CDSCO
POST APPROVAL CHANGES
Get authorized agent support for all your post approval changes to biological substance for already approved biologicals manufacturing site
Please Fill the Form
CliniExperts functions as an authorized agent in India. It holds a valid Drug Wholesale License in Forms 20B and 21B. With a firm position in the Indian Healthcare market, CliniExperts can help you to act in accordance with CDSCO requirements. The experts provide all the support throughout the filing of post approval changes for your biologicals.
What Are POST APPROVAL CHANGES?
Post approval changes are the changes made by the manufacturer in already approved biological product. These might be changes made in the manufacturing site, process or ingredients used as per the registration certificate (RC).
Who Can Apply
A CDSCO authorized Indian agent can apply for Post Approval Change services. This is done on behalf of a foreign manufacturer who does not possess an established business in the Indian market.
Inclusions In Post Approval Change Service
Changing the shelf life of the registration certificate (RC) by extending or reducing its validity
Deletion of the manufacturing site involved in the manufacturing of the product
Replacement or addition of a manufacturing facility
Change in source/supplier of auxiliary materials/reagents of biological origin (e.g., fetal calf serum, insulin)
Generation of new Master Cell Bank (MCB) from same expression construct with same or closely related cell line
Generation of a new MCB from a different expression construct with the same coding sequence and the same cell line
Change in the controls for the materials and/or critical control steps
Replacement or addition of an analytical procedure
Change in the container closure system(s) for the storage and shipment of the biological substance/product
Change in the source of an excipient from a vegetable or synthetic source to a TSE risk (e.g., animal) source
PAC also include services like changes in the process, packaging, labelling, or documentation. It also includes changing the manufacturer's name, adding manufacturer site involved in the process in RC. It also covers changes in the specification of drug ingredients in final product formulation.
Essential Tips
There are three essential points that need to be considered while filing the license application.
A valid registration certificate of the manufactured product is essential for filing the license.
Following this, only an Authorized Indian agent must submit the application.
Finally, all the documents should be in order with the post approval checklist.
Difficulties can be experienced if a proper justification for changes is not provided. There can be trouble if these changes impact the quality, safety, efficacy, and stability of the drug.
During the submission process, manufacturers may face issues if RC is expired and/or the application is not filed on a timely basis.
Application must thus be made keeping all these roadblocks in mind, which will help ensure a smooth PAC application and fast approval.
Expert Advise
The professionals have some advice for their clients regarding the license processing:
All the documents must be in accordance with the CDSCO checklist.
A compensation fee by the government will be taken as per the CDSCO requirement.
If applicable, the NRA approval and justification for post approval change will be required.
Primary Service
CliniExperts offer strategic planning services for product registration. In addition, they also assist in finding distributors and act as an authorized agent as well. Our hand in glove approach ensures that at no point you find yourself battling with any process by yourself.
Who Can Apply
The applicant who wishes to store, distribute and sale the drugs in wholesale can apply for wholesale License. The person should be a Registered pharmacist (RP) who have a degree or diploma in pharmacy from a recognized university. Further, arrange one person with same competency for it.
Frequently Asked Questions
Can we amend the approved manufactured biological product?
Yes. Amendments in an approved product can be done by post approval change services with the help of an authorized agent.
What are the requirements for form 40?
Form 40 is required for any changes to be made in the registration certificate (Form 41)
Does the application for post approval changes include a fee?
Yes. As per the government for minor changes 1800 USD and for major changes 5000 USD is charged.
What kind of problem can be faced while filing an application?
If you do not possess a valid RC, of have expired RC you cannot avail for post approval services.
Is there any form used for post approval applications?
Yes. There are specific forms to be filled for specific changes, in the type of post approval application.