Announcements

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 )

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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Notice

To all representatives of the companies,

Fees for the Application / Approval for Waiver of Registration Letters.

Please be informed that Fees for the waiver of Registration Letters will be changed as per the internal circular of National Medicines Regulatory Authority dated on 2023.01.25 in according with the Gazette Extraordinary 1052/33 dated 2018.01.05 as follows.

1. Approval for Waiver of Registration for the government supplies ( After getting approval from the committee)
2. Application for Waiver of Registration for private supplies ( Before forwarding to the committee)

(The Fees payable are not refundable)

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Chief Executive Officer

NMRA

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(Date : 08 February 2023)

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To All Importers of Cosmetic Products,

Re: Prior approval for temporary suspended Cosmetic Goods

All importers of Cosmetics Products are hereby informed to that NMRA is unable to issue prior approval for each consignments where goods are registered with NMRA as Cosmetics. Considering the needs in the current economic environment, import control may release following items that carry NMRA licenses and approvals under relevant HS codes of relaxed items.

Creams/Lotions/Solutions/Soaps

Shampoos/Conditioner

Mouth Washes/Tooth Paste

Hair Dyes/Colors

(Date : 01th February 2023)

All importers of Medical Devices are hereby informed to submit Application and additional details for Sample Import License of Medical Devices to Dossier Accepting Point, Medical Devices only on Tuesdays at NMRA Norris Canal Road Office with effective from 01st of January 2023.

Required documents for the Sample Import License Application

• Application form for Each product (Form C Schedule IV)
• Business Registration Certificate
• Letter of authorization
• Free Sale Certificate
• ISO 13485 Quality management system certificate (not mandatory for NMRA approved site)
• Declaration from the manufacturer regarding the confirmation of type and class of the medical device
• Existing Registration Certificate issued by NMRA/FMSA approval by the NMRA
• Product Catalogue / Brochure
• Sri Lanka Atomic Energy Authority approval for Radiation Emitting Device

Acknowledgement From for Sample Import License - Medical Devices

Chief Executive Officer

NMRA

(Date : 04 January 2023)

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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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Strengths of Cholecalciferol that are considered for registration in Sri Lanka,

I. 60,000 IU

II.1000 IU

III.400 IU

IV.200,000 IU

V.40,000 IU

VI.25mcg

VII.10,000 IU

VIII.5000 IU

(Date: 07 September 2022 , Amended on 30 January 2025)

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)