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Are you a manufacturer of cosmetics or any other product in the market and looking for the Post Approval Changes For Cosmetics then you are right page. Here you will get to know about “what is post approval changes and how can you apply for this?”
It is mandatory to have if you are making any changes in already marketed or approved products. So, with the help of the experts, you will get to know about the cosmetics post-approval changes.
Post Approval Changes (PAC) are modifications, alterations, or changes made by the manufacturers in already marketed or approved products. Changes are done as per the CDSCO (Central Drugs Control Organization), as per the registration certificate.
Here we consider cosmetics products because due to heavy demand innovations in products are done by manufacturers. Due to changes in demand & trends, consumers’ priorities also change.
Cosmetic manufacturers must be updated with changes to maintain quality and safety standards and build customer trust. The changes can be made in manufacturing sites, product composition, labelling, packaging, or specifications.
A post-approval change management protocol indicates specific changes the company wants to implement on the lifecycle of the product. They ensure how this product will be prepared and verified.
If you fall in any of the mentioned categories then you can simply apply for the post approval changes for cosmetics. It is necessary to obtain if you are making any changes in your current market product of cosmetics.
To get the PAC approval for the cosmetics license required essential documents. It ensures the alteration proposed as per the regulatory standards. The list of documents that are mandatory to attach are as follows. Make sure that all the documents are updated as per the guidelines:
The key points to remember for ensuring seamless and successful processing are as follows:
All the information provided must be correct
Labelling must be as per Cosmetic Rule 2020
Proper signed and stamped documents like product formula and specifications sheet
Additional documents
ELT Corporate is a team of experts that provides better consultancy for any kind of registration that is mandatory to have. The experts will guide you about which license is mandatory for you according to your business and needs. We will notify you about the documents that are required before applying and file an application for your required license or services.
Central Drug Standards Control Organization is the regulatory body that governs all the PAC services.
Post Approval Changes (PAC) can be made in Drugs, Cosmetics, Medical Devices, Biological Products etc.
The post approval regulatory affair is for maintaining compliance and ensuring the consumer about the quality, safety and efficiency of the product.
