Post approval changes are the amendments made by the manufacturer in the already approved drug or manufacturing site as per the registration.
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.
Changing the shelf life of the registration certificate (RC) by extending or reducing its validity.
Changes like deletion of the manufacturing site involved in the manufacturing of the product.
Services like changes in the manufacturing process, packaging, labelling, or documentation pertaining to the product.
Changing the name of the manufacturer without change in change in constitution
Changing foreign manufacturer address except for location
Changing in address of registered manufacturer in RC without change of location
Addition of manufacturer site involved in product manufacturing
Changes in the pharmacopeial specification of drug ingredients in finish product formulation in RC.
There are three important points that need to be kept in mind while applying for the license:
To begin with, a valid registration certificate of the manufactured product is necessary for the process of license preparation and submission.
Only a CDSCO Authorised Indian agent can submit the application
All the documents should be according to the post approval checklist
During the submission process, manufacturers can experience difficulties if the registration certificate is expired, or if the application is not filed on a timely basis. The process can get tough if a proper justification for changes is not provided. The application could get overruled if these changes impact the quality, safety, efficacy, and stability of the drug. Thus, all the above tips should be meticulously followed.
The CliniExperts professionals have some advice for their clients regarding the licensing and documentation process.
All the documents must fulfil the requirement given in the CDSCO checklist.
A government fee will be applied as per the CDSCO requirement.
If applicable, the NRA approval and justification for post approval change will be required.
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.
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.
Yes, changes in an approved drug can be done by Post Approval Change application. These services can be done with the help of an authorized agent like Cliniexperts. While applying, applicants shall submit a clear statement about the effect of change on quality, stability, validation, animal toxicity & clinical (safety & efficacy) status of the drug.
Yes. There are specific forms to be filled for specific changes.
Form 40 is required for any changes to be made in the registration certificate (Form 41).
Yes. As per the government charges for minor changes is 1800 USD and for major changes is 5000 USD.
If you do not possess a valid RC or have expired RC, you cannot avail of post approval services.