Zambia- Statutory law - Animal health
Animal Health
Zambia
SUMMARY
The law defines operative terms such as veterinary practice, veterinarian, veterinary para-professional, community animal health worker and related terms. Although the law establishes the Veterinary Statutory Bodies , such as the Veterinary Council and the Veterinary Association, and indicates their competences and functions, these functions, in certain cases, seem to overlap (e.g. development of standards of qualification, promotion of good practice and maintenance of high standards in the veterinary profession). Performing functions of a veterinarian without registration is a criminal offence. Persons must notify the proper authority immediately or forthwith in case of knowledge or suspicion of an infectious or notifiable disease, and the competent authorities can then appoint veterinary inspectors in order to take needed action. The law authorizes the Minister, in consultation with the Director, to declare an area to be a disease-free zone, and to undertake all the necessary measures such as regulating movement and transportation of people, animals and conveyance within, in and out of the zones. There is no provision for the formulation of a contingency plan, but the Minister can declare an animal disease emergency in certain cases. The law requires the competent authority to prepare and publish lists of animals that require a health certificate or permit before they may be imported into Zambia. Depending on the product and disease, the law enables different authorities to issue the proper certificate (the Director of Veterinary Services or a Veterinary Officer), and empowers the Minister to provide for the regulation of the importation of animals and related products. The Border Management and Trade Facilitation Act refers to generic temporary measures that a border authority may take in the interest of public safety and public health. The Stock Disease Regulations refer to the certificate and the statement of a foreign veterinary on whose opinion the importation of specified animal products is allowed, but only in the case of East Coast Fever and African Swine Fever. The law mentions a register of approved veterinary medicinal products, and provides for a prescribed list of veterinary medicinal products that the Authority may authorize a person to sell. The law allows for cases in which the authority may delegate its powers and functions to other actors, such as committees or authorities.
REGULATION OF THE VETERINARY PROFESSION
GENERAL PROVISIONS
The Animal Health Act includes semi-domestic and captive wild animals in the definition of livestock, while the Veterinary and Veterinary Para-Professions Act excludes birds, fishes, reptiles and amphibians from the definition of animal. Both Acts define the terms related to the veterinary practice that can be performed by veterinary surgeons and veterinary para-professionals, required by law to be registered. Performing functions of a veterinarian without registration is a criminal offence and committing alteration, fraud, false representation, forgery and other offences against registered veterinary surgeons and veterinary para-professionals is a more serious criminal offence. The Veterinary Association of Zambia regulates the veterinary professionals, including their registration. A veterinary surgeon can be appointed “veterinary inspector” by the Director to undertake designated official duties on behalf of the Department for a specified period and location.
The Veterinary Council has jurisdiction over both the public and private sectors of the Veterinary Profession. The Council has mandate to regulate the Veterinary profession, promote, ensure improvement and maintenance of quality veterinary services. It includes, as public officers, a Director responsible for veterinary services, a Deputy Director responsible for veterinary services, veterinary officers, tsetse control biologists, animal scientists and other staff from the Department within the Ministry responsible for livestock development.
The Ministry of Fisheries and Livestock has infrastructures for managing diseases and animal health, which includes forensic laboratories used by both the Ministry of Livestock and the DNPW under the Ministry of Tourism. The Department for Livestock Development, among other responsibilities, regulates the provision of veterinary services and collects, analyses and presents data related to the livestock sector, and certifies veterinary services. Other administrative functions that require a registered veterinary are provided for in the Animal Health Act. The law specifies exceptional circumstances in which functions, usually performed exclusively by registered veterinarians, may be performed by other people, such as the training of a trainee under direct supervision, or in the event of a contagious animal disease that can be transmitted to human beings. The law indicates basic educational requirements for practising as veterinarians, additional requirement may be further prescribed by regulations. The law allows for the suspension and revocation of registration in specific circumstances and their consequences; where the registration of a veterinary surgeon is cancelled, the practising certificate held by the veterinary surgeon shall be void and shall be surrendered to the Veterinary Council.
VETERINARIANS
The law generically defines the functions to be performed without making a clear distinction between veterinary and veterinary para-professionals, and refers to Ministerial statutory instruments to better regulate and clarify it. It mentions the need of a diploma or a qualification from a training institution recognized by the Veterinary Council of Zambia. It is an offence to perform functions of a veterinary or veterinary para-professional unless registered according to the provisions of the Veterinary and Veterinary Para-Professions Act 2010. The Veterinary Association should raise the character and status of the veterinary and veterinary para-profession and allied disciplines to promote honourable and good practice, and increase the confidence of the community in persons practising in the profession and allied discipline, but specific training to indigenous people or local communities is not provided for. The Association shall principally register veterinary and veterinary para-professionals, and regulate their professional conduct while the Council shall promote an understanding of professional ethics among veterinary and para-veterinary professionals, participate in the development of veterinary practice standard setting and maintain appropriate practice standards among veterinary and para-veterinary professionals that are consistent with the principle of self-regulation and the promotion of high standards of veterinary services. In addition to functions performed by veterinary and para-veterinary professionals, the Animal Health Act provides for exceptional cases in which an owner or occupier of land or premises may be ordered to perform certain actions and/or undertake specified measures in disease emergence situations to eradicate, contain or restrict the spread of the disease. In other exceptional circumstances, an Order may require an owner to vaccinate their animals against specific diseases with the help of a veterinary assistant who shall enter the vaccination dates and farmer cards into the stock register.
The law prescribes minimum qualification requirements for a veterinary para-professional. It further provides for the Minister's discretionary powers to prescribe the qualification requirements for registration of veterinary surgeons and other categories of professionals. The Veterinary Association accredits universities, technical colleges, institutions and programmes of instruction leading to the award of qualifications of veterinary and veterinary para- professionals; the Council issues the applicant with the temporary certificate of registration and indicates the conditions under which a holder of a provisional certificate or a temporary certificate may receive a certificate of registration. The Minister may, by statutory instrument, on the recommendation of the Council, prescribe the qualifications for registration; the categories or classes and the scope of practice for veterinary surgeons or veterinary para-professionals registered. However, the Ministerial Regulations specifying these requirements are not yet in place. The law stipulates the conditions under which the registration of a veterinary surgeon or veterinary para-professional and a practising certificate may be cancelled. The Minister has discretionary powers to prescribe, through a statutory instrument, qualifications for registration of veterinary surgeons. Criminal sanctions are in place for violation of the law, and the Veterinary and Veterinary Para-Professions Act provides for administrative disciplinary measures.
VETERINARY PARA-PROFESSIONALS
The Veterinary and Veterinary Para-Professions Act 2010. generically defines the functions to be performed without making a clear distinction between veterinary and veterinary para-professionals, and refers to Ministerial statutory instruments to better regulate and clarify it. It mentions the need of a diploma or a qualification from a training institution recognized by the Council. It is an offence to perform functions of a veterinary para-professional unless registered. The Veterinary Association should raise the character and status of the veterinary and veterinary para-profession and allied disciplines to promote honourable and good practice, and increase the confidence of the community in persons practising these professions, but specific training to indigenous people or local communities is not provided for. The supervisory framework for veterinary professionals and para-professionals consists of a Code of Ethics, which the Council adopts and enforces for the professional practice and conduct of all veterinary professionals and para-professionals. Criminal sanctions are in place for violation of the law, and part VII of the Veterinary and Veterinary Para-Professions Act provides for administrative disciplinary measures.
SURVEILLANCE AND MONITORING
NOTIFIABLE DISEASES
A notifiable disease is defined as an animal disease or other disease that fulfils one or more of the following conditions and which the Minister may, by statutory instrument, declare that it: (i) is not indigenous or native to Zambia; (ii) spreads rapidly with serious socio-economic consequences; (iii) is of major importance in the international trade of animals or animal products; (iv) is common to human beings and animals; or (v) for which any general or particular control measures have been prescribed. The Director of the Department for Veterinary Services shall formulate a list of notifiable diseases, and the Minister has the power to declare by statutory instruments an animal disease emergency under conditions listed in the law. The law provides for notifiable diseases that are mandates of the veterinary office and the Government to manage.
Screening is mandatory for disease detection, including of wildlife. It is duty of the local authority or medical officer of health to give notice of the disease outbreak in writing to the owner or occupier of the building in order to prevent or check infectious disease. The Public Health (Infectious Disease) Regulations gives instructions to the Authority in order to notify the chiefs, headmen and people residing in any town, village or district that it is their duty to report all cases of sickness or death among rodents.
It is compulsory for the owner to: notify the proper authority immediately or forthwith in case of knowledge or suspect of an infectious or notifiable disease; keep such animal separate from other animals that are not infected; prevent the movement of such animal outside the infected area; and prevent the sale of the infected animal. The owner of the carcass of any stock that died of any disease shall take all reasonable steps to ensure that no person other than a Veterinary Officer shall mutilate such carcass in any way and to forthwith dispose of it by burial at a depth of not less than six feet. Criminal sanctions are imposed in case of violations, including failure to comply with notifiable disease requirements or other offences related to matters of notifiable diseases.
VETERINARY INSPECTION
The law empowers the Director responsible for veterinary services to appoint veterinary inspectors of animal health facilities in order to take needed inspection actions and to ensure compliance with veterinary legislation.
In order to control or prevent the spread of diseases, veterinary inspectors and veterinary officers are empowered to: access to premises and vehicles for carrying out inspection; seize, re-call, destroy, detain, treat or otherwise dispose of any animal, animal product, animal by-product, article or animal feed; obtain any sample as the veterinary officer considers necessary; order any person to produce for inspection, or for purposes of obtaining extracts or copies, any book, document or other information concerning any relevant matter; suspend one or more activities or temporarily, partially or completely close an inspected premises; suspend or withdraw any permit, relating to any premises; and order the assembly of animals for inspection or inoculation.
The Council shall appoint veterinary professionals and para-professionals as inspectors of animal health facilities, which shall be inspected prior to the issuance of a licence and at least every 24 months thereafter. Inspectors have the power to inspect or close premises used as animal health facilities when they violate their licence terms. A veterinary professional and/or para-professional undertakes his/her action as inspector of animal health facilities only under authorization from the Council’s Registrar and is mandated to furnish the Council with a report for the action taken under authorization.
The law does not specifically refer to constraints and limits to the exercise of inspectors’ power, but only mentions a limit of time by which the inspector shall notify in writing the owner of a detained animal of the steps taken. Inspectors shall furnish the Council with a written report and any other information relating to an inspection. The law also refers to the power of the Director of the Department to make decisions regarding the appointment and operation of an inspector. The law provides immunity from legal action for an authorized officer, a veterinary professional or para-professional who operates in good faith and without negligence in the course fulfilling their duties. Access to protected areas by a veterinary must be authorized by the DNPW; only wildlife veterinarians under the DNPW do not need authorization.
DISEASE CONTROL
ZONING AND COMPARTMENTALIZATION
The Director responsible for veterinary services can declare an infected zone where there is reasonable suspicion or confirmation of the presence of a notifiable or emerging disease in any area, and different competent authorities are authorized to take specific measures in an infected zone. The Director may declare any land, premises or area that is infected or is suspected to be infected with a notifiable disease to be a quarantine area for such period as the Director may determine. An authorized officer has the power to enter any land or premises suspected of being contaminated with an infectious disease to take samples, inspect, prohibit removal of any animal, animal product, animal by-product, animal feed or article from the place, or carry out any action that prevents the spread of the disease from an infected place. A veterinary officer may seize, detain and destroy without compensation any animal, animal product, animal by-product, or article removed from an infected area in contravention of the provisions of the Animal Health Act, 2010.
The law indicates grounds on which a zone may be declared disease-free, and empowers the competent authority to define the period of no diseases occurrence to consider it free and the specific measures to prevent the introduction of diseases into such area. The Animal Health Act, 2010 defines a compartment as an area smaller than a zone with a clearly defined management practice and biosecurity plan, and that can be recognized as such within an infected zone. It also defines a disease-free zone as an area established for the maintenance of disease-free status of a sub-population of animals with a distinct health status, from specified disease or diseases, separated by natural or artificial boundaries. Distinct Ministerial statutory instruments shall establish zoo-sanitary border posts and internal check points.
The veterinary department is responsible with outbreaks of diseases in the national parks; when there is an outbreak of diseases, it is the veterinary department, in collaboration with DPNW and any other local authority, that deals with outbreaks of livestock and wild animals.
Infected or suspected areas can be declared quarantine areas. There are no Ministerial Regulations concerning specific measures to be taken in case of a declaration of a disease.
CONTROL MEASURES
The Minister or Director may issue an order to prohibit or regulate the entry and movement of any animal, animal product, animal by-product, article or conveyance within or out of any part of Zambia named in the order (quarantine areas, a tsetse fly area), and the Minister may make specific regulations regarding the matter. A veterinary inspector or officer shall, for the purpose of isolating animals in an infected area, regulate the movement of animals within an infected area. The movement of any animal, animal product, animal by-product requires a permit. The Animal Health (Veterinary Services Fees) Regulations, 2018 prescribes the applicable fees for the stock movement permit. Fisheries regulations require a certificate of origin to move, during the closed fishing season, fish from an open fishing area and an aquaculture facility. It is not possible to transit any fish in Zambia without a sanitary and phytosanitary certificate issued by the relevant authority in the country of origin, to be surrendered at the port of exit. A certificate of origin of fish shall be valid for a period not exceeding two days and shall not be transferable or assigned to any other person. In case of affected indigenous peoples and local communities, instructions issued to the headman of a village shall be deemed instructions to an owner of animals in such village, provided that such notice is issued in writing and in a language or dialect that is commonly spoken by, or understood among, the majority of the inhabitants of that village.
The Minister, by regulation, can provide for the disinfection or treatment, destruction or disposal of an animal, animal product, animal by-product or article infected, or appearing to be infected, with a disease, or anything liable to infect an animal with a disease, such as: infected or contaminated articles; premises on which such article is present: the place where animals infected with a disease are kept; and any conveyance or premises used for the conveyance, sale, exhibition or other purpose of animals. According to the Animal Health Act, it is the Minister or the Director who has the power to declare and regulate quarantine, isolation and other treatments of animals, but when the Act refers to the movement of animals in an infected area, it empowers a veterinary inspector or officer to regulate this movement. The Animal Health (Control and Prevention of Animal Disease) Order, 2014, provides details about mandatory vaccination that veterinaries can perform in order to prevent and control diseases.
If any stock at any time during its period of quarantine shows symptoms of a disease, the Veterinary Officer may, subject to the approval of the Director, order its destruction and that of any animal with which it has been in contact. The Minister may order the payment of compensation to animal owners, and may also withhold compensation in certain circumstances. Compensation is due only when the Government wants to control diseases spreading from the identifiable source, but not when the animals are already affected by the disease. The monies of the Animal Disease Control Fund shall be applied for the payment of compensation, but there is no mention concerning any insurance required for animal owners or farmers in the event that animals are destroyed. In certain cases such as the contagious bovine pleuropneumonia (CBPP), a lung disease that in cattle affects only the lungs, by removing the lungs, the meat is considered safe, certified fit for consumption, and sold mostly at government-negotiated prices.
The law imposes criminal sanctions in case of an offence related to animal diseases, with different scales of fines and imprisonment periods, based on the severity of the offence.
CONTINGENCY PLANNING AND EMERGENCY RESPONSE
CONTINGENCY PLANNING
Although there is not a specific definition of a contingency plan, the law provides for listed measures, which enables the Director responsible for Veterinary Services to manage emergencies, with large powers and allowing a local authority to address special and temporary measures in order to prevent the spread of a disease or to safeguard the health of a local community.
EMERGENCY RESPONSE
The Minister may declare an animal disease emergency where: (i) an introduced disease is capable of spreading rapidly; (ii) the presence, impact and extent of the disease, the potential for spread and its rate of spread, requires emergency eradication measures to eliminate the disease; (iii) a disease is of immediate or potential danger to the health of other animals or to human health; (iv) a Group 1 notifiable disease is detected in any area in Zambia; or (v) the animal was diseased at the time of slaughter. People in a village must be informed, in writing and by paying attention to each language or dialect commonly spoken or understood, through the headman of the village, for any purposes authorized under the provisions of the Act, without specific reference to animal disease emergency.
The Director shall submit to the Animal Disease Control Interdisciplinary Committee a periodic report on his activity to prevent the spread of the emergency. It shall include the status of the outbreak of disease, the measures undertaken to prevent the spread of the outbreak of disease, and such other information as may be requested by the Chairperson.
The law does not refer to any limitation in time for the measures taken to deal with the emergency. The Director may, where the Minister declares an animal disease emergency,designate a disease control zone; prohibit or restrict the entry or removal of any animal, animal product, article or animal feed from the area; specify the activities to be carried out in the area; restrict the movement of persons, vehicles and goods to and from the area; and take any other action that the Director considers appropriate to prevent the introduction or spread of the disease.
A veterinary officer while performing his/her functions may be accompanied and assisted by a police officer. In emergency circumstances, a local authority can exercise the powers of a Medical Officer of Health, in order to prevent the spread of a disease or to safeguard the health of a local community. The law does not specify conditions and circumstances by which the Minister may revoke a declaration of a disease emergency.
IMPORT CONTROL AND EXPORT CERTIFICATION
IMPORT
A person shall not import an animal, animal product or article without an import permit issued by the Director. A permit is required also to import fish. The law enables the competent authority (the Minister) to provide for the prohibition of importation of animal products, but it does not specify exactly the reasons on which the Authority may prohibit the importation, except for the reference made in the Public Health Act to the possibility to introduce any infectious disease.
The Minister, may, by statutory instrument, provide for the prohibition, restriction and regulation of the importation of any animal, animal product, animal by-product or article and the conditions under which animal feed may be imported. Compensation is withheld when the animal, animal product, animal by-product, article or animal feed was already infected or contaminated by a disease at the time it was imported into the country or did not meet the prescribed standard. In case of return, the owner shall pay any charges incurred during the impounding and the other measures taken by the veterinary officer; in case of destruction or another form of disposal, the law refers to the Ministerial power to provide for the imposition and recovery of fees for the measures taken and for the disposal of any animal or animal product in respect of which prescribed fees are not paid.
Approved points of entry for import of animals or animal products are not specified, but the Minister may designate ports of entry, routes and methods of transportation, and, by statutory instrument, in consultation with the Director, establish zoo-sanitary border posts and internal check points in order to control the spread of an animal disease.
The law does not refer to the registration of importers, but they must be authorized by the Director with an import permit.
The Food Safety Act, 2019 prohibits importing an article or any material or substance used for the manufacture of an article except under, and in accordance with, a health clearance certificate. The Minister may prescribe the criteria, terms and conditions for the issuance of health inspection reports and health clearance certificates. Stock Diseases Regulations concerning the limitation to importation of stocks and specified articles refer to three Schedules (third, fourth and fifth) containing lists of animal products and articles whose importation is forbidden without a permit issued by the Director (Third Schedule), or a certificate from a Veterinary officer (Fourth and Fifth Schedule).
The Stock Diseases Regulations refer to the certificate and the statement of a foreign veterinary on whose opinion the importation of specified animal products is allowed, but only in the case of East Coast Fever and African Swine Fever. Movement permits may be issued subject to such conditions as quarantine, isolation, disinfection, detention, the route to be followed, control of stock, or other like matters as the issuing officer in his or her discretion may specify therein.
An officer may inspect any animals, animal products, animal by-products, articles or animal feed destined for import into or export from Zambia to determine whether the consignment is sanitary-compliant. The law does not precisely and explicitly provide for the power of the inspector to deny the release of animals on the basis of a provision of a risk to human, animal or plant health, but it generically enables officers to inspect and detain animals and animal products to determine the sanitary compliance of consignment. The Animal Health Act allows an officer to detain an animal, animal product, animal by-product, article or animal feed for a period not exceeding two weeks, but according to section 33 of the Border Management and Trade Facilitation Act, 2018, an appropriate authority may at borders take temporary measures in the interests of defence, security, public safety, public order or public health, which shall not exceed a period of three months at a time.
Export
The law requires that prospective exporters be authorized by the Director with a permit. The Minister may, by statutory instrument, prohibit the export of animals, animal products, animal by-products or articles from Zambia, or any part of Zambia, in general or to one or more designated countries of destination, unless and until all regulations with regard to their export have been complied with, and may at any time, by like notice rescind such prohibition. The Minister may issue regulations for the purposes of regulating and controlling the export of animals, animal products, animal by-products or articles from Zambia or any part of Zambia, and prescribing the fees to be paid. The requirements of international treaties and agreements, and the requirements of the countries of destination shall be fulfilled.
The law prescribes that animals, animal products and articles destined for export outside Zambia be inspected to determine the compliance of the consignment. The law does not make any reference to an international health certificate to be obtained by exporters prior to exporting animals or related products, but the Food Safety Act requires a health clearance certificate to export them.
VETERINARY LABORATORIES
GENERAL PROVISIONS
Different Acts provide several definitions, although some of them do not specifically concern veterinary laboratories, but laboratories in general to control medicines and allied substances, and animal feed and fertilizers. Rather than providing a definition of official analysis, the law offers the detailed and complete definition of controlled veterinary action. Rather than providing a clear definition of reagent, the law gives the more generic definitions of ingredient and biological product. The Veterinary and Veterinary Para-Professions Act defines the term "animal health facility" in reference to any site, fixed or mobile, providing services for prevention, diagnosis and treatment of animal disease and includes a diagnostic centre. This definition covers the meaning of a "laboratory" as part of an Animal Health Facility. The law prescribes that official laboratory analyses may be undertaken only by approved laboratories. For the purposes of disease control and veterinary public health, the Minister as competent authority must approve a laboratory for the testing of animal feed, vaccines, veterinary products, animal products and animal by-products, disease diagnosis, and food safety and assurance. The Director shall require that a register of approved laboratories be maintained in the prescribed manner and form. The law empowers the authority to determine methods that the laboratories should use in conducting official analysis, but it does not mention reference laboratories. The Director responsible for Veterinary Services shall, in the execution of the functions of the Department, establish and maintain a national veterinary laboratory system and other means for analysing animal products and samples. The Minister is the authority providing for the methods to be employed and for the standards of hygiene of the laboratories The law contains a generic indication concerning quality of reagents used in preparation of samples. The Zambia Medicines Regulatory Authority is the authority responsible for general regulation and control of medicinal products (in which the law also includes veterinary medicinal products), and an Expert Advisory Committee advises the Board of the Authority on medicines and allied substances.
VETERINARY MEDICINAL PRODUCTS (VMPs)
GENERAL PROVISIONS
The law defines many key words relevant to veterinary medicine. According to the Medicines and allied substances (Marketing authorization of medicines) Regulations, 2019, veterinary medicine refers to a substance or mixture of substances manufactured, sold or presented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical or mental state, or the symptoms thereof, in an animal; the restoration, correction or beneficial modification of organic or mental functions in an animal; and an article intended for use as a component; however, it does not include a medical device or its component, part or accessory. A person who intends to place a medicine on the market shall apply to the Authority for a marketing authorization. The law identifies the Zambia Medicines Regulatory Authority as the authority responsible for general regulation and control of medicinal products (in which the law also includes veterinary medicinal products) and creates an Expert Advisory Committee tasked to advise the Board of Authority on medicines and allied substances.
REGISTRATION
The Minister may, on the recommendation of the Authority, by statutory instrument, provide for a list of substances to be considered as medicines. The law prescribes the creation of a register of approved veterinary medicinal products and a register of marketing authorization, which shall be kept at the offices of the Authority and shall be open to inspection by the public. An authorization is required to place on the market, manufacture, distribute and sell of defined categories of medicines and allied substances. The marketing authorization is valid for five years; the holder shall pay an annual retention fee. Suspension and revocation of veterinary medical products (VMP) registration is provided for by law. In case of offences, criminal sanctions are imposed.
LICENSING
It is illegal to import, export, manufacture, sell or expose for sale in Zambia a virus, vaccine, serum or an analogous product used for the purpose of diagnosis or treatment of any animal disease without a permit. The Medicines and Allied Substances (Pharmaceutical License) Regulation further stipulates the licensing procedures for operating estbalishments that manufacture, store, process, distribute or sell VMPs. The Zamra Authority may, upon application by a person, issue an agro-veterinary shop permit to sell a prescribed list of veterinary medicinal products, under the control and management of such persons as the Authority may authorize. The Minister is empowered to provide for necessary procedures and matters concerning the effective regulation of agro-veterinary shop permits. A marketing authorization is required for the placement of a medicine or allied substance on the market; it is registered and lasts five years. The law imposes criminal sanctions in case of offences related to authorization/licensing for manufacture, store, process, distribute or sell veterinary medicinal products.
SAFETY AND QUALITY CONTROL
The law require that VMPs are manufactured based on good manufacturing processes, and that the quality and concentration of the marketed dosage remain stable up to the expiry date for the VMP. ZAMRA may decide to withdraw any medicine or allied substance that is not in the public interest; the Ministry has the regulatory power to provide for monitoring the safety of medicines and allied substances, but there are no provisions concerning the establishment of maximum residue limits. The law provides for clear and comprehensive explanations on the labelling and packaging requirements. The Minister has the power to make provisions for the disposal of obsolete, expired medicines. in consultation with the Zambia Environmental Management Agency, and for their recall or withdrawal. The statutory instruments provide for disposal of these categories of medicines at the licensee’s or permit holder’s cost. Depending on the seriousness the offence, the law imposes criminal sanctions consisting of fines or imprisonment, or of the forfeit of the medicines to the State to be destroyed.
PRESCRIPTION AND USE
According to the Medicines and Allied Substances Act, prescription only medicines, including veterinary ones, can be dispensed only on prescription. A person may sell or supply veterinary medicine under the following categories: (i) prescription-only medicine ; (ii) pharmacy medicine; and (iii) general sale medicine. The law authorizes a veterinary surgeon to dispense a generic medicine specified in the prescription in case the prescription refers to the generic name of that medicine.. The law imposes criminal sanctions in case of offences.
PHARMACOVIGILANCE AND RECALL
The law mentions the issuance of a compulsory report of an adverse drug reaction, but only in case of a renewal of a marketing authorization, which shall be accompanied by a consolidated report of any amendments made to the marketing authorization, including adverse drug reaction reports and safety updates. The law does not prescribe that any actor in the VMP value chain may autonomously initiate the recall or withdrawal of suspected products, because this power is assigned only to the competent authority and to the Minister, who can direct the holder to dispose of the medicines or products kept in insanitary conditions, at the holder's cost, or return those that should not be available to the public. The Expert Advisory Committee of ZAMRSA shall review risk assessment and risk management measures relating to medicines and allied substances; it shall recommend containment measures, reporting mechanisms, remedial measures, monitoring procedures, and other appropriate conditions for medicines or allied substances. It is compulsory for a holder of a marketing authorization to maintain an appropriate pharmacovigilance system and consequently notify the competent authority, but it is not his/her duty to recall the concerned products. Competent authority is empowered by law to recall VMP in given situations. The law imposes criminal sanctions consisting of a fine and imprisonment for violation of the law.
IMPORT
The law requires an importer of medicinal products to obtain an import permit, for any product. An applicant for a permit to import any medicine or allied substance shall, before being issued with a permit, pay the applicable pre-clearance fee prescribed for quality assurance in respect of the medicine or allied substance. A person applying for a permit is not required to be a holder of a pharmaceutical licence. The law does not require all prospective importers to be registered, but prescribes the creation of a register of permit, kept by the Authority, and made available to the public for inspection. The law empowers the Authority to inspect the premises where medicines are kept in order to determine the applicant’s respect of the requirements and of the guidelines. Depending on the circumstances and the reasons, the law empowers the authority to reject an application of permit or to revoke it. In case of a revocation, the regulations prescribe that the medicines or allied substances should be quarantined; in case of medicines or allied substances stocked under unsanitary conditions, the regulations direct the permit holder to dispose of the medicines or allied substances at the permit holder’s cost. The law imposes criminal sanctions consisting of a fine or imprisonment.
EXPORT
All prospective exporters need not be registered, but must apply to the Authority for a permit and pay a prescribed pre-clearance fee. The permit will be registered in a register. The Authority has the power to inspect the premises where medicines are kept in order to determine the applicant’s respect of the requirements of the act and of the guidelines. No timeframe for the shipments to leave the country after inspection is prescribed.
INSTITUTIONAL FRAMEWORK RELEVANT TO ANIMAL HEALTH
INSTITUTIONAL SET-UP
The law defines the powers and responsibilities of each level of authority, including at the central and local level in relation to animal health. In the Ministry of Fisheries and Livestock, the Veterinary Services Department mandate is to deal with animal health, which encompasses all animals, meat inspection, the animal slaughterhouse and slaughter facility regulation. Other functions include animal feed laboratory inspections, and regulation of farm animals, and of the transportation of wild animals and livestock. The Department for Livestock Development, among other responsibilities, regulates the provision of veterinary services, collects, analyses and presents data related to the livestock sector, certifies veterinary services, and take other measures incidental or relevant to the veterinary profession. The Public Service Commission shall appoint, as public officers, a Director responsible for veterinary services, a Deputy Director responsible for veterinary services, veterinary officers, tsetse control biologists, animal scientists and other staff for the Department within the Ministry. The Veterinary Association of Zambia is responsible for veterinary services, veterinary officers, tsetse control biologists, animal scientists and other staff for the Department, within the Ministry responsible for livestock development. The Zambia Medicines Regulatory Authority regulates and controls the manufacture, importation, exportation, distribution and sale of medicines and allied substances, and grants pharmaceutical licences and marketing authorizations, including veterinary products.
INSTITUTIONAL COOPERATION AND COORDINATION
The law provides mechanisms for institutional coordination, mainly through local government systems. The Local Government Act, No. 2 of 2019 concerning the functions of a local authority in relation to agriculture, prescribes that a local authority shall: (i) control the keeping and movement of livestock; (ii) take measures for the destruction and control of bees and of dangerous animals and reptiles; (iii) control the slaughtering of animals where the meat is intended for human consumption; (iv) require the disposal of diseased animals and carcasses whose meat is unfit for human consumption; (v) establish and maintain abattoirs and cold storage facilities, and establish plans for the processing of by-products from abattoirs; and (vi) control the movement of the carcasses of animals.
DELEGATION OF POWERS
There are cases in which the authority may delegate its powers and functions to other actors, such as committees or authorities at the provincial level. The law prescribes the appointment of a representative from an NGO within the Ward Development Committee, but it does not mention the possible delegation of powers. The Medicines and Allied Substances Act establishes the Board of the Authority which shall carry out certain supervisory and advisory functions and establish and issue guidelines and standard, and enables the Board to constitute such committees as it considers necessary and delegate to the committee such of its functions as it considers fit. The Board may appoint as members of a committee, persons who are or are not members of the Board; however, at least one member of a committee shall be a member of the Board. The Board may delegate to the Director-General any of its functions under this Act.
The Local Government Act has established in each ward a Ward Development Committee, which shall prepare annual ward development plans, collect revenue, levies and fees, monitor and evaluate ward development projects, and promote community engagement in ward development planning.