CDSCO

POST APPROVAL CHANGES

Get authorized agent support for all your post approval changes to biological substance for already approved biologicals manufacturing site


BIOLOGICAL
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    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. At CliniExperts, all the support will be provided by the expert professionals throughout filing of post approval changes for your already approved and manufactured biological products.

    What Are POST APPROVAL CHANGES?


    Post approval changes are the changes, or any variations made by the manufacturer in the already approved biological product such as vaccine, r-DNA, or stem cell. These might be changes made in the manufacturing site, process or ingredients used as per the registration certificate (RC).

    Who Can Apply


    A CDSCO authorised local Indian agent can apply for Post Approval Change services on behalf of a foreign manufacturer who does not possess an established business in the Indian market.

    Inclusions In Post Approval Change Service

    Post approval change includes services like :

    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 and/or manufacturer of the bulk biological substance, the starting material or any intermediate of the biological substance

    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 the same expression construct with same or closely related cell line; or generation of a new MCB from a different expression construct with the same coding sequence and the same cell line; or adaptation of a MCB into a new fermentation medium

    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

    In addition, PAC include services such as changes in the manufacturing process, packaging, labelling, or documentation pertaining to the product. Besides that,it also includes services like changing the name of the manufacturer, changing foreign manufacturer address except for location, and addition of manufacturer site involved in product manufacturing in RC. Additionally, any changes involved in the pharmacopeial specification of drug ingredients in finish product formulation in RC.

    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 the process of license preparation and submission.


    Following this, only an Authorised 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 can experience problems if the registration certificate is expired and/or the application is not filed on a timely basis.

    The application must thus be made keeping all these potential roadblocks in mind, which will help ensure a smooth PAC application and rapid approval.

    Expert Advise

    The professionals at CliniExperts have some advice for their clients regarding the license processing and documentation.

    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

    Wholesale License (Form 20B, 21B)

    Regulatory Body: SLA   Application Forms: Form 19

    CliniExperts offer strategic planning services during product registration in addition to finding distributors and acting as an authorized agent in India. 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 cn apply for wholesale License. The person should be a Registered pharmacist (RP) who have a degree or diploma in pharmacy from a recognized university or competent person (CP). 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.

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