Accepting manual applications for NMRA processes- Medicine

To all marketing authorization holders of medicines

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

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

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

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

*Not required for products applied through Emergency Use Authorization

2. Applications for sample import licenses

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

3. Applications for marketing authorization (registration) of medicines

Applications submitted through eNMRA and evaluation report is not received

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

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

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

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

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

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 02^nd September 2021 and 30^th May 2022, section 64(1) of the NMRA act no.05 0f 2015 will not be considered when submitting the renewal dossiers or additional documents. These renewal applications will be accepted until 30th May 2022.

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

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

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

The following documents should be submitted with each renewal applications.

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

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