Announcements

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 )

All marketing authorization holders of medicine are hereby informed that NMRA would not register new products of Sitagliptin Tablets 25mg and renew or issue import license for existing Sitagliptin Tablets 25mg.

(Date: 22 December 2022)

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All marketing authorization holders of medicine are hereby informed that NMRA would not register new products of Loratadine Dispersible Tablets and renew or issue import license for existing Loratadine Dispersible Tablets.

(Date: 22 December 2022)

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All marketing authorization holders of medicine are hereby informed that NMRA would not register Olaparib Capsules.

(Date: 22 December 2022)

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All marketing authorization holders of medicine are hereby informed that NMRA would not register new products of Azithromycin Tablets 1g and renew or issue import license for existing Azithromycin Tablets 1g.

(Date: 22 December 2022)

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All marketing authorization holders of medicine are hereby informed that NMRA would not register new products of Compound Benzoic Acid Ointment and renew or issue import license for existing imported Compound Benzoic Acid Ointment products. This decision is not applicable for local products.

(Date: 22 December 2022)

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All marketing authorization holders of medicine are hereby informed that NMRA would not register new products of Gentamicin containing topical preparations and renew or issue import license for existing Gentamicin containing topical preparations.

(Date: 22 December 2022)

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All marketing authorization holders of medicine are hereby informed that NMRA would not register new products of Salbutamol Tables and renew or issue import license for existing Salbutamol Tablets. This decision is not applicable for local products.

(Date: 22 December 2022)

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All importers of medicine are hereby informed to submit following documents for the acceptance of sample import license applications of medicines.

1. Schedule 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 correctly selected should be originally signed by the applicant

2. Copy of company profile Approval Latter
3. Letter of Authorization
4. Price details
5. Registration Certificate (If applicable) (For Agency transferred, Site transferred or Existing products )
6. Agency Transfer Letter (If Applicable)
7. MEC approval letter for New Molecular Entities (This is mandatory to proceed the Sample License applications for NMEs)

(Date: 22 December 2022)

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Please provide the hard copy of Maximum Retail prices (MRPP) of medicines imported / manufactured by you as at 01.12.2022 within two weeks to pricing unit of NMRA with soft copy by emailing to pricing@nmra.gov.lk

(Date: 02 December 2022)

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All marketing authorization holders of medicine are hereby informed that,

1. RR file numbers will be assigned for the applications submitted for Re-Registration (RR), which are not submitted before six months of the expiry of Full Registration with the payment for processing fees for new application. and new registration will be granted from the date of signature of the CEO/NMRA in the new evaluation report.
2. previous dossiers will be used for the applications submitted for the Renewal, which are not submitted before six months of the expiry of provisional Registration and within one year after the expiry of that registration. And new registration will be granted from the date of signature of the CEO/NMRA in the new evaluation report.

(Date: 24 November 2022)

48^th Borderline Product Evaluation Committee decided to reject all the products (in any stage-Classification, Sample Import License and Registration) Which are export purposes and not to consider any clarification regarding the export purposes.

(Date: 27 October 2022)

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NMRA will recommence accepting applications for foreign manufacturing sites not inspected by a refence authority with effect from 17th October 2022.

1. The applications will be received only on Monday.
2. Application with all documents specified in F-MFR- 001 Issue 03 which is published in NMRA website should be submitted along with the payment receipt.
3. Approval process will follow the procedure prescribed in regulations 2 (3) to 2 (10) in Medicines
4. Approval will be granted only after a GMP inspection.

(Date: 17 October 2022)

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All marketing authorization holders of medicine are hereby informed that NMRA would register only following strengths of Cholecalciferol.

1. Cholecalciferol Tablets 60,000 IU
2. Cholecalciferol Chewable Tablets 60,000 IU
3. Cholecalciferol Tablets 1,000 IU
4. Vitamin D3Tablets 2,000 IU
5. Cholecalciferol Syrup 1,000 IU
6. Cholecalciferol Tablets 400 IU
7. Cholecalciferol Oral Drops 200,000 IU
8. Cholecalciferol Capsule 200,000 IU
9. Cholecalciferol Capsule 40,000 IU
10. Cholecalciferol Capsule 25mcg ( 10,000) IU
11. Cholecalciferol Soft Gelatin Capsule 25mcg (1,000D)
12. Cholecalciferol Tablets 10,000 IU
13. Cholecalciferol Tablets 5,000 IU

(Date: 07 September 2022)

All marketing authorization holders of medicine are hereby informed that NMRA register only Ascorbic acid tablets 100 mg and Ascorbic acid tablets 500mg. NMRA would not register new applications, renew or issue import license for other strengths of Ascorbic acid tablets.

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(Date: 07 September 2022)

All marketing authorization holders of medicine are hereby informed that NMRA would not register new applications, renew or issue import license for existing Silodosin Capsules.

(Date: 07 September 2022)

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All marketing authorization holders of medicine are hereby informed that NMRA would not register new applications, renew or issue import license for existing quetiapine Tablets 50mg.

(Date: 07 September 2022)

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All marketing authorization holders of medicine are hereby informed that NMRA would not register new applications, renew or issue import license for existing imported topical methyl salicylate containing products(as single or combination). This decision is not applicable for local products.

(Date: 07 September 2022)

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All marketing authorization holders of medicine are hereby informed that black warning as "NOT TO USE IN ASTHMA" should be included in labels of Glycopyrronium 12.5mcg + Formeterol fumarate dihydrate 12mcg + Fluticasone propinate 250mcg powder for inhalation in three language and to consider it as schedule IIC medicine.

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(Date: 07 September 2022)

All marketing All marketing authorization holders of medicine are hereby informed that NMRA would not register, renew or issue import license for Deflazacort Tablets 30mg.

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(Date: 07 September 2022)

All marketing authorization holders of medicine are hereby informed that NMRA would not register, renew or issue import license for Cyproheptadine Hydrochloride Oral solution.

(Date: 07 September 2022)

All marketing authorization holders of medicine are hereby informed that NMRA would not register new applications, renew or issue import license existing Terbinafine Hydrochloride Tablets 125mg.

(Date: 07 September 2022)

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To whom to be informed:

This is a notice for local agents and local manufactures regarding the submission of additional documents for classification applications.

Main purpose of this is to convey the decision of Borderline Product Evaluation Committee/BPEC on submission of additional data for Borderline Products Classification Applications.

Message:

Additional data for Borderline Products Classification Applications should be submitted within the following time period;

• Within one year time period for first time additional submission
• Within six months for subsequent submission

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(Date: 15 June 2022)

The applicants of the following applications cannot be contacted. Therefore, if there is anyone who is responsible for these applications, please send the name and the contact details of the regulatory affairs officer of the company to the email address, p36@nmra.gov.lk on or before 17th of June 2022.

1. NMRA/MED/017 - Lotus Pharmaceuticals (Pvt) Ltd
2. M/333/NP/NCE - The Esses Pharmacy (Pvt) Ltd
3. NMRA/MED/093 - Ravilux Company (Pvt) Ltd
4. L/NMRA/MED/165 - Rine Pharmaceuticals (Pvt) Ltd
5. M/244/NP - QVC Enterprise
6. M/394/NP - Medisolve (Pvt) Ltd
7. M/418/NP - Mediccon Pharmaceuticals

(Date: 01 June 2022)

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To: All applicants who submit samples for analysis for registration purposes.

The test methods followed by NMQAL are mostly Pharmacopoeia methods. Almost all pharmacopoeia monographs need Reference Standards and those standards should be obtained from the sources recommended in the test monograph. These sources are mainly United States Pharmacopoeia (USP), British Pharmacopoeia (BP), Indian Pharmacopoeia (IP), European Pharmacopoeia etc.

In most cases the laboratory is unable to issue quality reports of the samples received due to lack of Reference Standards. To overcome this difficulty the Authority Board granted approval to request the applicants to submit the Reference materials for pre marketing testing and deduct the cost for the Reference material from the total fee of the laboratory tests.

Hence, applicants are requested to submit the Reference Standard with the sample if the specification of the sample is one of the above pharmacopoeia.

NMQAL will deduct the cost of the Reference material which is indicated in the relevant latest standard catalogue published by the source (USP, BP, IP etc).

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Note: If the cost of the standards has been given in any other currency in the catalogue, foreign currency rates are converted at the selling rate on last working day of the preceding month which was published by the Central Bank of Sri Lanka and total payable amount is calculated as above accordingly.

If the test method is non pharmacopoeia (i.e. Manufacturer’s in house method) required Reference Standards (with relevant qualification data) must be provided by the applicant free of charge at the time of samples submitted to NMQAL for testing.

This procedure is effective from 06th June 2022.

(Date: 31 May 2022)

This is to inform you that, the Board of NMRA has approved to extend the Certificate of Registration & Manufacture License of Locally Manufactured Medicines for one year, from the expiry date.

If you are applying for the extension of Certificate & Manufacture License (Medicines), Please submit following documents for Administration division. (Ramanayaka Mawatha Building)

• Request Letter address to Chief Executive Officer
• Copy of Evaluation Report
• Previous Registration Certificate (Original)
• Previous Manufacturer License (Original)
• Copy of GMP Report

• Payment letters for the extension of certificates/License will be issued after clarifying the documents.
• Extended Certificates/License will be issued after submitting the Payment Receipt to the administration division.

• If you have any consignments/Shipment clearing / Tenders to apply. Please be kind enough to submit your applications/receipts as early as possible.
• All these rules about would be strictly followed to avoid difficulties and unnecessary disturbances of both parties and to issue the certificate and license without any delay.

Chief Executive Officer

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National Medicines Regulatory Authority

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(Date: 30 May 2022)

All marketing authorization holders of medicine are hereby informed that, prior to the submission date you must obtain an appointment to the submission of dossiers. Considering the prevailing situation of the country, record book will be available in the reception counter every working day from 9.00 a.m. to 3.30p.m to record details in order to get appointments.

(Date: 17 May 2022)

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All authorized agents for medicine are hereby informed that NMRA would not register new product of "Ofloxacin ear drop 0.6% w/v" with effect from 17.05.2022

(Date: 17 May 2022)

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All authorized agents for medicine are hereby informed that NMRA would not register new products of "Disulfiram Tablets" with effect from 17.05.2022

(Date: 17 May 2022)

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All authorized agents for medicine are hereby informed that NMRA would not register new product/ not renew registration or issue import license for existing products for the 21 pack size of "Oral contraceptive pills" due to compliance issue with effect from 17.05.2022

(Date: 17 May 2022)

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All authorized agents for medicine are hereby informed that NMRA would not register/renew registration in future without test report for "Nitrosamine impurities" for both "Angiotensin receptor blockers" and "Metformin" with effect from 17.05.2022

(Date: 17 May 2022)

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All marketing authorization holders of medicine are hereby informed that considering the terms given in NMRA Act for renewal submission, the authority has decided to give a grace period for submission of Re registration and Renewal Applications until June 2022. It is only applicable for registrations which will expire in Nov 2022.

Please note that only one new product dossier will be accepted per week from a local agent 17th May 2022 onwards. This limitation is not applicable to locally manufactured products, new applications of existing products due to site variations, late renewal products new applications of existing products due to agency transfer products & MEDREG products.

It is mandatory to present the regulatory pharmacist who is responsible when processing & submission of product dossiers to minimize unnecessary delays.

Further all local agents responsible for obtaining an appointment prior to the submission date. This record book available in the reception counter every Thursdays & Fridays from 9.00 a.m. to 2.30 p.m. Local agents should record requested details in the book and get an appointment.

In addition Dossiers accepting point of medicine will be open 19^th May 2022 from 9.00 a.m. to 3.30 p.m.

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(Date: 17 May 2022)

All authorized agents for local manufacturing of medicine  are hereby informed that NMRA would accept  to manufcure a generic product under multiple brands in the same factory with following recommendations  with effect from 17.05.2022

1.     A maximum of two brands allowed for local manufacturing

2.    More than two brands can be considered case by case for export purpose.

3.    Separate application should be submitted for each product

In case of a product withdrawal or withhold due to quality or safety issue, the decision shall be applied for all the said products.

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(Date: 28 March 2022)

All marketing authorization holders of medicines are hereby informed that renewal of registrations which hold full registration certificate will be accepted as per the format prescribed in the published guideline GL-021- Guideline on Registration of Medicines (V 1.0 / Rev No :0 effective date: 15/10/2019) with effect from 15/05/2022.

Dossiers should be submitted before the expiry of the current full registration certificate to entitle this format. Sales details & price details should be enclosed with each application as per the published web notice.

Web access to the published guideline (Click here to view)

However, if there is any practical difficulty to comply with above format, those dossiers will be accepted till 31st December 2022 as per the CTD format.

Please note that all renewal dossiers should be submitted as per the new format with effect from 01st January 2023.

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(Date: 28 March 2022)

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All authorized agents of cosmetic are hereby informed that all the Sunscreen products need to be registered under Cosmetic category.

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(Date: 28 March 2022)

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All authorized agents for cosmetic are hereby informed that NMRA would not register or renew cosmetic products with the label claim "killing bacteria/viruses" or similar meaning.

Amended product labels need to be submitted to the NMRA within three months of this notice.

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(Date: 28 March 2022)

The NMRA shall attempt to meet the target processing timelines for cosmetic applications as provided below;

*These timeframes shall apply to working days only, and exclude public holidays and weekends.

(Date: 28 March 2022)

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As per the SLSI 589:2018 specification, NMRA require warning statement as "Not recommended for Infants" of each and every commercial pack of Baby cologne products.

Amended product labels need to be submitted to the NMRA within three months of this notice.

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(Date: 28 March 2022)

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

1) Clonidine oral tablets 100mg

2) Guanfacine oral tablets 2mg

3) Fluoxetine oral tablets 10mg

4) Methylphenidate tablets extended-release form

5) Olanzapine Oral Dispersible Tablets 10mg

6) Aripiprazole oral tablets 10mg

7) Sertraline oral tablets 25mg

(Date: 19 March 2022)

Approval from NMQAL for analytical methods of the products claimed In-House specifications is mandatory for granting registration to the In-House drug products submitted after 18/01/2022.

Registration will not be granted for such products without the approval from NMQAL for analytical methods.

This is not applicable for innovator products and WHO pre-qualified products.

The link to the previous notice relevant to the above.

(Date: 24 February 2022)

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All authorization agents for medicine are hereby informed that NMRA would not register, renew or issue import license for Mefenamic acid suspension.

(Date: 23 February 2022)

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All authorization agents for medicine are hereby informed that NMRA would not register, renew or issue import license for Cimetidine tablets with effect from 23.02.2022.

(Date: 23 February 2022)

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All authorization agents for medicine are hereby informed that Paracetamol Oral Suspension is categorized as Schedule I.

(Date: 23 February 2022)

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All authorized agents for medicine are hereby informed that effective from 01.03.2022, submission of import details (with proof documents) for the applications of renewal and re registration dossiers should be mandatory.

Application form for the submission of sales details is attached herewith. (Click here to download)

(Date: 23 February 2022)

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To all Marketing Authorization holders of Medicines

Submission of price details with the registration dossiers and applications of Renewal of Import licenses

It is hereby noticed that, effective from 14th February 2022, submission of price details with the registration dossiers and applications of renewal of import licenses should be mandatory.

Application form for the submission of price details is attached herewith. (Click here to download)

If unable to enclose the completed application from or incomplete applications, price negotiation will not be proceeded by the NMRA

(Date: 08 February 2022)

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Accepting manual applications for NMRA processes- Medicine

To all marketing authorization holders of medicines

1. Applications for the approval of foreign manufacturing sites (Medicines)

• If the manufacturing site has been already approved either through eNMRA system or manually, a copy of the letter of approval shall be enclosed with each medicine registration application.
• If the manually submitted application for manufacturing site approval is pending and the products from the particular site has already been registered with NMRA, the copy of the acknowledgment shall be enclosed with each medicine registration application.
• A manual application shall be accepted for new sites if payment has been made for an application submitted through eNMRA. A verified payment receipt issued by the accounts department should be enclosed.
• A manual application shall be accepted for following foreign manufacturing site applications

If the full GMP report by a reference NRA or WHO is enclosed with the application. Site changes of existing products

A declaration by the manufacturer stating that an application through another local agent had not been submitted previously should be enclosed

*Not required for products applied through Emergency Use Authorization

2. Applications for sample import licenses

• If a sample license has been already applied through eNMRA, a manual application shall be submitted. A verified payment receipt issued by the accounts department should be enclosed the local agent.
• New applications for sample licenses shall be submitted manually for medicines with less than 15 registered products except for site variation, agency transferred products, WHO PQ products apply through CRP pathway & products registered in MEC recognized reference country (valid registration certificate should be enclosed with the application)

3. Applications for marketing authorization (registration) of medicines

Applications submitted through eNMRA and evaluation report is not received

This is to inform NMRA has decided to accept manual applications for all applications submitted through eNMRA.

If payment has already made for a registration application submitted through eNMRA, a manual application shall be submitted as per the CTD format. A declaration that copies of all documents submitted through eNMRA are submitted should be enclosed. A Verified payment receipt issued by the accounts department should be also submitted by the local agent.

Also, originals of the COPP, finished product COA and stability data should be submitted with the manual application.

Two market samples should be submitted with each application except cool items, narcotic products, cytotoxic medicines.

• A soft copy (in CD format) may be accepted for BE study & API drug master file.

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New applications

New applications for marketing authorization shall be submitted manually for the following products.

• If a sample license issued by NMRA available.

or

• Locally manufactured products

The following documents should be submitted with each new application.

CIF price with proof documents, retail price in country of origin, retail price in regional countries (If applicable) and Maximum Retail price per Unit.

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Renewal applications

This is to inform NMRA has decided to accept all re registration applications submitted before the expiry of the registration certificate/ extended registration certificate.

After reassessing the prevailing situation in the country due to COVID 19 pandemic, the National Medicines Regulatory Authority has decided to exempt the requirements specified under section 64 (1) of the NMRA act for a limited time period when accepting of renewal applications. Therefore, if the expiry of the registration certificate or extended registration certificate falls between 02^nd September 2021 and 30^th May 2022, section 64(1) of the NMRA act no.05 0f 2015 will not be considered when submitting the renewal dossiers or additional documents. These renewal applications will be accepted until 30th May 2022.

With each application a copies of extended registration certificate & import license should be enclosed. A declaration shall be submitted by the applicant if previous registration was not extended.

Additional data for the decision of “awaiting additional data” will be accepted only within one year from the date of CEO’s approval of the latest evaluation.

Two market samples should be submitted with each application except cool items, narcotic products, cytotoxic medicines.

The following documents should be submitted with each renewal applications.

• A declaration weather previous registration certificate & import license were extended. Copies of extended certificates & import licenses should be enclosed.
• Maximum Retail Price per Unit, CIF price with proof documents, retail price in country of origin, retail price in regional countries (If applicable) and MRP of the previous year with proof documents.

     All applications will be accepted on Mondays & Fridays from 9.00 a.m. to 3.30 p.m.

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(Date: 24 January 2022)

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Notice to All Applicants of Medicine Registration

Analytical method of all drug products claimed inhouse specifications needs to be approved by the National Medicines Quality Assurance Laboratory (NMQAL).

• Following documents should be submitted to the NMQAL for the approval of analytical method

1. Copy of the acknowledgement issued by the MRD after accepting the CTD of the drug product
2. Declaration from the manufacturer to the effect that the same details which are included in the CTD submitted to the MRD are included
3. Test methods of the finished product
4. Validation reports of the test methods
5. Label of the finished product
6. Certificate of analysis of the finished product
7. Details of all reference materials used in the test methods
8. Complete formulation of the finished product
9. Container closure details
10. Local agent/local manufacturer contact details (must include the name of the responsible contact person/s, designation, address, phone number, email address)

• Send soft copies of all of above 1-10 documents in the pdf format to the email: nmqal@nmra.gov.lk

(Date: 18 January 2022)

Sri Lanka Customs and National Medicines Regulatory Authority have decided to integrate the consignment clearance approval process through ASYCUDA system from 01st of January 2022.

You are hereby informed to submit the following documents to Sri Lanka Customs for the purpose of clearance of the consignment and to confirm the authenticity.

• Copy of the registration certificates & import licenses
• Copy of the Certificate of analysis (COAs) of the finished product relevant to consignment.
• Product labels.

(Date: 21 December 2021)

Notice to all Local Manufacturers and Importers of Medicines

Extension of Validity of Certificates of Registration for Medicines

It is hereby notified that the last date for accepting existing registration certificates for the purpose of extension is 29 December 2021. Therefore, please take necessary steps to handover the original certificates along with yellow slips on one of the following days, if your application has been recommended for extension:

• •Monday the 20^th of December 2021
• •Wednesday the 22^nd of December 2021
• •Monday the 27^th of December 2021
• •Wednesday the 29^th of December 2021

You are also reminded that a declaration should be enclosed stating whether the registration of the product was extended or not with each renewal (re-registration and additional data) submission and when making payments for renewal of registrations. Copies of extended certificates and licenses should also be enclosed.

Also, you are advised to refrain from making payments for the next registration if the extended registration is valid for more than 3 months.

(Date: 18 December 2021)

Please notice that, from 01 January 2022 onward, applications for pharmacy and transport licenses will be accepted only on Mondays, Wednesdays, and Fridays except public holidays.

Pharmacy Regulatory Division

NMRA

(Date: 16 December 2021)

කාරුණික දැනුම්දීමයි

සීමාස්ථ නිශ්පාදන ගනයට වැටෙන සියලු අයිතම ආනයනය කිරිම සඳහා ජාතික ඖෂධ නියාමන අධිකාරියේ පුර්ව ලියාපදිංචිය ලබා ගත යුතුය.
එබැවින් 2022.01.15 දිනයෙන් පසු අධිකාරියේ පුර්ව ලියාපදිංචිය ලබා නොගත් ඉහත කාණ්ඩයට ගැනෙන කිසිදු අයිතමයක් සඳහා රේගු නිශ්කාෂණ අනුමැති ලිපි නිකුත් නොකරන බව කාරුණිකව දැනුම් දෙනු ලැබේ.

(Date: 15 December 2021)

NOTICE

You are hereby inform that registration should be obtained from the National Medicines Regulatory Authority for the items fall under the category of Borderline Products prior to importing them.

NMRA will not issue any clearance letter to the Sri Lanka Customs for releasing the consignments of the above items after 15^th January 2022.

(Date: 15 December 2021)

Extension of the period of validity of Import Licenses which have the valid registration but have already expired or expire by December 31, 2021

The NMRA, having considered the present situation associated with the Covid-19 pandemic, has decided to extend the period of validity of import licenses which have the valid registration but have already expired or expire by December 31, 2021. Accordingly, the following information should be provided to the NMRA by email: mediext.nmra@gmail.com to extend the period of validity of import licenses.

Requirement criteria:

1. You can apply via this route only for extension of the period of validity of import licenses which have the valid registration but have already expired or expire by December 31, 2021 (Already extended certificates of registration and import licenses will also be considered if they meet the required criteria).
2. Import licenses will be extended according to the validity period of the registration certificates (validity period of the import license does not exceed the validity period of the registration).
3. Validity extension is granted for a maximum period of one year.

Process:

1. Please include all requests in one email using the tabular format below (If you have 05 or more applications you have an option to deliver them by hand (with a printout of the duly filled table) to the NMRA office located at 120, Norris Canal Road, Colombo-10. However, it is compulsory to email the requested information in the table).
2. After verifying the documents by the NMRA, you will be informed to pay the required payments to the NMRA Account Division at No. 47, W A D Ramanayake Mw, Colombo-02.
3. After completion of the payments, you should handover the relevant payment slip (yellow receipt) and a copy of the payment advice slip with the original registration certificate and original import license to the Medicines Import Licensing Division of the NMRA office located at 120, Norris Canal Road (For more details, please contact us at 0112698896 Ext. 422 or 300).
4. Then the validity extended import licenses will be issued to you within a period of one week.

Use the sample tabular format below to enter the relevant information according to the information contained in the registration certificate and the import license (preferably an editable Excel spreadsheet).

NB:

• Applications without required criteria will be rejected.
• Import licenses which will expire after December 31, 2021, will not be renewed through this process and those should be proceeded usual way and should be submitted to the NMRA at least 10 weeks in advance.

(Date: 28 November 2021)

To all importers / Local agents/Market authorization holders of medical Devices.

Exemption of Performance Evaluation (Clinical Evaluation) For Medical Devices (MDs) and In Vitro Devices (IVDs)

1.National Medicine Regulatory Authority (NMRA) has decided to use regulatory reliance principle and exempt the performance evaluation (Clinical evaluation/Sample Evaluation) for following general medical devices (Non IVD Medical Devices) and In-vitro diagnostics medical devices. The decision has been taken to expedite the registration process.

• -In-vitro diagnostics medical devices. (New applications) approved by World Health Organization (WHO) or WHO reference regulatory authorities (Food and Drug Administration -USA, Therapeutic Goods Authority-Australia, Health Canada, Health Sciences Authority – Singapore and Ministry of Health, Labor and Welfare – Japan). One year provisional registration will be granted.
• -Covid -19 essential medical devices (New application of Non IVD Medical Devices) approved by one of NMRA reference country (USA, Australia, Canada, UK, Netherland, Japan, Denmark, Germany, Switzerland, Norway, Sweden, France, Italy). One year conditional provisional registration will be granted with pending performance evaluation.
• -Already registered / marketed General Medical devices (Non- medical IVDs)  and in-vitro diagnostic medical devices (IVDs) which don’t have complaints/quality issues.(Renewal applications)

2. Application (File/Dossier) shall submit with all necessary documents including  original commercial packs/ labels.

3.Samples with commercial packs need to be submitted as a registration sample when required by NMRA.(Except for medical equipment)

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(Date: 23 November 2021)

To all marketing authorization holders of medicines.

1. Applications for the approval of foreign manufacturing sites (Medicines)

• If the manufacturing site has been already approved either through eNMRA system or manually, a copy of the letter of approval shall be enclosed with each medicine registration application.

• If the manually submitted application for manufacturing site approval is pending and the products from the particular site has already been registered with NMRA, the copy of the acknowledgment shall be enclosed with each medicine registration application.

• A manual application shall be accepted for new sites if payment has been made for an application submitted through eNMRA. A verified payment receipt issued by the accounts department should be enclosed.

• A manual application shall be accepted for following foreign manufacturing site applications

 If the full GMP report by a reference NRA or WHO is enclosed with the application.
 Site changes of existing products

A declaration by the manufacturer stating that an application through another local agent had not been submitted previously should be enclosed.

*Not required for products applied through Emergency Use Authorization

2. Applications for sample import licenses

• If a sample license has been already applied through eNMRA, a manual application shall be submitted. A verified payment receipt issued by the accounts department should be enclosed the local agent.
• New applications for sample licenses shall be submitted manually for medicines with less than 15 registered products except for site variation, agency transferred products, WHO PQ products apply through CRP pathway & products registered in MEC recognized reference country (valid registration certificate should be enclosed with the application).

3. Applications for marketing authorization (registration) of medicines

Applications submitted through eNMRA and evaluation report is not received.
This is to inform NMRA has decided to accept manual applications for all applications submitted through eNMRA.
If payment has already made for a registration application submitted through eNMRA, a manual application shall be submitted as per the CTD format. A declaration that copies of all documents submitted through eNMRA are submitted should be enclosed. A Verified payment receipt issued by the accounts department should be also submitted by the local agent.
Also, originals of the COPP, finished product COA and stability data should be submitted with the manual application.

Two market samples should be submitted with each application except cool items, narcotic products, cytotoxic medicines.

• A soft copy (in CD format) may be accepted for BE study & API drug master file.
New applications
New applications for marketing authorization shall be submitted manually for the following products.
• If a sample license issued by NMRA available.
or
• Locally manufactured products

The following documents should be submitted with each new application.

CIF price with proof documents, retail price in country of origin, retail price in regional countries (If applicable) and Maximum Retail price per Unit.

Renewal applications

This is to inform NMRA has decided to accept all re registration applications submitted before the expiry of the registration certificate/ extended registration certificate.
After reassessing the prevailing situation in the country due to COVID 19 pandemic, the National Medicines Regulatory Authority has decided to exempt the requirements specified under section 64 (1) of the NMRA act for a limited time period when accepting of renewal applications. Therefore, if the expiry of the registration certificate or extended registration certificate falls between 02nd September 2021 and 30th May 2022, section 64(1) of the NMRA act no.05 0f 2015 will not be considered when submitting the renewal dossiers or additional documents. These renewal applications will be accepted until 30th May 2022.

With each application a copies of extended registration certificate & import license should be enclosed. A declaration shall be submitted by the applicant if previous registration was not extended.

Additional data for the decision of “awaiting additional data” will be accepted only within one year from the date of CEO’s approval of the latest evaluation.
Two market samples should be submitted with each application except cool items, narcotic products, cytotoxic medicines.

The following documents should be submitted with each renewal applications.
• A declaration weather previous registration certificate & import license were extended. Copies of extended certificates & import licenses should be enclosed.
• Maximum Retail Price per Unit, CIF price with proof documents, retail price in country of origin, retail price in regional countries (If applicable) and MRP of the previous year with proof documents.

All applications will be accepted on Mondays & Fridays from 9.00 a.m. to 3.30 p.m.

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(Date: 09 November 2021)

for Medical devices

1.Exemption of requirements specified under section 64(1) of the NMRA Act for limited time period.

It is hereby noticed that, after reassessing the prevailing situation in the country due to COVID 19 pandemic, the National Medicines Regulatory Authority has decided to exempt the requirements specified under section 64 (1) of the NMRA Act for a limited time period when accepting of renewal applications. Therefore, if the expiry of existing registration certificate or expiry of extended registration certificate falls between 2nd September 2021 to 30th May 2022, Section 64 (1) of the NMRA Act No.05 of 2015 will not be considered when submitting the dossiers/documents for renewal of registration.

2.Accepting of Re-Registration Application

It is hereby informed that NMRA will accept re-registration application manually for routine process which is not covered by above (1). (This is not applicable for applications (dossiers) which have been submitted through eNMRA. These application can be submitted with the evidence)

Note : A copy of extended registration certificate and import license should be enclosed with each application (Dossier).A declaration shall be submitted by the applicant if previous registration was not extended.

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(Date:18 October 2021)

NMRA requires box warning and information for patient/care giver about serious mental health and side effects for asthma and allergy drug Montelukast to be included in the package insert (PIL) of the each and every commercial pack of Montelukast products -all oral dosage forms.
And,
Amended package insert/product information leaflet (PIL) need to be submitted to the NMRA within three months of this notice.

RISK OF NEUROPSYCHIATRIC REACTIONS: Healthcare professionals are advised to be alert for neuropsychiatric reactions, including changes in behavior, speech impairment, depression and obsessive-compulsive symptoms, in adults, adolescents, and children taking Montelukast. The risks and benefits of continuing treatment should be evaluated if these reactions occur. Patients should be advised to read the list of neuropsychiatric reactions in the product information leaflet and seek immediate medical attention if they occur.

Information for the Patient/Care giver:
What should patients and parents/caregivers do?

Patients and parents/caregivers should stop Montelukast and discuss with a health care professional right away if you or your child experience behavior or mood-related changes while taking the medicine.

These may include:

• agitation, including aggressive behavior or hostility
• attention problems
• bad or vivid dreams
• depression
• disorientation or confusion
• feeling anxious
• hallucinations (seeing or hearing things that are not really there)
• irritability
• memory problems
• obsessive-compulsive symptoms
• restlessness
• sleepwalking
• stuttering
• suicidal thoughts and actions
• tremor or shakiness
• trouble sleeping
• uncontrolled muscle movements

(Date: 08 October 2021)

Attention

All market authorization Holders (MA)/Manufacturers/Distributors

NMRA announces the issuance of

1. 1.GL-017 – Guidelines on Recalls of medicines, medical devices and borderline products
2. 2.GL-003 – Guideline for safe disposal of expired and unwanted pharmaceuticals

These guidelines are effective from 01.02.2021.

Therefore all MA holders should adhere to these guidelines with immediate effect. As a result all MA holders are advised to send following information to NMRA promptly in the event of product/batch recall and disposal of recalled/expired/unwanted products

• -GL-017 -Annexure III – Summary report of product/batches recall Submit within one week of reconciliation of the defective product/batch.

• -GL-003- Annexure II – Application form for disposal of unusable and unwanted pharmaceuticals with the Annexure I –Register of unusable and unwanted pharmaceuticals

Above information should be sent to NMRA before disposal of the product/batch and should be reach NMRA at least 2 weeks prior to expected destruction date. Disposal should be carried out according to the NMRA guidelines.

(Date: 23 September 2021)

To all market authorization holders

With reference to the pricing regulations; 2019 in the Gazette Extra Ordinary Bearing No. 2146/3 dated 21.10.2019 you are hereby requested to submit the unit price of medicines imported/ manufactured by you as at 30th March 2021 through the following email address on or before 16^th October 2021, using this excel format.

Email Address: pricing@nmra.gov.lk

(Date:17 September 2021)

To all applicants for personal user authorization letters.

This is to bring your notice, as there is a failure in the e-NMRA digital platform,NMRA has decided to implement the follwing action plan in a step-by-step manner in order to cater to applicants whose requirements were previously processed through the online system,until the system is restored.

If particular medicines required by a patient is not registered or not available in Sri Lanka,NMRA allows import of such medicines through a personal user Letter of Authorization.

The general public can apply for a personal user authorization letter by e-mail with following documents to the below mentioned e-mail address.(Please ensure to mention subject of the email as "Request for personal user Authorization Letter")

p30@nmra.gov.lk
p26@nmra.gov.lk

The following documents are required:

• Copy of a valid prescription issued by a registered medical Professional
• Request letter by the patient or a guardian of the patient(Please include following details)

• Name of the patient
• Address of the patient
• Name of the medicines
• Required quantity
• Contact details of the patient or the guardian

• Copy of the NIC/Passport/Driving license of the patient or the guardian
• Application form signed by the prescriber - Application form signed by the prescriber

(Date: 06 September 2021)

To all Principal investigators who is interested to submit clinical trials applications to the NMRA,

This is bringing to your notice, as there is a failure in the eNMRA digital platform, NMRA has decided to accept manually, until the system is restored.

A prior appointment may be made with the Clinical Trials Regulatory Division through p4@nmra.gov.lk , p9@nmra.gov.lk or p38@nmra.gov.lk to submit the application.

Following documents should be enclosed in the manual application.

1. 02 copies of acknowledgment forms

2. Application form

3. Documents as requested by the checklist in the application form

4. Acceptance of responsibilities by Principal Investigators

5. Soft Copy of the application (in a CD format)

(Date: 31 August 2021)

NMRA observes the proliferation of law quality substandard and falsified medical device in the market during this Covid pandemic situation putting the lives of the people at very high risk.

Retail pharmacies play a vital role and responsibility-in dispensing quality medical products to the people of the country. Therefore NMRA would like to drown your attention on the professional responsibilities you have in dispensing and strictly advice to sale only the NMRA approved medical products in your outlets.

For you convenience, NMRA will published the updated list on selected category of products in the NMRA website (www.nmra.gov.lk) in time to time.

‍

Chairman/CEO
National Medicines Regulatory Authority

‍

NMRA Approved Pulse Oximeter

(Date: 31 August 2021)