LAW ON AMENDMENTS AND MODIFICATIONS TO THE VETERINARY LAW

LAW
ON AMENDMENTS AND MODIFICATIONS TO THE VETERINARY LAW

The Law was published in the Official Journal of the Republic of Montenegro No. 27/2007
May 17, 2007

Article 1

In the Veterinary Law (Official Journal of the Republic of Montenegro No. 11/04) in the Article 2, the item 10) shall be deleted, and items 14), 39) and 48) shall be modified as follows:
14) pure-bred (breeding) animals breeding refers to breeding of pure-bred males and females, ova and sperm donors, poultry breeding stocks, fish breeding stocks;
39) establishment is a facility or space for animal breeding or organization of competitions of animals, sale of animals, hunting or obedience training, disposal, processing and destruction of animal carcasses and waste of animal origin, production, storage and trade in products of animal origin, raw material and foodstuffs of animal origin and animal feed;
48) authorised laboratory is a laboratory that meets the requirements set for carrying out certain activities in the veterinary field that is authorised by the administration body for carrying out such activities.

Thirteen new items shall be added after the item 51) as follows:
51a) veterinary-sanitary measure is a measure implemented for the purpose of protecting animal and human life and health from risks that may be induced by introduction, occurrence or spreading of highly dangerous infectious animal diseases and dangerous infectious animal diseases or protection of animal and human life and health from risks induced by presence of harmful substances in products, foodstuffs and raw material of animal origin or animal feed;
51b) risk is a certain level of probability of occurrence of infectious diseases or presence of harmful substances that may, directly or indirectly, jeopardize the animal and human health and life to a certain extent;
51c) risk analysis includes scientific estimate of risks, risk management and notification with a view to providing an appropriate level of protection of animal and human life and health;
51d) risk appraisal is the appraisal of the probability of introduction, occurrence and spreading of infectious diseases on the territory of the Republic and appraisal of potential negative effects on human and animal health caused by disease agents or presence of harmful substances in products, foodstuffs and raw material of animal origin or animal feed;
51e) risk management is identification and implementation of measures aimed at reduction of risk;
51f) appropriate protection level is the level considered appropriate for protection of animal and human health and life;
51g) low prevalence area is the area of the state or a number of states or parts thereof for which low prevalence level has been established, in line with the OIE (Office Internacional des Epizooties) recommendations, for the disease that is the object of efficient measures of disease monitoring, control or eradication;
51h) disease free area is the area of a state or several states or parts thereof for which absence of an animal disease has been confirmed, in line with the OIE recommendations;
51i) animal rearing is rearing animals for the purpose of production of foodstuffs, products and raw materials of animal origin;
51j) animal keeping is rearing and taking care of animals, with the exception of animal breeding;
51k) epizootiological area is an area covering the territory of one or several municipalities;
51 l) holding is an establishment or space where animals are bred or kept;
51n) international organizations are: Office Internacional des Epizooties (OIE), Food and Agriculture Organization of the United Nations (FAO), World Health Organization (WHO), World Trade Organization (WTO) (hereinafter referred to as: WTO) and other international organizations dealing with animal and human health protection the Republic of Montenegro is a member of..

Article 2

In Article 5, after the paragraph 6, a new paragraph shall be inserted as follows:
Animal owners or keepers, natural and legal persons, companies and entrepreneurs shall register holdings, establishments and animals and shall enable animal identification for the purpose of animal identification and movement control, animal disease control and eradication, control of residues in animals, raw materials, foodstuffs and animal feed, in line with the Law.
Former paragraphs 7, 8 and 9 shall be paragraphs 8, 9 and 10, respectively.

Article 3

In Article 6, after the paragraph 1, a new paragraph shall be inserted as follows:
Administration body takes part in activities and cooperates with international organizations

Article 4

In Article 7, paragraph 1, the words: List A diseases, List B diseases and other diseases shall be replaced with the words: notifiable diseases and other diseases.
After the paragraph 1, a new paragraph shall be inserted as follows:
Notifiable diseases are classified as highly dangerous infectious diseases, dangerous infections diseases.
In the former paragraph 2 which is changed into paragraph 3, the words: List A includes highly dangerous infectious diseases that shall be replaced with the words: Highly dangerous infectious diseases.
In the former paragraph 3 which is changed into the paragraph 4, as well as in other provisions of this Law, the words: List A diseases shall be replaced with the words: Highly dangerous infections diseases, in the appropriate grammatical case.
In the former paragraph 4 which is changed into the paragraph 5, the words: List B includes infectious diseases that shall be replaced with the words: Dangerous infectious diseases.
Disease lists accompanying this Law shall be deleted.
Former paragraphs 5, 6 and 7 shall be paragraphs 6, 7 and 8, respectively

Article 5

In Article 13, paragraphs 2 and 8 shall be deleted.

Article 6

In Article 28 paragraph 1 the words: List A infectious animal disease shall be replaced with the words: Highly dangerous infectious animal disease.

Article 7

In Article 31 paragraph 3 shall be modified as follows:
Consignments referred to in the paragraph 2 of this Article shall be accompanied by the prescribed international veterinary attestation (certificate) issued on the day of dispatch of the consignment, which must be duly stamped, identified with a serial number, written in the language in official use in the Republic and in the language of the country of origin, while for consignments in transit it may also be written in English language and other languages officially accepted in international trade, unless otherwise provided by an international contract."
Paragraph 6 shall be modified as follows:
Notwithstanding the paragraph 5 of this Article, import, transit and storage of consignments of foodstuffs, raw materials, products, feed and waste as well as imports and transit of pets shall be approved following the veterinary checks and control without laboratory analysis of consignments in case the consignment concerned is accompanied by an appropriate veterinary attestation (certificate), provided that several previous consignments originating from the same establishment had been safe for use, accompanied by appropriate international veterinary attestations (certificates).

Article 8

In Article 32 paragraph 1, at the end of the text, the full stop shall be replaced with a comma and the following words shall be added: in line with the risk analysis.

Article 9

In Article 33 paragraph 3 shall be modified as follows:
Notwithstanding the paragraph 2 of this Article, the administration body shall approve of imports of foodstuffs, raw materials, products, animal feed and waste from other establishments after establishing that regulations, standards and the system of veterinary-sanitary control in the exporting country are at least equivalent to the regulations of the Republic.
After the paragraph 4, a new paragraph shall be added as follows:
The contents and the form of the request for import approval or for establishment control and fees referred to in paragraphs 3 and 4 of this Article shall be laid down by the Ministry.

Article 10

After the Article 34, a title and seven new articles shall be added as follows:

"Veterinary-sanitary measures in international trade"

Article 34 a

Veterinary-sanitary measures in international trade may be undertaken:
1) only to the extent necessary for protection of animal and human life and health and shall be based on scientific principles and scientific evidence available, international standards, guidelines and recommendations;
2) in a manner that shall avoid arbitrary or unjustified discrimination among countries where the same or similar conditions prevail, including the discrimination of its own territory against other countries;
3) in line with the appraisal of risk against animal and human health and life, made in line with the methodology of international organizations;
4) in a manner that is not a hidden foreign trade barrier.

Article 34 b

In the appraisal of risk against animal and human health and life for the purpose of identification of veterinary-sanitary measures in international trade, the following shall be considered in particular:
1) scientific evidence, production processes and methods, methods of inspection and surveillance, sampling and sample analysis methods, prevalence of certain diseases, existence of disease-free zones or low-prevalence zones, appropriate environmental conditions, quarantine measures and other measures;
2) economic indicators including estimate of losses in production and trade in case of disease outbreak or spreading;
3) disease control and eradication costs;
4) efficiency as regards costs of other approaches aimed at risk reduction.
Notwithstanding the paragraph 1 of this Article, the administration body may, in case of absence of appropriate scientific evidence for an objective risk appraisal or in case of emergency, undertake temporary veterinary-sanitary measures on the basis of data available, including the data of international organizations or data on veterinary-sanitary measures of other countries.
Veterinary-sanitary measures shall be appropriate for veterinary-sanitary conditions in the region that animals, products, foodstuffs and raw material of animal origin and feed originate from, or are dispatched to, as appropriate. In making an assessment of veterinary-sanitary conditions in the region, the administration body shall also take into account the health condition of animals in the Republic and the exporting country, presence of diseases and existence of disease control and eradication program, identification of disease-free zones or low-prevalence zones, as well as criteria and guidelines of relevant international organizations.
Veterinary-sanitary measures may be undertaken for the purpose of ensuring the level of protecton of animal and human life and health higher than that achieved by measures based on international standards, guidelines and recommendations, provided that there is scientific justification for that, or in case it is estimated that such protection level is appropriate.
The administration body shall review the veterinary-sanitary measures, including the temporary measures referred to in the paragraph 2 of this Article and measures undertaken in case of emergency after new scientific data become available.
The act on veterinary-sanitary measures shall be published in the Official Journal of the Republic of Montenegro.
Article 34c

In case of absence of international standards, guidelines and recommendations or where a veterinary-sanitary measure fails to comply with international standards, guidelines or recommendations and when a measure may have a significant effect on foreign trade, the administration body shall:
1) issue a notification of intent to implement the measure in early stages of measure preparation;
2) notify the WTO members concerned, in compliance with rules of international agreements, of products this measure applies to; the justification of the measure proposed shall be attached to the notification;
3) at request of competent authorities of other countries, in compliance with rules of international agreements, present the text of the document introducing the measure proposed, stating the derogations from international standards, guidelines and recommendations; and
4) set the deadline for submitting the comments and shall organize consultative meetings at request of interested parties.
The notification referred to in the paragraph 1 item 2 of this Article shall be presented at least 75 days prior to the initiation of the procedure for adoption of the veterinary-sanitary measure proposed.
Article 34d

Where protection of animal and human life and health requires immediate undertaking of veterinary-sanitary measures, the Ministry shall determine the measures by urgent procedure.
Provisions of the Article 34c shall not apply when veterinary-sanitary measures are determined by urgent procedure.
The administration body shall notify the WTO members concerned on the measure adopted by urgent procedure that is not in line with international standards, guidelines or recommendations and in cases when it has a significant effect on foreign trade; and state the products this measure applies to and shall include an explanatory note on the measure, the nature of the emergency and it shall invite the interested parties to present their opinion as regards veterinary-sanitary measures adopted by urgent procedure.
Veterinary-sanitary measures adopted by urgent procedure shall be reviewed by the administration body within the period of six months from the day of publishing in the Official Journal of the Republic of Montenegro, in order to establish whetehr the measure continues to be necessary.

Article 34e

The administration body shall present information and documents and nofitifcations stemming from international agreements which refer to the following:
1) veterinary-sanitary measures proposed and adopted;
2) control, surveillance and approval procedures, production and quarantine procedures;
3) risk appraisal procedures, the method for determining the appropriate animal health protection level in the Republic;
4) membership and participation in activities of international and regional institutions and animal health protection system, existence and content of bilateral and multilateral agreements and contracts.
For supplying the information and documents referred to in the paragraph 1 of this Article a fee may be charged for the services in the amount of actual costs.
The fees referred to in the paragraph 2 of this Article shall be the revenues of the Budget of the Republic.
The amount of actual costs shall be laid down by the Ministry.

Article 34f

Veterinary-sanitary measures in another country shall be considered equivalent to the measures in the Republic provided that the administration body establishes that the measures of the country concerned are achieving the level of animal health protection that is the same as or higher than the level required in the Republic.
Veterinary-sanitary measure equivalence acknowledgement shall be published in the Official Journal of the Republic of Montenegro.
Article 34g

The procedure of checking the compliance with the veterinary-sanitary measures prescribed shall be applied:
1) urgently, without undue delay and discrimination against imported products when compared to similar domestic products;
2) solely on the basis of facts and information necessary for conducting the procedure before the body;
3) by informing the applicant of the request on the period of time necessary for completion of the procedure, potential deficiencies in the application, phase in the procedure and procedure results;
4) in the manner that ensures protection of confidential information;
5) by taking samples only in the quantity required for the control and approval procedures;
6) in cases where product specification has been changed following the control, the procedure for the product changed shall be applied only to the extent necessary for establishing that the product, though changed, complies with the relevant regulations.


Article 11

Article 35 paragraph 1 shall be modified as follows:
Breeding, keeping and trade in animals, slaughter of animals whose meat is used for public consumption, production, trade, storage and distribution of products, foodstuffs and raw materials of animal origin, preparation, treatment, processing, after-treatment, wrapping and re-wrapping of raw materials, foodstuffs, products of animal origin and animal feed, poultry breeding stock, fish breeding stock, bee queens, production, trade and storage of products for disinfection, pest and rodent control, collecting, processing and destruction of waste of animal origin may be done by companies, other legal persons and entrepreneurs only in establishments that meet the requirements prescribed as regards equipment, design, veterinary-sanitary and other requirements, depending on the type of the activity.
Paragraph 7 shall be modified as follows:
More detailed veterinary-sanitary requirements for establishments referred to in the paragraph 1 of this Article shall be laid down by the Ministry.

Article 12

In Article 39 paragraphs 1 and 2 shall be modified as follows:
The project documentation for construction and reconstruction of the establishments referred to in the Article 35 paragraph 1 of this Law must be in compliance with the veterinary-sanitary requirements.
Approval to the project documentation referred to in the paragraph 1 of this Article as regards compliance with the veterinary-sanitary requirements shall be issued by the administration body at request of the investor, the application shall be accompanied by a valid planning permission.
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Article 13

In Article 40 paragraph 2 shall be modified as follows:
Compliance with veterinary-sanitary requirements for establishments referred to in the paragraph 1 of this Article shall be established by the administration body, in its decision. Establishments that comply with the requirements shall be registered in the Establishment Register and shall be issued with a veterinary control number.
After the paragraph 2, a new paragraph shall be inserted as follows:
Establishments referred to in the paragraph 1 shall be deleted from the Register in case they fail to comply with the veterinary-sanitary requirements.
Former paragraph 4, which shall become paragraph 5, shall be modified as follows:
The detailed conditions for classification of establishments referred to in the paragraph 1 of this Article, the contents of the register and the procedure of registration in the register referred to in the paragraph 2 of this Article shall be laid down by the Ministry.

Article 14

In Article 41 paragraph 1 the full stop shall be replaced with a comma and the following words shall be added: evidence on registration in the Central Register of the Business Court shall be presented together with the application.
Paragraphs 4 and 6 shall be deleted.



Article 15

Title above the Article 42, 3. Residues of harmful and prohibited substances in animals, raw materials, foodstuffs and animal feed and Article 42 shall be modified as follows:

"3. Systematic residue control measures"

Companies, entrepreneurs and holdings engaged in breeding and trade in animals, slaughter, production, trade, treatment, after-treatment and processing of foodstuffs of animal origin, production and trade in feed must implement all the measures necessary, and internal control in particular, in order to ensure that animals, foodstuffs of animal origin and feed do not contain unauthorized residues.
Animal owners, veterinary workers and producers of foodstuffs of animal origin must abide by the preventive measures prescribed and withdrawal times set, when using medicinal products and other substances that may be transferred to foodstuffs of animal origin, in order to prevent the occurrence of unauthorized residues.
Foodstuffs of animal origin for public consumption that contain residues or contain residues in quantities above those permitted must not be placed on the market.
Maximum permitted concentrations of residues in excretions and body fluids of live animals, organs and tissues of slaughtered animals and meat, sampling method, laboratory analysis method and tissues for determination of residue presence shall be laid down by the Ministry.
The measures of systematic residue control (hereinafter referred to as: monitoring), conditions and measure implementation methods, control methods, sampling conditions and methods, sample storage and keeping records on samples and methods of laboratory analysis of samples for a specific residue or residue group, shall be laid down by the Ministry.
The Program of measures of systematic control of residues in animals, foodstuffs and animal feed (hereinafter referred to as: the Residue Monitoring Program), shall be adopted by the Ministry for the purpose of protection of human health.
The Residue Monitoring Program shall include in particular: the means necessary for program financing, measures to be undertaken in case of unauthorized residues, structure of organs and organizations for implementation of the Residue Monitoring Program, and other information of relevance for implementation of the Residue Monitoring Program.
The Residue Monitoring Program is adopted by the end of the current year for the following year.
The means for implementation of the Residue Monitoring Program shall be provided by the Budget of the Republic.
Annual report on monitoring results shall be presented to the Ministry by the administration body by March 31 of the current year for the previous year.
The Ministry may, on the basis of a risk analysis, order the prohibition of placing on the market and recall from trade the foodstuffs, slaughter waste and animal feed that contain certain harmful substances and order the prohibition of use of certain harmful substances.
For the purpose of protecting the human health, the Ministry may prohibit treating of animals with certain veterinary medicinal products, hormones and other substances where established that residues thereof in foodstuffs of animal origin may jeopardize human health.

Article 16

After Article 42, five new articles shall be inserted as follows:

Article 42a

A holding from which animals are placed on the market, companies and entrepreneurs engaged in trade of animals shall be registered in compliance with the law.
Holdings, companies and entrepreneurs in establishments for slaughter, treatment and processing of foodstuffs of animal origin may place on the market only the following:
a) animals not treated with unauthorized substances or products;
b) animals treated with authorized substances or products where withdrawal times prescribed have been observed;
c) foodstuffs originating from animals referred to in items a) and b) of this Article.

Article 42b

For the purpose of animal treating a veterinarian may use only the medicinal products authorized for placing on the market and he may apply it in line with the manufacturers instructions only for purposes that the medicinal products concerned are authorized for and under the conditions prescribed. The veterinarian treating animals shall keep records on the treatments.
Animal owner or keeper shall apply veterinary medicinal products prescribed only with approval and under control of the veterinarian, and he shall observe the manufacturers instructions and withdrawal times prescribed.
Animal owner or keeper referred to in the paragraph 2 of this Article shall keep records that include: date and nature of the treatment applied, therapy prescribed or veterinary medications used, name of the veterinarian, and he shall keep the prescriptions for the period of five years from the day of issuing of the prescription.
Information referred to in the paragraph 3 of this Article shall be entered in the records by the veterinarian.

Article 42 c

Where it is suspected that unauthorized substances or products were used for treating animals, or where it is suspected that authorized substances or products were used for purposes other than those authorized or under conditions other than those prescribed, the following measures shall be applied:
- prohibition of movement of animals from that holding and disposal, except under the surveillance of the inspector;
- taking samples from several selected animals and foodstuffs, by random sampling method.
Measures referred to in the paragraph 1 of this Article shall be implemented by the administration body.
Sample analysis shall be done in an authorized laboratory.

Article 42 d

Where it is established on the basis of analyses that unauthorized substances or products were used for treating animals or authorized substances or products were used for purposes other than those authorized or under conditions other than those prescribed, the following measures shall be applied:
- animal with positive results shall be slaughtered on the spot in the presence of the inspector or dispatched to the slaughterhouse and safely disposed of at the owners expense;
- the animals remaining at the holding shall be marked and placed under veterinary surveillance and samples shall be taken from all potentially suspicious animals and foodstuffs from that holding, including the holdings in the animal supply and dispatch chain, at the expense of the holding owner;
- control of feed and water for watering animals at the holding from which the animals originate from or were dispatched from, while for aquaculture animals, control of water they are caught or farmed in;
- other controls necessary for establishing the origin of unauthorized residues.
Where the analysis shows that half or more than half of samples are positive, the animal owner is entitled to choose between checking each potentially suspicious animal from his holding or slaughter of all animals.
In cases referred in the paragraph 1, line 1 and paragraph 2 of this Article, the animal owner is not entitled to indemnity or compensation.
Measures referred to in paragraphs 1 and 2 of this Article shall be implemented by the administration body.
Article 42 e

Imports of animals or foodstuffs of animal origin into the Republic may be done from countries implementing the systematic control measures in line with the residue monitoring program at least equivalent to that of the Republic.
Article 17

In Article 60 in paragraph 1, after the words export a comma and following words shall be inserted: funds collected on the basis of fees for veterinary services referred to in Article 64 items 6 and 7 of this law and funds collected on the basis of disinfection services provided at border crossings.
Paragraph 2 shall be deleted.
Former paragraph 3, which shall become paragraph 2, shall be modified as follows:
The amount of the fee for veterinary-sanitary checks carried out by the veterinary inspectorate, fees for suppliers of veterinary services referred to in Article 64 items 6 and 7 of this Law and disinfection services at border crossings, as well as the fees for the Veterinary Chamber for services of public interest referred to in the Article 74 item 4 of this Law and methods for calculation and collecting of the fees shall be laid down by the Government of the Republic of Montenegro.
After the paragraph 2 a new paragraph shall be inserted as follows:
The amounts of fees referred to in the paragraph 2 of this Article may not be higher than actual costs of the procedure and may not be an indirect protection of domestic product or indirect taxation of imports or exports, as appropriate.

Article 18

In Article 61 in the paragraph 4, full stop shall be deleted at the end of the text and the following words shall be added: on the basis of the request accompanied by the project documentation and a valid planning permission.

Article 19

In Article 63 in paragraph 2, before the word: veterinary the word: professional shall be added.
After the paragraph 2, a new paragraph shall be inserted as follows:
"Professional-technical veterinary services not related to diagnostics, determination of animal treatment method, surgery, interpretation of laboratory and specialist reports and providing professional opinion may be provided by auxiliary veterinary staff, only under surveillance of a licensed veterinarian.

Article 20

In Article 94 the words: certain A list infectious animal diseases shall be replaced with the words: Highly dangerous infectious animal diseases.

Article 21

In Article 96 in paragraph 1 item 2) at the end of the text a comma shall be placed and the following words added: Residue Monitoring Program and other programs of animal health protection referred to in the Article 11 paragraph 2 of this law.
After the item 2) a new item shall be added as follows:
2a) perform control beyond the Residue Monitoring Program for the purpose of revealing unauthorized substances or products applied to fattening animals or use of unauthorized substances or products or use of authorized substances or products for purposes other than those permitted or under conditions other than those prescribed.

Article 22

In Article 98 paragraph 1 after the item 6) four new items shall be added as follows:
6a) to order separate slaughter of animals when he suspects or has evidence that animals brought for slaughter were treated illegally or unauthorized substances and products were administered to them;
6b) to temporarily seize the carcasses and offal and take samples for the purpose of establishing the presence of unauthorized residues where he suspects or has evidence that animals brought for slaughter were treated illegally or unauthorized substances and products were administered to them;
6c) to destroy and safely dispose of carcasses, offal and other edible tissues of animals checked at the expense of the owner in case the results of the analysis are positive;
6d) to postpone slaughter of animals for as long as necessary in case he suspects or has evidence that animals were treated with authorized substances or products and that withdrawal times were not observed by the time of slaughter, until the level of residues of substances or products is lower or equal to the maximum permitted levels or for as long as prescribed by the instructions of the manufacturer of the authorized substance or product.
In paragraph 2 item 1) line 5 shall be modified as follows:
- consignment of animals, animal feed, products and foodstuffs for human consumption contain residues of unauthorized substances or products or residues of authorized substances or products above the maximum quantities allowed.

Article 23

In Article 100 paragraph 1 after the item 11) two new items shall be inserted as follows:
11a) where a holding from which animals are placed on the market, or companies or entrepreneurs engaged in trade in these animals are not duly registered, of where they place in production and trade animals treated with unauthorized substances or products or animals treated with authorized substances or products but prescribed withdrawal times were not observed, as well as foodstuffs originating from these animals (Article 42a paragraphs1 and 2);
11b) where a veterinarian uses medicinal products not authorized for placing on the market or fails to administer medicinal products in line with the manufacturers instructions for the purposes the medicinal products are authorized and under the prescribed conditions, fails to keep records on treatments, or where animal owner or keeper fails to administer veterinary medicinal products prescribed with approval and under supervision of the veterinarian and fails to observe the instructions of the manufacturer of the medicinal products or withdrawal times set, and fails to keep the records prescribed (Article 42b paragraphs 1,2 and 3);
After the item 13) a new item shall be inserted as follows:
13a) where professional and technical veterinary services not related to diagnostics, determination of animal treatment method, surgery, interpretation of laboratory and specialist reports and providing professional opinion is provided by auxiliary veterinary staff, without the surveillance of a licensed veterinarian (Article 19 paragraph 2).

Article 24

In Article 107 the words 36 months from the day this Law enters into force shall be replaced with the words: as of January 1, 2010.

Article 25

This Law shall enter into force on the eighth day following its publishing in the Official Journal of the Republic of Montenegro.