Introduction
The Veterinary Medicines Unit is a function of the Department of Product Evaluation and Registration which is responsible for ensuring the quality, safety, and efficacy of medicinal products (medicines) intended for use in animals. The Medicines and Related Substance Act, (MRSA) of 2013 defines a medicine means:
1 Any substance, mixture combination of substances manufactured, sold, or presented for use in — the diagnosis, treatment, alleviation, modification or prevention of disease, illness, abnormal physical or mental condition or the symptoms thereof, or restoring, correcting, or modifying any somatic or psychic or organic condition
2 A substance or mixture of substances that is used to manufacture medicine or is sold as a raw material, a pre-cursor chemical or intermediate.
3 A substance or mixture of substances that is used to manufacture medicine or is sold as a raw material, a pre-cursor chemical or intermediate.
4 Any labeled preparation in pharmaceutical dosage form that contains, as active ingredients, one or more substances of natural origin that are derived from plants or animals.
5 Herbal , or homoeopathic, ayurvedic, or other medicine that contains active ingredients and substances of natural origin and may be derived from any part of plants or animals in a pharmaceutical dosage form.
6 Vitamins and minerals prepared in a pharmaceutical dosage form. Any medical device or any premix
To protect animal health and the health of the public, no person shall import, export, manufacture, distribute, sell, promote, advertise, store, or dispense, any veterinary medicinal product unless the VMP is registered / approved by the Authority.
Mandate
- Develop and review the legislation, processes, and requirements for registration of VMPs in Botswana.
- Assess applications for registration, post registration changes, and renewal of VMPs, to ensure compliance with established criteria of quality, safety, and efficacy of medicinal products (medicines) intended for use in animals.
- Establish and maintain a register of all approved veterinary medicinal products and ensure timely updates and publication of this register.
- Administer the proviso for exemption from registration of medicines, to ensure access to urgently needed essential VMPs, in cases where there are no registered formulations, or in cases where registered are not available on the market.
- Collaborate with other strategic partners of the Authority, in all matters related to the regulation of the VMPs supply chain.
- Educate VMP stakeholders to ensure increased awareness to BoMRA, mandate, processes, and its requirements, among other things.
Scope of products
Currently, and in accordance with the MRSA of 2013, the veterinary medicines unit have initiated with the registration of the following medicinal products:
1. Pharmaceutical VMPs, also known as small-molecule medicines,
2. Immunological VMPs, particularly the vaccines
3. Complementary veterinary medicines.
The scope of the VMU may, resources and capacity permitting, be expanded to include other biological VMPs such as biotherapeutics and biosimilars, blood and blood products, as well as antiseptics and biocides for animal use.
The registration of acaricides (dips, sprays, pour-on, and/or spot-on formulations) is currently being handled by the Department of Crop Production under the Agrochemicals Act 35:09. Consultations and dialogue to address the overlap of the legislation and jurisdictional mandates spelled out in the MRSA and Agrochemicals Act are underway.
Personnel
The Unit is headed by a manager, leading a team of assessors from different professional backgrounds including, veterinary surgeons, pharmacists, and other biological science fields.
Currently the assessors are at different levels of knowledge base and experience.
Although, the Unit can assess applications for a range VMPs within their scope,The Authority is still working to enhance capacity to ensure the unit personnel is equipped with adequate knowledge, expertise, and experience to assess applications of varying complexities.
Processes
The listing exercise resulted in the establishment of the BV List, a part of the Veterinary Medicines Register.
In November 2020, BoMRA opened for submission of applications for registration of all other medicines. Where the applicants have fulfilled the quality, safety, and efficacy requirements, the VMP is included in the BOV List, also a part of the Veterinary Medicines Register.
Since the establishment of Veterinary Medicines Register, BoMRA has also introduced the process for submission of applications for authorisation of post MA changes for VMPs. The process for renewal of MAs, shall be implemented in due course, since it is time bound.
Summarised process steps towards submission of applications for registration of VMPs
Applications for registration of veterinary medicines involve the submission of a completed application form, together with a dossier of supporting documents in the CTD format. Applicants should note that the process for submission of applications for registration is a 2-step process. Firstly, the applicant submits the compiled application for assessment of completeness, also called technical screening and ONLY those applications that would have passed the technical screening will then be submitted for scientific evaluation of the application for registration of the VMP. Each of these 2 – process steps have own requisite fees as outlined below. The process has been summarised in the steps below.
Dossiers or applications should be compiled in accordance with the current veterinary medicine guidelines. Applicants are encouraged to refer to the relevant guidance documents for each type of VMP they are applying for, to ensure that they provide adequate supporting information and the required presentation format of their dossiers.
The application fees for veterinary medicines are stipulated on pages C1176 – C1177 of the Medicines and Related Substance Regulation, 2019 Schedule 5. Applicants should ensure that a full amount of the application fee, as quoted, is reflected in, or reaches the BoMRA account if their application is to be processed. All transactional charges should be borne by the applicant. Below is an extract of a few commonly asked fees for the main types of VMP applications:
Type of Product Application | Normal Application Pathway |
Expedited Application | ||
Foreign Manufactured | Partially local | Fully Local | ||
1. Screening Application fee (for all VMPs) | 870 | |||
2. Generic VMP + clinical data – clinical data Line extension | 4530 2360 1275 | 5000 | 2000 | 15190 7690 |
3. New Chemical Entity Line extension | 4530 2360 | 17060 7690 | ||
4. Biologicals (Vaccine) | 10 000 | 16000 | ||
Application Fees are charged using the local currency (BWP).
The applicant completes a service request form and submits to BoMRA using the following email vetmeds.services@bomra.co.bw . A sales quote shall be prepared and send to the client with the appropriate fees for the service required, to ensure that all BoMRA services are paid for prior to service delivery. A receipt will be issued to the Applicant upon verification of receipt of the payment by BoMRA.
The Authority is developing an integrated regulatory information management system (BRIMS) which shall be used once commissioned. All relevant application fees will be pre-defined in the system. The applicant will initiate an application by selecting the required service on the self-service portal. The applicant will complete the application and attach all supporting documentation on the same self-service portal. Once the compilation of the e-submission is complete, but prior to submission, a sales quote shall be autogenerated which will prompt the applicant to pay the requisite application fee.
During the transition period, once the applicant has paid the full amount of the application fee, they will either manually (via RMU) or electronically (via self-service portal) submit their compiled application. Electronic application submission is open 24/7 from any part of the world, whereas manual submission of applications will be open Monday to Friday from 0800 to 1700hrs.
Once the application is verified for completeness by RMU, it will be receipted in accordance with the BoMRA receiving process. The VMU manager will allocate the application to assessors for 1st and 2nd Assessment of Completeness of Applications (Technical screening). The application will then be screened for completeness using the screening checklist and a response of the outcome of the screening will be sent to the client within 60 days of receipt.
Applications that pass screening will progress to the evaluation stage. Communication to this effect will be sent within the stipulated 60-day period.
Applicants will be allowed only one chance to resubmit a complete application (i.e., an updated dossier) with no additional cost to the applicant. Thus, if an application is incomplete and fails the 1st screening stage, a List of Queries (LoQ) will be prepared and sent to the applicant, outlining the missing information required, the deadline for submission of the updated dossier, and a clause that stipulates that, “Failure to submit a complete application and/or within the stipulated 30 Days will result in the application being closed; and if the applicant wishes to pursue the registration of that same product in Botswana, a new application for screening, accompanied by the requisite screening fees shall be submitted to the Authority”.
Resubmitted screening applications will have the same processing TAT of 60 days. The resubmitted applications once received by RMU, will be allocated by the manager for re-screening. Applications that pass screening will progress to the evaluation stage. However, if an application is incomplete and still fails the re-screening stage, communication to this effect, outlining the missing information, and with a clause that stipulates that, “If the applicant wishes to pursue the registration of that same product in Botswana, a new application for screening, accompanied by the requisite screening fees shall be submitted to the Authority” shall be sent to the applicant.
The Authority (BoMRA) assess the scientific information using any of the following evaluation pathways:
Full assessment
This assessment pathway is applicable to all VMP (NCE or Generic) applications submitted upon payment of normal/expedited application fees but with no evidence of registration of such VMPs in those jurisdictions recognised by the Authority in line with the BoMRA recognition/reliance policy and procedures.
Abbreviated assessment
This assessment pathway is applicable to all VMP (NCE or Generic) applications submitted upon payment of normal/expedited application fees, if there is evidence of registration of such VMPs in those jurisdictions recognised by the Authority in line with the BoMRA recognition/reliance policy and procedures. In this case the following procedures will be applied.
Reliance procedure
Where the applicant is required to:
Submit same dossier as in the reference NRA (jurisdiction)
Evidence of registration in the reference NRA
provide a full unredacted assessment report from the reference NRA and,
declaration of sameness of the dossier submitted to the Authority and the reference NRA.
Recognition procedure
Where the applicant is required to just provide evidence of registration of the VMP in the reference NRA, in addition to the full eCTD dossier.
Timelines
Complete applications that contain all the required administration and technical / scientific information ordinarily get registered after 1 or 2 review cycles.
Acknowledging the general principles of FIFO, and unless in the case of a declared animal / public health emergency, the following timelines will apply:
if a product is registered, in a country recognised by BoMRA, an abbreviated assessment pathway shall be employed. With this pathway, a regulatory decision shall be made within 6 to 12 months from date of submission.
in cases where the applicant chose an expedited assessment pathway, a regulatory decision shall be made within 12 months from date of submission.
if it is a locally (partially/fully) manufactured VMP, where there is no evidence of registration from a recognised jurisdiction, a regulatory decision shall be made within 18 months from date of submission.
if it is a fully foreign manufactured VMP, where there is no evidence of registration from a recognised jurisdiction, a regulatory decision shall be made within 24 months from date of submission.
Validity of Marketing Authorisations
VMPs on the BV List
The marketing rights for VMPs on the BV List shall be valid for only 5 years from the initial date of listing, unless extended by way of Public Notice to stakeholders.
Within this 5-year term, MAHs are required to submit compliant applications for full MA / registration of these listed products.
Secondly, MAHs will be required to retain their products on the register in accordance with the defined annual retention process.
At the end of the 5-year term, any listed VMPs for which applications for registration have not been received shall be discontinued.
VMPs on the BOV List
The marketing rights for VMPs on the BOV List shall be valid for 5 years from the initial date of registration.
Within this 5-year term, MAHs are required to retain their products on the register in accordance with the defined annual retention process.
Before the lapse of the 5-year term, within 6 months of expiry of MA, the MA holder is required to apply for renewal of MA in accordance with the defined renewal process.
If by the end of the 5-year term, the application for renewal of MA of any VMP, have not been received, the affected VMP shall be suspended, pending cancellation, from the Veterinary medicines Register.
NB. It remains the responsibility of the Marketing Authorization Holder (MAH) to ensure that the VMP continuously maintains its quality, safety, and efficacy profile throughout its lifetime on the Botswana market.
Key VMP stakeholders
BoMRA foster constant collaboration with other strategic partners to improve on regulatory efficiency. These are some of the key stakeholders in relation to regulation of VMPs.
• Internally: DLE and PVCT on GMP compliance issues preregistration, as well as product quality, safety, and efficacy compliances post marketing.
• Local organisations like DVS, BVSC + profession, BVA, Veterinary Industry, Academia
• Regional collaborative initiatives such as veterinary ZAZIBONA, EAC etc, and
• other individual NRAs e.g., VMD UK, TMDA, MCAZ, ZAMRA, SAHPRA etc
• International organisations such as WOAH, FAO and WHO
Veterinary Medicines Zazibona
Botswana, through the Botswana Medicines Regulatory Authority (BoMRA), is an active and founding member of the Veterinary Medicines Zazibona, a collaborative procedure for Veterinary Medicinal Products (VMP) is a Southern African Development Community (SADC) initiative. Other active SADC MS include South Africa, Tanzania, Zambia, and Zimbabwe.
The collaborative procedure primarily focuses on the joint assessment of dossiers and Good Manufacturing Practices inspections of manufacturers by the active SADC Member States (MS) through the collaborative initiative. The initiative leverages on the lessons learnt as well as the success stories of the Zazibona Collaborative Procedure for human medicines and the success of other regional collaborative initiatives such as the EAC among others.
The Veterinary Medicines Zazibona Collaborative Procedure seek to facilitate with:
reduction of VMP registration timelines in the region,
improving on efficient utilisation of limited resources available in the region, and
ensure sustainable access to quality, safe and efficacious VMPs within the region as well as,
creation of a platform for regional capacity building among other objectives.
Allowing access to a bigger market to the Applicants/Manufacturers
The initiative is currently at its pilot phase, and the focus is to pilot with the joint assessments of only applications for registration of pharmaceutical (small molecule) VMPs. Members of the Veterinary Pharmaceutical Industry interested in participating in the pilot SADC VMP joint assessment procedure should comply with the following requirements:
Call for Expression of Interest (click here)
Letter of access of Proprietary Information (click here)
Intention to submit application form (click here)
Common application form (click here)
SADC (draft) Technical Guidelines on Registration of Veterinary Pharmaceuticals (click here)
QOS (Quality Overall Summary) – assessment template for quality section (click here)
BTIF (Bioequivalence Trial Information Form) – assessment template for the Bioequivalence section (click here).
Frequently Asked Questions
Department of Product Evaluation and Registration
1 .The Department of Product Evaluation and Registration is responsible for processing of applications submitted for registration and / or approval of human and veterinary medicines (including complementary medicines), and medical devices. The aim is to ensure the availability of safe, good quality and effective medical products intended for marketing, sale, and distribution in Botswana.
2 .It is also responsible for the processing of post registration amendments (Variations) made to any registered medical product. The department maintains registers for all the approved products and these registers are accessible to the public. It also provides impartial and objective information to the public / stakeholders with regards to the registration and / or approval processes, in form of guidelines. To view the register and guidelines visit www.bomra.co.bw.
You need to submit a dossier / application to BoMRA, upon payment of the relevant fee, and the dossier will be evaluated by the DPER – Veterinary Unit to determine the suitability (quality, safety, and efficacy) of the product.
The requirements for registration of veterinary medicines have been shared on BoMRA website www.bomra.co.bw. You can access the relevant guidelines on this link
The requirements for registration of complementary veterinary medicines, are different from the guidelines for Pharmaceutical and Immunological veterinary products mentioned above. A specific guideline for registration of complementary veterinary medicines is also available on the website.
Refer to the answer provided in general questions, No. 2 above.
The dossiers for registration of pharmaceutical and immunological veterinary medicines should be in CTD format. These should be submitted as an electronic text-selectable PDF and/or Word Format. However, the dossiers for registration of complementary veterinary medicines shall not be in CTD format. The dossiers shall be compiled in accordance with the current, specific guideline for registration of complementary veterinary medicines, which is available on the website.
BoMRA utilises different assessment pathways depending on:
- the choice of the applicant, and
- availability of evidence of registration of the VMPs in other jurisdictions that BoMRA recognises in line with the Recognition/Reliance Policy and procedures.
Acknowledging the general principles of FIFO, and unless in the case of a declared animal / public health emergency,
- if a product is registered, in a country recognised by BoMRA, an abbreviated assessment pathway shall be employed. With this pathway, a regulatory decision shall be made within 6 to 12 months from date of submission.
- in cases where the applicant chose an expedited assessment pathway, a regulatory decision shall be made within 12 months from date of submission.
- if it is a locally (partially/fully) manufactured VMP, where there is no evidence of registration from a recognised jurisdiction, a regulatory decision shall be made within 18 months from date of submission.
- if it is a fully foreign manufactured VMP, where there is no evidence of registration from a recognised jurisdiction, a regulatory decision shall be made within 24 months from date of submission.
- This timeline is subject to review.
You can send an email to the Veterinary Medicines Unit on registration.vetmeds@bomra.co.bw, stating exactly what you would like to know about the product, quoting the unique reference number assigned by BoMRA. After the commissioning of the integrated regulatory information management system, applicants shall be able to access their accounts, and track or verify the status of their applications online, on the self-service portal.
The applicable fees for registration of veterinary medicines are available on the website. You can access the fees here.
Regulation of Dips is currently done by the Registrar of Agrochemicals, in the Department of Crop Production, Ministry of Agriculture. A process of engagement has been initiated to determine if the regulation of dips should remain with the Ministry of Agriculture or be moved to BoMRA. Any new developments shall be communicated by way of a Notice to all Stakeholders.
BoMRA publishes the register of approved veterinary medicinal products on its website www.bomra.co.bw
The Authority has developed a process for exemption of medicines from registration in accordance with the provision of the MRSA section 23 (3). Refer to the guideline for exemption from registration of VMPs available on the website for more detailed process and requirements.
Yes, provided there are no exclusive distributorship rights declared.
Any medicinal product that is intended for use in or on an animal for the purposes of treatment, prevention, alleviating or diagnosis of a disease, clinical condition or infection by any pathogen should be registered by the Authority in Botswana. If the manufacturer, and / or potential applicant is not aware of the correct classification of their products in terms of the appropriate regulatory path to follow, there is a registrability process that the Authority, has developed. The Guideline and Registrability Application Forms are available on the website.
Yes, there are certain active substances that are prohibited for use in food producing animals. The reasons include the need to promote prudent AMU and management of AMR among other things. For specific details of the molecules of concern, refer to the Stautory Instrument 76 of 2020 and Statutory Instrument 103 of 1987.
No, currently there is no list of critical or essential medicines list for veterinary medicinal products
Currently the Veterinary Medicines ZAZIBONA has made a deliberate decision to invite expression of interests to submit applications for only pharmaceutical (small molecule) formulations, as a pilot project. These were submitted, and the selection was done. However, arrangements are underway to enable submission and assessment of the selected products. Any new developments related to the progress of this process shall be communicated in due course.
