Legal Hub

K    REGULATION OF THE VETERINARY PROFESSION 

KA - GENERAL PROVISIONS 

Does the law define the following terms? 
• "veterinary medicine"; 
• "veterinarian"; 
• "veterinary para-professional"; and 
• "community animal health worker". 

Does the law establish or designate a veterinary statutory body (VSB) to regulate veterinary professionals? 

KB - VETERINARIANS 

Does the law require veterinarians to be registered? 

Does the law declare it an offence to perform functions of a veterinarian unless registered? 

Does the law specify functions that may only be performed by registered veterinarians? 

Does the law specify any exceptional circumstances in which functions usually under the exclusive competence of registered veterinarians may be performed by non-veterinarians (e.g. in emergencies, or for acts performed by veterinary students)? 

Does the law prescribe, or mandate an authority to prescribe, minimum educational requirements and competencies for veterinarians? 

Does the law allow for revocation or suspension of a veterinarian's registration in specific circumstances (e.g. failure to adhere to an official code of conduct, or negligent performance of duties)? 

KC - VETERINARY PARA-PROFESSIONALS 

Does the law recognize the possibility that veterinary para-professionals undertake selected functions under the law?  

If so, does the law promote/prescribe the organization of trainings to the benefit of IPLCs at local level to become veterinary para-professionals? 

If so, does the law promote/encourage the particpation of women and of members of vulnerable/marginalized groups in these trainings? 

Does the law specify which functions may be performed by veterinary para-professionals/different categories of veterinary para-professionals? 

Does the law require veterinary para-professionals to be registered? 

Does the law declare it an offence to perform functions of a veterinary para-professional unless registered? 

Does the law prescribe, or mandate an authority to prescribe, minimum educational requirements and competencies for veterinary para-professionals/different categories of veterinary para-professionals? 

Does the law set out what type of supervisory relationship is required for veterinary para-professionals when undertaking their duties? 

Which kind of sanctions are imposed in case of offences against veterinary and para-veterinary profession regulations (criminal, administrative)? 

L   SURVEILLANCE AND MONITORING 

LA - NOTIFIABLE DISEASES 

Does the law require the competent authority to formulate a list of priority diseases for which notification is mandatory (i.e. a list of notifiable diseases)? 

Does the law provide for IPLC awareness to be raised about the existing list of priority diseases for which notification is mandatory? 

Does the law obligate persons who know of, or reasonably suspect, the presence of a notifiable disease to notify a relevant authority (e.g. veterinary service, veterinarian, veterinary inspector or police station) within a specified timeframe (e.g. as soon as possible and not later than 24 hours after identification or suspicion)? 

When a notifiable disease is identified or reasonably suspected, does the law require the owner or person in control of the animal(s) to isolate the affected animals from other susceptible animals as soon as possible? 

When a notifiable disease is identified or reasonably suspected, does the law prohibit the owner or person in control from doing any of the following without permission from the competent authority? 
• Move the animal from the premises on which it is currently held; 
• Transfer ownership of the animal through sale or otherwise; and 
• Bury or otherwise dispose of the animal or its waste material. 

Which kind of sanctions are imposed in case of offences to animal disease surveilance and monitoring regulations (criminal, administrative)? 

LB - VETERINARY INSPECTION 

Does the law empower the competent authority to appoint veterinary inspectors to take actions necessary to ensure and enforce compliance with veterinary legislation? 

Does the law grant veterinary inspectors the following powers to enable them to adequately carry out their functions? 
• access to premises and vehicles for carrying out inspections;  
• access to documents;  
• taking samples; 
• retention (setting aside) of animals and goods, pending a decision on final disposition; 
• seizure of animals, products and food of animal origin; 
• suspension of one or more activities of an inspected establishment; 
• temporary, partial or complete closure of inspected establishments; and 
• suspension or withdrawal of authorizations or approvals. 

Does the law impose constraints upon the circumstances in which inspectors may exercise the above powers, to avoid abuse or misuse of such powers? 

Does the law provide that officials shall be protected from legal action and physical harm when exercising their functions in good faith and in accordance with their powers and responsibilities? 

M   DISEASE CONTROL 

MA - ZONING AND COMPARTMENTALIZATION 

Does the law authorize veterinary inspectors to declare an infected zone in the event that they suspect the presence of a disease that poses a serious threat to animal, human and/or plant health (pending confirmation based on official analysis by the competent authority)? 

Does the law specify measures that the competent authority may apply within an infected zone (e.g. restriction upon the movement of animals, mandatory disinfection for persons and vehicles exiting the infected zone)? 

Does the law specify the grounds on which a declaration of an infected zone can or must be revoked (e.g. the disease threat has been reduced or neutralized)? 

Does the law authorize the competent authority to declare buffer zones between infected zones and disease-free zones to protect against the movement of an animal disease or infection from an area where it is present to an area where it is not? 

Does the law authorize the competent authority to declare disease-free zones, in areas that have been confirmed free from specific animal diseases or infection? 

Does the law authorize the competent authority to establish compartments within the country, to differentiate between health statuses of animal subpopulations within the country, based upon their management and husbandry practices related to biosecurity? 

MB - CONTROL MEASURES 

Does the law authorize the competent authority to regulate movement of people, animals and vehicles within, into and out of any zone? 

If so, does the law prescribe that in similar circumstances, affected IPLCs must be informed in a timely manner using culturally appropriate channels/tools?  

Does the law authorize the competent authority to implement disinfection measures or any other biosecurity measures deemed necessary? 

If so, does the law prescribe that, before implementing the disinfection, concerned IPLCs must be informed in a timely manner using culturally appropriate channels/tools?  

Does the law authorize the relevant authority (e.g. the Minister, or competent authority) to designate quarantine stations? 

Does the law permit veterinary inspectors to order the quarantine of animals if they have reason to suspect that they may either be suffering from a disease or may have otherwise been exposed to the risk of contracting such a disease? 

If so, does the law prescribe that before designating a quarantine station, affected IPLCs must be informed in a timely manner using culturally approriate channels/tools?  

Does the law permit the veterinary inspectors to treat or vaccinate animals for the purposes of disease control? 

Does the law permit veterinary inspectors to destroy and dispose of animals, animal products and other relevant materials for the purposes of disease control? 

Does the law require the relevant authority (e.g. the Minister, or competent authority) to issue compensation to animal owners in specific circumstances, in the event that animals are destroyed for the purposes of disease control? If not, does the law recommend or require farmers to engage in insurance schemes? 

Does the law provide that compensation benefit affected men, women and members of vulnerable and marginalized groups equally? How? 

Does the law specify the source of funding to be used for compensation? 

Which kind of sanctions are imposed in case of offences (criminal, administrative) related to animal desease control? 

N   CONTINGENCY PLANNING AND EMERGENCY RESPONSE 

NA - CONTINGENCY PLANNING 

Does the law define "contingency plan"? 

Does the law require the competent authority to formulate contingency plans for diseases of national priority (e.g. this may include all or a subset of diseases contained within a list of notifiable diseases, if required under the national legal framework)? 

Does the law permit contingency plans to mandate all of the following measures? 
• Administrative and logistic organization; 
• Exceptional powers of the competent authority; and 
• Special and temporary measures to address all identified risks to human or animal health. 

NB - EMERGENCY RESPONSE 

Does the law empower an appropriate authority (e.g. the Minister, or the competent authority) to declare an animal disease emergency? 

If so, does the law prescribe that upon declaration of an animal disease emergency the public and in particular IPLCs must be informed in a timely manner using culturally appropriate channels/tools?  

Does the law specify the grounds on which a disease emergency may be declared? 

Does the law require that a declaration of disease emergency must be based on risk and the duration must be no longer than is necessary to minimize the threat to animal and/or human health? 

Does the law specify conditions under which a declaration of a disease emergency must be revoked? 

Upon declaration of a disease emergency, does the law empower the competent authority to request assistance from other relevant public bodies (e.g. the police or military)? 

Upon declaration of a disease emergency, does the law empower the competent authority to approve emergency measures necessary to control the risk, provided they are limited in time and risk-based? 

Does the law specify any exceptional powers that may be exercised in the event that an animal disease emergency is declared? 

O    IMPORT CONTROL AND EXPORT CERTIFICATION 

OA - IMPORT 

Does the law obligate the competent authority to prepare and publish a list of animals and animal products that require an international veterinary health certificate before they may be imported into the country? 

If so, does the law provide for public awareness to be raised about the existing list of animals and animal products that require an international veterinary health certificate before they may be imported? 

Does the law permit the competent authority to prohibit importation of any animal or animal products if they reasonably suspect such animals or products could pose a serious risk to human, animal or plant health? 

Does the law empower the competent authority to specify establishments, geographical areas, or countries whose sanitary measures are considered to meet the requirements of the importing country? 

Does the law specify all approved points of entry for import of animals or animal products into the country? 

Does the law require all prospective importers to be registered with or authorized by the competent authority? 

Does the law require a prospective importer of animals or animal products to obtain an import permit for each shipment? 

Does the law require imported animals to be placed in quarantine for a specified period of time before they may be released into the country? 

Does the law require that animals and animal products be made available for inspection upon arrival at the point of entry? 

Does the law empower the appropriate inspector to deny release of animals or animal products into the country if they reasonably believe, based on risk assessment, that such animal or product may pose a serious risk to human, animal or plant health? 

Does the law authorize the appropriate inspector to request the return or destruction of animals or animal products that are denied import following inspection? 

Does the law specify who is responsible for the costs of return or destruction of animals or animal products that are denied import following inspection? 

Which kind of sanctions are imposed in case of offences (criminal, administrative) related to import control? 

OB - EXPORT 

Does the law require all prospective exporters to be registered with or authorized by the competent authority? 

Does the law require a prospective exporter of animals or animal products to acquire an export permit for each shipment? 

Does the law require a prospective exporter of animals or animal products to acquire an international veterinary health certificate prior to export? 

Does the law require the competent authority to inspect animals or animal products in order to determine whether to issue an international veterinary certificate for export? 

Which kind of sanctions are imposed in case of offences (criminal, administrative) related to export certification? 

P    VETERINARY LABORATORIES 

PA - GENERAL PROVISIONS 

Does the law define the following, or equivalent terms? 
• "Laboratory";  
• "Approved laboratory";  
• "National reference laboratory";  
• "Official analysis"; and 
• "Reagent". 

Does the law require that laboratory analyses conducted as part of official disease surveillance and control programs (i.e. "official analysis") may only be undertaken by specific approved laboratories? 

Does the law identify a competent authority responsible for regulation of veterinary laboratories that perform official analysis? 

Does the law empower the competent authority to designate "approved laboratories" that are authorized to undertake official analyses? 

Does the law empower the competent authority to designate "reference laboratories" to determine reference methods to be used in official analysis and to supervise operation of approved laboratories? 

Does the law prescribe quality requirements for reagents used in official analysis? 

Q   VETERINARY MEDICINAL PRODUCTS (VMPs) 

QA - GENERAL PROVISIONS 

Does the law define the following, or equivalent, terms? 
• "veterinary medicinal product"; and  
• "raw materials for use in veterinary pharmaceutical products"? 

Does the law identify a competent authority responsible for regulation and control of veterinary medicinal products? 

QB - REGISTRATION 

Does the law require the establishment of a register of approved VMPs? 

Does the law require that all VMPs be registered before they may be manufactured, stored, processed, distributed or sold? 

Is registration of VMPs time-limited, after expiry of which an applicant must re-apply for registration? 

Does the law authorize the competent authority to suspend or revoke VMP registration in specific circumstances?  

Which kind of sanctions are imposed in case of offences (criminal, administrative) related to veterinary medicinal products? 

QC - LICENSING 

Does the law require the authorization/licensing of establishments that manufacture, store, process, distribute or sell VMPs? 

Which kind of sanctions are imposed in case of offences (criminal, administrative) related to authorization/licensing to manufacture, store, process, distribute or sell VMPs? 

QD - SAFETY AND QUALITY CONTROL 

Does the law require that VMPs are manufactured based on good manufacturing processes, and that the quality and concentration of the marketed dosage will remain stable up to the expiry date for the VMP? 

Does the law require the establishment of maximum residue limits and withdrawal periods for all VMPs? 

Does the law prescribe labelling and packaging requirements for VMPs? 

Does the law prescribe requirements for the disposal of VMPs? 

Which kind of sanctions are imposed in case of offences (criminal, administrative) related to VMP safety and quality control? 

QE - PRESCRIPTION AND USE 

Does the law prescribe that specific VMPs may only be transferred to end users upon receipt of a prescription issued by a licensed veterinarian? 

Does the law authorize veterinarians to sell VMPs directly? 

If yes to the above, does the law establish measures to prevent conflict of interest between the prescription and the sale of VMPs (i.e. to prevent veterinarians from issuing prescriptions to increase sales of VMPs)? 

Does the law require that veterinarians may only prescribe VMPs to animals under their direct care? 

Does the law require veterinarians to keep records of all prescriptions issued? 

Which kind of sanctions are imposed in case of offences (criminal, administrative) related to VMP prescription and use regulations? 

QF - PHARMACOVIGILANCE AND RECALL 

Does the law obligate any person who reasonably believes that an animal has experienced an adverse reaction from receiving a VMP, or that a person has experienced an adverse reaction from handling a VMP, to report this to an appropriate authority (e.g. competent authority, pharmacist, veterinarian, distributor of VMP)? 

Does the law require any actor in the VMP value chain who reasonably suspects a VMP is likely to cause harm to animal or human health to initiate recall of all concerned products, and notify the competent authority? 

Does the law empower the competent authority to recall a VMP that is likely to cause harm to human or animal health? 

Which kind of sanctions are imposed in case of offences (criminal, administrative) related to pharmacovigilance and recall of VMPs? 

QG - IMPORT 

Does the law require a prospective importer of VMPs to obtain an import permit for each shipment? 

Does the law require all prospective importers to be registered with or authorized by the competent authority? 

Does the law require that VMPs must be made available for inspection upon arrival in the country prior to release? 

Does the law empower the competent authority to deny release and arrange for destruction of VMPs on specified grounds (e.g. they reasonably believe that such products may pose a risk to human, animal and/or plant health)? 

Which kind of sanctions are imposed in case of offences (criminal, administrative) related to PMV import regulations? 

QH - EXPORT 

Does the law require all prospective exporters to be registered with or authorized by the competent authority? 

Does the law require a prospective exporter of VMPs to acquire an export permit for each shipment? 

Does the law require that shipments must be made available for inspection prior to export, if deemed appropriate by the competent authority? 

Does the law prescribe a timeframe within which shipments must leave the country after inspection? 

Which kind of sanctions are imposed in case of offences (criminal, administrative) related to VMP export regulations? 

R   INSTITUTIONAL FRAMEWORK RELEVANT TO ANIMAL HEALTH 

RA - INSTITUTIONAL SET-UP 

Does the law define the powers and responsibilities of each level of authority, including at central and local levels, in relation to animal health? 

Does the law specify criteria (such as Proportionality and Necessity, as well as Participation, Accountability, Non-Discrimination, Transparency) according to which such powers should be exercised? 

Does the law provide for action taken by public authorities to be open to public scrutiny and assessed against measurable criteria? 

RB - INSTITUTIONAL COOPERATION AND COORDINATION  

Does the law provide for mandatory coordination among authorities involved in decision-making processes? 

Does the law identify the cases and matters for which institutional coordination is mandatory? 

Does the law define procedures and/or mechanisms through which coordination can be achieved? 

Does the law ensure there is no duplication/overlap of institutional coordinating bodies? 

Do coordination mechanisms include subsidiary entities (i.e. coordination mechanisms at the local level)? 

RC - DELEGATION OF POWERS 

Does the law empower the competent authority to delegate functions to other actors? 

Does the law provide for possible delegation of powers to non-governmental stakeholders under the public monitoring system? 

If so, does the law create facilities to enable women, young people or any marginalized/vulnerable group to assume these functions? If so, how? 

If so, does the law define the following with regard to delegation? 
• Functions that may be delegated; 
• Required controls on or supervision of delegated functions; 
• Procedures for making delegation; 
• Competencies/skills to be held by persons receiving delegation; and 
• Conditions for withdrawal of delegation.