Medicines Evaluations and Registrations

 

Introduction:

All medicines (for humans or animals) to be distributed, sold and for use in Namibia should first be registered or authorized by the Namibia Medicines Regulatory Council (NMRC).

Overview:

Registration of medicines is the focal point of any regulatory framework. The medicines evaluations and registrations Division of the NMRC is responsible for reviewing the safety, quality and efficacy of medicines and related substances submitted for the registration in terms of section 19 of the Medicines and Related Substances Control Act, Act 13 of 2003, regulations to the Act and NMRC registration guidelines. In addition it also reviews all post registration amendments (variations) made to any registered medicines and related substances. Those in need of applying for registration of medicines in Namibia are guided to download and acquaint themselves with the registration guidelines, application forms and the legal requirements.

Registration Process

 

Applications for registration of human medicines involve the submission of a completed application form together with a dossier of supporting documents in the Common Technical Document (CTD) format.

While, applications for registration of Veterinary medicines involve the submission of a completed application form together with a dossier of supporting documents in the format known as VMRF or the Common Technical Document (CTD) format.

All application for registration should be accompanied by the dossier

  • Electronic submission of documentation (CD or DVD) should be submitted for all CTD modules (1-5) or all VMRF parts in text-selectable PDF format and in Microsoft Word (required for templates/summaries, e.g. QOS–PD, BTIF, BW). Applicant are required to submit only Module 1 of the CTD AND Part 1 of the VMRF in hard copy and the rest of the modules including module 1 or part 1 should be submitted in CD or DVD.
  • Three samples of the smallest pack size for human products and one samples for veterinary products.
  • Screening fees. All fees are stipulated in the statutory fees schedule published in 2016, they can be downloaded here.

Registration steps:

  1. Medicine application dossiers are received and screened for completeness using the appropriate screening checklist and a response of the outcome of the screening will be communicated to the applicant within 30 days of receipt.
  2. Applications that pass screening will require payment of application fee to be allocated an application number and progress to the evaluation stage. In the event that an application is incomplete and fails the screening stage, the applicant can re-submit a complete application at a later date. This re-submission will incur another screening fee.
  3. A detailed review of the dossier is done and a report is generated. Deficiencies, missing information etc. is communicated to the applicant and a deadline to respond to queries outlined (i.e. 90 days from the date of the letter for applicant to respond).
  4. Completed evaluation reports and recommendations are forwarded to the Pharmaceutical and Analytical Committee of the NMRC or in case of Veterinary medicines to the Veterinary Medicines Committee of the NMRC.
  5. Products approved by NMRC based on the recommendations of the Pharmaceutical and Analytical Committee or the Veterinary Medicines Committee are allocated a registration number and gazetted. The product is then entered into the Medicines Register and notification of registration communicated to the applicants.
  6. Recommendations from these committees to Council may define whether a product is to be registered or not.

 

Alternative Registration/submission pathways

  1. Expedited “Fast-track? Registration Procedure

The Council may fast track review of applications for products as contemplated under regulations 45. Evaluation of the application within 6 months of NMRC time is guaranteed with this pathway.

More resources are outlaid towards processing applications submitted through the expedited review pathway thus higher fees are prescribed in the current fee schedule.

  1. WHO Collaborative Registration Procedure

This is a WHO Collaborative Registration Procedure for prequalified products. This collaborative procedure serves to facilitate and accelerate registration of products which have already been assessed and prequalified by WHO Prequalification Team-Medicines (WHO/PQTm). All applicants with WHO prequalified products are encouraged to use this route. With this pathway, finalisation of the application within 90 days of NMRC time is guaranteed.

Applicants wishing to use this route should submit an expression of interest and notify WHO PQ of their intention to use this procedure for registration of a particular product as outlined on the WHO PQ website.  

  1. ZAZIBONA

ZAZIBONA is a SADC collaborative registration initiative among the nine actively participating national medicines regulatory authorities (NMRAs), namely Botswana, Democratic Republic of Congo (DRC), Malawi, Mozambique, Namibia, South Africa, Tanzania, Zambia and Zimbabwe. The remaining seven SADC Member States participates in the collaborative process as non-active members, because they do not contribute assessment report but use the reports from the process in their country regulatory processes. The objective is to facilitate access to good quality medicines through work-sharing in assessment of applications for registration and inspection of manufacturing and testing facilities. Products that meet the assessment criteria are then granted registration in the participating countries. Where countries agree that it is necessary, variations to the products which have been registered under this collaboration may be handled through the same process.

The ZAZIBONA collaboration does not replace the need to submit applications for registration in participating countries in line with national requirements and final national registration decisions are the responsibility of individual participating authorities. Both new applications and applications in the pipeline are eligible for consideration under the procedure provided that the product application has been submitted to at least two of the participating countries and in the CTD format.

Applicants interested in having their products assessed under the ZAZIBONA initiative should indicate the registration pathway as ‘ZAZIBONA’ on their cover letter and indicate the list of country in which the same application has been submitted.

Retention of Products

Products successfully registered by the NMRC are gazetted and added to the medicines register(s). An annual retention fee is required for every registered product in line with the statutory fee schedule. Please note that retention fees should be paid before or by 31st March each financial year, failure to pay results in the removal/deregistration of the product.