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2020 |
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Date |
Product |
Manufacturer |
Market authorization holder |
batch /batches |
Remark |
|
15.12.2020 |
Warfarin Tablets BP (All strength) |
Centurion remedies Pvt Ltd, G/5 and G/6, Industrial Estate Gorwa, Vadodara-390016, Gujarat, India |
Yaden International Pvt Ltd |
All batches |
The product withdrawal decision was revoked by the Medicines Evaluation Committee |
|
2021 |
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Date |
Product |
Manufacturer |
Market authorization holder |
batch /batches |
Remark |
|
23.08.2021 |
Bupivacaine HCl in Dextrose Inj USP 5mg/80mg |
Ciron drugs and pharmaceuticals Pvt Ltd,N-118, 119, 113, 119/1, 119/2 &118/1, MIDC, Tarapur, Boisar, Dist.Palghar-401506, India |
Ceyoka Pvt Ltd |
0EB02119 |
batch withholding decision on was revoked based on NMQAL recommendation |
|
10.12.2021 |
Low Calcium (2.5mEq/L) Peritonial Dislysis Solution with Dextrose 1.5%w/v (Peritone) |
Peritone Health Sdn.Bhd, Lot 12, Industrial Zone 4, Kulim Hi-Tech Park, Kedah, Malaysia |
Infuxion Lanka Pvt Ltd |
L10182 L10205C1 L10205C2 |
Batch withholding decision was revoked based on the NMQAL recommendation on 10.12.2021. the decision was changed to discontinue to use containers which show the defect (Leakage) |
|
10.12.2021 |
Low Calcium (2.5mEq/L) Peritonial Dislysis Solution with Dextrose 2.5%w/v |
Peritone Health Sdn.Bhd, Lot 12, Industrial Zone 4, Kulim Hi-Tech Park, Kedah, Malaysia |
Infuxion Lanka Pvt Ltd |
L10202 |
Batch withholding decision was revoked based on the NMQAL recommendation on 10.12.2021. the decision was changed to discontinue to use containers which show the defect (Leakage) |
|
22.11.2021 |
PEG+ Electrolytes Powder for Oral Solution 69g (Klean Prep) |
Helsinn Birex Pharmaceuticals Ltd, Damastown, Mulhuddrt, Dublin 15, Ireland |
Hemas Pharmaceutical Pvt Ltd |
All batches |
The committee met on 22.11.2021 recommended to revoke the product withdrawal decision and initiate withdrawal of affected batches and batches expired in 2022. |
|
2022 |
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Date |
Product |
Manufacturer |
Market authorization holder |
batch /batches |
Remark |
|
15.11.2022 |
Amoxicillin Capsules BP 500mg |
SPMC, Sri Lanka |
HLF02, HLH25 |
batch withdrawal decision was revoked based on NMQAL recommendation |
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2023 |
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Date |
Product |
Manufacturer |
Market authorization holder |
batch /batches |
Remark |
|
03.05.2023 |
Metoprolol Tartrate Tablets BP 50mg |
Centurion remedies Pvt Ltd, G/5 and G/6, Industrial Estate Gorwa, Vadodara-390016, Gujarat, India |
Yaden International Pvt Ltd |
TM-190026 |
batch withholding decision was revoked based on NMQAL recommendation |
- Details
Contact Details
| Designation | Telephone | Fax | |
| Chairman | +94 112 303 156 | This email address is being protected from spambots. You need JavaScript enabled to view it. | |
| Chief Executive Officer |
+94 112 695 173 +94 112 303 072 |
+94 112 689 704 | This email address is being protected from spambots. You need JavaScript enabled to view it. |
| Director / NMQAL | +94 112 687 741 | - | This email address is being protected from spambots. You need JavaScript enabled to view it. |
| Section | Telephone | Extension |
| Regulatory Information Services (RIS) | ||
|
RIS acts as the point of contact for Market Authorization holders and their representatives. (Weekdays 08.30 - 16.00) |
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| Medicine Regulatory Division | +94 112 698 896 | 383/393/311/320 |
| Device Regulatory Division | +94 112 698 896 | 416/315 / 408 |
| Borderline products Regulatory Division | +94 112 698 896 | 415/391/389 |
| Cosmetic Regulatory Division | +94 112 698 896 | 319 / 308 |
| Manufacturing Regulatory Division | +94 112 671 038 | 427 / 420 / 421 |
| Pharmacy Regulatory Division | +94 112 698 896 | 344 |
| Finance Division | +94 112 303 157 | |
| Legal Division | +94 112 303 158 | |
| Law Enforcement Division | +94 112 303 162 | |
| Administrative Officer | +94 112 303 124 | |
- Details
NOTE:- It is mandatory for all applicants to submit,
1). Duly filled relevant application with the updated document list.
2). Duly filled acknowledgement form.
3). Check list marked with the available documents.
(Document list should be marked under availability column of the check list).
| This requirments will be in effective from 15/03/2023 onwards |
- Details
NOTE:- It is mandatory for all applicants to submit,
1). Duly filled relevant application with the updated document list.
2). Duly filled acknowledgement form.
3). Check list marked with the available documents.
(Document list should be marked under availability column of the check list).
| This requirments will be in effective from 15/03/2023 onwards |
- Details
As per regulation 29 of National Medicines (Clinical Trials) regulations 2145/2 of 19th October 2019, no amendments in the approved protocol of clinical trial can be made without seeking prior approval/notification from CTEC and relevant ERC.
Information to be supplied when submitting a protocol amendment;
i. An amended form as may be published in the NMRA web site should be completed.
- ii. A Bold Heading should note that this is an Amendment and the date.
- iii. Each amendment should be BOLD and in a BOX at the relevant position in the text.
- iv. Summary of changes should be submitted in a tabulated format with the authorized signatures.
- v. The amended supporting documents should be appended, including any new relevant publications.
The CTRD will review the application together with supporting documents and will referred to CTEC in its very next meeting for expert review if necessary and consideration for approval of the amendment(s)
(Refer details for processing of amendments – GL-027 Guideline for amendments to clinical trials)
- Details
- An inspection or audit of clinical trial site/s may be conducted by NMRA before or after the approval of a clinical trial.
- The aim of the inspection is to evaluate the acceptability of clinical data submitted to NMRA, and to ensure that legislation, on Good Clinical Practices (GCP) and Good Clinical and Laboratory Practice (GCLP) principles are in place as per the ICH-GCP Guidelines.
- The nominated members from CTEC or responsible officer of NMRA may contact the PI or sponsor for the date of inspection when required.
- However in the case of complaints or reports of unexpected adverse reactions, inspections may take place at short notice or may be unannounced.
- Details
- The CTEC will be responsible for evaluation and approval of the application, considering the reports submitted by reviewer.
- The CTEC may approve or may reject the application and specify the reasons for such rejection.
- If the trial is being approved by the CTEC the decision will be communicated to the applicants in writing, by the NMRA after obtaining the Ethical approval from respective ERC for the trial, by issuing the applicant a “Letter of Authorization”. The period of validity of such letter will be decided by the CTEC/CTRD based on the trial protocol and other relevant details.
- In case of rejection, the applicant may appeal and provide additional information where applicable and whenever required.
- Details
Following timelines will be applicable for the below mentioned regulatory activities regarding the processing of clinical trials application submitted for review;
- Processing of a clinical trial application – 75 days
- Processing of a variation – 35 days(i.e. for amendments requiring NMRA approval)
- Issuing of sample import licences of investigational and Non-investigational products - 7 days
- Details