Announcements

The National Medicines Regulatory Authority (NMRA) announces a final grace period for the registration of all currently operating unlicensed pharmacies.

Final Grace Period Announcement

Grace Period: From April 1, 2025, to July 1, 2025

1. The valid period of Classification Report is one year and the valid period is counted from approval date of the Classification Report ("Classified as a Borderline Product").

Only two additional data submissions are allowed for one Classification Application.

If a Classification Report is issued as a "awaiting additional data" for a new application;

• First additional data submission to be done within the three months from the date of first Classification Report issued.
• Second additional data submission to be done within three months from the date of second Classification Report issued

2. Sample Import Licence/ Formulation Approval

Sample Import Licence/ Formulation Approval requesting application to be submitted to NMRA within one year period from the date of approval of the Classification Report classified as a Borderline Product.

The valid period of Sample Import licence/ Formulation approval application is one year

3. Registration Dossier Submission.

Registration dossier to be submitted within the valid period of the Sample Import Licence/Formulation Approval.

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Notes:

If any applicant is failed to submit any of the above applications (1,2 & 3) within the valid period is subjected to reject the consignment clearance approval.

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Notice to all Authorized Local Agents,

This is to kindly inform all authorized local agents that, as discussed with the members of the SLCPI and the Pricing Committee, the NMRA will consider the average dollar rate of the previous three months for price approvals of Maximum Retail Prices (MRPs) of medicines from January 2025 onwards.

Accordingly for the month of March 2025, the corrected United States Dollar (USD) rate considered for pricing calculation is 298.01 for reviewing price details of medicines. All the prices recommended by using prevously published exchange rate, shall be recalculated and corrected.

We are apologizing for the inconvenience occurred on this.

This decision aims to ensure fair and consistent pricing of medicines while considering the fluctuations in the exchange rate. Please ensure that all price submissions for MRP approvals are prepared accordingly.

The National Medicines Regulatory Authority hereby announces the temporary withhold of accepting new retail pharmacy applications, with effective from 1st April 2025.

For the information of all marketing authorization holders;

The Pricing Division will hold a Public Day for local agents to discuss matters related to pending Applications on Thursday, 20th March 2025, at 10:00 AM. To participate, please schedule an appointment by entering your details in the book available with the Security Officer on the 2nd Floor.

Current issues related to the products coming under the category of borderline products;

A. Classification application submission and customs release for the products which may come under the borderline product category

As per the NMRA Act, since 2016, the Borderline Product Regulatory Division has being continuously involved in the product registration. Majority of importers have brought such products to the country without obtaining the product registration from NMRA and recently Sri Lanka Customs introduced an online platform called as ASYCUDA SYSTEM to release the products linking with other relevant government regulatory bodies.

Once introducing this ASYCUDA SYSTEM, many importers were unable to release their products through the system due to unavailability of product registration. As a result of, it creates a gap between a regulatory perspectives and continuation of market field causing an accumulation of goods at Sri Lanka Customs.

For this matter following solutions were proposed:

1. Products release through the ASYCUDA SYSTEM only;

Products that fall under the borderline category will be released only through the ASYCUDA system, and registration is a mandatory requirement. However, a deadline was proposed for the classification applications submission: April 30, 2025 to release the product through the ASYCUDA system without the product registration (Classification application submission is mandatory ) and the consignments could be released until 31, October 2025

2. Normal registration approval process will be effective for the applications submitted from May 1, 2025, and product release will be conducted through the ASYCUDA system only for the registered products.

3. Anyhow during the registration process (including the classification step) if any product is rejected, the consignment clearance will be discontinued (for 1 & 2).

4.For consideration of custom clearance of a product, it is mandatory to upload the acknowledgment form/s of application submission (Classification, Sample Import license and Registration Dossier) 3. Offence against the misleading/incorrect information found in a product:

5.Offence against the misleading/incorrect products;

Any misleading/incorrect information (related to a product) in an advertisement, on the label, PIL, packaging materials or in any other manner will be punishable offence under the requirements of the NMRA Act, No. 5 of 2015.

B. Publication of new guideline related in borderline products

A guideline will be published in due course for the following list of products, including TUL(Tolerable Upper Levels), Minimum, and Maximum levels. Once the guideline is published, adherence to the guideline will be required for the continuation of product registration

List of ingredients :Fluoride, Probiotics, Chondroitin, D-Mannose, Alpha-lipoic acid (ALA),Choline, Glucosamine, Co-enzyme Q10, Inositol, Omega 3 (EPA +DHA), Omega 6 (gamma Linoleic acid), Taurine, N-Acetyl cysteine, Methyl Sulphonyl Methane (MSM), N-Acetyl L-tyrosine, Vitamin K2, Phosphatidycholine (Lecithin), Carnitine and Boron

C. Export only products;

Export only products will not be considered for product registration under the category of borderline products.

Exceptions: product registration in reference NRAs

D. Model label for registered borderline products

A sticker or label on the commercial pack will be mandatory for all registered borderline products, with effective from August 31, 2025.

Model label:

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Notice to all Authorized Local Agents

Subject : Consideration of Average Dollar Rate for Price Approvals of MRP’s by NMRA

This is to kindly inform all authorized local agents that, as discussed with the members of the SLCPI and the Pricing Committee, the NMRA will consider the average dollar rate of the previous three months for price approvals of Maximum Retail Prices (MRPs) of medicines from January 2025 onwards.

Accordingly for the month of March 2025, the United States Dollar (USD) rate is considered as 297.27 for reviewing price details of medicines.

This decision aims to ensure fair and consistent pricing of medicines while considering the fluctuations in the exchange rate.

Please ensure that all price submissions for MRP approvals are prepared accordingly.

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Please be informed that all pharmacies-related regulatory activities done by the NMRA, including applications accepting, responsible pharmacists' interviews and issuing payment vouchers will be carried out only on Mondays, Wednesdays and Fridays from 8.30 am to 2.00 pm with effect from 2025/03/01.

Notice to all Authorized Local Agents

Subject : Consideration of Average Dollar Rate for Price Approvals of MRP’s by NMRA

This is to kindly inform all authorized local agents that, as discussed with the members of the SLCPI and the Pricing Committee, the NMRA will consider the average dollar rate of the previous three months for price approvals of Maximum Retail Prices (MRPs) of medicines from January 2025 onwards.

Accordingly for the month of February 2025, the United States Dollar (USD) rate is considered as 296.74 for reviewing price details of medicines.

This decision aims to ensure fair and consistent pricing of medicines while considering the fluctuations in the exchange rate.

Please ensure that all price submissions for MRP approvals are prepared accordingly.

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The colour code for Prednisolone Tablets 1 mg is Yellow.

No new products are registered and no existing products are renewed for Lomefloxacin Eye Drops as there is no advantage due to this is a second generation antibiotic.

All marketing authorization holders having valid registrations for Lomefloxacin Eye Drops are informed to submit the registration certificate along with the import license / manufacturing license for the product on or before 28th February 2025.

Download - From: F-MC-002

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Download - From: F-MC-001

For the information of all marketing authorization holders;

The pricing Division will hold a public Day for local agents to discuss matters tp pending Applications on Friday 17^th January 2025,at 9.30 A.M. To participate, please schedule an appointment by entering your details in the available with the Security Officer on the 2^nd Floor.

Applying Sample Import License of Medicines 

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 registrations until further notice. 

All marketing authorization holders are required to provide a copy of the medicine  database from the NMRA website as evidence for the 5 valid registrations. 

Categories of Sample Import License Applications 

1. Sample Import Licenses – Normal 

This category applies to sample Import License applications received along with the  purpose of “examination”. 

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2. Sample Import Licenses – Other 

 Applications submitted with following purposes 

- Test/Analysis ( Based on medicine evaluation sheet / *Acknowledgment  of medicine dossier) 

- Distribution as physician samples 

- Tender samples ( Requested by government institutes) 

*Acknowledgment of medicine dossier submission for medicine which are  mandatory to tested.(Merophenam, Thyroxine and Erythromycin)  

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3. Sample Import Licenses - Agency Transfer 

- This category applies only to sample import license applications with an agency  transfer.(Only change of the market authorization holder of Sri Lanka without changing  generic name, brand name and manufacturing facility of the product) 

- The product must have been registered by the previous market authorization holder, with  valid registration or registration expired within the last two years from the submission  date of SIL application.

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Sample Import License Application Requirements: 

Mandatory Documents: 

1. Part A of Form MR001 Revision 01 

2. Sample License Application Form (Form XI) 

Should comply with the Regulation 59(1) of the gazette No. 2145/1 and following should be  included) 

∙ Actual manufacturing site address 

∙ Importer with the address 

∙ Correct generic name dosage from and strength 

∙ Brand name (if any) 

∙ Requested quantity 

∙ Pack size & Pack type 

(Purpose of applying SIL should be correctly selected and originally signed by the applicant.) 

3. Copy of Manufacturing Site Approval Letter 

4. Letter of Authorization from the Manufacturer 

5. Price Details 

6. Other Supporting Documents (if applicable): 

• Previous Registration Certificate (Mandatory for SIL Agency Transfer and existing product). 
• Agency Transfer (Mandatory for SIL Agency Transfer). 
• MEC Approval Letter for New Molecular Entities. 
• Declaration Letter for import samples from other category (Mandatory for SIL - Other). 

*Other Regulatory Compliance Documents as applicable

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Only 7's, 14's and 21's pack sizes are allowed to be registered for Ribociclib Tablets.

No new products are registered and no existing products are renewed for Aceclofenac Sustained Release Capsule 200 mg.

No new products are registered and no existing products are renewed for pharmaceutical products except topical pharmaceutical preparations containing Bronopol as an excipient.

No new products are registered and no existing products are renewed for combination skin pharmaceutical preparations containing Corticosteroid + Zinc Sulphate.

Notice to All Authorized Local Agents

This is to kindly inform all authorized local agents that, as discussed with the members of the SLCPI and the Pricing Committee, the NMRA will consider the average dollar rate of the previous three months for price approvals of Maximum Retail Prices (MRPs) of medicines from January 2025 onwards.

Accordingly for the month of January 2025, the United States Dollar (USD) rate is considered as 298.58 for reviewing price details of medicines.

This decision aims to ensure fair and consistent pricing of medicines while considering the fluctuations in the exchange rate.

Please ensure that all price submissions for MRP approvals are prepared accordingly.

For the information of all marketing authorization holders and local manufacturers,

From 1st January 2025 onward, all import data for pharmaceuticals and manufacturing data from all local manufacturers must be submitted in the specified "Pharmaceutical import / consignment data submission format", along with the soft copies, to Market Control Division of the NMRA.

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Web Notice of the changes of Foreign Manufacturing Plant Approval Process from 01/01/2025

Please be informed that National Medicines Regulatory Authority will accept applications for registration of foreign manufacturing sites with following GMP approvals until further notice.

1. PIC/s Approved (Pharmaceutical Inspection Co-operation Scheme)
2. EU GMP Approved (European Union Good Manufacturing Practices)
3. WHO Prequalified or WHO approved. (Inspection should be done by WHO team)

This decision will be implemented with the effect from 01/01/2025

This temporary measure is implemented to maintain a high standard of quality and safety of medicines imported to Sri Lanka and to apply reliance regulatory approach recommended by WHO.

Please note that any manufacturing site with unregistered products and without above GMP approvals will be considered case by case. The requests should be submitted to CEO, NMRA in this regard. All such requests will be subjected to manufacturing peer review committee for consideration.

This decision is only applicable for medicines manufacturing sites applications.

Although all skin preparations containing a combination of a potent steroid and an antifungal are not allowed to be registered in Sri Lanka , the NMRA deiced allowing to market only the remaining stock of such products in the market . New consignments will strictly not be allowed .

Note : The potency of the steroid is considered as per the Topical corticosteroid preparation potencies classification in the BNF .

For the information of all marketing authorization holders;

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Borderline files accepting date will be held on 26th November (Tuesday) 2024 due to an unavoidable reason. [Only for this week]

From December onwards borderline file accepting date will be held on Thursday as usual.

The pricing Division will hold a Public Day for local agents to discuss matters related to pending application on Friday, 22nd October 2024,at 10:00 AM. To participate, please schedule an appointment by entering your details in the book available with the Security Officer on the 2nd Floor.

Consignment clearance approval for the products that may come under the category of borderline will not be granted with the effect from 30th November 2024.

(Date: 08 November 2024)

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To all MAH of Medicines,

In our ongoing efforts to ensure transparency within the National Medicines Regulatory Authority (NMRA), we are implementing a new procedure for accessing the Google sheet titled "Reviewing Status of New Medicinal Products" available on the NMRA website.

To facilitate this, we kindly request each company to provide one email address that will be used to access the aforementioned Google sheet by scanning and filling the below QR code on or before 20th of November 2024. This step is crucial for maintaining a streamlined and secure review process.

Your cooperation in this matter is highly appreciated.

https://docs.google.com/forms/d/e/1FAIpQLSdJfGjk9NJ-qkW-OD-lXgh1KwHoqVXpTJp-TWj1oGM1jbV9gQ/viewform?usp=sf_link

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CEO 
NMRA

Cefuroxime injection 1000 mg is not accepted for registration under "Need" clause.

All skin preparations containing a combination of a potent steroid and an antifungal are not allowed to be registered in Sri Lanka. All the certificates of such combinations should be returned to the NMRA before 04th of November 2024 and all available products in the market should be recalled by the relevant marketing authorization holders within 30 days from 28th October 2024.

Multivitamin & Multimineral products having amount more then or equal to therapeutic level as per the BNF for at least one are considered for registration under Medicines.

Apply wording "NMRA approved" for registered borderline products

To inform all marketing authorization holders of bordering products to print or place a non-peelable sticker on each commercial pack indicating the wording ' NMRA approved' and the details of market authorization holder with effect from 1st November 2024.

• Notice on Labeling Requirement

(Date: if applicable)

All marketing authorization holders of borderline products are here by informed that NMRA has decided to change the accepting date for borderline products from Tuesday to Thursday. (Effective from 24/10/2024)

(Date: 11^th June 2024)

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This applies for local manufacturers only

For initial registration

Comparative Dissolution study data should be submitted according to the WHO guidelines for Comparative Dissolution or Biowaiver. The comparator for the dissolution study should be decided in consultation with the NMRA.

At the end of the Provisional Registration period, for conversion from provisional Registration to Full Registration.

1. BCS Class I & III excluding narrow therapeutic index and modified release a Biowaiver study report should be submitted according to the WHO Biowaiver guideline.
2. BCS Class II & IV, narrow therapeutic index and modified release drug products a bioequivalence study should be submitted for Full Registration.
3. If a Bioequivalence study is not available for products in point 2, a commitment letter with evidence will be accepted for continuation of Provisional Registration.

Rolling Provisional Registration is granted for a maximum of four year within which a Bioequivalence study data should be submitted.

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All Market Authorization Holders of Medicines,

You are hereby informed that, effective from 27 September 2024, all market authorization holders are required to submit their eCTD dossiers using the following Google Form. This submission is in addition to the hard copy dossier submission.

https://docs.google.com/forms/d/e/1FAIpQLSe6lDBDbVbT7AiDKWXJrSt_NbhmP6xAYV96bEX2Z9MRrNFerg/viewform?usp=sf_link

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Important Instructions :

Rename the eCTD dossier : Before submitting, please rename your eCTD dossier according to the dossier number received from the accepting counter.

Submission Deadline : Ensure that both the eCTD and hard copy dossiers are submitted by the specified deadlines.

Declaration letter for verifying the sameness of the submitted manual and eCTD dossier

Soft copy should be renamed only with the dossier number

Please note that eCTD dossier should be submitted within 24 hours after submission of the manual dossier

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We appreciate your corporation in this matter.

( Amended on : 2024.11.12 )

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Warfarin Tablets 2 mg accepted for registering in Sri Lanka and the colour code is Lavender

NMRA has decided to implement colour codes for Warfarin tablets in order to prevent the confusion in identifying different strengths by the patients.

0.5 mg - White

1 mg - Brown

2 mg - Lavender

3 mg - Blue

5 mg - Pink

Failing to abide this will create unnecessary problem when clearing at custom

To All Marketing Authorization Holders of Cosmetics

Regulatory strengthening of controls on falsified products

The board of the national medicine regulatory authority decided to implement certain changes to the labeling requirements of cosmetics in order to enhance protection against falsified products coming into the market.

The requirements as follows:

• Printed or non-peelable stickers should be placed on each commercial pack indicating the wordings “NMRA approved” and the details of market authorization holder. The sticker indicating the retail price of the product shall be used. A specimen is given below as an example.

The sticker is recommended to be implemented immediately for all batches released to the market with effect from 1^st September 2024. The batches already released to market are not affected by this decision.

The requirements will be made compulsory for imported and local manufacturing products after a grace period of three months from 1^st September 2024.we expect your fullest corporation to implement these controls and help prevention of falsified products getting into the market.

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To all Market Authorization Holders, Importers and Local Manufactures of Medicines, Medical Device, Borderline Products, and Cosmetics.

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Hereby inform you all that the custom clearance of all Medicines, Medical Devices, Borderline Products, Cosmetics and Raw Materials for manufacturing will be facilitated through ASYCUDA system after 19.09.2024.

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On 19.09.2024 onwards all consignees need to upload their documents to the ASYCUDA system according to the following format,

* Mandatory documents

NM4 - This becomes mandatory when requested by NMRA or product is unregistered.

NM5 - This becomes mandatory in sample importations.

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CEO / NMRA

To all Market Authorization Holders and Manufactures 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 Wednesday to Thursday. This will be effective from 05. 09. 2024 onwards. 

Hereafter the official file accepting date of the Manufacturing Regulatory Division will be Thursday of every week. 

CEO/NMRA 

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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 or anybody accredited by the SLAB for the standard ISO 22716/2007 with effective from 01st 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 or anybody accredited by the SLAB for the standard ISO 22716/2007. 

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 acknowledgement. Applicant should apply for ISO 22716 GMP certification along with the acknowledgement given by NMRA. 

CEO/NMRA 

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Updated labeling requirements for medicines (NMRA approved sticker and Bar/QR code)

‍Web publication of drafted guideline for safe dispose of expired & unusable pharmaceuticals to the purpose having public comments.

Send your comments to pa24@nmra.gov.lk on or before, 30.08.2024

To all Local manufacturers of Medicines and Medical Devices,

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NMRA decided to grant an approval for the 6 months requirement of raw materials, packaging materials, testing materials and excipients for the local manufacturers to avoid delays of the approval process.

Local manufacturers should submit following documents for the approval.

1. Request Letter
2. GMP Certificate / Preliminary approval ( for new sites)
3. Performa Invoice / List of the Products

Separate request needs to be submitted for an individual supplier. For subsequent approvals, the local manufacturer should submit details of "Imports in the preceding 6 months".

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CEO / NMRA

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 December 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

Chief Executive Officer

NMRA

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(Date: 03 June 2024)

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Renewal of Licenses for Retail pharmacies and wholesale Establishments due to change of the pharmacist

please note that the following will be implemented with effect from 01^st March 2024.

1. Pharmacist interview will be  conducted on the same day that the application for the change of pharmacist is submitted to the NMRA.
2. The owner of the pharmacy is responsible to arrange a video conference to demonstrate the arrangement and operations of the pharmacy as required by the interview officer during the interview ( please find the internal arrangement checklist below )
3. 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 arrangement

For Retail Pharmacies

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For Wholesale Establishment.

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( Date: 07 February 2024 )

NOTICE TO ALL RETAIL PHARMACISE AND WHOLESALE ESTTABLISHMENTS

Group A

It is mandatory to submit an inspection report issued by the area food and drug inspector / authorized officer along with

1. 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 )
2. Duly filled acknowledgement from
3. 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 and Friday to Pharmacy Regulatory Division NMRA

1. 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 )
2. Duly filled acknowledgement from
3. check list marked with available documents

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( Date: 07 February 2024 )

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

CEO / NMRA

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( Date: 11 June 2024)

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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).

( Date: 11 June 2024)

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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/closedform

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Chief Executive Officer

NMRA

( Date: 03 June 2024)

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.

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( Date: 31 May 2024)

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.

( Date: 31 May 2024)

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.

( Date: 30 May 2024 )

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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

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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

( Date: 29 May 2024)

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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 palning to manufacture in the site.

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

CEO / NMRA

( Date: 29 May 2024 )

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Checklist for Accepting Sample Import License Application of Medicine

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( Date: 15 May 2024 )

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

Local agent ho find it difficult to submit details via 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 pricing@nmra.gov.lk 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 medivines.

Your corperation in this matter is greatly appreciated.

CEO,

NMRA

( Date: 09 May 2024 )

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To all Marketing Authorization Holders of Medicines,

NMRA is publishing herewith a link to obtain Agency transferred dossier details pending at NMRA.

Please provide the required details on or before 20^th of May 2024.

Click on the link below or scan the QR code to fill the Google Form.

https://docs.google.com/forms/d/e/1FAIpQLSfnzI1AKFnc2qn-ATvTz1vAUJSq4xgktF_ZfWRx-1w3h4uJ7A/viewform?usp=sf_link

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( Date: 09 May 2024 )

All Marketing authorization holders / Local manufacturers of medicine are hereby informed that the e-mail address for the notification of Drug Master File (DMF) of Active Pharmaceuticl Agent (API) is "dmf@nmra.gov.lk".

The hard copy of e-mail sent by the manufacturer should be attached with the relevant dossier of the product.

( Date: 29 April 2024 )

To all Market Authorization Holders of Medicines,

NMRA is publishing herewith a link to obtain Manufacturing site changed dossier (Sterile & Non-sterile medicines) details pending at NMRA. (Please note that if you already submitted these details via the link which was published in Feb 2024, no need to fill this form again.)

Please provide required details on or before 15^th May 2024.

https://docs.google.com/forms/d/e/1FAIpQLSeC6YRVZaJLAVgAdVD8FflxR2i8hNAqLDn3Q2IwUo7sekn6yQ/closedform

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( Date: 21 April 2024 )

To All Marketing Authorization Holders of Medical Devices

All importers of Medical Devices are hereby informed that NMRA will terminate the email confirmation process for the foreign manufacturing site application (FMSA). Hence, you can submit FMSA application without the email confirmation which is issued by the Head of Medical Device Division/NMRA with effect from 22nd of April 2024.

This applies for pending email confirmations as well.

Chief Executive Officer

NMRA

( Date: 18 April 2024 )

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To all Marketing Authorization Holders of Medical Devices,

It is here by informed that all dossiers and other applications for medical device registration will be accepted after applying by filling out the Google form linked below or scanning the provided QR code

https://docs.google.com/forms/d/e/1FAIpQLSf8-B5VcCc1VXW7WL0fUhRiiap2BH6fQ6DvN2a2Yj1JpzLXig/viewform?usp=sf_link

Please fill out the following relevant checklist and submit two copies along with the dossier to the accepting point

Annex 01

Annex 02

Annex 03

CEO/NMRA

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( Date: 26 March 2024 )

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Dear Local Agents/Importers,

In accordance with the regulations outlined in the NMRA Act, it is mandatory to submit import details of medicines to the National Medicines Regulatory Authority. To facilitate this process and ensure compliance, we kindly request all local agents and importers to provide accurate information regarding the medicines imported between January 2023 and the present date.

To steamline the data collection process, we have created a Google Form for your convenience. Please take a few minues to fill out the form (https://docs.google.com/forms/u/2/d/e/1FAIpQLSf9cRIDzWL1HE-ZgqmT5RCDL7H7QjjxlVwR1dCYQzCWwBRlHQ/viewform) with details for each medicine imported within the specified period. Thank you for your prompt attention to this matter,

Click on the above link or scan the QR code to fill the Google Form on or before 31st March 2024.

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Chef Executive Officer/NMRA

(Date: 23 March 2024)

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To all market Authorization Holders of Medicines,

NMRA is publishing herewith a link to obtain renewal dossier details which will expire in January to July 2024. Please provide details on or before 10th of April 2024.

https://docs.google.com/forms/d/e/1FAIpQLScqV5pKj9_wjqHMqfm9Xg9l3fh2y6ICf2-sOJKSIyhkRKM8EA/closedform

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(Date: 22 March 2024)

To all Marketing Authorization Holders of Pharmaceuticals,

It is here by informed that all dossiers & related documents for medicine registration will be accepted after applying by filling the Google form through the link or the QR code below.

https://docs.google.com/forms/d/e/1FAIpQLSe0PPekww_RuZiOdHXvo_QzmJv2V2ux-MZfP6ayCEVQ07uBpQ/viewform

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Please fill the following checklist and submit two copies with the dossier to the accepting point.

Checklist

( Date: 15 March 2024 )

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 registrations until further notice.

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( Date: 14 March 2024 )

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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 will be Wednesday of every week.

CEO/NMRA

( Date: 14 March 2024 )

Dear Local Agents and Importers,

We have created a Google Form to collect contactable email addresses directly with manufacturers.

Google Form Link:

https://docs.google.com/forms/d/e/1FAIpQLSeznRrM2K_1B5-ooJTzrFwU_JWt8Xh0sM8QEkCo-Mlsc1YZHw/viewform?usp=sf_link

Click on the above link to fill the Google Form on or before 31^st March 2024.

We appreciate your prompt attention to this matter. Thank you for your invaluable support.

Chief Executive Officer/NMRA

( Date: 12 March 2024 )

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NOTICE 02

Renewal of licenses for Retail Pharmacies and Wholesale Establishments due to change of the pharmacist

Please note that the following will be implemented with effect from 01^st March 2024.

1. Pharmacist interview will be conducted on the same day that the application for the change of pharmacist is submitted to the NMRA

2. 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)

3. 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.

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Checklist for internal arrangements

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( Date: 07 February 2024 )

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

1. Duly filled renewal application with the updated supportive documents

2. Duly filled acknowledgement form

3. Check list marked with available documents

On Monday, Wednesday or Friday to Pharmacy Regulatory Division, NMRA

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Group B

It is mandatory to submit following documents without inspection report directly on Monday, Wednesday or Friday to Pharmacy Regulatory Division NMRA

1. Duly filled renewal application with the updated supportive documents

2. Duly filled acknowledgement form

3. Check list marked with available documents

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(Date: 07 February 2024)

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All Marketing authorization holders of borderline products are hereby informed that NMRA has decided to extend registrations of borderline products up to 30th April 2024, if the additional documents have already been submitted.

For this purpose please provide,

1. Request for the extension

2. Copy of certificate of registration of borderline product and License to import borderline product.

3. Acknowledgement of submitted additional documents for relevant certificate and recently issued evaluation.

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‍(Date: 06 February 2024)

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To All Stakeholders, Manufacturers, Importers, Distributors, and Users of Medical Devices

It is hereby informed to all stakeholders, including manufacturers, importers, distributors, healthcare providers, and end-users, about updates related to medical devices within our jurisdiction.

Any instrument, apparatus, appliance, software, material or any other article, whether used single or in combination, including the software necessary for its proper application intended by the manufacturer used in or on human beings for the purpose of Laser procedures, Micro needling, Thread lifting, Cavitation, Electro muscle stimulation, High intensity ultrasound tightening and Fraxel radio frequency technology for skin tightening should be registered under the medical devices.

For further information or clarification on any of the above points, please contact Medical Device Regulatory Division, NMRA.

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(Date: 18 January 2024)

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To all market Authorization Holders of Medicines, NMRA is publishing herewith a link to obtain renewal dossier details which will expire in January, February and March 2024. Please provide required details on or before 17th January 2024.

https://docs.google.com/forms/u/3/d/e/1FAIpQLSfT4987PKSvQNE1PikfC5H7Vy6zF8gR4QMw3ai3VxyhAnvlzw/closedform

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(Date: 11 January 2024)

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To All Importers of Medicine

Extension of registration for Pharmaceuticals up to 30^th June 2024

All marketing authorization holders of medicine are hereby informed that NMRA has decided to extend registrations of Pharmaceuticals of which the registration expires on or before 31^st December 2023 up to 30^th June 2024, if there are no reports of quality failures.

For this purpose please provide

1. The original certificate of registration of a Medicine and License to import a registered Medicine.
2. Acknowledgement of submitted additional documents for relevant certificate / license.

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(Date: 03 January 2024)

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All local manufacturers and marketing authorization holders of medicine are hereby informed that NMRA has decided to temporary stop accepting new medicines applications, new site master files, formulation applications and new foreign site registration applications from published date of this notice to 1st of February, 2024.

However, new medicines applications, which are having less than five registered products in NMRA will be accepted as per the routine procedures and proceeded on priority basis. New foreign site registration applications on site transfers of already approved sites in NMRA will proceed as per the routine procedures.

(Date: 21 December 2023)

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To all importers of Medicines

All authorized agents for medicine are hereby informed that priority registration will be granted for the following products.

Zidovudine 300 mg + Lamivudine 150 mg Tablets

Efavirenz Capsules / Tablets 600 mg

Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg Tablets

Lopinavir 200 mg + Ritonavir 50 mg Tablets

Abacavir Sulfate Capsules / Tablets 300 mg

Lamivudine Tablets 150 mg

Atazanavir Sulfate 300 mg + Ritonovir 100 mg Tablets

Darunavir Ethanolate 600 mg + Ritonovir 100 mg Tablets

Raltegravir Tablets 400 mg

Dolutegravir Tablets 50 mg

Tenofovir Disproxil 300 mg + Lamivudine 300 mg + Dolutegravir 50 mg Tablets

Tenofovir Alafenamide 25 mg + Emtricitabine 200 mg + Dolutegravir 50 mg Tablets

Abacavir 60 mg + Lamivudine 30 mg Tablets

Abacavir Sulfate 120 mg + Lamivudine 60 mg Dispersible Tablets

Zidovudine 60 mg + Lamivudine 30 mg Dispersible Tablets

Lopinavir 100 mg + Ritonavir 25 mg Tablets

Efavirenz Capsules / Tablets 200 mg

Nevirapine Oral Suspension 50 mg / 5 ml - 100 ml

Dolutegravir Tablets 10 mg

Zidoviduine Syrup 5 mg / 5 ml

Lamivudine Syrup 5 mg / 5 ml

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(Date: 24 November 2023)

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All marketing authorization holders of medicine are hereby informed that NMRA would not register new products, renew or issue import license of existing external preparations containing combinations of antifungal with potent or very potent steroids.

Combinations of antifungal with mild steroid can be considered for registration. The potency of steroid is considered as per the classification mentioned in the BNF.

(Date: 13 November 2023)

As per the announcement published on 25.08.2023 at NMRA official website, applicants are informed to submit following documents.

1. Request letter for the certificate extension

2. Original GMP Certificate

3. Copy of the latest GMP report

Applicant can submit above mentioned documents on every Monday at the dossier accepting point to the manufacturing regulatory division's officials.

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(Date: 13 September 2023)

All marketing authorization holders of cosmetics are hereby informed that cosmetic dossiers will be accepted on the 31st Thursday, August 2023 instead of 30th Wednesday, August 2023 due to unavoidable circumstance. Sorry for the inconvenience caused.

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(Date: 29 August 2023)

All local manufactures of Medicines, Medical Devices, Borderline Products and Cosmetics are hereby informed that the NMRA has decided to grant one year extension to the validity of the GMP certificates issued to Local Manufacturers who are manufacturing Medicines (only for the category B), Medical Devices, Borderline Products (only for the external preparations) and Cosmetics

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(Date: 25 August 2023)

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Please be informed that the public day for Market Authorization Holders (MAH) of Medicines will be held on every Thursday starting from 24th August 2023 at 9.00 to 3.30 pm at NMRA premises.

Maximum allowed participants are as follows;

SLCPI Members           -  7

Non SLCPI Members   -  3

Sri Lanka Chamber of the Pharmaceutical Industry (SLCPI) will be issued appointments for SLCPI members.

Non SLCPI Members - Appointments can be collected from NMRA on every Tuesdays during office hours.

Your kind co-operation in this regard will be highly appreciated.

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(Date: 22 August 2023)

To all Marketing Authorization Holders of Medical Devices, are hereby informed that Medical Device Dossiers will be accepted on 3rd of August 2023 instead of 01st of August 2023 due to the public holiday (Poya day). Sorry for the inconveniences caused.

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(Date: 31 July 2023)

All marketing authorization holders of cosmetics are hereby informed that Cosmetic dossiers will be accepted on the 20th Thursday, July 2023 instead of 19th Wednesday, July 2023 due to unavoidable circumstance. Sorry for the inconvenience caused.

(Date: 18 July 2023)

To All Importers of Medical Devices

All importers of medical devices are hereby informed to submit following documents for the acceptance of new dossiers and re-registration dossiers of medical devices

Required documents for the new dossiers and re-registration dossiers of medical devices ‍

Comprehensive table of content (Index)

Application form signed by authorized person (schedule 1 Form A/Form B)

Letter of authorization from legal manufacturer

Copy of foreign manufacturing site approval letter (If applicable)

Copy of GMP report issued by NMRA for locally manufactured products

Copy of sample license (for New)/ previous registration (for RR)

Original free sale certificate issued by relevant health authority

Hygienic certificate (If applicable)

ISO certificate

EC certificate

EC design examination certificate (If applicable)

COA/Finished product inspection report

Stability report with protocol & declaration of shelf life (If applicable)

Sterility report (If applicable)

EO residual test report (If applicable)

Electrical safety data report (If applicable)

Performance evaluation test report for IVD (If applicable)

Biological evaluation report (If applicable)

Third party test report (If applicable)

Bovine Spongiform encephalopathy (BSE) report (If applicable)

Atomic energy authority approval for radiation emitting devices

List of countries with evidence for other country registration

List of standard accessories, spare parts, reagent & consumables (If applicable)

Instruction for use (IFU) for IVD kits

Product labels-Original/Artwork/ Draft & product catalogue

(Date: 30 June 2023)

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All the local Manufacturers are hereby informed that if the molecule is a NME, such application should be submitted to NME Part 1 Pathway before applying for formulation approvals.

After getting MEC approval for particular NME, those approvals should be attached to the formulation approval applications.

‍(Date: 21 June 2023)

All marketing authorization holders of medicine are hereby informed that NMRA decided to revoke the decision taken to register only Extended Release Donepazil Hydrochloride Tablets based on the recommendation given by 77th Medicines Evaluation Committee held on 25th April 2023.

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(Date : 24 May 2023)

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All marketing authorization holders of medicine are hereby informed that NMRA decided to re-register multivitamin products which were registered as medicines under the CDDA Act can be continued under medicines based on the recommendation given by the 76th Medicines Evaluation Committee held on 28th March 2023.

(Date : 24 May 2023)

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All local manufacturers and marketing authorization holders are hereby informed that dossier accepting point of Medicines Regulatory Division will be opened on 04th of May (Thursday) 2023 from 9.00 a.m. to 3.15 p.m.

(Date : 03 May 2023)

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All Marketing authorization holders of medicine are hereby informed that 74th Medicines Evaluation Committee held on 24th January 2023 recommended not to register new products of Levofloxacin Eye/Ear drops and not to renew or issue import license for existing Levofloxacin Eye/Ear drops.

(Date : 18 April 2023)

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All Marketing authorization holders of medicine are hereby informed that 72nd Medicines Evaluation Committee held on 22nd November 2022 recommended not to register new products of topical preparations containing Clobetasol Propionate with an antifungal and not to renew or issue import license for existing topical preparations containing Clobetasol Propionate with an antifungal.

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All Marketing authorization holders of medicine are hereby informed that 72nd Medicines Evaluation Committee held on 22nd November 2022 recommended not to register new products of Ketorolac Tromethamine Orally Disintegrating Tablets and not to renew or issue import license for existing Ketorolac Tromethamine Orally Disintegrating Tablets.

(Date : 18 April 2023)

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To All Local Agents of Cosmetic Products,

All Local Agents of Cosmetics Products are hereby informed to submit their application, additional details and Sample Import License of cosmetics to the dossier accepting point, on 4th April 2023 at NMRA Norris Canal Road Office from 1.30 pm onwards.

(Date : 03 April 2023)

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All applicants of Cosmetic Products are hereby informed to submit their additional details for renewal the registration certificate (additional) of Cosmetics to the dossier accepting point, only on Wednesday at NMRA Norris Canal Road Office effective from 01st of March 2023.

(Date : 01 March 2023)

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To All Importers of Cosmetic Products,

All importers of Cosmetic Products are hereby informed to submit their application and additional details for Sample Import License of Cosmetics to the dossier accepting point, only on Wednesday at NMRA Norris Canal Road Office effective from 01st of February 2023.

Required documents for the Sample Import License Application

Application form

Business Registration Certificate

Valid Original Letter of authorization (as a Sole Agent LOA or Tabulated LOA)

Declaration from the manufacturer stated no more Importers registered in Sri Lanka.

Declaration from the importer.

Product label (Art work / Scanned commercial label)

Application for Sample license of Cosmetics for Test / Registration Purposes

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(Date : 10 February 2023)

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නිවේදනයයි.

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සියලුම සමාගම් නියෝජිතයින් වෙත.

ලියාපදිංචියෙන් නිදහස් කිරීමේ ලිපි සඳහා අයදුම් කිරීම / අනුමැතිය ලබාදීමට අදාලව ගාස්තු අය කිරීම සම්බන්ධවයි.

ජාතික ඖෂධ නියාමන අධිකාරියේ 2023.01.25 දින නිකුත් කරන ලද අභ්‍යන්තර චක්‍රලේඛය අනුව එදින සිට ලියාපදිංචියෙන් නිදහස් කර ගැනීමේ ලිපි :(WOR) සඳහා ගාස්තු අයකර ගැනීම, 2018.01.05 දිනැති 1052/33 අංක දරණ ගැසට් පත්‍රය ප්‍රකාරව සිදු කරනු ලබන බව දන්වා සිටිමි.

එම ගැසට් පත්‍රයට අනුව,

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1.රජයේ සැපයීම්වලට ලියාපදිංචියෙන් නිදහස් කිරීමේ අනුමතය සඳහා (අනුමැතිය ලැබීමෙන් පසු) 

2.පෞද්ගලික සැපයීම්වලට ලියාපදිංචියෙන් නිදහස් කිරීමට ඉල්ලුම් කිරීම සඳහා (කමිටුව වෙත ඉදිරිපත් කිරීමට පෙර) 

යන පරිදි නැවත නොගෙවන පදනමින් මුදල් අය කරනු ලබන බව දන්වා සිටිමි.

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 මෙයට,

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…………………………..

 ප්‍රධාන විධායක නිලධාරී.

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(Date : 08 February 2023)

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