Announcements

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 )

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.

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Chairman/CEO
National Medicines Regulatory Authority

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NMRA Approved Pulse Oximeter

(Date: 31 August 2021)

Accepting Manual Applications carried out via e-NMRA (Medicine) (New)

Accepting Manual Applications carried out via e-NMRA (Medical Device)

Accepting Manual Applications carried out via e-NMRA (Borderline Product)

Accepting of Clinical Trial applications manually

සියලුම තොග සහ සිල්ලර ඖෂධශාලා (Pharmacy Wholesale and Retail) බලපත්‍ර අයදුම්කරුවන් වෙත කරනු ලබන නිවේදනයයි

To all applicants for personal user authorization letters

• Application form signed by the prescriber

(Date:31 August 2021)

All authorized agents for medicine are hereby informed that "No new registration/renewa of registration for Vitamin C sustained release tablets 500mg" will be accepted by the NMRA.

(Date: 28 August 2021)

All authorized agents for medicine are here by informed that No registration for Mefenamic Acid Dispersible Tablets 100mg will be accepted by NMRA.

(Date: 282 August 2021)

To all importers / Local agents of medical Devices.

This is to bring to your notice, as there is a failure in the eNMRA digital platform, NMRA has decided to implement the following action plan in a step-by-step manner in order to cater to applicants whose requirements were previously processed through the online system and new applicants who wish to start registration until the system is restored.

1. Local agent profile creation

•This process is suspended temporally until the system is restored.

2. Applications for the approval of foreign manufacturing sites (Medical Devices )

• Applications submitted through online and which are at screening level and pending processing fee.

• Application (File) shall submit manually with the online evidence.
• Documents should be in the file as per NMRA guidelines already published in NMRA web site. In addition, manufacturer should provide a confirmation letter to the authority stating that there is no further local agent appointed.
• Local agent shall submit a consent letter to withdraw the application when the authority notice duplications and decide to withdraw the latest application as per reference number. (Files may be submitted to the authority by more than a local agent)
• Use only transparent plastic file covers for documentation.
• NMRA admin division will send the evaluation report via email to the company.

• Application submitted via online and which are at review level, approval after processing fee

• Application (Dossier) shall submit manually with payment evidence. (A verified payment receipt issued by the accounts department of NMRA shall enclose)
• Documents should be in the file as per NMRA guidelines already published in NMRA web site.
• In addition, Local agent should submit a confirmation letter stating that documents which are attached in the manual application is same as the online application.
• Use only transparent plastic file for documentation..
• NMRA admin division will send the evaluation report via email to the company.

• New application ( There is no online process)

• If a local agent wish to apply for registration of foreign manufacturing site, following steps to be followed.
• Manufacturer shall send the letter of appointment and a confirmation letter to CEO/NMRA stating that there is no further local agent appointed. Both documents to be submitted via email to legal department of NMRA to check the authenticity of appointment letter. It will be informed to Focal Point of MDR division through.
• Local agent shall submit application /file manually. Documents should be in the file as per NMRA guidelines already published in NMRA web site. Payment note for processing fee shall be issued by accepting pharmacists after the recommendation of focal point of MDR/Division.
• Use only transparent plastic file for documentation.
• NMRA admin division will send the evaluation report via email to the company.

Applications for foreign manufacturing site approval will be accepted on Tuesday from 9.00 a.m. to 3.30 p.m.

3. Applications for sample import licenses of medical devices.

• NMRA will be accepted sample import license applications only for following products.

• For SPC tenders
• For DHS tenders
• Products essential for pandemic or emergency
• Monopoly items
• Change of manufacturing sites.
• Delay submission of for renewal due to pandemic situation etc.
• NMRA requests based on the recommendation of Committees.
• Novel medical devices
• New technology products manufactured or approved in a NMRA reference countries.
• There is no registered medical devices available in the market.

If a sample import license application has already been applied through eNMRA, a manual application shall submit with a copy payment receipt and approval of foreign manufacturing facility.

Applicant who has already applied for registration of foreign manufacturing site through online and which are pending, shall submit manual sample import license application after submitting manual application for registration of foreign manufacturing site and completed the relevant processing fee of foreign manufacturing site registration.

All new applications (Not applied through eNMRA) shall submit sample import license application after the approval of foreign manufacturing site. Approval of foreign manufacturing site shall submit with the sample import license application.

Applications for sample licenses should be submitted to NMRA new premises located at No. 72 W. A .D Ramanayake Mawatha, Colombo 00200 on Mondays and Thursday from 9.00 a.m. to 3.30 p.m.

4. Registration of medical devices- New applications

• Application can be applied only for following products.

• For SPC tenders
• For DHS tenders
• Products essential for pandemic or emergency
• Monopoly items
• Change of manufacturing sites.
• Delay submission of for renewal due to pandemic situation etc.
• NMRA requests based on the recommendation of Committees.
• Novel medical devices
• New technology products manufactured or approved in a NMRA reference countries
• There is no registered medical devices available in the market.

Maximum 03 files / week will be accepted from a local agent.

The approval of foreign manufacturing site and copy of sample import license should be attached in the file.

If an application has already been applied through eNMRA, a manual application shall be submitted with a copy payment receipt and approval of foreign manufacturing facility.
Use box file covers for documentation.

Re-registration application will not be accepted until further notice. If re-registration application has already been applied through eNMRA, a manual application shall submit with a copy payment receipt and approval of foreign manufacturing facility.

Applications will be accepted on Tuesday from 9.00 a.m. to 3.30 p.m.

5. Registration of medical devices – Renewal Applications

• NMRA will accept all re-registration applications manually (applications submitted through eNMRA and not submitted through eNMRA) for routine process.
• 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 re- registration.
• With each application a copy of extended registration certificate & import license should be enclosed. A declaration shall be submitted by the applicant if previous registration was not extended.
• Applications will be accepted on Tuesday from 9.00 a.m. to 3.30 p.m.

6. Additional data / sample/ request for demonstration

• For the decision of “Awaiting data”, “Awaiting sample” and “Awaiting demonstration” will be accepted only within one year from the date of CEO’s approval of the latest evaluation.
• Applications will be accepted on Tuesday from 9.00 a.m. to 3.30 p.m.

(Date: 28 August 2021)

All authorized agents for medicine are here by informed that No more applications will be accepted for products with 15 or more registered products for the same INN in the same strength.

Need for 15 registered products will also be viewed on the case -by -case basis.

(Date: 28 August 2021)

‍

All authorized agents for medicine are here by informed that If a reusable pen is available for a particular finished product of human Insulin, the single use, on-reusable pen would not be registered.

(Date: 282 August 2021)

To all marketing authorization holders of Borderline Products

This is to bring to your notice, as there is a failure in the eNMRA digital platform, NMRA has decided to implement the following 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, in order to continue an uninterrupted services.

Borderline Products Registration Process:

1.Local agent Profile Creation-Suspended temporally until further notice

2.Product Classification (Preliminary evaluation):

New Applications Submission:

• Foreign and Local applications shall be submitted manually as per the documents specified in “Required documents for product classification” under borderline product category
• If the application has already applied through online system it (full application) should be re-submitted manually (hard copies) with the evidence for online submission (at least a document with online submitted classification application reference number)
• If the applicant already paid the payment for the classification process the receipt should be attached to the application (full application) and should submit a confirmation letter stating that the documents which are attached in the manual are same as the in the online submitted application
• Local agent shall submit a consent letter to withdraw the application when the authority notice duplications and decided to withdraw the latest applications as per the reference number (same product submitted by more than one local agent)
• NMRA shall be able to reimburse the processing fee if any application withdraw from the process due to duplications by the NMRA.

Additional Documents Submission:

This is applicable for those who received “Classification Report” through e-NMRA system.

Foreign and Local applications which are having the classification report as “pending decision” &/ or “request additional documents” shall be submitted the initial full application (as per the documents specified in “Required documents for product classification” under borderline product category + copy of payment receipt) manually with the copy of above mentioned classification report ( + manually issued classification reports if available after the online classification report) and requested additional documents.

Applicant should submit a confirmation letter stating that the documents which are attached in the manual application are same as the in the online submitted application.

Note:

• All manual applications will be accepted on Mondays from 9.00 a.m. to 3.30 p.m. only
• The relevant pharmacists in the respective regulatory division would not be held responsible if sequence of any application that had been submitted through eNMRA system breached when implementing the above manual procedure
• New reference number will be given according to the sequence of manual applications submission.

3. Formulation Approval / Sample Import License –Manual Process

4. Registration Dossier Submission (New Applications & Additional Documents Submission)-Manual Process

‍

(Date: 28 August 2021)

To all marketing authorization holders of medicines and medical devices

Extension of certificates of registration, import licenses and manufacturing licenses

Revised Closing Date for applying for extension of certificates of registration, import licenses and manufacturing licenses for medicines

This is to bring to your notice that closing date for applications for extension of registration certificates and licenses for medicines/medical devices will be extended until 31st October 2021.

You are hereby informed that after reassessing the prevailing situation in the country due to COVID 19 pandemic, the National Medicines Regulatory Authority has decided to extend the validity of certificates of registration, manufacturing and import licenses pertaining to Medicines and Medical Devices for a period of one year. This extension can be considered for the certificates of registration and licenses expired after 30th of June 2019 and would be expired up to 31st December 2021.

‍

1.    Following conditions shall be applied.

• This extension is applicable for re registration and renewal applications only.
• Marketing authorization holders should apply for extension of each certificate of registration and license before 31st October 2021. No request for extension of certificate of registration and license under this scheme will be entertained after this date.
• Applicant will be charged relevant fees for the certificates and licenses including any arrears payments.  

2.    Procedure of extension shall be as follows.

Extension of certificates of registration, import licenses and manufacturing licenses for medicines

i.    Applications will be accepted only by manually on every Mondays & Wednesdays at 9.00 am to 11.00 am.    
ii.    Following documents should be submitted.
a.    Request for extension (Click here to download the request form)
b.    Copy of previous (latest) evaluation report
c.    Copy of last registration certificate / import license
d.    Copy of acknowledgement and payment receipt for re registration/ additional data submission

e.   Checklist for extension of medicine registration via manual route (02 copies) (Click here to download the checklist)

iii.    Above mentioned documents should be handed over to the NMRA manually.
iv.    After screening of the request the applicant will be informed to submit original certificate with payment to NMRA. A seal will be placed in the original certificate indicating the period of extension and other relevant conditions.  
v.    NMRA may reject any request for extension for a product which is not complying to NMRA Act and Regulations.

Extension of certificates of registration, import licenses and manufacturing licenses for medical devices

i.    Applications will be accepted through online via following emails.

         exd.nmra@gmail.com

ii.    Following documents should be submitted.
a.    Request for extension (Click here to download the request form)
b.    Copy of previous (latest) evaluation report
c.    Copy of last registration certificate / import license
d.    Copy of acknowledgement and payment receipt for re registration/ additional data submission

iii.    Heading of the email should clearly mention "Request for extension- dossier number"
iv.    After screening of the request the applicant will be informed to submit original certificate with payment to NMRA. A seal will be placed in the original certificate indicating the period of extension and other relevant conditions.  
v.    NMRA may reject any request for extension for a product which is not complying to NMRA Act and Regulations.

Special Notes:

• For medical devices marketing authorization holder should apply for re registration/ renewal through automation system before six month on the expiry of above extension.
• Please do not reapply repeatedly for the same application.

(Date: 20 August 2021)

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

The NMRA, having considered the present pandemic situation, has decided to extend the period of validity of import licenses which have the valid registration but have already expired or expire by October 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 October 31, 2021 (Already extended certificates of registration and import licenses will also be considered if they meet the required criteria).
2. Import licences 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 table 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 medicine 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.

The table below should be filled (Excel spreadsheet is better) according to the information contained in the registration certificate and the import license.

NB:

1. Applications without required criteria will be rejected.
2. Import licenses which will expire after October 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: 06 August 2021)

All authorized agents for cosmetics are hereby informed, NMRA will entertain only the registration of hand sanitizer liquid products manufactured as per the WHO recommended hand rub formulation and temporary withhold the new application for registration of Hand sanitizer Gel products during COVID 19 pandemic since from 02nd February 2021.

(Date: 29 June 2021)

ඖෂධ ශාලා බලපත්‍රවල වලංගු කාලය දීර්ඝ කිරීම.

සියලුම තොග ඖෂධශාලා (Wholesale) සහ සිල්ලර ඖෂධශාලා (Retail) බලපත්‍ර හිමියන් වෙත.

රටේ උද්ගතව ඇති වසංගත තත්ත්වය මත ඖෂධ බෙදාහැරීමේ කටයුතු බාධාවකින් තොරව පවත්වා ගැනීම සඳහා තොග ඖෂධ ශාලා (Wholesale) සහ සිල්ලර ඖෂධ ශාලාවලට (Retail) අදාළ බලපත්‍ර උපරිම වශයෙන් 2022/12/31 දක්වා දීර්ඝ කිරීමට ජාතික ඖෂධ නියාමන අධිකාරිය තීරණය කර ඇත.

මේ සඳහා අයදුම් කළ හැක්කේ කවරෙකුට ද?

මෙම දීර්ඝ කිරීම වලංගුවන්නේ 2018/01/01/ දින හෝ ඊට පසු දිනකදී වලංගු කාලය අවසන් වී ඇති තොග ඖෂධ ශාලා (Wholesale) සහ සිල්ලර ඖෂධ ශාලා (Retail) බලපත්‍ර සම්බන්ධයෙන් පමණි

❖ බලපත්‍ර දීර්ඝ කිරීම සිදු කරනුයේ එක් එක් ප්‍රදේශවලට නියමිත දිනයන්හිදී පමණි.

ඔබ දිස්ත්‍රික්කයට වෙන් කර ඇති දිනය දැන ගැනීම සඳහා Tentative Scheduled Dates for Licence Renewal for each Districts Licence

❖ ඔබගේ බලපත්‍රය දීර්ඝ කිරීමට අදාළ දිනය හෝ හිඟ වාරික සහ 2022 වසරට අදාළ බලපත්‍ර ගාස්තු පිළිබඳ තොරතුරු දැනගැනීම සඳහා SPC Retail & Wholesale outlets, Cargills food city pharmacies,  Colombo District, Colombo district (RDHS), Colombo Distric (1-15),  Trincomalee District, Batticaloa District, Gampaha District (Mr.Niyaz), Gampaha District (Mr.Bandara), Gampaha District (Mr.Karunarathne) Kalutara Dstrict, Vavuniya District, Mannar District, Kilinochchi District, Kalmunai District, Jaffna District,  Matara District / Galle District / Rathnapura District / Hambanthota District /  Puttalam District / Kandy District / Matale District/ Badulla District/ Nuwara Eliya District/ Kegalle District/ Monaragala District/Ampara District Tentative Scheduled Dates for Licence Renewal for each Districts Licence . (අනෙකුත් දිස්ත්‍රික්කවලට අදාළ තොරතුරු ඉදිරි දිනවලදී දැනුම්දෙනු ඇත.)

➢ www.nmra.gov.lk වෙබ් පිටුව වෙත (Announcement)

හෝ

➢ ඔබ ප්රදේශයේ ආහාර සහ ඖෂධ පරීක්ෂක නිලධාරී වෙත යොමුවන්න.

ඖෂධ ශාලා බලපත්‍රවල වලංගු කාලය දීර්ඝ කිරීම සඳහා අවශ්‍ය ලේඛන

1 දීර්ඝ කිරීම සඳහාවන අයදුම්පත.
:මෙම අයදුම්පත Request-form-for-Pharmacies-extension වෙබ් පිටුවෙන් බාගත (Download)  කරගත හැකිය.*

2  2018/01/01/දින සිට ඊට හෝ ඊට පසු දිනකදී වලංගු කාලය අවසන් වූ තොග ඖෂධ ශාලා (Wholesale) සහ සිල්ලර ඖෂධ ශාලාවලට (Retail) අදාළ ජාතික ඖෂධ නියාමන අධිකාරිය විසින් නිකුත් කළ බලපත්රයේ මුල් පිටපත :(Original License)

3 ඔබ විසින් ගෙවිය යුතු හිඟ වාරික හෝ 2022 වසරට අදාළ බලපත්‍ර ගාස්තු ගෙවූ පසු බැංකුවෙන් නිකුත් කරනු ලබන බැංකු රිසිට්පත.

මුදල් තැන්පත් කළ යුතු ආකාරය

➢ බැංකුව - ලංකා බැංකුව
➢ ශාඛාව - රීජන්ට් වීදිය
➢ ගිණුම් අංකය - 78088835
➢ ගිණුම් හිමියාගේ නම - ජාතික ඖෂධ නියාමන අධිකාරිය

අයදුම් කරන්නේ කෙසේද?

නිසි පරිදි සම්පූර්ණ කරන ලද අයදුම්පත්‍රය සහ අදාළ ලේඛන

1 ඔබගේ ප්‍රදේශයේ ආහාර සහ ඖෂධ පරීක්ෂක නිලධාරී වෙත
හෝ

2 ඖෂධ ශාලා සංගම් එකමුතුවේ නියෝජිතයෙකුට
හෝ

3 ඔබ විසින් සකසා ගන්නා ලද අවම වශයෙන් සාමාජිකයන් දස දෙනෙකුගෙන් (10) යුත් කණ්ඩායමක් නියෝජනය කරමින් එක් අයෙකු හෝ මඟින් ඔබ ප්‍රදේශයට වෙන් කළ දිනයට ජාතික ඖෂධ නියාමන අධිකාරිය වෙත ලැබීමට සැලැස්විය යුතු වේ.

සැලකිය යුතුයි.

❖ අදාළ දිස්ත්‍රික්ක සදහා වෙන් කර ඇති දිනයට බලපත්‍ර වලංගු කාලය දීර්ඝ කිරීම සඳහා යොමු කරන අයදුම්පත් පිළිබද සංක්ෂිප්ත තොරතුරු ඇතුළත් ලේඛනයක් පහත දක්වා ඇති ආකෘතියට අනුව සම්පූර්ණකර ඔබ ප්‍රදේශයට වෙන් කර ඇති දිනයට අවම වශයෙන් දින (3) කට පෙර

1. ඔබගේ ප්‍රදේශයේ ආහාර සහ ඖෂධ පරීක්ෂක නිලධාරී මඟින්
හෝ

2. ඖෂධ ශාලා සංගම් එකමුතුවේ නියෝජිතයෙකු මඟින්
හෝ

3 ඔබ විසින් සකසා ගන්නා ලද අවම වශයෙන් සාමාජිකයන් (10) දෙනෙකුගෙන් යුත් කණ්ඩායමක් නියෝජනය කරමින් එක් අයෙකු හෝ මඟින් enmra.pharmacy@gmail.com විද්‍යුත් ලිපිනය මගින් ජාතික ඖෂධ නියාමන අධිකාරිය වෙත යොමු කළ යුතු වේ.

ආකෘති අංක 01

❖ ජාතික ඖෂධ නියාමන අධිකාරිය වෙත ඔබ පැමිණෙන සෑම විටම ඔබගේත්, අපගේත්, රටේත් ආරක්ෂාව උදෙසා නිසි සෞඛ්ය රීති අනුගමනය කළ යුතු වේ.

(Date: 23 June 2021)

Additional notification on renewal of expired import licenses with valid registration certificates of medicines registered with the NMRA.

Further to the notice dated June 15, 2021 published on our website regarding the above matter, the NMRA has decided to accept the applications (following the same guidelines published on the NMRA website) until 4.00 p.m. July 05, 2021. As such you can submit requests (by email: mediext.nmra@gmail.com) to extend import licenses that expired on or before June 30, 2021 but have a valid registration certificate.

You are further informed that the normal procedure to be followed for obtaining/extending import licenses which do not fall under this category.

• Please include all the requests in a single email using the given table (If you have 10 or more applications you have the option to physically submit them (with a printout of the duly filled table) to the NMRA office located at 120, Norris Canal Road, Colombo-10. However, you should provide the information requested in the table by email).

Renewal of expired import licenses with valid registration certificates of medicines registered with the NMRA

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The NMRA has decided to renew the import licenses which have expired but their registrations are still valid. Accordingly, the following information should be sent to the NMRA by email: mediext.nmra@gmail.com

Conditions:
1.    You can apply via this route only for renewal of import licenses which have expired but their registration is still valid.
2.    Import license will be renewed according to the validity period of the registration certificate (validity period of the import license does not exceed the validity period of the registration).
3.    This extension will be granted for a maximum period of one year.
4.   The registration certificates that have been extended due to the current pandemic situation will not be considered under this process (Please refer to the document with caption: " Extension of certificates of registration, import licenses & manufacturing licenses” already published on the NMRA website).

Process:
1.    The company required to provide information using following model format with scanned copies of` relevant registration certificate/s and import license/s (most recent) (If you have 10 or more applications you have the option to physically submit them to the NMRA office located at 120, Norris Canal Road, Colombo-10. However, you should provide the information requested in the table by email).
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 medicine 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 license/s will be issued to you within a period of one week.

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The table below should be filled according to the information contained in the registration certificate and import licence.

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(Date: 15 June 2021)

To Local Manufacturers.

You are hereby informed that after reassessing the prevailing situation in the country due to COVID 19 pandemic, the National Medicines Regulatory Authority has decided to extend the validity of Manufacturing Licenses and GMP Certificates for a period of one year. This extension can be considered for the Manufacturing licenses and GMP Certificates expired after 30th of June 2019 and would be expired up to 31st December 2021.

1.    Following conditions shall be applied.

     i.    Local Manufacturers should apply for extension of each Manufacturing License and GMP Certificate before 31st August 2021. No request for extension under this scheme will be entertained after this date.
    ii.    Applicant will be charged relevant fees for the Manufacturing Licenses and GMP Certificates including any arrears payments.  

2.    Procedure of extension shall be as follows.  
    i.    Applications will be accepted through online via following email.
exlm.nmra@gmail.com
    ii.    Following documents should be submitted by the applicant.

•     Request for extension (Click here to download the format)
•     Copy of latest Certificate of Registration (for Manufacturing Licenses) / copy of latest GMP report (for GMP Certificates)
•    Copy of latest Manufacturing License / GMP Certificate.
•    Copy of acknowledgement for Manufacturing License / GMP Certificate request submission.

   iii.    Heading of the email should clearly mentioned “Request for extension – Manufacturing License Number / GMP Certificate Number.”
   iv.    After screening of the request, the applicant will be informed to submit original certificate with payment to NMRA. A seal will be placed in the original License / Certificate indicating the period of extension and other relevant conditions.  
  v.    NMRA may reject any request for extension for a product which is not complying to NMRA Act and Regulations.

(Date: 14 June 2021)

It is hereby notified to all market authorization holders of cosmetics, as informed earlier with effective from 01/02/2021, broadcasting or publishing any new advertisements pertaining to cosmetic products should have obtained the prior approval from the National Medicines Regulatory Authority.

Further NMRA has informed that all the advertisements pertaining to the cosmetic products should obtain the prior approval on or before 31/05/2021. However after considering the prevailing situation in the country due to COVID 19 pandemic, National Medicines Regulatory Authority is decided to extend the above date until further notice.

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(Date: 31 May 2021)

To all Wholesale and Retail Pharmacy License Holders

You are hereby informed that after reassessing the prevailing COVID 19 pandemic situation in the country, the National Medicines Regulatory Authority has decided to extend the validity of wholesale and Retail Pharmacy License for a period of one year with effect of year 2021. This extension can be considered only for the licenses which had a validity in year 2018 or thereafter and would be expired up to 31st December 2021.

The following conditions will be applied.

1. This extension is applicable for renewal applications only.
2. Wholesale and Retail Pharmacy License holders should apply for extension of each license before 31st August 2021. No request for extension of license under this scheme will be entertained after this date.
3. Applicant will be charged relevant fees for the licenses including any arrears payments for the previous years  
4. Following documents should be submitted by the applicant

• Request for extension (Download the request form)
• Original license
• Payment receipt as a proof

After screening of the request & payment verification, an official stamp will be placed on the original License indicating the period of extension and other relevant conditions.

NMRA may reject any request for extension of the licenses which do not comply with the requirements of the Act and regulations

The extension will be automatically cancelled with the immediate effect when online license is issued.

Wholesale and Retail  Pharmacy License Holders  should apply for the  subsequent renewal through the automation system

(Date: 22 May 2021)

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To all marketing authorization holders of medicines and medical devices

Extension of certificates of registration, import licenses and manufacturing licenses

Revised Closing Date for applying for extension of certificates of registration, import licenses and manufacturing licenses for medicines

This is to bring to your notice that at the meeting held with the Sri Lanka Chamber of Pharmaceutical Industry and Hon. State Minister of Pharmaceutical Production, Supplies and Regulation which was held on 15th July 2021, a decision was taken to bring forward the closing date for applications for extension of registration certificates and licenses for medicines, by one month.

As such, the applications which are entertained through the email exm.nmra@gmail.com will be closed on 31st July 2021 at 12 a.m.

You are hereby informed that after reassessing the prevailing situation in the country due to COVID 19 pandemic, the National Medicines Regulatory Authority has decided to extend the validity of certificates of registration, manufacturing and import licenses pertaining to Medicines and Medical Devices for a period of one year. This extension can be considered for the certificates of registration and licences expired after 30th of June 2019 and would be expired up to 31st December 2021.

1.    Following conditions shall be applied.

• This extension is applicable for re registration and renewal applications only.
• Marketing authorization holders should apply for extension of each certificate of registration and licence before 31st August 2021. No request for extension of certificate of registration and licence under this scheme will be entertained after this date.
• Applicant will be charged relevant fees for the certificates and licences including any arrears payments.  

2.    Procedure of extension shall be as follows.

i.    Applications will be accepted through online via following emails.
     For medicines – exm.nmra@gmail.com                  

     For medical devices - exd.nmra@gmail.com

ii.    Following documents should be attached with the email.
a.    Request for extension (Click here to download the request form)
b.    Copy of previous (latest) evaluation report
c.    Copy of last registration certificate / import license
d.    Copy of acknowledgement and payment receipt for re registration/ additional data submission

iii.    Heading of the email should clearly mentioned “Request for extension - dossier number”
iv.    After screening of the request the applicant will be informed to submit original certificate with payment to NMRA. A seal will be placed in the original certificate indicating the period of extension and other relevant conditions.  
v.    NMRA may reject any request for extension for a product which is not complying to NMRA Act and Regulations.

Special Notes:

• For medical devices marketing authorization holder should apply for re registration/ renewal through automation system before six month on the expiry of above extension.
• Please do not reapply repeatedly for the same application.

(Date: 21 May 2021)

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All representatives of companies,

All authorized agents for Medical devices are hereby informed that National Medicines Regulatory Authority (NMRA) would entertain applications for registration of following products on priority and expedited review basis for the management of COVID 19 pandemic.

01.    Bi PAP
02.    CPAP
03.    High Flow Nasal Oxygen Therapy System
04.    Pulse Oximeters
05.    Finger Tip Pulse Oximeters
06.    Patient monitor - Basic
07.    Patient monitor – Advance
08.    Multipara patient monitor
09.    Ventilators -Transport
10.    Portable ultrasound scan Machine

You are hereby instructed to start the initial process via eNMRA and submit manual dossier for registration.
Companies who have already applied for registration or renewal are hereby requested to submit information to NMRA to expedite process.
Inquiries : mjf.nmra@gmail.com

(Date: 20 May 2021)

Although a product has more than one vitamin, if those ingredients are above the therapeutic dose and if that product carries therapeutic indication claims such product is not accepted as a borderline product. (31st BPEC, 16/02/2021)

(Date: 29 March 2021)

All authorized agents for medicine are hereby informed that No registrationfor oral preparation of Paclitaxel solution will be accepted by NMRA.

CEO

NMRA

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(Date: 15 March 2021)

All authorized agents for medicine are hereby informed that No new registrations for following products/combination products will be accepted by NMRA,

1. Moxifloxacine + Dexamethasone

2. Doxylamine Succinate + Pyridoxime Hydrochloride

3. Mefenamic acid tablets 250 mg

4. Warfarin Sodium Tablets 10 mg

CEO

NMRA

(Date: 15 March 2021)

All authorized agents for medicine are hereby informed that following products will not be accepted/ registered as medicine by NMRA.

1. Sterile Talc powder

2. Cuticulin tablets

3. Omega-3-fish oil

CEO

NMRA

(Date: 15 March 2021)

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All authorized agents for medicine are hereby informed that all new products will need Bio availability/ Bio equivalence data for full registration with effect from 26.02.2021.

For BCS class I and class III products that have WHO bio waiver monographs, comparative dissolution data are accepted.

CEO

NMRA

(Date: 15 March 2021)

To all importers and manufacturers requesting priority evaluation,

NMRA has noticed that sevral priority requests are being made to NMRA including multiple applications. It is difficult to communicate this type of request among responsible officers.

Therefore, to minimize the difficulties in tracing the files and communication gaps, it is requested to apply a separate letter for each application.

Please note that according to regulation 134 of 2145/1 on 14th October 2019, target process timeline are being also published.

Appreciate your adherence to above timelines.

(Date: 04 March 2021)

NMRA has decided to suspend accepting of Waiver of Registration (WOR) applications for KN 95 respirators until the issued once up to 4th December 2020 are reviewed.

1)    NMRA will allow importation of ONLY N95 or KN95respirators (N95 or KN95 mask) to Sri Lanka.      

2)    SurgicalN95 respirators or Medical grade KN95 respirators with exhalation valve is NOT allowed for Importation.

3)   Following documents should be submitted by the applicant / local agent

Request Letter
Business Registration (BR) of the applicant
WOR application (Click here to download)
Test Report including below mentioned test parameters & conclusions (Should be in English language or translation need to be submitted)Quality certificates including ISO Certificate, EC certificate etc, Approval issued by other NRAs (National Regulatory Authorities) to prove export sale (Eg : US FDA, EUA approval) if available
Proforma Invoice/Commercial Invoice
Label and other supportive documents (Color scanned Immediate and Outer pack)Any other relevant document which may be requested by NMRA if necessary

4)   Applications will be proceeded ONLY through online.

5)   Procedure for approval is as follows.

6)    Following main specifications as per the Guideline on COVID-19 Technical Specifications for Personal Protective Equipment and Related IPC supplies issued by the WHO(WHO/2020-nCoV/MedDev/TS/InfDev dated 7 August 2020) should be fulfilled to obtain a Waiver of Registration (WOR) approval for N95 or KN 95 Respirators.

7)    Please note that NMRA will not be able to proceed any application;

8)   which are not submitted according to the above procedure OR with incomplete documents

9)   Time period for processing will be 7 working days after receiving to NMRA.

10)  Maximum quantity allowed for importation is 1Million per week.

Make sure to attach above required documents and send to following Email address: worappnmra@gmail.com

Note: Please refrain from unnecessary communications through telephone calls within the timelines mentioned, allowing NMRA to provide you a fast tract service.

(Date: 04 December 2020)

You are hereby informed that NMRA would not register or renew existing topical applications containing an anti - bacterial, an anti - fungal, an anti - inflammatory agent as triple combinations and phase out all existing products with effect from22nd September 2020.

 (Date: 22 October2020)

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You are hereby informed that NMRA has decided to register / renew registration of Paclitaxel Injection only when accompanied with compatible saline bottles and giving sets with effect from 28th July 2020. 

(Date: 22 October2020)

You are hereby informed that NMRA would not register or renew existing Cholecalciferol Injection with effect from 22nd September 2020.

(Date: 22 October 2020)

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Since NMRA is not in a position to carry out onsite GMP inspections of overseas manufacturers in the near future due to prevailing COVID 19 pandemic situations , accepting of applications for new foreign manufacturing sites will be restricted with effect from 9th October 2020 .Applications for new foreign manufacturing sites will be accepted only from the manufacturers who fulfill one of the following criteria, until further notice.

Manufacturing sites located in a reference country, i.e. PIC / S member

Manufacturers who have expressed interest to apply for marketing authorization through the WHO collaborative registration procedure. Manufacturing sites that manufacture products identified as in need of ( more ) sources of supply . E.g. COVID 19 related products , orphan drugs , breakthrough therapies, products having less than three registered manufacturers .

When manufacturing of an existing product is transferred to anew site.

Your corporation on the matter would be much appreciated.

(Date: 08 October 2020) 

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It is hereby notified that all applicants who submitapplications to obtain import licenses for medicines should submit theapplication along with the following documents with effect from 31st of August2020 as per Regulation 48 ( 4 ) of the National Medicines ( Registration andLicensing of Medicines ) Regulations , 2019 published in the Gazette ExtraOrdinary bearing No. 2145/1 dated 14.10.2019 of the Democratic SocialistRepublic of Sri Lanka :

Regional and country of origin retail price per unit.

Unit price in December 2019 in Sri Lanka.

CIF price details.

Suggested maximum retail price per unit by the importer (in SLRs)

(Date: 07 October 2020)

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All toothpastes with claim of "For sensitive teeth "should be applied for the preliminary Evaluation (Product Classification) under borderline products Regulatory Division/ NMRA.

(Date: 26 August 2020)

You are hereby informed that National Medicines Regulatory Authority (NMRA) would not register or renew existing Nitroglycerin controlled release Tablets with effect from 28-07-2020.

(Date: 22 August 2020)

The National Medicines Regulatory Authority (NMRA) as the central regulator responsible for the regulation and control of all aspects of medicines, medical devices and borderline products, gives serious consideration to affordability when granting market authorization to the said medicinal products, in the best interest of the public. Unilateral increase in prices of medicinal products without prior approval of the NMRA is a violation of conditions of market authorization.

Market authorization holders who unilaterally increase price of medicinal products without prior approval of the NMRA commit an offence under the NMRA Act No 5 of 2015 and regulations made thereunder. Failure to fully comply with this directive will compel the NMRA to take appropriate action in terms of section 65 of the Act without any further notice.

Chairman,

National Medicines Regulatory Authority

(Date: 11 August 2020)

Extension of validity period of registration certificate and licenses of Medicines, Medical Devices, Borderline products and Cosmetic Products and licenses of retail pharmacy, Wholesale and transport for therapeutic goods.

I. Extension of the validity period of registration certificate and licenses.

It is hereby noticed that, considering the prevailing situation in the country due to COVID 19 pandemic, the National Medicines Regulatory Authority has decided to extend the validity period of certificates of registration and import licenses pertaining to Medicines, Medical Devices, Borderline Products and Cosmetics and licenses pertaining to retail pharmacy, Wholesale and transport for therapeutic goods up to 31st December 2020. The extension is applicable for certificates and licenses expiring after 30th of June 2019.

NMRA will reconsider this decision to be revoked, if the country is declared as “COVID 19 free nation” by the Health Authorities.

II. Extension of approval to import of products which are less than 75% of shelflife up to 31st December 2020.

NMRA has decided to give following concession,

• For Medicines at least 6 month of shelf life to be retained with the product at the time of importing.• For parenterals at least 12 month of shelf life to be retained with the product at the time of importing.• For Vaccines prior approval to be required from the NMRA if the shelf life is below than the 66%.

(Date: 30 July 2020)

The NMRA on Friday 17 July issued notices of cancellation of registrations and import licenses under Section 65 of the NMRA Act No 5 of 2015 to the following pharmaceutical companies in relation to 10 medicines for arbitrarily and unilaterally increasing their retail prices thereby violating provisions of the NMRA Act and regulations made thereunder:

The increase in retail prices of medicines by the aforementioned companies in violation of conditions of registration issued by the Authority will cause much hardship to patients especially in the background of the ongoing COVID 19 pandemic. Therefore, punitive action has been taken against offending companies under powers vested with the Authority to  ensure affordability of medicines available to the public.

(Date: 17 July 2020)

Oseltamivir capsules may be dispensed at Rajya Osusala outlets and outdoor pharmacies of registered private healthcare institutions based on prescriptions issued by specialist/consultant doctors’ immediate effect.

National Medicines Regulatory Authority

(Date: 14 July 2020)

To all market authorization holders

Deviation from the prices specified in the Certificate of Registration

It has been brought to our notice that some market authorization holders bid for the government tenders quoting the unit prices higher than those mentioned on the relevant certificate of registration.

Retail prices agreed by the particular local agents are also an important factor that is considered in the decisions for accepting the dossiers, evaluating them on priority basis and granting registration for the particular medicines. Furthermore, as per provisions given in the National Medicines Regulatory Authority Act No 05 of 2015 NMRA has the power to decide the prices and it is specified in the certificate of Registration.

Hence NMRA would not hesitate to cancel the registration of such items which violates the conditions on registrations repeatedly, without prior notice.

Yours faithfully, Chief Executive Officer National Medicines Regulatory Authority

(Date: 1 July 2020)

o all importers and local manufacturers of pharmaceutical products,

You are hereby informed that NMRA would not register or renew existing of Topical applications containing an anti-bacterial, an antifungal and an anti-inflammatory agent in combination with effect from 17-02-2020.

Chief Executive officer NMRA

(Date: 10 July 2020)

• All applicants who submit applications under Borderline Products should submit the composition of unit dose along with the batch manufacturing formula.
• Amount of all active ingredients per unit dose should be given in the form of vitamin or mineral and units according to the “Guideline on Product Categorization Reference Details Vitamins & Elements.”

Example:

• Minerals in elemental level (Na but not as Sodium chloride)
• Vitamins (Vitamin A but not as retinol, beta-carotene, etc)
• Units (Vitamin D in µg/day, Zn in mg/day)

All noncompliant applications with above will be rejected with effect from 13th of July 2020.Advertisements of all registered Borderline Products should get the prior approval from the NMRA (fee specified in the fees regulation) with effect from 13th of July 2020.
Validity period of Preliminary Evaluation Report (Classification Report) is one year and product registration dossiers should be submitted within the validity period of the Classification Report. Additional details for the online submitted Classification Applications should be submitted to borderline.nmra@gmail.com

(Date: 07 July 2020)

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Restriction for issuing Waiver of Registration (WORs) with effect from 26th of June 2020 With reference to the National Medicines Regulatory Authority Act, No. 05 of 2015, no medicine, medical device or border line product shall be manufactured or imported without registering such items with the National Medicines Regulatory Authority (NMRA).

However, with the objective of assuring urgent availability of the face masks, personal protective equipment, IR thermometers, PCR kits and machines and hand sanitizers required for battling against the pandemic COVID 19, the NMRA had temporarily waived off the requirement for registration for the said items.

At present, since the COVID 19 is under control and adequate stock of the above items have already been imported to fulfill the requirement of Sri Lanka, the NMRA has decided to restrict issuing waiver of registration (WOR) for the said articles. Accordingly, applications would no longer be accepted for the WOR with effect from 26th June 2020 and the applicants are advised to obtain registration for the same before importation of above-mentioned products as per requirements of the NMRA Act.

Those who have already applied for the WOR are hereby informed to submit the requested documents and the samples on or before 26th June 2020.

Please note that the NMRA would be compelled to reject the applications for WOR which do not fulfil the above requirements within the specified time.

NMRA is not responsible for demurrages for above mentioned products which will be imported after 26th June 2020.

(Date: 15 June 2020)

To all representatives of companies,

All authorized agents for pharmaceuticals are hereby informed that NMRA would entertain applications for registration of Frusemide (Furosemide) Iv Injection on priority and expedited review basis.

Chief Executive Officer NMRA

(Date: 24 March 2020)

To all representative of companies,

All authorized agents are hereby informed that NMRA will not be accepting any dossier(Medicine, Medical Devices & Borderline products) without following information:

The retail price of the country of origin.

The retail price of the other countries the products is exported.

The maximum retail price you are going to sell in Sri Lanka.

Chief Executive Officer NMRA

(Date: 24 March 2020)

NMRA has decided to implement the following color codes for warfarin tablets in order to prevent the confusion in identifying different strengths by the patients.

0.5 mg - White 1mg - Brown 3mg - Blue 5mg - pink

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

‍

Chief Executive Officer NMRA

(Date: 18 January 2020)