effects on Ability to Drive or Operate Machinery or Impairment of Mental Ability
Post-Marketing Data
Appendix
References
Synopses of Individual Studies
Page 13 of 13
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