Applications for Renewal of Marketing Authorization of Medicinal Products (COMMON DEFICIENCIES)



THE UNITED REPUBLIC OF TANZANIA

MINISTRY OF HEALTH

TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY




ISO 9001: 2015 CERTIFIED

APPLICATIONS FOR RENEWAL OF MARKETING AUTHORIZATION OF MEDICINAL PRODUCTS

COMMON DEFICIENCIES

These common deficiencies have been prepared to assist applicants intending to submit applications for renewal of marketing authorization of medicinal products to adequately and perfectly compile the dossier in accordance with applicable guidelines. This will avoid queries which results in unnecessary delays in authorizing the re-registration of the products.

The common deficiencies observed in the applications for renewal of marketing authorization are listed below: -

  • Failure to submit products samples;
  • Renewal applications included unapproved variations;
  • Use of inappropriate renewal application form;
  • Application form not dully filled and signed;
  • Failure to include Quality Information Summary (QIS) document
  • Dossier not compiled inline with the current guidelines;
  • Failure to submit Mock up labels, summary of product characteristics;
  • Failure to provide Batch Manufacturing records (BMRs), annual product quality review (APQR), API and FPP specifications;
  • Stability studies conducted inline with climatic conditions of zone ivb (30oC ± 2oC/75% ± 5% ) not submitted;
  • Storage instruction on product labels, summary of product characteristics and package insert is not inline with the current requirements i.e. Store below 300C or Do not store above 300C or Store between 20C to 80C;
  • Measuring cup and package inserts are not included in the commercial pack for oral liquid preparations;
Issued by:
The Director General
Tanzania Medicines and Medical Devices Authority (TMDA),
P.O. Box 1253, Dodoma.
Tel; +255 222 450512/658 445222/777 700002
Fax; +255 222450793
Email: info@tmda.go.tz
Website: www.tmda.go.tz