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To all Market Authorization Holders of Medicines,

NMRA is publishing herewith a link to obtrain multisource generic product dossier details having reference country registration pending at NMRA.

Please provide required details on or before 30th June 2024.

Please note that the lists of reference countries were published on the NMRA website.

Click on the link below to submit the details into the Google form.

https://docs.google.com/forms/d/e/1FAIpQLSffLbLw18DJPtPzD_m3_Q4a2NKdadwYhN5rAfh1g_bVlgZqvQ/viewform?usp=sf_link

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CEO / NMRA

All Marketing Authorization Holders of Medicine are here by informed that NMRA has decided to accept medicine applications on 18.06.2024 (Tuesday) due to public holidays on Monday(17.06.2024) and Friday (21.06.2024).

To all Marketing Authorization Holders of Medical Devices,

All Medical Device Marketing Authorizations Holders are hereby informed that NMRA has decided to undertake an action plan to publish the information of all registered manufacturers through an online platform. Therefore, medical device marketing authorization holders whose details are not available in the below list of manufacturing site registration details must enter their information into the link provided.

You must attach a scanned copy of Manufacturing site approval letter or any evidence of manufacturing site registration as an authentication of your registration.

Please provide the required details on or before 31st July 2024.

List of Manufacturing site registration details

Click on the link below to submit the details into the Google form.

https://docs.google.com/forms/d/e/1FAIpQLSewxXglorCe90U1NvjUh8kMtXSUrpz5-IahmNsFAsYwBAolvQ/viewform?usp=sf_link

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Chief Executive Officer
NMRA

You are hereby informed when submitting a request for Waiver Of Registration (WOR) by the SPC, the supplier registration should be completed using the Medical Supply Management Information System (Swastha) of the Ministry of Health.

All Marketing Authorization Holders (MAHs) of Borderline Products are hereby informed that the Borderline Products Regulatory Division has decided to :

  1.  Accept transferred applications that have already been submitted to the Medicines Regulatory Division, whether as new applications, re-registrations, or renewals. The remaining balance for the Borderline Products new registration fee should be paid to proceed with the application.
  2. Accept transferred applications that have already been submitted to the Medical Devices Regulatory Division :
    • For new applications, payment is not required since the new application fee for Medical Devices is same as the Borderline Products new application fee.
    • For renewal applications, the remaining for the Borderline Products new registration fee balance should be paid to proceed with the application.
  3.  Accept transferred applications that have already been submitted as cosmetic products, whether as new applications or renewals. Borderline Products new registration fee should be paid to proceed with the application.

Furthermore, the NMRA has decieded to waive off the process of sample licensing and classification for such transferred applications.

Please contact the Borderline Products Regulatory Division to clarify whether a new dossier should be submitted with the payment. Applications referred from the cosmitcs division must be submitted with a new dossier.

All Marketing Authorization Holders of Borderline products are hereby informed that the processing and file accepting day for borderline Products Regulatory Division will be changed from Monday to Tuesday.

Hereafter the official file accepting day of Borderline products Regulatory Division will be Tuesday of each week.

This will be effective from 04.06.2024 onwards.

Reference National Regulatory Authorities Identified for Market Authorization of Medicines

  1.  Australia - TGA
  2.  Austria - AGES
  3.  Belgium - FAMPH
  4.  Bulgaria - BDA
  5.  Canada - Health Canada
  6.  Croatia - HALMED
  7.  Cyprus - MoH-PHS
  8.  Czech Republic - SUKL
  9.  Denmark - DKMA
  10.  Estonia - SAM
  11.  Finland - FIMEA
  12.  France - ANSM
  13.  Germany - BfARM & PEI
  14.  Greece - EOF
  15.  Hungary - OGYEI
  16.  Iceland - IMA
  17.  Ireland - HPRA
  18.  Italy - AIFA
  19.  Japan - PMDA
  20.  Latvia - ZVA
  21.  Liechtenstein - Office of Health
  22.  Lithuania - VVKT
  23.  Luxembourg - MoH
  24.  Malta - Medicines Authority
  25.  Netherlands - MEB
  26.  Norway - NOMA
  27.  Poland - URPL
  28.  Portugal - INFARMED
  29.  Romania - ANMDMR
  30.  Slovakia - SUKLO
  31.  Slovenia - JAZMP
  32.  Spain - AEMPS
  33.  Sweden - SMPA
  34.  United Kingdom of Great Britain and Northern Ireland - MHRA
  35.  United States of America - USFDA
  36.  European Medicines Regulatory Network

 

Reference National Regulatory Authorities Identified for Market Authorization of Vaccines and New Molecule Entities 

  1.  Australia - TGA
  2.  Belgium - FAMPH
  3.  Canada - Health Canada
  4.  France - ANSM
  5.  Germany - BfArM & PEI
  6.  Italy - AIFA
  7.  Netherlands - MEB
  8.  United Kingdom of Great Britain and Northern Ireland - MHRA
  9.  United States of America - USFDA

To all manufacturers of cosmetics products in Sri Lanka,

This is to inform you that you are requested to obtain the ISO 22716 / 2007 certification for the cosmetics manufacturing plant from the SLSI with effective from 1st of May 2024.

NMRA has decided, not to conduct a Good Manufacturing Practice (GMP) Inspections for cosmetics manufacturing plants further and NMRA will rely on the ISO 22716 GMP certification provided by accredited body SLSI.

Already approved sites will be granted two years grace period until 31st May 2026 to adhere to the process. For the site already applied, NMRA will conduct GMP inspection and those will be required to obtain ISO 22716 within two years from 1st May 2024. For the new applications, applicant should submit a site master file with basic information about the site and the products which are planning to manufacture in the site.

New applications to be submitted to the Manufacturing Regulatory Division NMRA and NMRA will issue an acknowladgement. Applicant should apply for ISO 22716 GMP certification along with the acknowledgement given by NMRA.

CEO / NMRA

All importers of Medicines are hereby informed that, in response to your feedback and to facilitate the process, the National Medicines Regulatory Authority decided to offer an alternative method for submitting import data.

Local agents who find it difficult to submit details via the Google form are hereby instructed to utilize the attached format. Please fill out the details according to the given format in an Excel sheet with the necessary details for each Medicine imported during the mentioned period and send the Excel sheet to This email address is being protected from spambots. You need JavaScript enabled to view it. with the subject line : "Collection of Import Data - Medicines."

Important Note : 

  • Please do not include details of medicines which have already been submitted via the Google Form.
  • Each local agent is requested to submit only one Excel sheet containing the import data for all medicines.

Your corperation in this matter is greatly appreciated.

CEO,

NMRA

120, Norris Canal Road, Colombo 10
 011-2687743
 info@nmra.gov.lk