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Procedure For Submission ofan Application for Renewal of Registration ofa Pharmaceutical Product for Human Use

Regulatory Authority:

National Drug Authority (NDA)

Local Authorised:

Yes

Classification:

Generic Drugs, Biologics, New Drugs

Registration Timeline:

6-12 months

License Validity:

5 Years

Valid up to:

6 Months

1. Responsibility and Language:

a) The Marketing Authorization Holder (MAH) is responsible for applying for the renewal of product registration.
b) The application should be in English, and certified or notarized English translations must accompany any documents in other languages.
c) A complete index to various appendices must be included in the application.
d) Summaries should be in Word format, and body data in PDF format with bookmarks and OCR readability.
e) All pages should be numbered as “page x of y.”
f) The application, including required documents, should be submitted on a CD-ROM addressed to the Secretary to the Authority, National Drug Authority.
g) A separate application is needed for each registered product.

2. Application for Renewal of Registration:

  The renewal application must be submitted at least 90 days before the registration expires.

  The application should include:

a) A consolidated report of changes made to the registered drug or preparation, vaccine, or other immunological products during the validity of its registration, whether reported to the Authority or not.
b) A report of additional adverse drug reactions detected during the lifetime of the registered product.
c) One sample of the registered product.
d) Specimens of the current package insert and copies of coloured mock-up labels.
e) For prescription medicines, the application should be accompanied by a Summary of Product Characteristics (SmPC).
f) Patient information leaflet for pharmaceutical preparations with potential for long-term use.
g) Submission of periodic post-marketing surveillance and safety studies as per current requirements.

3. Additional Information:

If the submitted information is insufficient, the Authority may request additional information necessary for the renewal.

The applicant may be requested to provide complete and accurate additional information up to three times. If the information remains inadequate, the renewal application may be rejected, requiring a re-application for registration.

4. Post-Renewal Variation to Pharmaceutical Products:

All variations to a registered pharmaceutical product must follow the requirements outlined in the Application Guidelines for Variation of Registered Medicinal Products.

5.Assessment and Validation:

Upon submission, the National Drug Authority (NDA) will assess the information provided in the renewal application.

The manufacturer may present proforma invoices for importing raw and packaging materials based on the assessment results, facilitating startup production trials.

The manufacturer can manufacture at least three consecutive batches for validation purposes.

Process validation is crucial to establish the consistency of meeting quality attributes and process parameters. It should be documented, considering the product life cycle.

6.Stability Studies:

Batches manufactured for process validation should be of the same size as intended commercial scale batches, and their shelf life should not exceed 24 months.

Accelerated stability studies should commence with conditions set at 40°C ± 2°C, 75% RH ± 5% RH for 6 months.

After completing process validation, the manufacturer should initiate stability studies on samples from the manufactured batches.

7.Post-Manufacturing Information Assessment By NDA:

The manufacturer submits executed batch records, reports of validation, and finished product samples for a minimum of three consecutive batches to NDA.

NDA assesses the information for correctness and completeness, conducts sample analysis, and informs the manufacturer of the assessment results.

If all batches meet the required specifications, NDA grants pre-marketing authorization, allowing the manufacturer to sell on the Uganda market.

8.Post-Authorization Procedures:

The manufacturer proceeds with accelerated and long-term stability studies.

After production of not more than six batches or within six months from pre-marketing authorization, the manufacturer applies for product registration.

NDA evaluates the product dossier and registers the product if all submitted information complies with registration guidelines.

A new pharmaceutical product cannot be on the market beyond six months from pre-marketing authorization or beyond the production of the sixth batch without registration.

 This procedure ensures a thorough and systematic approach to the renewal, validation, and post-authorization processes for pharmaceutical products in Uganda.

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