INSPECTION & LICENSING

 

The Inspection and Licensing section is mainly responsible for compliance and enforcement of the Medicines and Related Substances Control Act, 2003 (Act 13 of 2003). Licensing and Registration of premises have been introduced in reviewing the applications for licences and issuing the licences is the responsibility for this section. Ensuring that all manufacturers in and outside the country who apply for registration of their products in Namibia and those with registered products in Namibia follow the current Good Manufacturing Practices (cGMP) as outlined in the WHO cGMP guidelines is also one of the activities of this section. 

Compliance and Enforcement

The inspectorate is concerned with compliance and enforcement as its core functions. This involves current Good Manufacturing Practices (GMP) inspections to ensure compliance in the following establishments: manufacturing, testing, distribution, wholesaling and importing of medicines.

Good Distribution Practice shall also be complied with;

  • Good Distribution Practice: is a quality system which ensures that medicinal products are stored and handled consistently under appropriate conditions as required by Council on registration as given in the specifications so that the quality of the product will be maintained during storage and distribution.
  • Compliance verification: this involves compliance verification and investigation activities in the area of medicines as defined in the Medicines and Related Substances Control Act, 2003. This involves collection of samples from distribution outlets for examination to ensure that standards are maintained post registration.
  • Enforcement of the law: This involves activities to ensure compliance with the law regarding the sale and use of medicines as provided for in the Act. The activities involve inspection of pharmacies, dispensing medical practitioners, hospitals and all health facilities.
  • Liaising with customs officers: Visiting all border posts to ensure that only registered medicines are imported and that importation is done by licenced manufacturers and wholesalers/distributors Inspection of general retail outlets: This activity is aimed at ensuring that medicines are sold only by authorized persons and in authorized premises.

Licensing and Registration of premises

The inspectorate manages and issues licences as required in the Medicines Control Act, 2003. The Inspectorate Section is responsible for ensuring that:

  • Wholesalers / distributors of medicines have import/export licences. All health practitioners who are not pharmacists and who intend to sell/dispense have a licence for that purpose from NMRC.
  • Pharmacists who prescribe and dispense medicine schedules other than schedule 1 must have a licence for that purpose.
  • All medicine manufacturers are registered with NMRC All foreign manufacturers comply with cGMP before registration of their products with NMRC and that the level of cGMP is maintained by periodic assessment or inspection of the site as the Council may determine.

Requirements

  • The manufacturing of pharmaceuticals requires compliance with cGMP (current Good Manufacturing Practice).
  • All premises where medicines are manufactured must be registered with the NMRC after payment of the prescribed fee.
  • Import/export licences are granted to registered Manufacturers, Wholesalers and Distributors.
  • Licences are issued for a period of one calendar year and are renewable annually during the first month of the year.

Types of licences/permits

  • The manufacturing of pharmaceuticals requires compliance with cGMP.
  • Procedure for obtaining a License for selling/dispensing of medicine.
  • Application shall be made to Council in the prescribed format and accompanied with the prescribed fee.
  • The business premises shall be inspected to ensure they are suitable for the intended purpose. The business premises shall be inspected to ensure they are suitable for the intended purpose.
  • Change of premises Any change of a registered premise must be approved by Council. 

Inspection of Pharmaceutical Operations

The following inspection types shall be undertaken:

  • Spot inspection: The inspections are conducted randomly during the premises operating times. This is to ensure that premises are trading in compliance with specified requirements. Random checks are carried out to ensure that licensed premises are under the continuous personal supervision of registered persons in line with the relevant legal requirements.
  • Routine inspection: The Inspections unit conducts routine inspections for all regulated entities at least once a year. The frequency of inspections can be increased or reduced based on the risk associated with the premises.
  • Investigative inspection: Investigations may be carried out because of non-compliances identified in the inspection process or using intelligence gathered by BoMRA, other agencies or reported by members of the public. Investigation activities are frequently conducted in conjunction with other law enforcement agencies.
  • Pre-licensing inspection: Inspection checks are conducted to assess compliance with the minimum requirements before issuing of license for operating a pharmaceutical business operation.
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Stephanie Freygang

Inspector
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Solly Angala

Inspector
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Jason Bok

Inspector 
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Lazarus Kalisto

Inspector
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Popyeni Nillenge

Inspector
 
 

 

 

ADVERTISEMENTS

Legislative mandate: Section 24 of and Regulation 16 of the Medicines and Related Substances Control Act, 13 of 2003.

Purpose and Operations

Outlines the regulations for advertising medicines and scheduled substances in accordance with Namibia's Medicines and Related Substances Control Act 13 of 2003. Designed to uphold transparency, accuracy, and safety in pharmaceutical marketing. This ensures that all advertisements meet the required standards set forth by the Act.

Definitions

Advertisement: in relation to a medicine or a scheduled substance, means a written, a pictorial, a visual or other descriptive matter or verbal statement or reference - (a) appearing in a newspaper, a magazine, a pamphlet or other publication; (b) broadcast on television or radio; (c) distributed to members of the public; or (d) brought to the notice of members of the public in any manner, which is intended to promote the sale of that medicine or scheduled substance.

Medicine: a substance or a mixture of substances prepared and used or purported to be suitable for use or manufactured or sold for use in - (i) the diagnosis, treatment, mitigation, modification or prevention of a disease, abnormal physical or mental state, or the symptoms thereof, in humans or animals; or (ii) restoring, correcting or modifying any somatic, mental or organic function in humans or animals; whether or not administered by or through a medical device; (b) a veterinary medicine; or (c) a complementary medicine.

Public: Includes a section of the public concerned with manufacturing, dispensing, selling or administering, or the issue of prescriptions for, medicines or scheduled substances;

REQUIREMENTS

1. Proof of payment

  • N$ 200- 00 per page advertised

2. Cover Letter

  •  Indicate the medicine being advertised.
  • State the purpose of the advertisement.
  • Specify the intended audience for the advertisement.

3. Advertising Material (as per Regulation 16 (4))

  • Product Namibian Registration Number
  • Product Name and Strength
  • Proprietary Name and Manufacturer's Name
  • Product-specific Indications (where applicable)
  • Approved Name and Quantity of Each Active Ingredient:

 For a medicine containing only one active ingredient, the name and quantity should be in lettering the same size as the largest lettering used for the proprietary name and displayed adjacent to it.

 For a medicine containing multiple active ingredients, the name and quantity should be in lettering half the size of the largest lettering used for the proprietary name.

 If a name other than the proprietary name is used, it should be in lettering the same size as the largest lettering used for the proprietary name in the advertisement.

An advertisement of a medicine must be approved by the Council before such advertisement is used to advertise medicine to the public. This medicines are those that do not contain a scheduled substance or contain a Namibian Schedule 0 or a Namibian Schedule 1 substance that are advertised to the public.

 

 

PHARMACEUTICAL AND CLINICAL SUPPLIES PRODUCTS    QUALITY COMPLAINTS REPORTING FORM

 

Purpose and Operations

Outlines the procedures to be followed in reporting quality issues related to medicines and related substances as well as to medical devices. The goal is to ensure that all products maintain high standards of quality and do not pose any risks to patients or the general public.

 

Download Pharmaceutical Products Quality Reporting Form

 

Definitions

Medicine: a substance or a mixture of substances prepared and used or purported to be suitable for use or manufactured or sold for use in - (i) the diagnosis, treatment, mitigation, modification or prevention of a disease, abnormal physical or mental state, or the symptoms thereof, in humans or animals; or (ii) restoring, correcting or modifying any somatic, mental or organic function in humans or animals; whether or not administered by or through a medical device; (b) a veterinary medicine; or (c) a complementary medicine.

Public: includes a section of the public concerned with manufacturing, dispensing, selling or administering, or the issue of prescriptions for, medicines or scheduled substances;

Medical device: means any instrument, appliance, material, machine, apparatus, implant or diagnostic reagent used or purported to be suitable for use for medical or veterinary purposes, and includes a part or an accessory of a medical device.

Quality complaints: means issues or defects related to the safety, efficacy, and integrity of a pharmaceutical product. These complaints can arise at any point during the product's lifecycle, from manufacturing to distribution, and typically concern deviations from expected standards that may compromise the product's quality or safety.

Procedures

1.Identification of the Issue: Any healthcare professional detect any quality concerns related to medicines, medical devices, or related substances (e.g., contamination, incorrect labelling, product defects).

2.Collect Information: Gather all relevant details, including:

  • Product name, batch number, and expiry date.

  • Description of the issue (e.g., contamination, packaging defect, change in colour, change in formulation etc).

  • Details of when and how the issue was identified.

  • The % of the affected quantity over total quantity received from the supplier / manufacturer

3.Complete a Quality Complaint Form: Fill out the regulator's official quality complaint form, which can usually be accessed online or obtained from the regulator’s office.

4.Submit the duly filled Quality Complaint Form: Send the completed form and supporting evidence (e.g., product photos, videos, product samples: a minimum of 200tablets/capsules, minimum of 300mls for liquids, a minimum of 90ml for solution for injection, a minimum of 75ml of powder for injection/oral solution and a minimum of 150g for creams and ointments) to the NMRC via their specified reporting channels such as email the form to: NMRC.Inspectors@mhss.gov.na, and send the sample(s) at the same time to: 

Namibia Medicines Regulatory Council, Inspection and Licensing:

15 Ruhr Street Northern Industry, Windhoek

P / Bag 13366 Windhoek

Tel: 061 203 2410 

5.Investigations: The inspectors will do the investigations, send the samples to Quality Surveillance Laboratory (QSL) as soon as it is received. They will as well reach out to the local representative of the manufacturer to carry out the investigation.

6. Results: Once the QSL release the results to the NMRC inspectors, they will respond to the complainant on the ways forward regarding the complaint.

 The manufacturer is also expected to report their investigation findings to the NMRC inspectors within a reasonable time period, based on the urgency of the complaint.

Follow-Up: Keep a record of the complaint submission and follow up with the regulator if needed for further investigation or feedback.

 

 

 

 

PHARMACEUTICAL WASTE DISPOSAL

Legislative mandate: Section 33 of and Regulation 21 & 33 of the Medicines and Related Substances Control Act, 13 of 2003.

Purpose and Operations


The purpose of these regulations is to ensure the safe and lawful handling, seizure, and disposal of medicines and scheduled substances in compliance with the Medicines and Related Substances Control Act 13 of 2003, as amended by Act 8 of 2007. These provisions safeguard public health by regulating the possession, sale, and disposal of medicines, particularly those that are unfit for use, expired, counterfeit, misbranded, or improperly stored.

Definitions

Advertisement: in relation to a medicine or a scheduled substance, means a written, a pictorial, a visual or other descriptive matter or verbal statement or reference - (a) appearing in a newspaper, a magazine, a pamphlet or other publication; (b) broadcast on television or radio; (c) distributed to members of the public; or (d) brought to the notice of members of the public in any manner, which is intended to promote the sale of that medicine or scheduled substance.

Medicine: a substance or a mixture of substances prepared and used or purported to be suitable for use or manufactured or sold for use in - (i) the diagnosis, treatment, mitigation, modification or prevention of a disease, abnormal physical or mental state, or the symptoms thereof, in humans or animals; or (ii) restoring, correcting or modifying any somatic, mental or organic function in humans or animals; whether or not administered by or through a medical device; (b) a veterinary medicine; or (c) a complementary medicine.

Public: Includes a section of the public concerned with manufacturing, dispensing, selling or administering, or the issue of prescriptions for, medicines or scheduled substances;

REQUIREMENTS

1. Proof of payment

  • N$ 200- 00 per page advertised

2. Cover Letter

  •  Indicate the medicine being advertised.
  • State the purpose of the advertisement.
  • Specify the intended audience for the advertisement.

3. Advertising Material (as per Regulation 16 (4))

  • Product Namibian Registration Number
  • Product Name and Strength
  • Proprietary Name and Manufacturer's Name
  • Product-specific Indications (where applicable)
  • Approved Name and Quantity of Each Active Ingredient:

 For a medicine containing only one active ingredient, the name and quantity should be in lettering the same size as the largest lettering used for the proprietary name and displayed adjacent to it.

 For a medicine containing multiple active ingredients, the name and quantity should be in lettering half the size of the largest lettering used for the proprietary name.

 If a name other than the proprietary name is used, it should be in lettering the same size as the largest lettering used for the proprietary name in the advertisement.

An advertisement of a medicine must be approved by the Council before such advertisement is used to advertise medicine to the public. This medicines are those that do not contain a scheduled substance or contain a Namibian Schedule 0 or a Namibian Schedule 1 substance that are advertised to the public.

 

 

PRODUCTS RECALLS

Overview:

Product recalls in Namibia are regulated by the Namibia Medicines Regulatory Council (NMRC) in collaboration with the Holder of the Certificate of Registration (HCR)/Wholesalers/Distributors/Importers for the medicine. Recalls or withdrawals are initiated when issues concerning the safety, quality, or efficacy of a product arise. The NMRC monitors the recall process to ensure that unsafe products are effectively removed from the market.

 

Download the Medicine Recall/Withdrawal Guidelines

 

Objective:

The primary goal of product recalls is to protect public health by removing medicines from the market that do not meet safety, quality, or efficacy standards. The NMRC works closely with the HCR/Wholesalers/Distributors/Importers to define and implement appropriate recall actions.

Responsibilities of HCR/Wholesalers/Distributors/Importers:

The HCR/Wholesalers/Distributors/Importers is responsible for initiating and managing the recall process. Each HCR/Wholesalers/Distributors/Importers must provide the NMRC with contact details of two authorized individuals who can discuss and execute the recall, even after hours. The HCR/Wholesalers/Distributors/Importers is also responsible for conducting follow-up checks to ensure the success of the recall and implementing corrective actions.

Voluntary Recalls:

Most recalls are initiated voluntarily by the HCR/Wholesalers/Distributors/Importers, who recognizes the problem and takes action. However, NMRC can enforce a recall if the medicine’s registration has been cancelled or if it is being sold illegally in Namibia. If the recall is not performed effectively, NMRC will intervene and ensure the product is removed from distribution, with the cost of this process borne by the responsible party.

NMRC Recall Enforcement:

Scope of Action:

In cases where the recall is deemed inadequate, the NMRC will take direct action to remove the product from sale or distribution. The NMRC’s recall enforcement ensures that unsafe or unauthorized medicines do not remain on the market, protecting public health in Namibia.

Full Accountability:

The HCR must take full responsibility for managing the recall and ensuring its success. This includes monitoring the effectiveness of the recall and taking corrective measures to prevent future issues.

Media Release: 

In the event of a product recall requiring a media release, the NMRC and the Holder of the Certificate of Registration (HCR)/Wholesalers/Distributors/Importers will jointly prepare the content. The release will provide details about the product, explain the issue clearly without causing undue alarm, and advise consumers on the appropriate response. The HCR/Wholesalers/Distributors/Importers is responsible for issuing the media release, but if they refuse, the NMRC will issue it, with all costs covered by the HCR/Wholesalers/Distributors/Importers.

Conclusion:

The NMRC plays a crucial role in safeguarding the public by ensuring that medicines on the Namibian market meet high standards of safety, quality, and efficacy. Through clear guidelines and close collaboration with the HCR/Wholesalers/Distributors/Importers, the NMRC ensures that recalls are handled swiftly and effectively, minimizing risks to public health.

Classes and Types of Recall 

Classes

Class Description Examples
Class I Class I is for defective / dangerous / potentially life-threatening medicines that predictably or probably could result into serious health risk/adverse events or even death.

1. Wrong product (label and contents are different products). 

2. Correct product but wrong strength, with serious medical consequences.

3. Microbial contamination of sterile injectable or ophthalmic product.

4. Chemical contamination with serious medical consequences. 

5. Mix up of some products with more than one container involved. 

6. Wrong active ingredient in a multi-component product with serious medical consequences.
Class II For medicines that possibly could cause temporary or medically reversible adverse health problem or mistreatment.

1. Mislabelling: e.g. wrong or missing text or figures. 

2. Missing or incorrect information - leaflets or inserts. 

3. Microbial contamination of non-injectable, non-ophthalmic sterile product with medical consequences. 

4. Chemical/physical contamination (significant impurities, cross-contamination, particulates). 

5. Mix up of products in containers (“rogues”). 

6. Non-compliance with specification (e.g. assay, stability, fill/weight). 

7. Insecure closure with serious medical consequences (e.g. cytotoxics, child-resistant containers, potent products).
Class III

For medicines that are defective but are unlikely to cause a problem; or which do not comply with the requirements of the Medicines and Related Substances Control Act (Act 13 of 2003)

In terms of the requirements printed packaging material, product specifications, labelling etc.

 

Types

Type Description Action Taken
Type A

This type of product recall is designed to reach all suppliers of medicines (all distribution points) i.e. wholesalers throughout the country and those in charge of hospital services in various regions (private as well as state), retail outlets, doctors, nurses, pharmacists, authorized prescribers, dispensers and individual customers or patients through media release (radio, television, national press etc).

 The product recall letter should be forwarded to distribution points plus through media release.
Type B

This type of recall is designed to reach wholesalers throughout the country, heads of hospital services, retail outlets, doctors, nurses, pharmacists, authorized prescribers and dispensers.

 The product recall letter should be forwarded to distribution points.
Type C This type of recall is designed for specific retail outlets where the product in question has been distributed. Specific telephone calls, recall letters to or representative calling at distribution points to arrange for a return of the product.

 

Inspection and Licensing Contacts