All Marketing Authorization Holders of Medicine are here by informed that NMRA has decided to accept sample import license applications only for the Medicines which have less than 5 valid regustrations until further notice.
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To all Market Authorization Holders and Manufacturers of Medicines, Medical Devices, Borderline products and Cosmetics.
Hereby inform you all that the processing and file accepting date of Manufacturing Regulatory Division will be changed from Monday to Wednesday. This will be effective from 20.03.2024 onwards.
Hereafter the official file accepting date of the Manufacturing Regulatory Division wil be Wednesday of every week.
CEO/NMRA
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NOTICE 02
Renewal of licences for Retail Pharmacies and Wholesale Establishments due to change of the pharmacist
Please note that the following will be implemented with effect from 01st March 2024.
- Pharmacist interview will be conducted on the same day that the application for the change of pharmacist is submitted to the NMRA.
- The owner of the pharmacy is responsible to arrange a video conference to demonstrate the arrangements and operations of the pharmacy as required by the interview officer during the interview (Please find the internal arrangement checklist below)
- The pharmacist should be present in person to the NMRA for the interview on the same day that the application for the change of pharmacist is submitted to the NMRA.
Upon successful completion of the interview, the applicant is required to make the necessary payment on the day of interview to obtain the renewal license.
Checklist for internal arrangements
- For Retail Pharmacies
| Requirements | Remarks |
| Wheel chair access | Need to be facilitated |
| Patient waiting area | Minimum 3 chairs and water dispenser/water pot |
| Ventilation | Proper Air Condition facility needed |
| Counters | Separate counters available for prescription receiving, dispensing and counseling. Counters should be label |
| Pharmacy Area | Medicine arrangement in shelves according to acceptable method. Labeling preferred |
| Prescription Book | Should be update up to date |
| Temperature Control | Temperature monitors allocate for the room temperature and refrigerator. Allocate Separate temperature charts for the room temperature and refrigerator |
| Expiry Drugs | Facilitate lockable cupboard |
| Floor | Should be clean |
| Lighting | Proper lighting facility |
- For Wholesale Establishments
| Requirements | Remarks |
| Ventilation | Proper Air Condition facility needed |
| Medicine storage | According to acceptable method |
| Stock Control | Traceable system needed |
| Temperature Control | Temperature monitors allocate for the room temperature and refrigerator. Allocate Separate temperature charts for the room temperature and refrigerator |
| Expiry Drugs | Facilitate lockable area |
| Return Drugs | Facilitate demarcated area |
| Recalled Drugs | Facilitate demarcted area |
| Floor | Should be clean. Tertiary packaging should be on pallets not on the floor |
| Lighting | Proper lighting facility |
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Dear Local Agents and Importers,
We have created a Google Form to collect contactable email addresses directly with manufacturers.
Google Form Link:
Click on the above link or scan the QR code to fill the Google Form on or before 31st March 2024
We appreciate your prompt attention to this matter. Thank you for your invaluable support.
Chief Executive Officer / NMRA
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NOTICE TO ALL RETAIL PHARMACIES AND WHOLESALE ESTABLISHMENTS
Group A
It is mandatory to submit an inspection report issued by the area food and drug inspector/ authorized officer along with
- Duly filled renewal application with the updated supportive documents (Please refer web link- https://www.nmra.gov.lk/index.php?option=com_content&view=article&id=662)
- Duly filled acknowledgement form
- Check list marked with available documents
On Monday, Wednesday or Friday to Pharmacy Regulatory Division, NMRA.
Group B
It is mandatory to submit following documents without inspection report directly on Monday, Wednesday or Friday to Pharmacy Regulatory Division NMRA
- Duly filled renewal application with the updated supportive documents (Please refer web link- https://www.nmra.gov.lk/index.php?option=com_content&view=article&id=662)
- Duly filled acknowledgement form
- Check list marked with available documents
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