MAH Registration Instructions

There are 5 steps for the MAH to register and be able to submit data to the NHRA-MVC Traceability Hub. The first three steps are pre-requisites to the NHRA-MVC Traceability Hub registration process for MAH’s

Collect the required Identification Numbers from GS1.

You must have already registered with GS1 and been given your Global Location Number (GLN) and your Global Company Prefix (GCP)

2. Collect the Required Identification Numbers from NHRA

You must have already registered with NHRA and been given your DUR License Registration Number and your MAH Identification Number

3. Complete the Participation Agreement Contract with the NHRA-MVC Traceability Hub

You wil be provided with a Client ID number from the NHRA-MVC Traceability Hub.

4. Select the Registration Link for MAHs and enter your information as an MAH.

5. Complete the payment submission also performed on the NHRA-MVC website.

The required registration fee schedule is available on the NHRA-MVC website www.NHRA-MVC.bh.
You cannot proceed beyond this point until the payment is successfully processed by the NHRA-MVC Traceability Hub Administrative team.

STEP 1 – Pre-requisite Collect the Required Identification Numbers from GS1

All MAHs must be registered with GS1 and have a Global Location Number (GLN) and Global Company Prefix (GCP) assigned. Note that later in the registration process for MAH’s, you will need to identify all products by their assigned Global Trade Identification Numbers (GTINs). Keep this information for use in the Product Registration process. Make sure you know the GS1 Global Location Number (GLN) and Global Company Prefix (GCP) assigned to this MAH location.

You can obtain the GLN and GCP using the GS1 Lookup Directory
GS1 Global Trade Identification Number (GTIN) information can be found using the GS1 GTIN Management site.

STEP 2 – Pre-requisite Collect the Required Identification Numbers from NHRA

In addition to registering with GS1, registration applications must be submitted and approved by the NHRA to permit pharmaceutical products to be sold in Bahrain. Payment must be made to the NHRA at the time of registration. The NHRA registration process contains all of the necessary MAH location information. Registration also includes separate applications containing all product information from the country where the pharmaceutical product has been released (COO) with certificate of analysis signed by the responsible qualified person. It must prove the medicine adheres to the quality, safety and efficacy based on the current Bahrain guidelines and procedures.

The NHRA will review all aspects of the MAH and determine its legitimacy and accept payment for registration.
The Pharmaceutical Products Regulation (PPR) Dept members review the scientific aspects of each application and reach a conclusion on the likely balance of any benefits versus risk before arriving at a decision.

All MAH’s need to complete these registrations with the NHRA and have the identification information for their organization ready when they register with the NHRA-MVC Traceability Hub.

Identification Number issued by the PPR and the Identification Number issued to your organization by the NHRA indicating the MAH is registered and approved in the Kingdom of Bahrain.
See the International Manufacturing Site Registration Procedure for obtaining the DUR and MAH Identification Number
For local manufacturing, see Pharmaceutical Manufacturer Licensing Procedure for obtaining the DUR and MAH Identification Number

STEP 3 – Pre-requisite Complete the Participation Agreement Contract with the NHRA-MVC Traceability Hub

All MAH’s, Distributors / Wholesalers and Dispensers must complete a Participation Agreement contract with the NHRA’S NHRA-MVC Traceability Hub before the MAH registration can be completed.

You can find the NHRA-MVC Traceability Hub Participation Agreement contract on the NHRA-MVC website at www.NHRA-MVC.bh
Select the Participation Agreement Request

You will need to provide all required information to identify your organization with NHRA’S NHRA-MVC Traceability Hub. After this information is submitted, you will be contacted by NHRA NHRA-MVC Traceability Hub staff to complete the Participation Agreement. The Participation Agreement is mandatory for all MAH’s and is non-negotiable.

Request Form for Participation Agreement Contract

Information Needed	Comments
Company Name	As shown in GS1 and NHRA sites
Company Address	As shown in GS1 and NHRA sites
City	As shown in GS1 and NHRA sites
State	As shown in GS1 and NHRA sites
Zip Code / Postal Code	As shown in GS1 and NHRA sites
Country	As shown in GS1 and NHRA sites
Time Zone	Time Zone for the MAH location
Name of the Administrative Contact	The person who will sign the Participation Agreement and handle financial payment
E-mail address for the Administrative Contact	The Company issued email address for the person designated as the Administrative Contact
Phone Number for the Administrative Contact	The Country Code plus phone number for the person designated as the Administrative Contact
Number of Manufacturers Registered with NHRA	The number of unique manufacturing sites your company uses to produce the medicines registered with the National Health Regulatory Authority.
Number of Medicines Registered with NHRA	The number of unique medicines your company registered with the National Health Regulatory Authority, including various dosages, strengths, Unit of measures, etc.

The MAH will be expected to provide invoicing information and a payment method for the registration to the NHRA’s, Bahrain Medical Value Chain. The person the MAH identifies as its Administrative Contact must have the authority to execute a contractual agreement on behalf of the MAH and authorize payment to the NHRA’s Bahrain Medical Value Chain (NHRA-MVC) from the MAH.

STEP 4 – Register as an MAH

Once the MAH has completed its NHRA and GS1 registrations, the Administrative Contact must select Registration Link for the MAH Registration. Your NHRA-MVC Traceability Hub Participation Agreement contract (STEP 3 above) must be fully executed before the registration will be finalized by NHRA.

Go to www.NHRA-MVC.bh
Select the Registration Link for MAH’s

MAH Participation Registration Form

Information Needed	Comments
Company Name	As shown in GS1 and NHRA sites
Company Address	As shown in GS1 and NHRA sites
City	As shown in GS1 and NHRA sites
State	As shown in GS1 and NHRA sites
Zip Code / Postal Code	As shown in GS1 and NHRA sites
Country	As shown in GS1 and NHRA sites
Time Zone	Time Zone for the MAH location
Name of the Administrative Contact	The person who will sign the Participation Agreement and handle financial payment
E-mail address for the Administrative Contact	The Company issued email address for the person designated as the Administrative Contact
Phone Number for the Administrative Contact	The Country Code plus phone number for the person designated as the Administrative Contact
NHRA-MVC Participation Agreement Contact Number	Approved Agreement Number you receive from the NHRA-MVC
GS1 Global Location Number	As shown in GS1 look-up site
GS1 Company Prefix	As shown in GS1 look-up site
DUR License Number	As shown in NHRA sites
NHRA Assigned MAH Number	As shown in NHRA sites
VAT #	Provided by your Company
Name of your company Technical Point of Contact (POC)	The person who will act as the Point of Contact (POC) for the technical onboarding of the MAH
E-mail address for the Technical Point of Contact	The Company issued email address for the Point of Contact (POC) for the technical onboarding of the MAH
Phone Number for the Technical Point of Contact	The Country Code plus phone number for the Point of Contact (POC) for the technical onboarding of the MAH
Number of Manufacturers Registered with NHRA	The number of unique manufacturing sites your company uses to produce the medicines registered with the National Health Regulatory Authority.
Number of Medicines Registered with NHRA	The number of unique medicines your company registered with the National Health Regulatory Authority, including various dosages, strengths, Unit of measures, etc.

STEP 5 – Complete the Payment Submission

Process the NHRA-MVC registration fees for MAH’s.

Payment Submission Form

Information Needed	Comments
Company Name	As shown in GS1 and NHRA sites
Company Address	As shown in GS1 and NHRA sites
City	As shown in GS1 and NHRA sites
State	As shown in GS1 and NHRA sites
Zip Code / Postal Code	As shown in GS1 and NHRA sites
Payment Method	Credit card, Invoice #, Purchase Order #
Name of the Administrative Contact	The person who will sign the Participation Agreement and handle financial payment
E-mail address for the Administrative Contact	The Company issued email address for the person designated as the Administrative Contact
Phone Number for the Administrative Contact	The Country Code plus phone number for the person designated as the Administrative Contact
NHRA-MVC Participation Agreement Contact Number	Approved Agreement Number you receive from the NHRA-MVC

Registration Validity Checks

After you have submitted your MAH location information and the required documentation, the NHRA-MVC Administrative team will verify your company and confirm the MAH and its intended products are in good standing with the PPR.

The NHRA-MVC Traceability Hub Administrative team will validate the MAH. The process and steps taken by the NHRA-MVC Traceability Hub Administrative team to validate the MAH within the NHRA are highly confidential and will not be disclosed to protect the integrity of the process and avoid registration tampering.
The NHRA-MVC Traceability Hub Administrative team will also confirm the Participation Agreement contract is fully executed and in place. The Agreement is essential to the relationship between the MAH and NHRA.
The NHRA-MVC Traceability Hub Administrative team will verify the payment method and process the payment made to the NHRA-MVC Traceability Hub.

With successful confirmation and your payment successfully processed, the Administrative Contact and the Technical Point of Contact will receive an email stating the registration is complete and the technical testing will be initiated.