Basic information
Outline of the system
The Medicine Regulatory Authority (BoMRA) was established through an Act of parliament; the Medicines and Related Substances Act of 2013. The act provides for the regulation of medicines, medical devices, and cosmetics in Botswana in order to promote human and animal health by providing guarantees for quality, safety and efficacy of medicines and medicinal products throughout the supply chain. The department of inspection and licensing through the Import/Export control unit (IMPEX) is responsible for establishing and maintaining an effective and efficient import/export control system for BoMRA to ensure compliance with all Botswana import/export control laws and regulations governing medicines and related substances. A manual permitting system was developed and successfully rolled-out between 2019 and 2020 for the control of imports and exports of human and veterinary pharmaceuticals.
Product coverage
Import/export control Function:
The function provides for issuance of import license/permits for pharmaceutical products. Licenses/permits are issued per "Product Category" i.e. General human medicines, Narcotics and Psychotropics, veterinary medicines, Medicated feed, complementary medicines, cosmetics and medical devices. Licenses/permits are issued according to registration status i.e. registered or exempted products.
Import/export control provides management of the following processes:
(i) Import Permit;
(ii) Export Permit; and
(iii) Transit Permit.
Nature of licensing
Automatic
If Automatic, administrative purpose
Non-Automatic
If Non-Automatic, description of the notified Non-Automatic Licensing regime
Products under restriction as to the quantity or value of imports
BOMRA issuance of licenses/permits is to ensure that only products that are registered or exempted are imported. This also allows for visibility of the supply chain as records are retained for all permits issued further minimizing the importation of substandard and falsified products. Moreover, restriction for Narcotics and Psychotropics through the use of import permits and Quota allocation as set up by the United Nations' International Narcotics Control Board allows for better control of the flow of products that could end up on the illicit market.
Questions for products under restriction as to the quantity or value of imports
See Answers 6.1-6.11.
The system applies to products originating from which country?
The import permit requirement is applicable to all countries around the world. Over the past two years of BoMRA establishment, import permits were issued for import, export or transit for the following countries Argentina; Austria; Bangladesh; Belgium; Canada; Denmark; France; Germany; India; Ireland; Italy; Kenya; Malaysia; Mauritius; Namibia; Netherlands; United Kingdom; USA; Slovakia; South Africa; Spain; Switzerland; Zambia; Zimbabwe.
Expected duration of licensing procedure
Legal requirements
Is the licensing statutorily required?
These controls are established in accordance with the laws and regulations governing Medicines practices and services. The laws and regulations applied are listed below:
• Medicines and Related Substances Act (MRSA) 2013;
• Medicines and Related Substances Regulations (MRSR) 2019;
• The Single Convention on Narcotic Drugs 1961;
• The Convention on Psychotropic Substances 1971;
• The 1988 Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances;
• WHO Good distribution practices for Medicines TRS 957, 2010, Annex 5; and
• WHO guidelines on import procedures for Medicines No.917, 2003, Annex 3.
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
The import permit is regulated under the Medicines and Related Substances Act of 2013. The Act provides for the registration, regulation of the sale, distribution, importation, exportation, manufacture and dispensing of medicines and related substances, and this is not subject to administrative discretion.
Is it possible for the government to abolish the system without legislative approval?
Eligibility of applicants
Is there a system of registration of persons or firms permitted to engage in importation?
Only registered traders are allowed restricted licenses for over the counter and complementary medicines.
What persons or firms are eligible to apply for a licence?
All authorized importers are allowed non-restrictive importing. The licensing unit of the Authority is responsible for licensing of all authorized importers and a database is kept for such.
Is there a registration fee?
Registration is done at a Fee of P1,250.00 per annum.
Is there a published list of authorized importers?
All authorized importers are published in the BoMRA website.
Contact point for information on eligibility
Ministry/Authority
Address
Telephone
Fax
E-mail address
Website
Contact officer
Submission of an application
Administrative body(ies) for submission of an application
Botswana Medicines Regulatory Authority
Documentation requirements
What information is required in applications?
Information required for application include the qualified persons information, premises detail and attachments required are copy of a valid registration card (BHPC/BVSC card), copy of pharmacist's/veterinarian registration certificate, copy of Expiring BOMRA Approval License, at least two references and a brief C.V. of the pharmacist (Pre-licensing), declaration letter for continuous personal supervision by a pharmacist/veterinarian, Private Practice license (For community pharmacy), proof of payment, purchase order, name of exporting country and port of entry.
What documents is the importer required to supply with the application?
Window of submission of an application
How far in advance of importation must application for a licence be made?
N/A.
Are there any limitations as to the period of the year during which application for licence can be made? If so, explain
N/A.
Issuing the license
Can a licence be granted immediately on request?
N/A.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
N/A.
Which administrative body is responsible for approving application of licences?
N/A.
Must the applications be passed on to other organs for visa, note or approval?
N/A.
Are there any other conditions attached to the issue of a licence?
(a) Yes. For the control on the use of such products.
(b) Yes. This is for the packaging and notifying the authority upon importation.
Fees and other administrative charges
Is there any licensing fee or administrative charge?
Yes.
What is the amount of the fee or charge?
An import license for general medicines is P50 and for Narcotics and Psychotropics is P100 while for transit license is P100 each license.
Is there any deposit or advance payment required associated with the issue of licences?
No.
Amount or rate?
Is it refundable?
What is the period of retention?
What is the purpose of this requirement?
Refusal of an application
Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria?
An applicant may be rejected in terms of restricted products such as vaccines for notifiable diseases that needs prior authorization from competent authorities such as Veterinary services. An applicant can be rejected for an unregistered product.
Are the reasons for any refusal given to applicants?
Have applicants a right of appeal in the event of refusal to issue a licence?
An applicant can appeal a refusal for issue of a license
If so, to what bodies and under what procedures?
To the Chief Executive officer or the Minister of health and wellness.
Importation
Are there any limitations as to the period of year during which importation may be made?
N/A.
What documents are required upon actual importation?
The following documents are required upon importation: An import license, an approved purchase order, an invoice and packing list.
(i) In the case of HFDs: - authorized purchase order, valid import permit and corresponding export permit.
(ii) For importation of veterinary medicinal products: - valid import permit and corresponding purchase order.
(iii) Other (human) medicines: - only import permit.
Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
(i) Registration of products;
(ii) Licensing of authorized importers;
(iii) Issuance of trade license;
(iv) Registration of professional.
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
General medicines licenses validity is two (2) months from the date of issue. Psychotropic and/or Narcotics license validity is Six (6) months from the date of issue. No extension is allowed.
Is there any penalty for the non-utilization of a licence or a portion of a licence?
No penalty.
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Not transferable.
Foreign Exchange
Is foreign exchange automatically provided by the banking authorities for goods to be imported?
Foreign exchange is always made available by relevant authorities.
Is a licence required as a condition to obtaining foreign exchange?
Is foreign exchange always available to cover licences issued?
What formalities must be fulfilled for obtaining the foreign exchange?
The following questions are only for products under restriction as to the quantity or value of imports (whether applicable globally or to a limited number of countries or whether established bilaterally or unilaterally)
Where is information on allocation and formalities for licences published? Is the overall amount published? The amount allocated to goods from each country? The maximum amount allocated to each importer? How to request any exceptions or derogations from the licensing requirement?
Only authorized pharmaceutical distributors are allowed to import narcotics and psychotropics in Botswana. This is stipulated in the national legislation; Botswana Medicines and Related Substances Act of 2013 and supporting regulations of 2019. All registered importers are required to submit annual estimates for products to be imported. Moreover, a permitting system is in place to ensure that only approved quantities are imported. Licenses ensure that all distributors account for the amount authorized and brought into the country. These provides a means for adherence to the allocated quota by the country as no importation is allowed without licenses.
Botswana is required to comply with the Treaty Obligations as enshrined in United Nations International Narcotics Control Board's (INCB) 1961 Single Convention on Narcotic Drugs, the 1971 Convention on Psychotropic Substances and the 1988 Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances. In accordance with these conventions, countries are issued with annual quotas for the different controlled substances listed under each of these conventions. The annual quotas are published on the INCB website as Assessments of annual medical and scientific requirements for substances listed in Schedule II, III and IV of the 1971 Convention on Psychotropic Substances and Totals of estimates of annual medical and scientific requirements for narcotic drugs listed in Schedules I and II of the 1961 Single Convention on Narcotic Drugs, as amended by the 1972 Protocol Amending the Single Convention.
All these requirements are communicated with importers through various means of communications such as press releases, emails, letters and phone calls. There are no exceptions or derogations to this requirement.
Is the size of the quota determined: on yearly, six-monthly or quarterly basis? Are there cases where the size of quota is determined on a yearly basis but licences are issued for imports on a six-monthly or quarterly basis? In the latter case, is it necessary for importers to apply for a fresh licence on a six-monthly or quarterly basis?
All INCB country quotas are issued on an annual basis, however, import licenses are issued on demand as long as there is a quota balance for the products required. A license is a single consignment issue hence should be requested with each import.
Are licences allocated for certain goods partly or only to domestic producers of like goods? What steps are taken to ensure that licences allocated are actually used for imports? Are unused allocations added to quotas for a succeeding period? Are names of importers to whom licences have been allocated made known to governments and export promotion bodies of exporting countries upon request? If not, for what reason? (Indicate products to which replies relate)
All authorized imported are given an Acknowledgement Form, BOMRA/IL/IE/P01/F06, to complete and return to BoMRA after importation of all narcotics and Psychotropics within thirty (30) days of receiving consignment together with an export license. This acknowledgement is completed and signed by the authorized person. The acknowledgement is also used to update monthly returns on imports. All unused quota allocations are relinquished at the end of the year. A copy of the licenses is normally sent to the relevant regulatory authority in the exporting country. Upon receipt of import licenses, the exporting country will issue an export license and send a copy to BoMRA, a copy is made and filed while the original is returned with an acknowledgement letter to the exporting country.
From the time of announcing the opening of quotas, as indicated in I above, what is the period of time allowed for the submission of applications for licences?
All quota request is submitted to INCB on 30 June annually for the subsequent year. This allows for the authority to request the submission of quotas by the end of April annually. Once the quota is allocated for the country then importers can immediately apply for importation of the products.
What are the minimum and maximum lengths of time for processing applications?
All licenses are processed within a minimum period of 24 hours and a maximum of 48 hours.
How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
As soon the country quota is issued by the INCB a license can be issued to an importer to bring products into the country.
Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
BOMRA is the competent authority in issues related to importation of pharmaceuticals except for complementary and over the counter medicines sold in general traders who need a trade license. Furthermore, there importers must fulfil tax requirements set by the customs agency.
If the demand for licences cannot be fully satisfied, on what basis is the allocation to applicants made? First come, first served? Past performance? Is there a maximum amount to be allocated per applicant and if so, on what basis is it determined? What provision is made for new importers? Are applications examined simultaneously or on receipt?
Only authorized pharmaceutical distributors are allowed to import narcotics and psychotropics in Botswana. If an applicant is unauthorized, they will not be issued a license. Also, the applicant must have a valid trade license and have submitted a quota estimate.
All new applicants must possess a suitable warehouse and be issued with a license following inspection in order to qualify to import.
In the case of bilateral quotas or export restraint arrangements where export permits are issued by exporting countries, are import licences also required? If so, are licences issued automatically?
N/A.
In cases where imports are allocated on the basis of export permits only, how is the importing country informed of the effect given by the exporting countries to the understanding between the two countries?
No import based on export license only.
Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?
The licenses are issued for products to be imported from external not domestic market. Only products issued with a transit permit cannot be sold in domestic market.