|
SRILANKA |
|
|
Authority |
Drug Regulation Authority MOH |
|
website |
www.health.gov.lk/ |
|
if any |
|
|
REQUIREMENT FOR PRODUCT REGISTRATION |
|
|
S.No. |
INDEX |
Page# |
|
|
1. |
Name of the Applicant. |
|
|
|
2. |
Address. |
|
|
|
3. |
Status of Applicant. |
|
|
|
4. |
Name of the Drug. |
|
|
|
5. |
Dosage form of the Drug. |
|
|
|
6. |
Formula composition. |
|
|
|
7. |
Main Pharmacological group and ATC – class to which the drug belongings: (e.g. diuretic etc. C 03 CA 01). |
|
|
|
8. |
A certificate of health authorities of the country in which it is produced, confirming that the drug is in use there and the period of use and if not, reasons for not marketing it in the country of origin (Free sale certificate, Certificate according to the W.H.O. Certificate Scheme on Pharmaceutical Products moving in International Commerce – the recommended format should be used). |
|
|
|
9. |
Published reports on controlled clinical trails, establishing the therapeutic efficacy of the drug (Uncontrolled studies would be accepted only if controlled clinical trails are not necessary to prove efficacy). In the case of combination drugs, evidence must be provided to justify the inclusion of all the active constituents in the formulation. |
|
|
|
10. |
Summary of toxicity tests and test for teratogencity indicating the safety of the drug. |
|
|
|
11 |
Data sheet giving the following information: |
|
|
|
|
A |
Pharmacology |
|
|
|
A.1 |
Pharmacological actions |
|
|
|
A.2 |
Mechanism of action (if known) |
|
|
|
A.3 |
Relevant Pharmacokinetic data |
|
|
|
A.4 |
Bioequivalence/Bioavailability data (when necessary) |
|
|
|
B |
Clinical Information |
|
|
|
B.1 |
Indications |
|
|
|
B.2 |
Contraindications |
|
|
|
B.3 |
Precautions |
|
|
|
B.4 |
Warnings |
|
|
|
B.5 |
Adverse effects |
|
|
|
B.6 |
Drug interactions |
|
|
|
B.7 |
Dosage regimen |
|
|
|
B.8 |
Average dose and dose range for adults and children |
|
|
|
B.9 |
Dosing interval |
|
|
|
B.10 |
Average duration of treatment |
|
|
|
B.11 |
Dosage in special situations e.g. renal, hepatic and cardiac insufficiently |
|
|
|
B.12 |
Overdosage |
|
|
|
C |
Pharmaceutical information |
|
|
|
C.1 |
Dosage form and strength |
|
|
|
C.2 |
Description of the product. |
|
|
|
C.3 |
Packing and Package sizes. |
|
|
|
C.4 |
Manufacturing formula |
|
|
|
C.5 |
Manufacture of Product – Complete Manufacturing Master Formula |
|
|
|
C.6 |
Manufacturing process |
|
|
|
C.7 |
Validation of important manufacturing operations. |
|
|
|
C.8 |
Packaging operations |
|
|
|
C.9 |
Quality Control |
|
|
|
C.10 |
Quality control of starting materials (active and inactive) |
|
|
|
C.11 |
Control of intermediate products-in-process control. |
|
|
|
C.12 |
Control of the finished product. |
|
|
|
C.13 |
Information concerning Shelf-life, stability and storage conditions. |
|
|
|
C.14 |
Packing Materials |
|
|
12 |
List of countries in which the drug is approved or registered for sale. |
|
|
|
13 |
A quantity of the raw material of the active ingredient sufficient for its analysis should be submitted along with its certificate of analysis |
|
|
|
14 |
Fully packed samples of the drug in the form that it will be offered for sale should also be sent, to enable analysis of the product. |
|
|
|
15 |
A sample of the labels used on the container should be supplies |
|
|
|
16 |
All data should be submitted in English, organized as this schedule IV, with an Index in a hard file cover in duplicate. |
|
|
toc for srilanka, toc formate for product registration
