CDSCO

POST APPROVAL CHANGES

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


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    CliniExperts can act as an authorised Indian agent for any foreign manufacturer or importer applying for the Post Approval Changes in already marketed products. The professional experts assist through all the paperwork during the application process, allowing for a speedy process and results.

    What Are POST APPROVAL CHANGES?


    Post Approval Changes (PAC)are specific changes or alterations that a manufacturer makes to an already marketed or approved products mentioned in the Registration Certificate . Post Approval services are required for those products and the manufacturing sites which are already registered in certificate COS-2 and changes are made concerning the product details or the manufacturing site. The regulatory body involved in PAC services is the Central Drugs Standard Control Organisation (CDSCO)- Cosmetic Division.

    Who Can Apply


    Authorised Indian Agent can apply for the Post Approval Changes on behalf of a foreign manufacturer or an Indian importer.

    Inclusions In Post Approval Change Service

    The eligibility criteria for Post Approval Changes Services are as follows:

    Change in the manufacturing site.

    Change in the legal manufacturer name and address.

    Change in product composition, labelling and specification.

    Change in product composition, labelling and specification.

    Post Approval Change for a typographical error in form COS-2 instead of COS-1.

    The pre-requisite services for PAC-

    Updated GST certificate and IEC Certificate

    Updated GMP cert. /Mfg. license

    Updated product documents such as product formula, specification sheet and artwork.

    The closely related services to PAC-

    Registration Certificate in COS-2

    Registration Certificate in COS-4A

    The farthest related services to PAC-

    Registration Certificate in COS-2

    Registration Certificate in COS-4A

    Essential Tips

     

    The main things to remember during the process of PAC application preparation and submission are:

     

    Accurate information about the required post approval changes is necessary.


    All essential documents like GMP certificate, FSC, GST certificate., product label, composition sheet and specifications must be updated.


    All documents such as specification sheets and product formulas need to be signed and stamped.


    In case of a change in the name of the Indian agent, an Updated Certificate of Incorporation must be issued from the registrar’s office.

     

    The possible problems that might be faced during the application filing and submission process are:


    If the specification sheet and product formula are not signed and stamped.


    If the label does not comply with the labelling manner mentioned in New Cosmetics Rules 2020 If the authorisation from the manufacturer is not apostilling in the country of origin.

    Expert Advise

    The CliniExperts professionals advise their clients regarding the PAC licensing process and documentation. The expert advice includes:

    The labelling of the product should be done as per the requirement mentioned in the New Cosmetics Rules 2020

    All the documents should be in line with the New Cosmetics Rules 2020.

    There should be no non-cosmetic claims mentioned on the label.

    All the addresses, names and other details mentioned on every document should be the same.

    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

    Who can apply for the Post Approval Changes?

    An Authorised Indian agent can apply for the Post Approval Changes and will act on behalf of any foreign manufacturer or importer who needs to make changes to the already approved product.

    What mandatory documents are required foran Indian agent name change?

    The mandatory documents required for the name change process are a Certificate of Incorporation, Importer Exporter Code copy and a GST Copy.

    Will the Registration Certificate number change in the post approval application, or will it remain the same?

    No. The Registration Certificate number will remain the same in the post approval application process.

    Is apostille authorisation from the manufacturer and part-1 required in the post-approval application?

    Ans: Yes. The apostille authorisation from the manufacturer and part-1 is required in case there is a change in the name and address of the Indian agent or the legal manufacturer.

    Which rule is followed to comply with the label of the product?

    To comply with the label of the product, the applicant must follow the New Cosmetics Rules 2020. (Chapter VI- Labelling, Packing and Standards for Sale or Distribution of Cosmetics)

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