Checking and Sending Registration Documents to the Customer

| 3 minutes

As each registration document is completed or received from the Vendor, RA Dept. will place the documents in each registration folder and send a task to BD Salesperson to check the document. This SOP lists the important points to check in the registration documents and the process on how to send the registration document:

SENDING REGISTRATION DOCUMENTS TO THE CUSTOMER

1. Files to be sent to the Customer must be present in the “Final” sub-folder under the correct registration folder.
2. Registration Documents can only be sent to the Customer via email. If for urgent reasons they are sent over other methods of communications (WhatsApp, Skype), make sure to also send a follow up email and attach the same documents over email.
3. Files that are too big can be sent over WeTransfer with BD Salesperson email as the “Sender”. Make sure to send an email with the link to the WeTransfer and mention the list of documents sent over WeTransfer.

POINTS TO CHECK IN A REGISTRATION DOCUMENT

• General Product Information.
• Registration Applicant and Marketing Authorization Holder (MAH).
• Inclusion of product BRAND NAME in the provided documents.
• Removing of Unnecessary Vendor Information.
• Final Packaging Artwork in the Registration Documents.
• Consistent Details of Product Packaging and Registration Document.
• Documents to be Prepared for Dossier from the Agent.

The important points while checking registration documents above are explained further below:

• General Product Information

Important General Information of the product in a registration document include:

- Product Brand Name (should be the same as packaging)
- Product Generic Name
- Product Dosage/Strength
- Product Packaging
- Shelf Life (if it is consistent with the samples/as informed to the Customer)
- Manufacturer Name and Address
• Registration Applicant and Marketing Authorization Holder (MAH)

In most registrations, the information of Applicant or MAH is needed in the registration document (such as CTD dossier and SmPC) and the application form. Make sure that the Applicant/MAH information is as follows:

1) STANDARD

Applicant: AdvaCare Pharma USA
Address: HK operations address
Marketing Authorization Holder (if required to be filled separately): AdvaCare Pharma USA

2) If the information "USA" is not accepted as the main applicant.

Applicant: AdvaCare International Limited (subsidiary of AdvaCare Pharma USA)
Address: HK operations address
Marketing Authorization Holder (if required to be filled separately): AdvaCare Pharma USA

3) If the applicant has to be of the Country of Origin of product.

Applicant: AdvaCare International (Shanghai) Limited / AdvaCare International India Private Limited (a subsidiary of AdvaCare Pharma USA)
Address: SH operations address / INDIA operations address
Marketing Authorization Holder (if required to be filled separately): AdvaCare Pharma USA

Note: some country MOH does NOT allow manufacturers to be the Applicant/MAH, and only the local representative. In this case, ask for proof such as a formal guideline that provides this statement and send a task to BD Dept. Manager and VP for approval.
• Inclusion of product BRAND NAME in the provided documents

Most product documents such as SmPC, COA, CTD dossier, and even COPP are made on a per registration basis, as much as possible include the product brand name before the generic name in the main parts of the document. For example:

• Removing Unnecessary Vendor Information

Some documents may contain Vendor information that are irrelevant to the document. For example, a COA may contain websites, email addresses or contact details of the Vendor in the header/footer even though a standard COA does not need this information. Ask the RA Dept. to remove the information.

• Final Packaging Artwork in the Registration Documents

Some documents require packaging artwork to be attached in the file, such as CTD Dossier. BD Salesperson needs to make sure to inform RA Dept. the final packaging to attach in the documents, as artwork may be revised after documents have been completed.

• Consistent Details of Product Packaging and Registration Document

Product packaging often contains some basic information of the product such as administration methods and dosage, intended use, etc. As product packaging and registration documents are prepared separately, BD Salesperson needs to work with RA Dept. to make sure that the final information is consistent.

• Documents to be Prepared for Dossier from the Agent

Some dossiers such as CTD Dossier, BE Studies, DMF, etc. can be obtained from the Agent. In this case, RA Dept. will prepare a document with the product information, which will be used by the Agent to create said documents. BD Salesperson is responsible to ensure that the general product information to be provided is correct, so that there will be no discrepancies in the final dossier obtained from the Agent.

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