Veterinary Medicines
Ensures the safety of medicines used in animals
Overview
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:
Any substance, mixture combination of substances manufactured, sold, or presented for use in
i. the diagnosis, treatment, alleviation, modification or prevention of disease, illness, abnormal physical or mental condition or the symptoms thereof, or
ii. restoring, correcting, or modifying any somatic or psychic or organic condition; or
Any controlled substance, to..
Any controlled substance, to the extent that it complies with paragraph (a).
A substance or mixture of..
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.
Any labelled preparation in..
Any labelled preparation in pharmaceutical dosage form that contains as active ingredients, one or more substances of natural origin that are derived from plants or animals.
Herbal tea, or..
Herbal tea, or homoeopathic, ayurvedic, or other, medicine that contains as active ingredients, substances of natural origin, and may be derived from any part of plants or animals in a pharmaceutical dosage form.
Vitamins and..
Vitamins and minerals prepared in a pharmaceutical dosage form.
Any medical..
Any medical device; or
Any premix.
Any premix.
Mandate
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:
- Pharmaceutical VMPs, also known as small molecule medicines,
- Immunological VMPs particularly, the vaccines
- 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 spelt out in the MRSA and Agrochemicals Act are underway.
Processes
The Botswana Medicines Regulatory Authority, BoMRA, at inception started off with listing of VMPs that had been on the market based on legitimate authorisations previously issued from the Department of Veterinary Services. 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.
Compilation of applications or Dossiers
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.
Payment of requisite application fees
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 | Foreign Manufactured | Partially local | Partially local | Expedited Application |
|---|---|---|---|---|
| Screening Application fee (for all VMPs) | 870 | 870 | 870 | 870 |
|
Generic VMP + clinical data - clinical data Line extension |
- 4530 2360 1275 |
5000 | 2000 |
15190 - - 7690 |
|
New Chemical Entity Line extension |
4530 2360 |
5000 | 2000 |
17060 7690 |
| Biologicals (Vaccine) | 10 000 | 5000 | 2000 | 16000 |
Manual Process
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 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.
Automated Process on BRIMS
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.
Submission of applications for registration of VMPs
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. Click here to complete the online sample submission form.
3.1. Assessment of Completeness of Applications (Technical Screening)
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.
a. Passed Screening:
Applications that pass screening will progress to the evaluation stage. Communication to this effect will be sent within the stipulated 60-day period.
b. Failed 1st Technical Screening Cycle:
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”.
c. Failed 2nd Technical Screening Cycle:
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.
3.2. Assessment of Scientific Information and registration timelines
The Authority (BoMRA) assess the scientific information using any of the following evaluation pathways:
a. 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.
b. 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:
i. Submit same dossier as in the reference NRA (jurisdiction)
ii. Evidence of registration in the reference NRA
iii. provide a full unredacted assessment report from the reference NRA and,
iv. 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:
01
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.
02
In cases where the applicant chose an expedited assessment pathway, a regulatory decision shall be made within 12 months from date of submission.
03
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.
04
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
1. 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.
2. 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.
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
1. 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.
2. 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
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:
01
Call for Expression of
Interest
02
Letter of access of Proprietary Information
03
Intention to submit application form
04
Common application
form
05
SADC (draft) Technical Guidelines on Registration of Veterinary Pharmaceuticals
06
QOS (Quality Overall Summary) – assessment template for quality
section
07
BTIF (Bioequivalence Trial Information Form) – assessment template for the Bioequivalence section