FREQUENTLY ASKED QUESTIONS (FAQs)
1. How long does the registration process typically take?
There are currently no specific timelines for the registration of medicines, owing to the current backlog of applications for registration, post-registration amendments and other conflicting obligations. The NMRC is actively engaging with stakeholders and partners to clear the backlog of applications to make provision for the review and assessment of medicine dossiers.
2. What are the requirements for companies outside Namibia intending to register products with the NMRC?
It is important to note that you are required to appoint a local representative for your product(s) in Namibia. The local representative will facilitate communication with the NMRC regarding any particulars related to products from your company. As regulators, it is unfortunately out of our jurisdiction to appoint or recommend a local representative on your behalf.
Should you require assistance in appointing a local representative, you may contact our professional pharmacy bodies/organizations such as the Pharmaceutical Society of Namibia (PSN) (https://www.psn.com.na/index.php/about-us) and Pharmacists Care Association (PCAN) (https://www.linkedin.com/in/pharmacists-care-association-of-namibia-pcan-245386264?lipi=urn%3Ali%3Apage%3Ad_flagship3_profile_view_base_contact_details%3BMy%2FBumXJSOO7QJBTtp8RqA%3D%3D ) about your intention to register medicines in Namibia and your need for a local representative. You may contact them via email at: secretary@psn.com
3. Does one need an import license to import sample products for registration?
No. One does not need an import license to import samples for medicines registration in Namibia. As per the NMRC regulations, only one sample per strength of the product, in the smallest pack size is required for registration purposes.
4. Kindly confirm if Type IN and AN Variations that do not require a new registration certificate, is still exempted from payment, or is N$ 1500 payment now required?
IN and AN variations that do not require changes to registration certificates are exempted from payment.
5. When an applicant has already submitted 2 strengths of a product and they have both passed screening and the application fees have been paid and would like to add another line extension. Do they need to submit a full CTD application- or a line extension amendment.
The applicant will be required to submit a full CTD application and pay screening fee. According to the variation guideline under “15.0 Examples of changes that make a new application necessary”, change in the dose and/or strength of one or more APIs results in the submission of a new application.
6. Is a Bio-Equivalence (B.E) study mandatory?
Yes, a BE study is mandatory in regulatory processes to ensure that a generic drug is equivalent to the innovator/comparator drug in terms of dosage form, safety, strength, route of administration, quality and intended use.
7. If a Bio-Equivalence (B.E) Study can not be provided, can a Bio-waiver be used instead?
A biowaiver in regulatory settings can be considered when a drug product meets specific criteria, allowing you to avoid in vivo bioavailability and bioequivalence studies. This is generally accepted for immediate-release solid oral dosage forms (like tablets or capsules) that rapidly dissolve and have high solubility.
The decision to pursue a biowaiver rather than a bioequivalence (BE) study is based on factors such as:
Drug solubility and dissolution: The drug should be highly soluble and rapidly dissolve in the gastrointestinal tract. (Should be a BCS Class I or III)
Dosage form: Immediate-release solid oral formulations are most likely to qualify.
Excipient compatibility: The excipients used should not impact dissolution or absorption
Drug products having a narrow therapeutic index are excluded from consideration for a BCS-based biowaiver.
8. How many times a year does the Council sit?
The Namibia Medicines Regulatory Council sits four times a year; once every quarter.
9. Does NMRC regulate medical devices?
Currently NMRC does not currently regulate medical devices, except under the following circumstances:
If the device has an active pharmaceutical ingredient, then the device in question, follows the conventional medicine registration route.
For Covid Antigen test kits, that requires NMRC's approval.
The NMRC is currently working on guidelines for regulating medical devices.