Get Minor Variation For Registered Pharmaceutical Product In Uae

Navigating the process of submitting a Minor Variation for a registered pharmaceutical product can appear daunting. This guide aims to simplify the online form-filling process by providing clear, step-by-step instructions tailored to users with varying degrees of experience.

Follow the steps to complete your Minor Variation application online.

1. Click ‘Get Form’ button to obtain the form and open it in your preferred online editing tool.
2. Fill in the details of the Marketing Authorization Holder (MAH) with their name, address, city, postal code, country, and website.
3. Enter the details of the local distributor including authorized distributor name and store license information.
4. Input the details of the manufacturing site, including site name, date of the latest GMP certification, and registration certificate number issued by the Drug Control Department.
5. List the products affected by the variation, specifying trade name, dosage form, active ingredients, strength, and registration certificate number.
6. Clearly describe the specific variations you are applying for, as per the UAE variation descriptions.
7. Provide justification for any consequential changes that may arise from the variations, if applicable.
8. Specify the precise present and proposed wording or specifications for the changes.
9. Review your application to ensure there are no missing fields and that all required documents are attached.
10. Sign the declaration, including your name, designation, date, and company stamp.
11. Once everything is filled, save your changes, download the form, and prepare to submit it.

Complete your Minor Variation application online today and ensure compliance with regulatory standards.