Law Amending And Supplementing The Law On Veterinary Activities

Original Language Title: Закон за изменение и допълнение на Закона за ветеринарномедицинската дейност

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Name of law Law amending and supplementing the law on veterinary activity Name of the Bill a bill amending and supplementing the law on veterinary activities date adopted 11/01/2013 number/year official journal 7/2013 Decree No 10

On the grounds of art. 98, paragraph 4 of the Constitution of the Republic of Bulgaria

I DECLARE:

To be published in the Official Gazette the law amending and supplementing the law on veterinary activities, adopted by the National Assembly of the HLI 11 January 2013.

Issued in Sofia on 18 January 2013.

The President of the Republic: Rosen Plevneliev

Stamped with the State seal.

Minister of Justice:

Diana Kovatcheva

LAW

amending and supplementing the law on veterinary activities (official SG. 87 of 2005; amend., SG. 30, 31, 55 and 88 from 2006, and 51/84 of 2007, issue 13, 36 and 100 from 2008, issue 27, 35, 74, 95 and 102 of 2009 and 25/41 of 2010 No. 8 and 92 from 2011 and issue 77 , 82 and 97 by 2012.)

§ 1. In art. 2, item 1 creates a letter "l":

"l) manufacture, importation, marketing, storage and use of the in vitro diagnostic veterinary medicinal products."

§ 2. In art. 7 make the following amendments and additions:

1. In paragraph 8. 1 creating a 12:

12. control over the manufacture, importation, storage, marketing and use of the in vitro diagnostic veterinary medicinal products. "

2. a new paragraph. 2:

"(2) the Disinfection, disinsectization, deratizaciâta and devastaciâta are performed by health professionals subject to the conditions and in the order specified by an Ordinance of the Minister of agriculture and food."

3. The current paragraph. 2 it al. 3 and in it:

a) point 8 shall be replaced by the following:

"8. the means of transport with which animals are transported;"

b) point 18 shall be replaced by the following:

"18. the means of transport with which raw materials and foodstuffs of animal origin, animal by-products, and products derived from them;"

in t. created) 20 and 21:

"20. the persons who have received a certificate of registration of in vitro diagnostic veterinary medicinal resources;

21. manufacturers and traders of the means of identification of the animals. "

4. The current paragraph. 3 it al. 4 and in her words "para. 2 "are replaced by" para. 3 "and the words" website "shall be replaced by" website ".

5. The current paragraph. 4 it al. 5.

6. a para. 6:

"(6) in a list is kept of BABH authorisations for the use of animal by-products."

7. The current paragraph. 5 it al. 7. § 3. In art. 12, after the word "transport" is added "information technology and communications.

§ 4. In art. 23, para. 1, item 2 (b), the words ' feed materials, compound feedingstuffs, feed additives and premixtures "shall be replaced by ' feedingstuffs '.

§ 5. In art. 25 the following modifications are made:

1. In paragraph 8. 1, the words ' animal tissue ' shall be replaced by "veterinarnomedicinsko" and the words "in the territory of one veterinary station" and the comma after them are deleted.

2. paragraph 2 is repealed.

§ 6. In art. 26 the following amendments and supplements shall be made:

1. In paragraph 8. 1:

and in the text) before item 1, the words ' Animal tissue ' shall be replaced by "Veterinarnomedicinsko";

b) in paragraph 1 the word "hospital" shall be replaced by "the hospital".

2. in the Al. 2, after the words "they" added "and the requirements of good veterinary practice", and the word "Ordinance" shall be replaced by "provisions".

3. in the Al. 3 the words "veterinary medicinal" are replaced by "health".

§ 7. In art. 27 the following amendments and supplements shall be made:

1. In paragraph 8. 1, the words ' Animal tissue ' shall be replaced by "Veterinarnomedicinsko".

2. in the Al. 2 the words "animal tissue ' shall be replaced by" veterinarnomedicinsko ".

3. in the Al. 3 the word "healing" is replaced by "animal health".

4. in the Al. 4, the words ' animal tissue ' shall be replaced by "veterinarnomedicinsko".

5. a para. 5:

"(5) the holdings may register self veterinarnomedicinsko establishment of the territory."

§ 8. In art. 28 the words "animal tissue ' shall be replaced by" veterinarnomedicinsko "and the words" recover their costs for labour and materials "shall be replaced by ' paid work undertaken.

§ 9. In art. 29 the following modifications are made:

1. Paragraphs 1 and 2 shall be repealed.

2. Paragraph 3 shall be amended as follows:

"(3) the data of veterinary surgeons exercising their profession, and the data from their personal stamps shall be entered in the register under art. 7, para. 3, item 12.

§ 10. In art. 30 the following modifications are made:

1. In paragraph 8. 1, the words ' animal tissue ' shall be replaced by "veterinarnomedicinsko", the words "veterinary medicinal" are replaced by "veterinary", the word "healing" is replaced by "animal health" and the words "and the seat of the veterinary Division ' shall be deleted.

2. in the Al. 2, paragraphs 1 and 3, the words "veterinary medicinal" are replaced by "animal health".

§ 11. In art. 31 the abbreviation "BABH" is replaced by "ODBH".

§ 12. In art. 32 the following modifications are made:

1. In paragraph 8. 1 the words "veterinary medicinal" are replaced by "animal health".

2. in the Al. 2:

a) in paragraph 1 the words "veterinary medicinal" are replaced by "animal health";

b) point 2 is amended as follows:

"2. the address and the type of veterinary facility;"

c) in point 3 and 4, the words "veterinary medicinal" are replaced by "animal health".

§ 13. In art. 34 the following modifications are made:

1. In paragraph 8. 2 in the first sentence the words "everywhere in healing" are replaced by "in veterinarnomedicinsko".

2. in the Al. 3 the word "medical" is replaced by "veterinarnomedicinsko".

3. Paragraph 4 is hereby repealed.

§ 14. In art. 35 the following modifications are made:

1. In paragraph 8. 1 in the text before item 1 the words "veterinary medicinal" are replaced by "animal health".

2. in the Al. 2:


and in the text) before item 1, the words ' animal tissue ' shall be replaced by "veterinarnomedicinsko";

(b) in point 6), the words "medical" are replaced by "in veterinary".

§ 15. In art. 36, the words "and shall notify UAS ' shall be deleted.

§ 16. In art. 37 following amendments and supplements shall be made:

1. In paragraph 8. 1 the words "veterinary medicinal" are replaced by "animal health".

2. paragraph 2 is replaced by the following:

"(2) the approval of projects for the construction and reconstruction of health facilities and the issue of documents for placing in service shall be carried out after the issuance of an opinion by the ODBH."

3. a para. 3: "(3) to issue an opinion on the Al. 2 collect the fee fixed by the tariff referred to in art. 14, para. 2. "

§ 17. In art. 39 following amendments and supplements shall be made:

1. In paragraph 8. 1:

and in the text) before item 1 the words "veterinary medicinal" are replaced by "animal health";

b) in point 1 the words "medical" are replaced by "in" veterinary;

c) in paragraph 3 the words "veterinary medicinal" are replaced by "animal health";

d) in item 4 the words "entrusted to the hospital with a contract under art. 46 (d) ' shall be replaced by the words "carried out by the veterinary institution in accordance with the State programme and programmes for the prevention, control and eradication of animal diseases".

2. in the Al. 2:

a) in item 5, the words "and electronic" shall be deleted;

(b) in point 12) the word "Code" is replaced by "requirements";

in point 13), the words ' of animals within the territory of the country "shall be replaced by the words" territory of the State of the animals and skins and wool, derived from animals grown for personal consumption "and the words" ODBH and UAS ' shall be replaced by "BABH";

(d)) that is created 14:

"14. bring in the integrated information system of BABH:

(a)) their preventive, curative and diagnostic activities;

(b) measures carried out by the State) prevention programme and in programmes for control and eradication of animal diseases;

in the identified data);

d) data for newborns, purchased, sold, slaughtered and dead animals of species identifiable. "

§ 18. In art. 40, para. 1 creating a t. 6:

"6. the identification of animals and the introduction of data into the integrated information system of BABH."

§ 19. In art. 41, the words "veterinary medicinal" are replaced by "health".

§ 20. Article 43 is repealed.

§ 21. In art. 44 the following modifications are made:

1. In paragraph 8. 1:

and in the text) before item 1, the words ' animal tissue ' shall be replaced by "veterinarnomedicinsko";

b) in paragraph 2 the word "healing" is replaced by "animal health".

2. in the Al. 2 in the text before item 1 the words "medical" are replaced by "in veterinarnomedicinsko".

3. in the Al. 5, the words "medical" are replaced by "in veterinarnomedicinsko".

§ 22. In chapter IV, title of section II shall be replaced by the following: "conditions and procedure for the award of State measures implementation preventive measures under the programmes and programme for the control and eradication of animal diseases".

§ 23. Article 46 (a) shall be replaced by the following:

"Art. 46. The Bulgarian food safety agency shall inform the Commission and the competent authorities of the Member States on the implementation of the measures:

1. for the prevention, control and eradication of diseases under art. 47, para. 1;

2. the State preventive program;

3. the surveillance programmes and eradication of animal diseases. "

§ 24. Article 46b shall be amended as follows:

"Art. 46 (b) (1) the volume of the measures under the State programme and programmes for prevention, control and eradication of animal diseases and the deadline for their implementation shall be determined by the national annual preventive plan, approved by the Executive Director of BABH.

(2) the plan referred to in paragraph 1. 1 can be adjusted when you change the settings or epizootic at the change of the number of animals. "

§ 25. In article 46 shall be amended as follows:

"Art. 46. the Prices payable for the implementation of the measures under the programmes referred to in art. 46 b, para. 1, annually approved by the Council of Ministers, which shall be published in the Official Gazette and shall be published on the website of the Ministry of agriculture and food. "

§ 26. Article 46 shall be amended as follows:

"Art. 46. (1) the cost of implementing the measures under art. 46 (b), as well as for making and transporting the samples necessary for the surveys provided for in the programmes referred to in art. 46 (b), shall be granted as State aid by State Fund "Agriculture".

(2) State Fund "Agriculture" provides state aid under paragraph 1. 1 subject to the provisions of the law on State aid. "

§ 27. Article 46 (e) shall be replaced by the following:

"Art. 46 e. Implementers of the measures under the programmes for the control and eradication of animal diseases and the State preventive program are veterinarians. "

§ 28. Article 46 is amended as follows:

"Art. 46. (1) measures under the State programme and programmes for prevention, control and eradication of animal diseases in the objects registered by the procedure of art. 137, are performed by registered veterinary surgeons, concluded a contract in accordance with art. 137.

(2) measures under the State programme and programmes for the prevention, control and eradication of animal diseases in the objects, in which animals are kept only for personal use, shall be carried out by registered veterinary surgeons, concluded a contract in accordance with art. 137 b. "

§ 29. Article 46 (g) shall be replaced by the following:

"Art. 46. When, by 1 November the owners or users of the sites registered by the procedure of art. 137, or the owners of the animals kept for personal use only, not a contract in accordance with art. 137 a, according to art. 137 b, UAS, in consultation with the Director of the veterinarian determines ODBH to conclude treaties. "

§ 30. Article 51 shall be replaced by the following:


"Art. 51. (1) the animals shall be subject to official identification and holdings – registration in BABH.

(2) the Bulgarian food safety agency is the competent authority for control over the official identification of animals.

(3) the Bulgarian food safety agency supports an integrated information system with data for the identified animals and holdings and provides access to the data the European Commission upon request.

(4) the numbering of the means used for official identification is determined by BABH.

(5) the requirements for the means of official identification of animals and their use, the terms, the order and control in the collection, introduction, maintenance and use of the information in the system under paragraph 1. 3 shall be determined by an Ordinance of the Minister of agriculture and food.

(6) the conditions and procedures for the identification of bovine animals are laid down in Regulation (EC) No 1760/2000 of the European Parliament and of the Council of 17 July 2000 establishing a system for the identification and registration of bovine animals and regarding the labelling of beef and beef products and repealing Council Regulation (EC) No 820/97 , hereinafter referred to as "Commission Regulation (EC) No 1760/2000.

(7) the procedure for identification of sheep and goats shall be determined by Regulation (EC) No 21/2004 of 17 December 2003 establishing a system for the identification and registration of ovine and caprine animals and amending Regulation (EC) No 1782/2003 and directives 92/102/EEC and 64/432/EEC.

(8) the conditions and procedures for the identification of equidae are laid down in Regulation (EC) no 504/2008 of 6 June 2008 implementing Directive 90/426/EEC and Directive 90/427/EEC on methods of identification of equidae (OJ L 149/3 of 7 June 2008), hereinafter referred to as "Commission Regulation (EC) no 504/2008".

(9) the conditions and procedures for official identification of animals, for which requirements are laid down in a regulation of the European Union, shall be determined by regulations the Minister of agriculture and food.

(10) the amount of funds for official identification and the cost of animal identification are provided as State aid by State Fund "Agriculture".

(11) State Fund "Agriculture" provides state aid under paragraph 1. 10 under the terms of the law on State aid.

(12) in connection with the maintenance of the integrated information system on al. 3 BABH has a right of access to the national database "population" of Directorate General "civil registration and administrative service at the Ministry of regional development and public works."

§ 31. Create art. 51A and 51B: "art. 51. (1) the funds for official identification of animals are produced and/or traded only by persons who are entered in the register under art. 7, para. 3, item 21.

(2) for entry in the register of manufacturers and dealers means for identification of animals shall submit an application form to the Executive Director of the applied BABH:

1. unified identification code according to art. 23 of the law on the commercial register or updated status document issued by a competent authority of another State;

2. a copy of the employment contract with a person who will reflect the motion of the means of identification in the integrated information system of BABH – where the applicant will not reflect the personal data;

3. a declaration in a form that the manufacturer, the dealer will, respectively, at its own expense replace damaged or illegible means of identification within the warranty period within 20 days of notification of the damage;

4. twenty number samples of the means of identification and placement, where the applicant is a manufacturer or dealer who will run for the first time on the market means of identification;

5. a document for paid fee for entry in the register at a rate fixed by the tariff referred to in art. 14, para. 2.

(3) the Executive Director shall appoint the Commission by order BABH for checking the documents annexed to the application and the samples of the means of identification referred to in paragraph 1. 2, item 4, that will be produced or marketed for their compliance with the requirements of the Ordinance under art. 51, para. 5.

(4) within 14 days from the filing of the application the Commission under para. 3 submit to the Executive Director of an opinion on the Protocol with BABH conformity of documents and samples with the requirements. A copy of the record shall be given to the manufacturer or dealer.

(5) within three days of receipt of the opinion referred to in paragraph 1. 4 BABH Executive Director issued an order for entry in the register or to refuse registration. When entering in the register the applicant shall be issued a certificate from the Executive Director of BABH.

(6) the issued certificate is annulled and entry in the register is deleted by order of the Executive Director of BABH:

1. at the written request of the manufacturer or trader;

2. when using non-approved by BABH means of identification;

3. failure to comply with requirements of the Ordinance under art. 51, para. 5;

4. in the case of motion of the misstatement means of identification.

(7) the refusal under para. 5 and the order under paragraph 1. 6, item 2, 3 and 4 shall be notified and may be appealed pursuant to the administrative code.

(8) the persons entered in the register under art. 7, para. 3, t. 21, are required to reflect the movement of the means of identification of animals under the conditions and by the order of the Ordinance under art. 51, para. 5.

Art. 51 (b) (1) manufacturers and dealers of equipment for official identification of animals are required to market the only means of identification for which samples are approved by the order of art. 51A.


(2) where producers and merchants, entered in the register under art. 7, para. 3, t. 21, wish to place on the market means of official identification, other than those referred to in para. 1, they perform in BABH sample application, to which 20 number samples of new means of identification and for placing them.

(3) the Executive Director shall appoint the Commission by order BABH for inspection of samples of the new means of identification. Within 10 days of submission of the application referred to in paragraph 1. (2) the Commission shall submit to the Executive Director of BABH statement of compliance of the samples with the requirements of the Ordinance under art. 51, para. 5.

(4) the Executive Director shall notify the persons writing BABH al. 2 of the result of the examination under paragraph 1. 3. "

§ 32. In art. 60, para. 1 the words "para. 2 "are replaced by" para. 3. "

§ 33. In art. 63 the words "by an Ordinance of the Minister of agriculture and food" shall be replaced by ' in Regulation (EC) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residues in foodstuffs of animal origin (OJ L 15/1 of 20 January 2010), hereinafter referred to as "Commission Regulation (EU) No 37/2010".

§ 34. In art. 71 is hereby amended as follows:

1. In paragraph 8. 2 paragraph 1 shall be replaced by the following:

"1. the unified identification code according to art. 23 of the law on the commercial register or updated status document issued by a competent authority of another State; ".

2. in the Al. 3 the words "para. 2 "are replaced by" para. 3. "

§ 35. In art. 73 in the text before item 1 the words "para. 2 "are replaced by" para. 3. "

§ 36. In art. 108, para. 2 is hereby amended as follows:

1. In paragraph 4, the words "article. 120, para. 3 "shall be replaced by" art. 118, para. 1. "

2. In paragraph 6, the word "computerized" is replaced by "Integrated".

§ 37. Article 120 shall be amended as follows:

"Art. 120. (1) the Council of Ministers shall, on a proposal from the Minister of agriculture and Forests shall approve annually the list of communicable diseases under art. 118, para. 1, the cost of maintenance and BABH development of Integrated information system of cost and BABH under art. 46, para. 2 for the implementation of the preventive program.

(2) the costs under paragraph 1. 1, with the exception of the costs referred to in art. 46, at the expense of the State budget, the budget for the budgetary year BABH. "

§ 38. Article 122 shall be repealed.

§ 39. In art. 127, Pará. 3 the words "Ministry of transport" shall be replaced by "the Ministry of transport, information technology and communications" and the words "Ministry of economy and energy" are replaced by "the Ministry of economy, energy and tourism.

§ 40. In art. 129, para. 1 creating a 12:

"12. the grounds for feeding of carrion birds."

§ 41. Article 132 is amended as follows:

"Art. 132. (1) the owners of farm animals:

1. provide veterinarnomedicinsko service of animals kept by contract under art. 137 a, respectively, under art. 137 (b);

2. comply with the requirements of animal welfare;

3. comply with the animal health requirements set out in order to grow, the movement and transport of animals;

4. within three days in writing notify the veterinarian serving the holding for newborns and purchased animals of species that are subject to identification;

5. immediately notify, in writing, for dead animals, veterinarian serving the holding, the Mayor of the locality and the site for the disposal of animal by-products, serving the territory concerned;

6. within 24 hours prior to a change of ownership, transport or slaughtering of animals of the species which are subject to identification, intended for their personal consumption, in writing notify the veterinarian serving the holding;

7. within three days from the date of birth of the animals of the species which are subject to identification, shall notify in writing the veterinarian serving the holding:

and official identification) of newborn animals and introduce the data of identification in the integrated information system of BABH, or (b)) for the official identification of newborn animals and entered data into the integrated information system of BABH;

8. keep a register of the animals on the holding in which the fit newborns, slaughtered, the dead, the sales and the animals; the register shall be kept for at least three years from the last entry;

9. sign and retain the passports of bovine and equidae and present them at the request of the control authorities;

10. the official responsible for the identification and implementation of measures under the programmes for the control and eradication of animal diseases and of the preventive program of animals;

11. do not have the right to carry out the movement and trade of animals that have not been identified and which do not fulfil the measures on programmes for the eradication and surveillance of animal diseases and prevention program, as well as raw materials and foods derived from such animals;

12. the Protocol with the veterinarian serving the holding:

a means of identification) and official passports of slaughtered for personal consumption bovine and equidae;

(b)) the passports of dead bovine and equidae;

in the official means of identification) of slaughtered for personal consumption swine, sheep and goats;


13. keep a diary on the pattern in which the veterinarian serving the holding recorded the prophylactic activities as well as date of delivery of the STATUS, name of VMPS; applied quantity; lot number and withdrawal period of VMPS; name and address of the vendor identification number of the treated animal; the journal is stored for 5 years from the last entry, including in cases where the activity of the site is terminated before the expiry of that period;

14. keep for at least three years from the date of issue papers for the movements of the animals;

15. transmit the object of disposing of animal by-products, dead animals and specified risk material has slaughtered for personal consumption of bovine animals and small ruminants;

16. respect the withdrawal deadline fixed for the STATUS and/or medicated feedingstuffs, to the placing on the market of raw materials and foods derived from treated food-producing animals;

17. comply with the prescribed dose and duration of treatment of animals with medicated feedingstuffs in prescription by a veterinarian;

18. provide continuous access to life nov″dniâ the object of the inspection authorities of BABH and other competent authorities;

19. do not allow animals in the facility are not identified under art. 51, which have not been carried out operations involving State preventive program or who are of a different health status;

20. perform the requirements of veterinarians, relating to the implementation of the measures for the prevention, control and eradication of animal diseases;

21. be carried out annually in the period from October 1 to 20 inventory of the animals on site and submitted to the official veterinarian responsible for the relevant municipality, Declaration in a form approved by the Executive Director of BABH;

22. lead and kept a list of entity staff registered by the procedure of art. 137;

23. comply with the requirements of annex III to Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene.

(2) the information referred to in para. 1, item 4, 5, 7, 8 and 13 are introduced by the veterinarian serving the holding, in the integrated information system of BABH within 7 days from the date of the notification under paragraph 1. 1 for the event.

(3) the persons referred to in para. 1 prove ownership of bovine animals, equidae, small ruminants and swine:

1. for newborns:

a) bovine and equidae – with a passport issued by an order determined by the Ordinance of the Minister of agriculture and forests, by the veterinarian, concluded a contract under art. 137 or 137 (b);

b) small ruminants and pigs, with the Declaration by the owner of the animal's mother;

2. for acquired otherwise animals – with a contract for transfer of ownership or other document certifying the acquisition of ownership of animals.

(4) animal owners provide the official veterinarian controlling object, a copy of the document referred to in paragraph 1. 3, item 1 (b) and paragraph 2 within three days from the date of its issue. "

§ 42. Article 133 shall be replaced by the following:

"Art. 133. The mayors and mayoral deputies:

1. contribute to the implementation of the measures for the prevention, control and eradication of animal diseases;

2. the rajonirat pastures and vodopoite depending on the epizootic situation, and, if necessary, prohibit their use;

3. take measures to ensure that the animals in landfills;

4. organize the collection of dead stray animals in accordance with the requirements of Regulation (EC) no 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (animal by-products regulation) (OJ L 300/1 of 14 November 2009) , hereinafter referred to as "Commission Regulation (EC) no 1069/2009 ';

5. arrange the disposal of animal by-products out of objects of art. 259, para. 1 and 2 in the cases specified by Ordinance No. 22 of 2006. for the conditions and procedures for the disposal of animal by-products and products derived therefrom, and the specified risk material outside of the sites registered in RVS (SG. 21 of 2006);

6. take measures to prevent the use of communal pastures and watering of the animals that have not been identified and that measures have not been carried out in the State program and in preventive programmes for the control and eradication of animal diseases;

7. take measures to ensure the free movement of animals through the streets of the settlements;

8. determine the route of movement of animals from herds pooled in the streets of the settlements. "

§ 43. In art. 135 the following modifications are made:

1. In paragraph 8. 1 the words "art. 142 of ' shall be deleted.

2. in the Al. 2 the words "the Ordinances under art. 132, para. 2 "are replaced by" the Ordinance under art. 137, para. 10. "

§ 44. In art. 137 following amendments and supplements shall be made:

1. Paragraph 1 shall be amended as follows:

(1) the owners or users of holdings shall submit an application for registration form to the Director of the applied to ODBH:

1. copy of the document of ownership or the right to use the site;

2. a copy of the document for the commissioning of the object, where such is required by law on the territory;

3. a copy of the contract with a veterinarian for prevention, treatment and diagnosis of animal diseases, which will be grown on the site;

4. a document for paid fee fixed by the tariff referred to in art. 14, para. 2. "


2. in the Al. 2 the second sentence is deleted.

3. in the Al. 6, the words "the Ordinances under art. 132, para. 2 "are replaced by" the Ordinance referred to in para. 10. "

4. in the Al. 7, after the words "para. 6 "insert" and "reported.

5. in the Al. 9:

a) in item 3, after the word "owner" or "user added";

(b) in item 5) Finally a comma and add "with the exception of the apiaries, which fits the number of harvested bee families.

6. a para. 10:

"(10) animal health requirements to identify holdings by an Ordinance of the Minister of agriculture and food."

§ 45. Create art. 137 a – 137 in:

"Art. 137. (1) each year, by 1 November the owners or users of the sites registered by the procedure of art. 137, concluded with registered vets contracts for prevention, treatment and diagnosis of animal diseases and for implementation of measures under the State programme on prevention and control programmes and eradication of animal diseases. The model treaty for the implementation of measures under the State programme on prevention and control programmes and eradication of animal diseases shall be approved by the Executive Director of BABH after consultation with UAS.

(2) before 15 November the veterinarian shall draw up a list of objects that will serve under the contracts. The list and a copy of the contracts shall be awarded by the official veterinarian of the respective municipality.

(3) upon termination of the contract the owner or operator of the holding is required within 7 days of the termination of his contract with another vet, and to send a copy of the contract in its part concerning the implementation of measures under the State programme on prevention and control programmes and eradication of animal diseases, the official veterinarian of the respective municipality.

(4) replacing the veterinarian under para. 1 at the discretion of the owner or keeper of the holding can be done up to two times within a calendar year in the month of January, the month of June, respectively, provided that the owner or operator of the holding has paid the amounts due under the contract under paragraph 1. 1 of the veterinarian who serves so far holding.

 (5) the Owner or keeper of the holding who wishes to change the veterinarian under para. 1, the Director shall notify the relevant ODBH within at least 7 days before the date of conclusion of the contract with another vet.

(6) the Director shall determine by order of ODBH Commission within the time limit referred to in paragraph 1. 5 to carry out an inspection of the documentation associated with the veterinary services of the holding.

(7) in the composition of the Commission under para. 6 include the official veterinarian in animal health, with responsibility for the relevant municipality, the head of the Department of animal health, "the same officer ODBH and Department responsible for the operation of Integrated information system of BABH.

(8) the Commission under para. 6 draw up Protocol, which contains the findings of the checks carried out. This Protocol is drawn up in three copies – one for ODBH, veterinarian, who has worked the holding and to the veterinarian, who will conclude a new contract.

(9) in the presence of the Commission under para. 6 the veterinarian, who has worked with holding Protocol transmits the animal health documentation of the object of the veterinarian, who will conclude a new contract.

(10) the Director of the respective ODBH shall draw up a list of veterinarians who have concluded contracts on al. 1 who sends in the central management of BABH for publication on the website of BABH.

Art. 137 (b). (1) in the objects, in which animals are kept only for personal needs, prevention, treatment and diagnosis of animal diseases and the implementation of measures under the State programme on prevention and control programmes and eradication of animal diseases shall be carried out by registered veterinary surgeons, concluded a contract with the owner of the animals.

(2) for contracts under para. 1 apply the requirements of art. 137.

Art. 137. the performers concluded contracts under art. 137 and 137 (b), shall bring into the integrated information system of BABH data under art. 39, para. 2, item 14 of the animals in the objects for which contracts have been concluded. "

§ 46. In art. 139, para. 1 make the following amendments and additions:

1. point 10 shall be replaced by the following:

"10. the feeding of farmed animals with herbage within the meaning of art. 11 (1) (c) of Regulation (EC) no 1069/2009; ".

2. an item 16:

"16. the trade in raw materials and foods derived from animals kept in entities that are not registered under art. 51. "§ 47. Article 139 (a) shall be replaced by the following: "art. 139. (1) where an offence under art. 139, para. 1, item 4 – 6 official veterinarians shall immediately notify the Director in writing of the relevant issuing ODBH disposition on the pattern of killing animals and guide them in the disposal site for the disposal of animal by-products.

(2) killing animals is carried out by the Commission, set out in the order under paragraph 1. 1.

(3) For the killing, Committee on al. 2 be drawn up on the model.

(4) the Commission under para. 2 carry out the handover of the bodies of animals at the site for the disposal of animal by-products.

(5) the order under paragraph 1. 1 may be appealed pursuant to the administrative code. The appeal of the injunction does not stop its implementation. "

§ 48. In chapter six, section II to create art. 139 b-139 (e):


"Art. 139. (1) (b) to establish a violation under art. 139, para. 1.1-3 and 7-9 official veterinarians shall immediately notify the Director in writing of the relevant issuing ODBH disposition model for targeting animal sanitary slaughter in a slaughterhouse designated in the order.

(2) the Director of ODBH organizes:

1. stay on the animals to transport for slaughter;

2. carrying out a clinical examination of the animals;

3. the animals are transported to the slaughterhouse under para. 1;

4. the implementation of the raw materials and products fit for human consumption that are harvested in the slaughter of the animals;

5. the transmission of animal by-products derived from the slaughter of the animals in the facility for the disposal of animal by-products.

(3) the slaughter of animals shall be carried out in the presence of the Commission set out in the order under paragraph 1. 1.

(4) after completion of slaughter Commission under para. 3 Protocol drawn up on the model, indicating the type and quantity of the raw materials and the products derived from slaughtered animals.

(5) the order under paragraph 1. 1 may be appealed pursuant to the administrative code. The appeal of the injunction does not stop its implementation.

Art. 139 in. (1) where an offence under art. 139, para. 1, item 10 – 16, depending on the type and severity of the violation shall be issued:

1. an act to implement the measure under art. 131, para. 1 – by the official veterinarian;

2. an order to terminate the activities of the holding in the cases under art. 139, para. 1, item 15 – from the Director of the respective ODBH.

(2) in the application of the measure referred to in paragraph 1. 1, item 2 the animals of the holding are opting for sanitary slaughter.

(3) the costs for the massacre at al. 2 shall be chargeable to the owner of the animals.

(4) the acts referred to in paragraph 1. 1 may be appealed pursuant to the administrative code. An appeal shall not have suspensive effect.

Art. 139. The cost of disposing of the carcasses of killed animals in art. 139 a, expenditure under art. 139 b, para. 2, item 1, 3 and 5, as well as the cost of the slaughter of the animals and for the storage of raw materials and products fit for human consumption, obtained on slaughtering shall be borne by the budget of BABH.

Art. 139 e. (1) where raw materials and products from animals slaughtered under art. 139 (b) are fit for human consumption, they are transmitted free of charge to homes for medical-social care.

(2) the Commission under art. 139 b, para. 3 supplied with raw materials and products Protocol under para. 1 representative of the respective home for medical and social care.

(3) the Protocol on al. 2 contains a description of the type and quantity of the raw materials and the products derived from slaughtered animals, and shall be drawn up in duplicate, for home and for the respective ODBH for medical and social care.

(4) the cost of transportation of raw materials and products referred to in para. 1 are for the account of the home for medical and social care.

§ 49. In art. 143 is hereby amended as follows:

1. In paragraph 8. 2 the words "veterinarian under art. 46 in, al. 1, in whose jurisdiction is located the holding "are replaced by" the person under art. 46 d ".

2. in the Al. 5 the word "print" is replaced by "print" and the words "and the stamp of veterinarian under para. 2 ' shall be deleted.

§ 50. In art. 165, para. 1, item 3, after the word "transport" is added "information technology and communications.

§ 51. In art. 166, para. 5 Finally a comma and add "information technology and communications.

§ 52. In art. 168 Item 4 is created:

"4. the sports horses specialising in caravan, featuring up to two seats."

§ 53. In art. 222 is hereby amended as follows:

1. In paragraph 8. 2, item 1 the words "para. 2 "are replaced by" para. 3. "

2. in the Al. 3, paragraph 3, the words "para. 2 "are replaced by" para. 3. "

§ 54. In art. 226 words "art. 7, para. 2 "are replaced by" article. 7, para. 3. "

§ 55. In art. 229, para. 2 paragraph 1 shall be replaced by the following:

"1. the unified identification code according to art. 23 of the law on the commercial register or updated status document issued by a competent authority of another State; ".

§ 56. In art. 245, para. 1 the words "the Ordinances under art. 59 ' are replaced by ' Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs, hereinafter referred to as "Commission Regulation (EC) No 852/2004, Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (1), hereinafter referred to as" Commission Regulation (EC) No 853/2004 " and Council Regulation (EC) no 1069/2009 ".

§ 57. In art. 246 is hereby amended as follows:

1. In paragraph 8. 1:

and in the text) before item 1, the words ' raw materials and foodstuffs of animal origin "shall be replaced by ' the objects of art. 245, para. 1 ";

b) in paragraph 2 the words "Ministry of transport" shall be replaced by "the Ministry of transport, information technology and communications.

2. in the Al. 2 the words "the Ordinances under art. 59 ' are replaced by ' Regulation (EC) No 852/2004, Regulation (EC) No 853/2004 and Regulation (EC) no 1069/2009 ".

3. in the Al. 4, the words "the Ordinances under art. 59 ' are replaced by ' Regulation (EC) No 852/2004, Regulation (EC) No 853/2004 and Regulation (EC) no 1069/2009 ".

§ 58. In art. 248 in the text before item 1 the words "para. 2 "are replaced by" para. 3. "

§ 59. Article 251 shall be amended as follows: "Article. 251. It shall be prohibited:

1. the placing on the market and consumption of raw materials and foodstuffs of animal origin obtained in urgent or sanitary slaughter which is not carried out animal health control;

2. the return of food of animal origin from the sites for wholesale and retail trade in objects of production, except in the cases under art. 19 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the General principles and requirements of food law, establishing the European food safety authority and laying down procedures in matters of food safety, hereinafter referred to as "Commission Regulation (EC) No 178/2002.


§ 60. In art. 257, para. 1 creating a t. 6:

"6. raw materials and foodstuffs are derived from animals kept in entities that are not registered by the procedure of art. 137. "

§ 61. In art. 262, para. 1 paragraph 1 shall be replaced by the following:

"1. the unified identification code according to art. 23 of the law on the commercial register or updated status document issued by a competent authority of another State; ".

§ 62. Article 271 shall be amended as follows:

"Art. 271. (1) the Director of the respective ODBH may permit the use of animal by-products in the cases referred to in Regulation (EC) no 1069/2009.

(2) natural and legal persons who wish to use animal by-products shall submit to the Director of ODBH sample application, to which a document for paid fee fixed by the tariff referred to in art. 14, para. 2.

(3) the Director shall determine by order of ODBH Committee to carry out an inspection in the establishment to comply with the requirements of Regulation (EC) no 1069/2009.

(4) upon establishment of the discrepancies with the requirements of Regulation (EC) no 1069/2009 the Commission shall give the applicant written instructions for removing them and set a time limit for this.

(5) after the removal of disparities, the applicant shall notify the Director in writing and the Al ODBH. 3 checked of the object.

(6) the Commission shall submit to the Director of a proposed opinion ODBH allow the use of animal by-products or refusing to use them.

(7) within 30 days from the filing of the application, by the removal of shortcomings, the Director of the authorisation issued ODBH model for the use of animal by-products in the conditions of use and storage, or refuse to issue a reasoned solution.

(8) the refusal under para. 7 has been reported and may be appealed pursuant to the administrative code.

(9) in a list is kept of ODBH authorisations for the use of animal by-products, which contains:

1. name (name and address) and registered office of the person who carries on business;

2. the location of the object in which it carries on business;

3. the number and date of the authorization;

4. purpose, category and type of authorised for the use of animal by-products;

5. number and date of the order for termination or withdrawal of a permit.

(10) in the central management of a list of waters BABH authorisations for the use of animal by-products, which contain the data from the lists of ODBH. The list shall be published on the website of BABH. "

§ 63. Create art. 271 a-271 in:

"Art. 271. The persons authorised for the use of animal by-products shall keep a logbook in which fit the type, quantity, origin and date of entry of the products into the object.

Art. 271 (b). each consignment of animal by-products, which are used by the order of art. 271, shall be accompanied by a commercial document in accordance with Regulation (EC) No 142/2011 of 25 February 2011 for the application of Council Regulation (EC) no 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption, and for the application of Directive 97/78/EC as regards certain samples and articles exempt from veterinary checks at the border under that directive (OB L 54/1 of 26 February 2011). A copy of the document is stored in the establishment of origin and of destination on the site for at least two years from the date of issue.

Art. 271. (1) in In violation of the requirements related to the use of the animal by-products referred to in art. 271 shall apply art. 253 and article. 254, para. 3.

(2) by an order of the Director of the respective ODBH authorisation to use animal by-products referred to in art. 271:

1. it takes – in the cases under art. 236, para. 1, item 3, 4, 5 and 6;

2. is terminated – in the cases under art. 236, para. 1, item 1 and 2.

(3) the order for withdrawal of authorisation under paragraph 1. 2 are reported and may be appealed pursuant to the administrative code.

§ 64. Article 275 is amended as follows:

"Art. 275. (1) natural and legal persons, as a result of the activities of which are receiving animal by-products are required to transmit them into objects of art. 259, para. 1 or 2 with the exception of the cases referred to in Decree No 22 of 2006. for the conditions and procedures for the disposal of animal by-products and products derived therefrom, and the specified risk material outside of the sites registered in RVS.

(2) the persons referred to in para. 1 pay the owners of the objects of art. 259, para. 1 and 2, the costs of collection, transportation, disposal and storage of animal by-products at a price agreed upon between them.

(3) the owners of the sites for the disposal of animal by-products are obliged to transmit the resulting from the disposal of products for disposal or recovery pursuant to Regulation (EC) no 1069/2009. The cost of disposal or recovery are negotiated between the owner of the object and the owner of the disposal site for disposal or recycling of products.

(4) at the expense of the State budget are costs of al. 1 and 2 for dead animals, animal by-products derived at the time of slaughter of the animals kept in the objects for personal use only, and for animals in art. 141, para. 1, as well as for the germinal products, raw materials and foodstuffs of animal origin, animal by-products and products derived therefrom referred to in art. 141, para. 2 except in the cases under art. 142, para. 1, in which the costs are borne by the owners of the animals.


(5) the costs referred to in paragraph 1. 4 the objects of art. 259, para. 1 and 2 shall be agreed between the Minister of agriculture and food and the owners of these objects. "

§ 65. Article 276 shall be amended as follows:

"Art. 276. (1) in the Republic of Bulgaria shall be imported, marketed and used, stored, licensed STATUS for use under this chapter or under Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency , hereinafter referred to as "Commission Regulation (EC) No 726/2004.

(2) the requirements under paragraph 1. 1 apply for Medicated pre-mixes are produced industrially or by a method involving an industrial process.

(3) where, on account of the characteristics of a product arises a doubt whether it is STATUS as it falls into the definition of § 1, item 9 of the additional provisions, but falls in the scope of the definition of the products referred to in another Act, for that product shall apply the requirements of this chapter.

(4) the requirements of this chapter apply to active substances used as starting materials for the manufacture of VMPS and certain substances in the composition of the VMPS with anabolic, anti-infectious, anti-parasitic, anti-inflammatory, hormonal or psychotropic effect.

(5) where, after the issuing of a licence for the use of STATUS changes occur related to the species of animal for which the product is intended, strength, pharmaceutical form, route of administration or other changes shall apply the provisions of art. 314.

(6) the holder of a license for use of VMPS is responsible for the placing on the market, including the STATUS and when has appointed a representative. "

§ 66. In art. 277 following amendments and supplements shall be made:

1. In paragraph 8. 1, the words "by the Ordinance under art. 63 "shall be replaced by ' in Regulation (EC) No 37/2010".

2. in the Al. 2, the words "Annex I, annex II or annex III to the Ordinance under art. 63.0 "shall be replaced by" table 1 "Allowed" substances from the application of Regulation (EC) No 37/2010 ".

3. in the Al. 4, the words "annexes to the Ordinance under art. 63 "shall be replaced by ' annex of Regulation (EC) No 37/2010" and after the word "change" is added "issued an order by which".

4. in the Al. 5:

(a)) in the text before paragraph 1, after the word "consumption" is added "pursuant to Regulation (EC) no 504/2008";

b) in point 1, the words "Annex I, annex II or annex III to the Ordinance under art. 63 "shall be replaced by" table 1 "Allowed" substances from the application of Regulation (EC) No 37/2010 ';

c) in paragraph 2 the words "annex IV to the Ordinance under art. 63 "shall be replaced by" table 2 "banned substances" of the annex to Regulation (EC) No 37/2010 ".

5. in the Al. 6, the words "the Ordinance under art. 63 "shall be replaced by ' Regulation (EC) No 37/2010".

§ 67. Article 278 is amended as follows:

"Art. 278. A license for use of VMPS is issued by the Executive Director of BABH to a natural or legal person established in the territory of a Member State. "

§ 68. In art. 279 following amendments and supplements shall be made:

1. point 1 shall be amended as follows:

"1. the unified identification code according to art. 23 of the law on the commercial register or updated status document issued by a competent authority of another State; ".

2. In paragraph 2 (a), after the word "product" is a comma and add "model of immediate and outer packaging and package leaflet for use".

3. point 4 shall be replaced by the following:

"4. a copy of the license to manufacture or contract with a licensed manufacturer of STATUS and/or active substances, where the person referred to in art. 278 is not a manufacturer, or contract with a licensed wholesaler with VMPS and/or active substances in cases where the person under art. 278 is not an wholesaler and VMPS or active substances are produced in a Member State; ".

4. In paragraph 5, add "and a declaration by the qualified person referred to in art. 353 that active substances included in the composition of VMPS, are manufactured in compliance with the requirements of good manufacturing practice ".

5. a new item 6:

"6. a copy of the certificate of good manufacturing practice;".

6. Current item 6 becomes item 7.

§ 69. Art is created. 279:

"Art. 279. The documents referred to in art. 279, paragraph 2 shall be supplied on paper or electronically, with the exception of the summary of product characteristics, the immediate and outer packaging and package leaflet for use which shall be submitted to the electronic medium. "

§ 70. In art. 280 following amendments and supplements shall be made:

1. In paragraph 8. 1 the words "generic licensed in a Member State and/or in the Republic of Bulgaria reference medicinal STATUS or if it has been licensed for use not less than eight years ' shall be replaced by ' a generic of a reference STATUS which is licensed or has been licensed in a Member State for at least eight years.

2. in the Al. 2 anywhere the word "medicinal" shall be deleted and the second sentence, after the words "Member State" shall be inserted "to submit within a period of one month".

3. Paragraph 4 is replaced by the following:

"(4) shall not be issued a license for the use of a generic STATUS before the expiry of 10 years from the date of first issue of a license for use of the reference STATUS, and for STATUS, intended for fish or bees or other species designated by the European Commission, this period may be extended to 13 years in a decision of the European Commission."

4. in the Al. 6 the words "generic" are replaced by "generic", and the word "drug" shall be deleted.

5. Paragraph 7 shall be amended as follows:


(7) the applicant presents data from preclinical and clinical trials in cases where the biological STATUS, similar to a reference biological STATUS, does not meet the definition of a generic STATUS due to divergence in terms of raw materials or manufacturing processes of the biological STATUS and those of the reference biological STATUS. The type and amount of additional data which the applicant should submit, must meet the relevant criteria under the Ordinance under art. 284. the results of the other tests and trials, referred to in the dossier of the reference product, don't perform. "

6. in the Al. 8 the words "para. 5 ' shall be replaced by "para. 4 ", the comma after the word" licence "shall be replaced by the end point, and the text is deleted and the second sentence:" this period cannot be longer than 13 years for STATUS, intended for four or more types of food-producing animals. "

7. in the Al. 9 the word "original" is replaced by "reference".

8. in the Al. 10 the words "generic reference VMPS" is replaced by "generic".

9. Paragraph 14 is replaced by the following:

"(14) carrying out the necessary tests and trials related to the product, to implement the requirements under paragraph 1. 1-10 is not a violation of patent rights or of the supplementary protection certificate.

§ 71. In art. 281 following amendments and supplements shall be made:

1. In paragraph 8. 1 in the first sentence the words "the Republic of Bulgaria and/or" shall be deleted and the words "violates patent rights" are replaced by "violating the law on the protection of industrial and commercial property".

2. in the Al. 2 Add ", in accordance with Regulation (EC) No 37/2010".

3. in the Al. 3, after the words "from the" STATUS "is added in accordance with Council Regulation (EC) No 37/2010" and after the words "and the results of the" added "extra".

§ 72. Art is created. 281:

"Art. 281. (1) for the licensing of homeopathic VMPS, intended for food-producing animals, a special simplified procedure applies when:

1. apply in the way described in the monograph of the European Pharmacopoeia or, in the absence of such – in other pharmacopoeias of Member States;

2. the labelling, packaging or other STATUS associated with the product information no specific therapeutic indication;

3. are sufficiently diluted, which ensures the safety of the product as a homeopathic STATUS does not contain more than one desetohilâdna part of the mother tincture.

(2) For STATUS under para. 1 apply the requirements for the issuance of a license under art. 279, with the exception of the requirements under art. 291, para. 1-4, as well as the requirement for submission of proof of therapeutic effect.

(3) For homeopathic VMPS, intended for food-producing animals, and apply the requirements of Regulation (EC) No 37/2010. "

§ 73. In art. 282 following amendments and supplements shall be made:

1. Paragraph 1 shall be amended as follows:

"(1) for the issue of a licence for the use of a series of homeopathic VMPS, derived from the same homeopathic stock homeopathic stocks accordingly apply the simplified procedure where an application under art. 279. "

2. in the Al. 2:

and before that) the text shall be amended as follows: 1 "to prove the quality of the homeopathic VMPS and homogeneity of the lot to the application under para. 1 apply the documents referred to in art. 279, t. 1, 3-6 and the registration dossier that contains: ";

b) in paragraph 1 the word "roads" is replaced by "way";

c) in paragraph 4 the word "relevant" is replaced by "the homeopathic".

3. Paragraph 3 is replaced by the following:

"(3) application of the homeopathic VMPS is allowed and, in the cases under art. 322. "

4. Paragraph 4 is replaced by the following:

(4) application of the homeopathic VMPS is allowed and, in the cases under art. 323, when its active substances are listed in table 1 "Authorised substances" from the application of Regulation (EC) No 37/2010. "

5. a para. 5:

"(5) in the case of homeopathic VMPS apply requirements of section V, title vi and VII of this chapter section."

§ 74. Create art. 282 and 283 (b):

"Art. 282. The requirements under art. 281 and 282 shall not apply to immunological homeopathic VMPS.

Art. 282 b. Homeopathic STATUS, with the exception of those referred to in art. 281 a, para. 1, are licensed for use under art. 279, art. 280, para. 11-13. "

§ 75. Article 283 shall be repealed.

§ 76. In art. 284 words "under art. 279-283 ' shall be deleted and the word "regulations" shall be replaced by "Decree".

§ 77. In art. 285 following amendments and supplements shall be made:

1. In paragraph 8. 2, paragraph 1 the word "regulations" shall be replaced by "Ordonnance".

2. a new paragraph. 3:

"(3) to perform analyses for the preparation of the assessment under paragraph 1. 1 the applicant shall pay the fee set out in the tariff referred to in art. 14, para. 2. "

3. The current paragraph. 3 it al. 4 and in the second sentence, after the words "notification" to be added "validation of the analytical method and/or the" and finally "be added no later than 180 days".

4. The current paragraph. 4 is repealed.

5. Al are created. 5, 6 and 7:

"(5) in the cases referred to in para. 4 when the applicant fails to submit the requested information and/or substances within 180 days from the date of receipt of the written notice, the Executive Director of BABH by order terminates the procedure for granting of the licence and shall notify the applicant in writing.

(6) the order under paragraph 1. 5 is reported and may be appealed pursuant to the administrative code. An appeal shall not have suspensive effect.

(7) in the cases referred to in para. 5 may apply for issue of a licence for the use of STATUS by the procedure of art. 279. "

§ 78. In art. 288 following amendments and supplements shall be made:

1. In paragraph 8. 1 the words "seven months" shall be replaced by ' 210 days ' and the words ' and article. 282, para. 2 ' shall be deleted.

2. paragraph 2 is repealed.

3. in the Al. 3:

(a) in item 2) add "under the conditions of use under which the licence was issued;

b) a new paragraph 3:


"3. the risk-benefit balance in use of VMPS, intended for zootechnical use, is adversely affecting animal health, animal welfare and consumer safety;"

in the past) so 3 and 4 shall become paragraph 4 and 5;

(d)) the current item 5 becomes item 6 and shall be amended as follows:

"6. the applicant proposed withdrawal period is inadequate to ensure that foodstuffs obtained from treated animals do not contain residues of VMPS, posing a possible hazard to the health of the consumer, or are not presented sufficient evidence of this period;"

(e)) the current item 6 becomes item 7;

is the current point 7) becomes point 8 and add "with administrative or regulatory action."

4. Paragraph 4 is replaced by the following:

"(4) the Executive Director of BABH may refuse the granting of an authorisation to use the VMPS in al. 1 and when there are changes in the acts of the European Union relating to the imposition of restrictive measures and it is necessary to protect human and animal health. "

5. in the Al. 5, the words "and 4" shall be replaced by "and" reported.

§ 79. Art is created. 288:

"Art. 288. (1) in exceptional circumstances, after consultation with the applicant, the Executive Director of license issued for use BABH of VMPS, provided that the applicant has introduced specific procedures relating to the safety of VMPS, BABH notification of any incident relating to its use, and for taking appropriate action. Such license shall be issued only when there are objective reasons which can be verified.

(2) the conditions referred to in paragraph 1. 1 shall be entered in the licence and in the register under art. 290.

(3) an annual performance evaluation of BABH the conditions under which the licence was issued. When the assessment is negative, the Executive Director of license suspended by order BABH.

(4) the order under paragraph 1. 3 has been reported and may be appealed pursuant to the administrative code. An appeal shall not have suspensive effect.

§ 80. In art. 289 following amendments and supplements shall be made:

1. In paragraph 8. 1 Add "or the decentralised procedure".

2. in the Al. 2, the words "and apply" shall be replaced by ' except in cases where the application is submitted by "and add" or decentralised procedure ".

§ 81. In art. Al 290. 2 is repealed.

§ 82. In art. 291, para. 4, the words "website" shall be replaced by "website".

§ 83. In art. 292 following amendments and supplements shall be made:

1. Paragraph 2 is repealed.

2. in the Al. 4 the word "documents" is replaced by "consolidated list of all submitted documents," after the word "licence" shall be inserted "as well as" and the second sentence: "the Executive Director of BABH may at any time require the applicant to submit the listed documents."

3. in the Al. 9, after the word "quantity" is added "delivered before the expiry date of the licence.

§ 84. In art. 293 following amendments and supplements shall be made:

1. In paragraph 8. 1, after the word "innovation" is added "and change" and add "which are necessary for the production and control of VMPS on generally accepted scientific methods.

2. a new paragraph. 2:

"(2) the changes in the Al. 1 shall be approved by the Executive Director of BABH. "

3. the Previous para. 2 and 3 become respectively al. 3 and 4.

§ 85. In art. 295 following amendments and supplements shall be made:

1. In paragraph 8. 1:

and in the text) before item 1 finally added "in charge of the pharmacovigilance system and is found in the territory of a Member State of the European Union, and";

b) point 1 shall be amended as follows:

1. develop and maintain a system for the collection and processing of information obtained about all suspected adverse reactions, occurring in the application of VMPS, and report it to the manufacturer, including its representatives; "

c) in paragraph 2, the word "reports" is replaced by "periodic reports" and the word "periodically" shall be deleted;

d) in point 3, the words "in front of" BABH shall be deleted and the words "information related to the system referred to in paragraph 1" shall be replaced by "additional information at the request of BABH, necessary for the assessment of the benefit/risk ratio in the use of STATUS";

e) in item 4 the words "studies of the STATUS after its placing on the market ' shall be replaced by" studies related to market surveillance after the issuance of the licence to use ".

2. Paragraphs 2, 3 and 4 shall be repealed.

§ 86. In art. 296 following amendments and supplements shall be made:

1. In paragraph 8. 1:

a) in paragraph 1, the words ' animal ' shall be deleted and the words "other countries" shall be replaced by ' Member States or third countries; in exceptional circumstances, these reactions shall be communicated electronically in the form of a report ";

b) in paragraph 2, the words "any information about" shall be replaced by the words "all" and finally a comma and add "which has received information which suggests that may occur";

c) in paragraph 3 the words "form" and the second sentence shall be deleted;

d) points 4 and 5 are amended:

4. ensure that information about all suspected serious unexpected adverse reactions, human adverse reactions and any suspected transmission of infectious agent, appeared on the territory of a third country after use of STATUS shall be reported immediately, but not later than 15 days after receiving the information, the European Medicines Agency and the competent authorities of the Member States in whose territory the VMPS is licensed for use;


5. ensure that information about all suspected adverse reactions and serious adverse reactions in people after using hi-tech VMPS, licensed in the European Union, or STATUS, which are the subject of mutual recognition procedure or the decentralised procedure, is submitted to the competent authority of the reference Member State; ".

2. a para. 3:

"(3) upon submission of the information referred to in para. 1, item 3-5 the holder of the license for use of STATUS must comply with the requirements of the Ordinance under art. 382. 6. "

§ 87. In art. 297, para. 4 Finally, the comma and added "as well as information on the number of prescribed recipes."

§ 88. In art. 298 following amendments and supplements shall be made:

1. In paragraph 8. 1:

and in the text) before item 1, the words ' must ' shall be deleted;

b) point 2 is amended as follows:

' 2. before placing on the market of the present STATUS of research and control at the request of BABH samples of each batch of bulk product and/or the final STATUS, sufficient to perform three studies and accompanied by the documents referred to in item 3 – where it is necessary for the protection of the health of animals and people; "

in) is created item 3:

3. "presented at the request of BABH copies of all documents for batch control STATUS, signed by a qualified person, for I have in accordance with art. 353 a, para. 1, which certifies that the control tests carried out on the STATUS and/or with active substances and intermediate products of the manufacturing process are in accordance with the conditions under which the licence was issued for use. "

2. Paragraphs 2, 3 and 4 shall be repealed.

§ 89. Create art. 298 and 299 (b):

"Art. 298. (1) the Executive Director of BABH shall inform the competent authorities of the Member States in which the immunological STATUS is licensed to use, and the European Directorate for the quality of medicines of its intention to control a specific batch or batches of the product.

(2) where a competent authority of a Member State is informed that BABH intends to control the specific lot or lots immunological STATUS, licensed for use in the Republic of Bulgaria, BABH does not control this batch or batches.

 Art. 298. (b) (1) following evaluation of the documents referred to in art. 298, para. 1, item 3 BABH new tests of samples submitted in accordance with the methods referred to in the dossier of the product.

(2) where the Member State in which the product is licensed for use and, where necessary and the European Directorate for the quality of medicines are for I have lasni can be carried out only part of the test under para. 1.

(3) For immunological STATUS, licensed under Regulation (EC) No 726/2004, the tests may be reduced after agreement of the European Medicines Agency.

(4) in the cases referred to in para. 1 and 2, where the tests are carried out by the competent authority of a Member State, BABH acknowledges the results of these tests.

(5) the tests provided for in para. 1 shall be made within 60 days of receipt of the samples from the batch of immunological STATUS, except in cases where the European Commission BABH informed that they require to conduct a longer term.

(6) the Executive Director shall inform the BABH al. 5 the competent authorities of the Member State in which the product is licensed for use, European Directorate for the quality of medicines, the holder of the licence for use and, where appropriate, and the licence holder to produce, for the results of the tests.

(7) where it finds that the batch BABH immunological STATUS does not correspond to the documents referred to in art. 298, para. 1, item 3 or the license for use of VMPS, Executive Director of BABH take the measures under art. 317 in respect of the holder of the licence to use and, where necessary and in respect of the licence holder to produce, and shall inform the competent authorities of the Member States in which the product is licensed for use. "

§ 90. Article 299 shall be amended as follows:

"Art. 299. the issue of a license for use of VMPS does not relieve the manufacturer of the product and the licence holder from liability for failure to comply with the requirements provided for in this chapter. "

§ 91. Article 300 shall be amended as follows:

"Art. 300. (1) For small changes type IA and type IB and type II major changes in the scope of the license to use the STATUS laid down in Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (OB, L 333/7 of 12 December 2008) , hereinafter referred to as "Commission Regulation (EC) No 1234/2007, the licence holder shall submit an application form to the Executive Director of the applied BABH documents connected with the changes, as well as a document for paid fee fixed by the tariff referred to in art. 14, para. 2.

(2) the interconnected changes shall be indicated in the request under para. 1 in compliance with the requirements of art. 7 of Council Regulation (EC) No 1234/2007.

(3) in BABH evaluation of the documents annexed to the application for variation of type IA and type IB under art. 8 and 9 of Regulation (EC) No 1234/2007.

(4) on the basis of the assessment under paragraph 1. 3 the Executive Director within 30 days of submission of the application, approve the change or reasoned refused approval.

(5) where the approved changes require an amendment to the contents of the license for use of VMPS, Executive Director of the issued license BABH addition to and enter the changes in the register under art. 290. The changes in the license for use shall be recorded in the summary of product characteristics, labelling and package leaflet for use of the product, when it is needed.


(6) where the approved changes did not require an amendment to the contents of the license for use of VMPS, Executive Director of BABH writing shall inform the applicant of the approval and implement the documents relating to the change in the STATUS file.

(7) in BABH evaluation of the documents annexed to the application for the change type II by the procedure of art. 285 and 287.

(8) the Executive Director of BABH on the basis of the opinion of the Commission under art. 287 approves change of type II or reasoned refused approval.

(9) the Executive Director shall approve the changes by BABH type II, as follows:

1. within 60 days from the filing of the application, which can be extended to 90 days – the change referred to in part 1 of annex V of Regulation (EC) No 1234/2008;

2. within 90 days of submission of the application – for change set out in part 2 of annex V of Regulation (EC) No 1234/2008;

3. within 60 days – for all other changes.

(10) the Executive Director of BABH:

1. issue an addition to the license for use of VMPS, when approved changes require modifying the contents of the licence and enter the changes in the register under art. 290; changes in license for use shall be recorded in the summary of product characteristics, labelling and package leaflet for use of the product, where appropriate;

2. inform the applicant in writing for the approval of changes, where the approved changes did not require an amendment to the contents of the license, and apply the documents relating to the change in the STATUS file.

(11) the refusal under para. 4 and 8 are reported and may be appealed pursuant to the administrative code.

§ 92. In art. 301, para. 2 the word "regulations" shall be replaced by "Ordonnance".

§ 93. In art. 304, para. 2 the word "regulations" shall be replaced by "Ordonnance".

§ 94. In art. 306, para. 1, after the word "application" be added "for a change".

§ 95. Article 314 is amended as follows:

"Art. 314. (1) For changes to the scope of the license to use the STATUS laid down in Regulation (EC) No 1234/2007, the licence holder shall submit an application form to the Executive Director of BABH.

(2) an application under subsection. 1 documentation is applied under art. 279, paragraph 2, relating to the change of the scope of the license to use, and a document for paid fee in the amount set out in the tariff referred to in art. 14, para. 2.

(3) depending on changes in the scope of the license, the applicant shall provide samples and/or products under art. 279, item 3.

(4) the assessment of the information submitted with the application under para. 1 documentation is carried out by the procedure of art. 285 and 287.

(5) the Executive Director shall issue a new licence for BABH use or addition to existing license by the procedure of art. 288 depending on changes in the scope of the license for use. "

§ 96. Article 315 is amended as follows:

"Art. 315. (1) the holder of the licence holder may transfer its rights on the licence of another person satisfying the conditions under art. 278.

(2) in the cases referred to in para. 1 the person who wishes to acquire the rights under the licence to use, submitted to the Executive Director of the application to which the BABH apply:

1. a written agreement entered into between the licence holder and the person to whom the rights are transferred;

2. data concerning the qualified person referred to in art. 295 – name, address and professional qualifications;

3. other documents related to the change, if any;

4. a document for paid fee fixed by the tariff referred to in art. 14, para. 2.

(3) in establishing the shortcomings in the Al. 2 notify the applicant BABH within 30 days from the filing of the application to submit the additional required information. The period referred to in para. 5 shall be suspended from the date of notification to provide the requested information.

(4) where, within the period referred to in paragraph 1. 3 the applicant does not submit the information, the procedure for the transfer of rights to the use of the licence STATUS shall be terminated by order of the Executive Director of BABH.

(5) within 30 days of the date of submission of the application referred to in paragraph 1. 2 the Executive Director shall issue the license BABH transferee to use and enter the change in the register under art. 290, para. 1 or reasoned refused issue. The license is valid until the expiry of the licence issued to the previous holder.

(6) the refusal under para. 5 is reported and may be appealed pursuant to the administrative code.

(7) the new license holder for use take the full rights and obligations of the previous holder of the licence.

(8) the period for which the licence was issued for use on VMPS, remained unchanged in the transfer of the rights. "

§ 97. In art. 316 following amendments and supplements shall be made:

1. In paragraph 8. 1:

(a)) in the text before point 1 after the abbreviation "VMPS" is added "and ordered him to block and download STATUS of the market ';

b) in item 4 the words "manufacturer" shall be replaced by "in" license;

in point 5) shall be repealed;

d) in point 7, the words "article. 353, para. 4 "shall be replaced by" art. 353 a, para. 1 ";

e) in point 8 the figure "3" shall be replaced by "four";

is so created) 9-11:

"9. the holder of the licence holder has not provided the reports referred to in art. 296, para. 1, item 6;

10. are not complied with the conditions specified in the licence;

11. failure to comply with the requirements of the Ordinance under art. 361, para. 2. "

2. paragraph 2 is replaced by the following:

"(2) the Executive Director shall terminate the license with order BABH for use of VMPS:

1. at the written request of the holder;

2. where it is banned for use on VMPS after the issue of the licence;

3. where an active substance of VMPS, intended for food-producing animals are excluded from table 1 "Authorised substances" of the annex to Regulation (EC) No 37/2010;

4. where an active substance is included in the VMPS table 2 "banned substances" of the annex to Regulation (EC) No 37/2010;

5. when the merchant's activity has been terminated. "

3. a para. 4:


"(4) Orders under para. 1 and 2 shall be published on the website of BABH. "

§ 98. Art is created. 316:

"Art. 316. (1) the Executive Director of BABH by order may suspend the validity of the license for use of VMPS to establish the circumstances under art. 316, para. 1, item 2 – 4, 10 and 11.

(2) where it is established that there are no circumstances under para. 1 or the holder of the licence holder has taken actions to remedy the violations under art. 316, para. 1, item 2 – 4, 10 and 11, the Executive Director of the order repealed BABH suspension of license.

(3) the order under paragraph 1. 1 shall be notified and may be appealed pursuant to the administrative code. An appeal shall not have suspensive effect.

§ 99. In art. 317, para. 1 the words "item 1 – 6 ' shall be replaced by ' paragraphs 1 – 4, 6, 10 and 11".

§ 100. In art. 318 al. 1 shall be amended as follows:

(1) the owner of VMPS or authorized person married him and destroyed in accordance with the law on waste management, where the product:

1. it is prohibited to use and trade in accordance with art. 317;

2. has expired;

3. is there a deviation in performance as a result of improper storage or transport;

4. is produced by a person who does not have a license for the production of VMPS;

5. is traded or held by a person who is not a license to trade with VMPS;

6. is not licensed for use;

7. is imported by a person who does not have a licence issued by the order of art. 356. "

§ 101. In art. 319 following amendments and supplements shall be made:

1. The current text becomes paragraph 1.

2. a para. 2:

"(2) the Executive Director shall notify in writing to the European Commission BABH in prohibited under para. 1. "

§ 102. Article 320 shall be amended as follows:

"Art. 320. in the complicated epizootic situation BABH Executive Director with a warrant may authorise the temporary use of unlicensed use of immunological STATUS in the absence of appropriate licensed STATUS, after having informed the European Commission about the conditions under which the product will be used. "

§ 103. Art is created. 320:

"Art. 320. (1) where an animal is imported or exported to a third country, it must take certain preventive measure, the Executive Director of BABH may allow the animal to attach the immunological STATUS, which is not licensed for use in the Republic of Bulgaria, but is authorised under the legislation of the third country.

(2) in the cases referred to in para. 1 BABH control on importation and use of immunological STATUS. "

§ 104. Article 321 shall be amended as follows:

"Art. 321. where the health situation requires, the Executive Director of BABH by order may authorize the use of VMPS, licensed for use in another Member State, to be used in accordance with the requirements of this chapter. "

§ 105. Article 322 is amended as follows:

"Art. 322. (1) where, in the Republic of Bulgaria no licensed STATUS, suitable for relieving the suffering of unproductive animals, by way of exception, the veterinarian may apply on his own responsibility with treatment:

1. the veterinary medicinal product authorised in accordance with this section or pursuant to Regulation (EC) No 726/2004 for other or in the same species, but with other therapeutic indications;

2. the medicinal product authorised for human use in the Republic of Bulgaria or under Regulation (EC) No 726/2004, or

3. licensed for use under the law STATUS of another Member State for the same or for a different kind of animals for the same or another medical condition – when there is no product referred to in paragraph 1;

4. the veterinary medicinal product prepared in a pharmacy by a certified person on prescription of a veterinarian – where there is no STATUS under item 2 and 3.

(2) for the treatment of equidae shall apply the requirements of para. 1, provided that the products derived from animals not intended for human consumption.

(3) Substances, necessary for the treatment of equidae, for which the withdrawal period must not be less than six months, are set out in the annex to Regulation (EC) no 950/2006 of 13 December 2006 to draw up in accordance with Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products on the list of substances which are essential for the treatment of equidae. "

§ 106. Article 323 shall be amended as follows:

"Art. 323. (1) where, in the Republic of Bulgaria no licensed STATUS, suitable to relieve unbearable suffering to food-producing animals on a holding, the veterinarian may apply on his own responsibility with the treatment: 1. veterinary medicinal product authorised in accordance with this section or pursuant to Regulation (EC) No 726/2004 for other or in the same species, but with other therapeutic indications;

2. the medicinal product authorised for human use in the Republic of Bulgaria or under Regulation (EC) No 726/2004, or

3. licensed for use under the law STATUS of another Member State for the same or for a different kind of animals for the same or another medical condition – when there is no product referred to in paragraph 1;

4. the veterinary medicinal product prepared in a pharmacy by a certified person on prescription of a veterinarian – where there is no STATUS under item 2 and 3.

(2) the requirements under paragraph 1. 1 apply if pharmacologically active substances contained in STATUS, are included in table 1 "Allowed" substances from the application of Regulation (EC) No 37/2010 and the veterinarian who administered the treatment has determined an appropriate withdrawal period. "

§ 107. In art. 324 Al is created. 3:

"(3) For homeopathic VMPS, intended for food-producing animals, the active substances which are listed in table 1 of the annex to Regulation (EC) No 37/2010, the withdrawal period referred to in paragraph 1. 1 is zero days. "


§ 108. In art. 325, para. 1 the word "three" is replaced by "5".

§ 109. In art. 326.6 t is created:

6. veterinary medicinal products intended for clinical trials in the development of new VMPS. "

§ 110. In chapter eleven in the section I created art. 329:

 "Art. 329. (1) the Bulgarian food safety agency shall issue to the holder of the license to use certificates in accordance with the certification scheme of the World Health Organization.

(2) for the issue of a certificate under subsection. 1 the holder of the licence holder shall submit to the Executive Director of BABH sample application that implements a document for paid fee in the amount set out in the tariff referred to in art. 14, para. 2.

(3) the Executive Director of BABH issue the certificate within 14 days from the filing of the application referred to in paragraph 1. 2. "

§ 111. In Chapter Eleven, the name of section II shall be replaced by the following: "procedure for the mutual recognition of a licence for the use of veterinary medicinal products and decentralised procedure".

§ 112. Article 330 is amended as follows:

"Art. 330. (1) where in a Member State has issued a license for the use of STATUS and an application for the issuance of a license to use for the same STATUS in several Member States, including in the Republic of Bulgaria shall apply mutual recognition procedure of license.

(2) where, in a Member State has not been issued a license for the use of STATUS and an application for the issuance of a license for use of the same STATUS in several Member States, including in the Republic of Bulgaria shall apply decentralised procedure for the issuing of a licence of use. "

§ 113. Article 332 is amended as follows:

"Art. 332. (1) The recognition or the issuing of a licence for the use of STATUS in more than one Member State face in art. 278 application by applied identical record to the Executive Director of BABH and to selected Member States thereof, hereinafter referred to as "interested". The dossier shall contain the administrative information and scientific and technical documentation under art. 279, as well as information on the implementation of the requirement of art. 280, para. 9, where there is one.

(2) in the application the person under art. 278 indicate the Member States concerned and the Member State of reference state that the Authority already compet to draw up a report or update the assessment report on the STATUS of the file. Where necessary, the report shall contain an assessment of the originally specified maximum residue limit of STATUS under art. 280, para. 9 and the results under art. 281, para. 3. (3) where the submission of the application referred to in paragraph 1. 1 was issued a license for the use of STATUS in a Member State, the holder of the licence of use required by the reference Member State to update the report on the evaluation of the dossier of the licensed for use STATUS.

(4) the reference Member State assessment report updates of the STATUS within 90 days of receipt of a valid application. The report together with the approved summary, labelling and package leaflet for use of the product shall be sent to the Member States concerned and to the applicant.

(5) when an application referred to in paragraph 1. 1 has not been issued a license for the use of STATUS in a Member State, the applicant shall indicate the reference Member State shall prepare a draft of the report on the evaluation of the dossier and the draft summary, label and package insert for use on VMPS within 120 days from the receipt of a valid application and shall send them to the concerned Member States and the applicant.

(6) within 90 days of receipt of the documents referred to in para. (4) and (5) the Member States concerned shall approve them and shall inform the reference Member State. The reference Member State shall record the approval, ends the procedure and inform the applicant.

(7) the Executive Director of BABH within 30 days after completion of the procedure under paragraph 1. 3 or 5 respectively, issued a decision on recognition of a license for use of the STATUS or use of the license STATUS and list them in the register under art. 290.

(8) where the Republic of Bulgaria is a Member State of reference she has obligations under para. 4-6. "

§ 114. In art. 333 make the following amendments and additions:

1. In paragraph 8. 1 the words "para. 4 "shall be replaced by" para. 6 "and the words" para. 2 and 4 "shall be replaced by" para. 4 and 5 due to a potential serious risk to human or animal health. "

2. in the Al. 2. in the third sentence the words "para. 5 ' shall be replaced by "para. 7. "

3. in the Al. 3 the words "para. 2 and 3 ' shall be replaced by "para. 4 and 5 "and after the words" art. 319 "comma and added al. 1. "

§ 115. In art. 334 words "by the procedure of art. 279 "shall be deleted.

§ 116. In art. 335, para. 1 in the text before point 1, the words "in the European Union ' shall be replaced by" centrally ".

§ 117. Art is created. 337:

"Art. 337. The conditions and procedures for changes to the licenses for use of VMPS, issued under the mutual recognition procedure and decentralised procedure shall be governed by Regulation (EC) No 1234/2008. "

§ 118. Article 338 shall be amended as follows:

"Art. 338. Any request for changes to the license for the use of STATUS issued by mutual recognition procedure and the decentralised procedure, shall be provided to the Member States in which the product has been licensed for use. "

§ 119. In art. 339 last comma and added al. 1. "

§ 120. In chapter eleven section III with art. 340, 341 and 342 is hereby repealed.

§ 121. In art. 343 following amendments and supplements shall be made:

1. Paragraph 2 shall be replaced by the following: "(2) the production license of VMPS is issued for full and partial manufacture and various processes such as cutting and packaging."

2. in the Al. 4, the words "or appointed persons" shall be deleted.

3. a para. 6:

(6) when the VMPS were imported in the Republic of Bulgaria and destined for another Member State, they shall be accompanied by a copy of the license for the production of STATUS. "

§ 122. Art is created. 343:


"Art. 343. The manufacture of active substances used as starting materials shall include full or partial production, cutting, packaging, repackaging or re-labeling before the inclusion of the substance in the VMPS. "

§ 123. Article 344 shall be amended as follows:

"Art. 344. to obtain the license for the production of STATUS and/or active substances the persons under art. 343 need to: 1. indicate in the application the types of STATUS and/or active substances and pharmaceutical forms which are to be manufactured or imported and also the place of manufacture and/or control;

2. have adequate premises, technical equipment and equipment for the control of STATUS and/or active substances referred to in paragraph 1;

3. have at all times at least one qualified person under art. 353. "

§ 124. In art. 345, para. 1 make the following amendments and additions:

1. In the text before point 1, the words "the person submits ' shall be replaced by" persons under art. 343, para. 1 submit ".

2. point 3 shall be replaced by the following:

"3. the unified identification code according to art. 23 of the law on the commercial register or updated status document issued by a competent authority of another State; ".

3. In paragraph 4, the words "para. 1.1 ' shall be replaced by ' section 2 '.

4. point 5 shall be replaced by the following:

"5. the list of STATUS or active substances, indicating:

a) types and pharmaceutical forms;

b) description of manufacturing process and methods of analysis;

in the name of) active substances or microorganisms, strains in VMPS;

(d)) the way of the application of STATUS. "

5. a new item 6: ' 6. schemes of the premises for the manufacture, control and storage; ".

6. Current item 6 becomes item 7.

§ 125. In art. 347 following amendments and supplements shall be made:

1. In paragraph 8. 1. Add 2 and with the requirements for good manufacturing practice (GMP).

2. in the Al. 2:

(a) in item 1) Finally a comma and add "including the qualified person referred to in art. 353 ';

b) point 2 is amended as follows:

"2. the inadequacy of the documentation provided, the conditions for the manufacture, control and storage of STATUS and/or active substances and GMP requirements.

3. in the Al. 3 Add "but for not more than 180 days".

4. Al are created. 5, 6 and 7:

"(5) in the cases referred to in para. 3 when the applicant does not comply with the instructions within 180 days from the date of receipt of the written notice, the Executive Director of BABH by order terminates the procedure for granting of the licence and shall notify the applicant in writing.

(6) the order under paragraph 1. 5 is reported and may be appealed pursuant to the administrative code. An appeal shall not have suspensive effect.

(7) in the cases referred to in para. 5 may apply for issue of a licence by the procedure of art. 345. "

§ 126. In art. 348 following amendments and supplements shall be made:

1. In paragraph 8. 1 the words "three months" are replaced by "90 days" after the abbreviation "VMPS" is added "or active substances".

2. in the Al. 2, after the words "para. 1 "insert" and "reported.

3. in the Al. 3 after the abbreviation "VMPS" is added "or active substances".

§ 127. Art is created. 348:

"Art. 348. (1) the Executive Director may issue BABH license for production of VMPS or of active substances, provided that the applicant will perform the instructions given BABH during the procedure for the granting of the licence.

(2) in the cases referred to in para. 1, when the guidelines are not met within the specified time limit on them, the Executive Director of BABH by order takes the license.

(3) the order under paragraph 1. 2 are reported and may be appealed pursuant to the administrative code.

§ 128. In art. 350, para. 1 make the following amendments and additions:

1. In the text before point 1 after the abbreviation "VMPS" is added "and/or active substances".

2. In paragraph 4, after the abbreviation "VMPS" is a comma, the Union "and" shall be deleted and then added "and active substances".

§ 129. In art. 351 following amendments and supplements shall be made:

1. In paragraph 8. 1 after the abbreviation "VMPS" is added "or active substances".

2. in the Al. 4 in the first sentence, the words "of one month" shall be replaced by "30 days" in the second sentence the words "three months" are replaced by "90 days".

§ 130. In art. 352 following amendments and supplements shall be made:

1. Paragraph 1 shall be amended as follows:

"(1) the Executive Director of the license changes BABH production excludes from its scope certain types of products or licence takes all the products have not been complied with some of the requirements under art. 344 or are not fulfilled requirements of the authorities of BABH. "

2. a new paragraph. 2:

(2) depending on the type and extent of violations of the requirements for the manufacture or import, the Executive Director of BABH may, with orders to:

1. stop the production or importation of STATUS and/or active substances;

2. suspend the validity of the license for the production of certain products or all products;

3. license under item 2. "

3. The current paragraph. 2 it al. 3.

4. The current paragraph. 3 it al. 4 and, after the words "para. 1 "insert" and 2 are reported and ".

§ 131. Art is created. 352:

"Art. 352. When BABH Executive Director has issued a warrant for a change in the scope of the license to produce, he reissued the license and enter the change in the register under art. 350, para. 1. "

§ 132. In art. 353 following amendments and supplements shall be made:

1. Paragraph 2 shall be replaced by the following:

"(2) the qualified person referred to in paragraph 1. 1 must:


1. possesses a qualification document for training in high school or course, equivalent to this training recognised by the order of the law for the recognition of professional qualifications or the Ordinance on State requirements for the recognition of higher education is acquired and periods of study completed in foreign universities (official SG. 69 of 2000; amend., SG. 25 and 79 from 2009. , PC. 59 by 2010 and PC. 102 by 2011);

2. There are at least two years ' practical experience in a licensed pharmaceutical manufacturer, associated with a qualitative analysis of medicinal products, the quantitative analysis of active substances and other tests necessary to ensure the quality of the products. "

2. Create a new para. 3-7:

"(3) the duration of the practical experience in al. 2, item 2 may be reduced by one year, when the training course in higher school lasts for at least 5 years, or by a year and a half – when the training course has a duration of at least six years.

(4) training in higher school and the course under par. 2, item 1 should have a duration of at least 4 years and include theory and practice for one of the following disciplines: Pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology or biotechnology.

(5) the minimum period of training in high school can be a lasting three-and-a-half years when it is followed by a course in theory and practice, with a duration of at least one year practical training lasts at least 6 months and was conducted in a pharmacy. The course must be completed by an examination at university level.

(6) where, in a Member State higher schools carry out training lasting more than three and over 4 years or courses under para. 2, paragraph 1 of the same duration, the statement of qualification, issued by the higher education institution with over three years of training, or after completion of a course with the same period of training, it is believed that meets the condition for the duration of the training referred to in paragraph 1. 4 and qualification documents issued at the completion of higher education, or over three courses and over 4 years are recognised as equivalent documents to each other.

(7) training and the course under par. 2, item 1 shall include theoretical and practical training in the following subjects: experimental physics, General and inorganic chemistry, organic chemistry, analytical chemistry, pharmaceutical chemistry, including analysis of medicinal products, General and applied Biochemistry (medical), Physiology, microbiology, pharmacology, pharmaceutical technology, toxicology and farmakognoziâ. "

3. The current paragraph. 3 it al. 8 and in her words "para. 2 "are replaced by" para. 2-7.

4. the Previous para. 4, 5 and 6 are repealed.

§ 133. Art is created. 353:

"Art. 353. (1) the qualified person referred to in art. 353, para. 1:

1. a certificate for the release of the batch with which ensures that each batch has been manufactured and controlled STATUS in accordance with the requirements of this section and the terms of the license for use of the product;

2. issue a certificate of release of the imported batch STATUS, including when the batch has been manufactured in a Member State, which shall ensure that before release of the lot on the market in a Member State is carried out a full qualitative analysis, a quantitative analysis of at least the active substances and all tests or controls necessary to ensure the quality of the STATUS in accordance with the requirements of the license for use.

(2) the carrying out of analyses, tests and checks at al. 1, item 2 shall not be required for the placing on the market of consignments STATUS, accompanied by a certificate of release, issued by a qualified person established in the territory of a Member State of the European Union.

(3) the qualified person does not perform the analyses, tests and checks at al. 1 2 when the STATUS of a third party, entered into an agreement with the European Union, which ensures that in this country apply GMP requirements at least equivalent to those in the European Union, and that they have carried out the analyses, tests and controls to ensure the quality of the product.

(4) the qualified person shall keep a logbook in which entered data, to ensure that each batch of VMPS is produced and controlled in accordance with the requirements of this section and is in accordance with the license for use of VMPS.

(5) the journal under para. 4 shall be kept for at least 5 years after the last entry and shall be presented to the authorities of BABH upon request.

(6) upon the formation of administrative-penal or criminal proceedings for violations committed by the qualified person, the Executive Director of inform BABH the licence holder to produce, that should eliminate the qualified person from Office pending completion of proceedings initiated against him. "

§ 134. In art. 354 following amendments and supplements shall be made:

1. In paragraph 8. 1:

a) in paragraph 2, the word "use" is replaced by "production";

(b) in point 3) add "and provides them access to the site at any time for the production and control";

in point 6) add "and/or active substances and use as starting materials only active substances which have been manufactured in accordance with the requirements of good manufacturing practice;

d) point 7 is replaced by the following:

"7. waters records of all delivered by it STATUS and/or active substances including delivered samples, which contains:

a) delivery date;

(b)) name of STATUS and/or active substances;

c) quantity supplied;

d) name and address of the consignee;


e) batch number STATUS and/or active substances. "

2. paragraph 2 is replaced by the following:

"(2) the documentation referred to in paragraph 1. 1, item 7 shall be kept for at least three years from the last entry and shall be made available to the authorities of BABH upon request. "

§ 135. In art. 355 following amendments and supplements shall be made:

1. The current text becomes paragraph 1.

2. a para. 2:

"(2) in the cases referred to in para. 1 persons must be provided with a copy of GMP certificate issued to the manufacturer of the STATUS of the competent authority of the Member State or another State party to the agreement on the European economic area, and when the STATUS of a third party, entered into an agreement with the European Union, which ensures that in this country apply GMP requirements at least equivalent to those in the European Union – the copy of GMP certificate issued by the competent authority of the third country. "

§ 136. In art. 356 following amendments and supplements shall be made:

1. Paragraph 1 shall be amended as follows:

"(1) for obtaining a licence for the manufacture of VMPS persons under art. 355 apply a pattern to which apply:

1. the documents referred to in art. 345, para. 1, item 1, 3 and 5-7;

2. the qualifications and experience of the managers of the manufacture, control and quality assurance in the country of production and of a qualified person responsible for the quality of imported VMPS in the Republic of Bulgaria;

3. a copy of the Act of putting into operation of the storage facilities of the STATUS in the Republic of Bulgaria, issued under the territory. "

2. a new paragraph. 3:

"(3) in the cases referred to in para. 2 shall not carry out on-the-spot inspection of the facility for the production of STATUS in a third country, entered into an agreement with the European Union, which ensures that in this country apply GMP requirements at least equivalent to those in the European Union. "

3. The current paragraph. 3 it al. 4 and, after the words "the license" is added "change," and "stop words and art. 361, para. 3 "shall be deleted.

§ 137. Article 357 shall be repealed.

§ 138. In art. 359 the following modifications are made:

1. In paragraph 8. 1 the words "para. 5 ' shall be replaced by "para. 8. "

2. paragraph 2 is replaced by the following: "(2) the persons under art. 355 are entitled to sell the VMPS wholesalers. "

3. Paragraph 3 is repealed.

§ 139. In art. 360 following amendments and supplements shall be made:

1. Paragraph 1 shall be amended as follows:

(1) the importers of VMPS must:

1. comply with the requirements of art. 354, para. 1, item 1, 4 and 5;

2. have in stock only, VMPS who hold a licence for use;

3. notify the inspection authorities of BABH of any change in the conditions under which the licence was issued for production, and to provide access to the sites for production, storage and control;

4. comply with the GMP requirements;

5. keep a dossier that contains:

a) date of purchase and sale;

(b)) name of VMPS;

in) number and expiry date the batch STATUS;

d) purchased and sold quantities of VMPS;

e) name and address of the supplier and the buyer. "

2. in the Al. 2, after the word "Documentation" add "under para. 1, item 5.

§ 140. In art. Al-361. 3 is repealed.

§ 141. In art. 362 after the abbreviation "VMPS" is added "and active substances".

§ 142. In art. 363 the following endorsements are added:

1. In paragraph 8. 3 after the abbreviation "VMPS" is added "and/or active substances".

2. in the Al. 4 after the abbreviation "VMPS" is added "and/or active substances".

3. a para. 5:

"(5) wholesale of active substances, intended for the manufacture of VMPS may carry persons who hold a licence under subsection. 1. "§ 143. In art. 364, para. 1 paragraph 1 shall be replaced by the following:

"1. the unified identification code according to art. 23 of the law on the commercial register or updated status document issued by a competent authority of another State; ".

§ 144. In art. 365 following amendments and supplements shall be made:

1. In paragraph 8. 3 Finally, the comma and added "but for not more than 180 days".

2. Create a new para. 5 and 6 and para. 7:

"(5) where the applicant does not remedy the deficiencies within a period of 180 days from the date of receipt of the written notice, the Executive Director of BABH by order terminates the procedure for granting the license and shall notify the applicant in writing.

(6) the order under paragraph 1. 5 is reported and may be appealed pursuant to the administrative code. An appeal shall not have suspensive effect.

(7) in the cases referred to in para. 5 you may submit an application for the issuing of a licence by the procedure of art. 364. "

3. The current paragraph. 5 it al. 8.4. Al is created. 9:

"(9) a licence under subsection. 8. "

5. The current paragraph. 6 it al. 10 and in her words "para. 5 ' shall be replaced by "para. 8 and reported. "

§ 145. In art. 366, para. 2, item 5, after the word "groups" insert "and/or active substances".

§ 146. In art. 368, para. 2 Add "and a document for paid fee in the amount set out in the tariff referred to in art. 14, para. 2. "

§ 147. Article 369 is replaced by the following: "art. 369. (1) wholesalers with VMPS may deliver STATUS of wholesale and retail traders with VMPS, animal health establishments under art. 26, al. 1, paragraphs 1 and 2, as well as to other persons upon presentation of a prescription issued by a registered veterinarian.

(2) wholesalers with VMPS may deliver active substances for the production of VMPS only other wholesalers with VMPS and producer STATUS.

(3) For delivery at al. 1 and 2 shall be granted a financial document or signed gear-reception Protocol, indicating the type, quantity, batch number and the expiry date of STATUS and/or active substance and the date of delivery.

(4) it is prohibited to wholesale with VMPS, whose data and on the package leaflet do not comply with the requirements of the Ordinance under art. 361, para. 2. "

§ 148. Art is created. 369:


"Art. 369. When the merchant does not have a license to use a particular, VMPS but intends to deliver this STATUS by another Member State for the purpose of trade, have written to notify the holder of the license for use of the product and the Executive Director of design for its BABH. "

§ 149. In art. 370 the following modifications are made:

1. Paragraph 2 shall be replaced by the following:

"(2) the holder of a licence for wholesale STATUS develop and implement an action plan in case of emergency to download the product from the market on the disposition of the Executive Director of the joint and BABH download in the product licence holder to produce or license for the use of STATUS."

2. in the Al. 3 the words "item 2 and 3 ' shall be replaced by" item 1 – 4, 6 and 7 ".

§ 150. In art. 374 following amendments and supplements shall be made:

1. In paragraph 8. 1:

a) point 4 is repealed;

(b)) is created point 7:

"7. for the new active substance included less than five years in the composition of a licensed guide STATUS."

2. a new paragraph. 3:

"(3) the prescribed in the recipe quantity STATUS must be minimally necessary for appropriate treatment."

3. The current paragraph. 3 it al. 4.

4. The current paragraph. 4 it al. 5 and in her words "para. 3 "shall be replaced by" para. 4 "and the word" three "is replaced by" 5 ".

§ 151. In art. 375, para. 1 is hereby amended as follows:

1. In the text before paragraph 1 the word "receipt" is replaced by "issue".

2. point 1 shall be amended as follows:

"1. the unified identification code according to art. 23 of the law on the commercial register or updated status document issued by a competent authority of another State; ".

3. In paragraph 2 the word "Act" shall be replaced by "a copy of the Act".

§ 152. In art. 376 following amendments and supplements shall be made:

1. In paragraph 8. 2 Finally a comma and add "but for not more than 180 days".

2. Create a new para. 4 and 5 and para. 6:

"(4) where the applicant does not remedy the deficiencies within a period of 180 days from the date of receipt of the written notice, the Executive Director of BABH by order terminates the procedure for granting the license and shall notify the applicant in writing.

(5) the order under paragraph 1. 4 has been reported and may be appealed pursuant to the administrative code. An appeal shall not have suspensive effect.

(6) in the cases referred to in para. 4 may submit an application for the issuing of a licence by the procedure of art. 375. "

3. The current paragraph. 4 it al. 7.

4. a para. 8:

"(8) a licence under subsection. 7 for an indefinite period. "

5. The current paragraph. 5 it al. 9 and in her words "para. 4 "shall be replaced by" para. 7 and reported. "

§ 153. In art. 379 following amendments and supplements shall be made:

1. In paragraph 8. 2 Add "and a document for paid fee in the amount set out in the tariff referred to in art. 14, para. 2. "

2. a new paragraph. 5:

"(5) in the cases referred to in para. 3 and 4, where the applicant does not comply with the instructions of the Commission within 120 days, apply the requirements under art. 376, para. 4-6. "

3. The current paragraph. 5 it al. 6.

§ 154. Article 381 is replaced by the following:

"Art. 381. it shall be prohibited to retail with VMPS, whose data and on the package leaflet do not comply with the requirements of the Ordinance under art. 361, para. 2. "

§ 155. In art. 382 is hereby amended as follows:

1. In paragraph 8. 1 the word "information" is deleted.

2. paragraph 2 is repealed.

3. in the Al. 3:

a) in paragraph 2 the word "effectiveness" is replaced by "efficiency";

b) point 3 is replaced by the following:

"3. the withdrawal period;"

c) in paragraph 4 the word "prescribed" is replaced by "particulars on the labelling and package leaflet for use of the product.

4. in the Al. 4. t 6 is repealed.

5. Paragraph 5 shall be amended as follows:

"(5) the Bulgarian Agency on food safety provided by entering in the database under art. 57, paragraph 1, point (d) of Regulation (EC) No 726/2004, the information gathered by the system under paragraph 1. 1 information to the other competent authorities of the Member States and of the European Medicines Agency. The information must be made available to all Member States. "

§ 156. In art. 383 following amendments and supplements shall be made:

1. Paragraph 1 shall be amended as follows:

(1) following the evaluation of pharmacovigilance data, the Executive Director of BABH by order may:

1. license to use;

2. suspend the validity of the licence;

3. make changes to the license for use relating to the limitation of the testimony for use, change the dosage, addition of contraindications, adding new safeguards. "

2. a new paragraph. 2:

"(2) in the cases referred to in para. 1, the Executive Director shall immediately inform the holder of BABH license for use of VMPS, the competent authorities of the other Member States and the European Medicines Agency for the action taken. "

3. The current paragraph. 2 it al. 3 and the word "end" is replaced by "stop" and the words "interested parties" are replaced by "the competent authorities of the other Member States".

§ 157. Article 384 is hereby repealed.

§ 158. In art. 385, para. 1 Finally a comma and add "as well as on production and wholesale trade with active substances".

§ 159. In art. 386 following amendments and supplements shall be made:

1. In paragraph 8. 1 Add "and experts".

2. paragraph 2 is replaced by the following:

"(2) the officers referred to in para. 1 carry out periodic and unannounced inspections and, if necessary, send samples of VMPS and active substances for laboratory tests in the laboratory or in an accredited laboratory BABH of the European Union. "

3. a para. 3:

(3) verification of the conditions for the production of active substances for compliance with GMP requirements may also be performed at the request of the manufacturer of the active substances. "

§ 160. Article 387 is amended as follows:

"Art. 387. The control is carried out by:

1. laboratory testing of samples from the VMPS and active substances;

2. inspection of documents and the conditions for the production, import, storage and control of VMPS;


3. inspection of documents and the conditions for the production, storage and control of active substances;

4. inspection of documents and the conditions for wholesale and retail trade with VMPS;

5. inspection of documents and the premises of the holders of a licence for the use of STATUS. "

§ 161. In art. 388 following amendments and supplements shall be made:

1. In paragraph 8. 1:

and before that) the text shall be amended as follows: 1 "Inspectors and experts from BABH:";

b) in paragraph 1 the word "sale" shall be replaced by "control," and finally a comma and add "as well as the documents and the premises of the holders of a licence to use the" STATUS;

c) in item 4 after the abbreviation "VMPS" is added and the active substances, and then a comma and add "as well as for violations of the requirements of this chapter;

d) in item 5 Finally add "for laboratory analysis of raw materials and finished products;

e) point 7 shall be repealed;

is in item 8) the words "para. 1, item 2 and al. 2 "are replaced by" paragraph 3 ";

(g) in item 9) Finally a comma and add "as well as to comply with the requirements for the validation of production processes and to ensure the repeatability of the batches of immunological STATUS";

h) in item 10 (b) "a comma and added al. 1. "

2. paragraph 2 is replaced by the following:

"(2) in carrying out the checks referred to in paragraph 1. 1 holders of licences for the production, use and trade of VMPS and registered veterinarians are required to provide assistance and to provide access to objects in the Al. 1, item 1 and to the documentation related to their activities. "

3. a new paragraph. 3:

"(3) the employees of ODBH set for control of VMPS, checked the sites for trading, storage and application of VMPS, give a conclusion on the compliance of retail sites with STATUS with the requirements of this chapter and shall carry out the activities referred to in para. 1, item 3-5. "

4. The current paragraph. 3 it al. and 4 shall be replaced by the following:

"(4) the results of the checks referred to in paragraph 1. 1, item 1, 2, 6, 8, 9 and 10 shall draw up a detailed report, a copy of which shall be provided to the persons checked. "

5. Al are created. 5 and 6:

"(5) when the checks referred to in paragraph 1. 1 the inspectors and experts from BABH can open packages with VMPS or active substances to make copies of documents and capture at the premises of the control.

(6) the officers referred to in para. 1 do not have the right to disclose information obtained in carrying out the checks. "

§ 162. Art is created. 388:

"Art. 388. (1) the Executive Director shall issue a certificate of GMP BABH within 90 days after the inspection of the object STATUS and production checks under art. 388, para. 1, item 9 and 10, when they established the requirements for GMPS.

(2) the certificate referred to in paragraph 1. 1 is valid for three years.

(3) When the verification under paragraph 1. 1 shall be carried out at the request of the European Directorate for the quality of medicines, BABH Executive Director shall issue a certificate of conformity with the monograph.

(4) the Bulgarian Food Safety Agency entered into the database of the European Union (EudraGMP) information on GMP COMPLIANCE certificates issued or information about discrepancies with GMP requirements.

§ 163. In art. 389 the following endorsements are added:

1. In paragraph 8. 1 item 3 is created:

"3. the ordered culling and destroying the VMPS in the cases under art. 318, para. 1. "2. In the Al. 2 creating item 3: "3. under item 3 – with an order of inspector discovered the infringement. "

§ 164. In art. 391, para. 2, after the words "explores in" insert "".

§ 165. In art. 393 words "in the Pharmacopoeia" shall be replaced by ' the European Pharmacopoeia ", and the words" International veterinary code "are deleted.

§ 166. In art. 394 creates item 5:

"5. inactivated immunological STATUS, manufactured from pathogens and antigens obtained from an animal or animals from a holding, and which apply to the animal or animals of the same object."

§ 167. After art. 410 chapter twelve is created "a" with art. a-410 and 410:

Chapter Twelve "" a "

IN VITRO DIAGNOSTIC HEALTH TOOLS

Art. 410. (1) in vitro diagnostic health funds may be used for the implementation of the measures referred to in the State program of prevention, after the issue of a certificate of registration BABH of the diagnostic tool.

(2) the introduction of in vitro diagnostic veterinary medicinal resources from third countries can be carried out only by an authorised by the manufacturer a person registered as a dealer under the commercial law or under the legislation of a Member State of the European Union or of another State party to the agreement on the European economic area, Switzerland or the Swiss.

Art. 410 (b) (1) for the issue of a certificate of registration of in vitro diagnostic veterinarnomedicinsko tool manufacturer, respectively the person under art. 410 (a), para. 2 submit an application form to the Executive Director of the applied BABH:

1. updated status document issued by the competent authority of the country of registration of the applicant;

2. original power of attorney or notarized power of attorney – where the application is lodged by the authorized representative;

3. original or notarized power of Attorney – in the cases under art. 410 (a), para. (2);

4. a copy of the document issued by an accredited laboratory in a Member State, of the means of compliance with the technical specification of the manufacturer;

5. details of the manufacturer, containing a common technological and/or analytical specifications, manufacturing processes and quality control;

6. Description of the analytical and diagnostic parameters of the diagnostic tool;


7. Declaration by the manufacturer that the production of the diagnostic tool is in accordance with the requirements of the Ordinance under art. 410;

8. instruction for use the Bulgarian language;

9. a copy of the registration document issued in another State, if any;

10. three samples to perform testing of in vitro diagnostic veterinarnomedicinsko;

11. other documents and data specified in the Ordinance under art. 410;

12. document for paid fee fixed by the tariff referred to in art. 14, para. 2. (2) where the documents referred to in paragraph 1. 1, item 1-7 and 9 are in another language, they shall be accompanied by a certified translation into Bulgarian language.

Art. 410. the requirements for the data that contains the documentation for the issue of a certificate of registration, the package leaflet for use and manufacture of in vitro diagnostic tool veterinarnomedicinsko, and the order to carry out the sensitivity test shall be determined by an Ordinance of the Minister of agriculture and food.

Art. 410. (1) within 60 days from the filing of the application in BABH checked the documentation and testing for the sensitivity of in vitro diagnostic veterinarnomedicinsko.

(2) in establishing the gaps in the documents submitted, the Executive Director of BABH shall notify the applicant of their removal. In this case, the period referred to in paragraph 1. 1 shall be suspended.

(3) the Executive Director of BABH within 7 days of receipt of the results of the examination and test under para. 1 a certificate of registration or refuse a reasoned and shall notify the applicant.

(4) the certificate referred to in paragraph 1. 3.

(5) Test for sensitivity in the Al. 1 shall be carried out in the laboratory of BABH.

Art. 410 e. (1) the Executive Director of BABH refuse to issue a certificate of registration when:

1. the quantitative and qualitative composition of the in vitro diagnostic veterinarnomedicinsko is different from that indicated in the information provided by the applicant documentation;

2. in vitro diagnostic veterinarnomedicinsko tool does not have the required sensitivity, specificity, reproducibility and accuracy;

3. data on the package and/or leaflet do not comply with the requirements of the Ordinance under art. 410 in.

(2) the refusal under para. 1 shall be notified and may be appealed pursuant to the administrative code.

(3) in vitro diagnostic veterinary medicinal remedies, received a certificate of registration shall be entered in the register of BABH that contains:

1. name of the diagnostic tool;

2. the number and date of issue of the certificate of registration;

3. to diagnose diseases, intended use the diagnostic tool;

4. name, registered office and address of the manufacturer and the management of the person referred to in art. 410 (a), para. 2, received the certificate.

(4) in the event of a change of circumstances of the recorded al. 3, paragraph 4 and article. 410 b, para. 1, item 5, 6 and 8, the holder of the registration certificate within three days of the occurrence of the change in writing notify the Executive Director of BABH and apply documents relating to her, for her coverage in the register.

(5) in the event of a change of circumstances of the recorded al. 3, item 3 application by the procedure of art. 410 (b).

(6) in the event of a change of circumstances be issued further to the registration certificate.

(7) when downloading the diagnostic tool from the market, the holder of the registration certificate shall notify BABH.

Art. 410. (1) the Executive Director of BABH by order deleted the registration of in vitro diagnostic veterinarnomedicinsko where:

1. diagnostic tool will not effect referred to in the documentation, diagnostic sensitivity and/or specificity;

2. the diagnostic tool is not as declared in the registration documentation, qualitative and quantitative composition;

3. the ban on the use of the diagnostic tool after issue of the certificate of registration;

4. the information submitted in the registration dossier, is incorrect.

(2) the order under paragraph 1. 1 shall be notified and may be appealed pursuant to the administrative code.

Art. 410 g. (1) the holder of the registration certificate is required to block, download from the market and destroy a lot of in vitro diagnostic veterinarnomedicinsko tool, where it is found that the consignment does not satisfy the registration documentation, as well as in the cases under art. 410, para. 1.

(2) when established under subsection BABH discrepancies. 1, the Executive Director of BABH by order provides the holder of the certificate of registration to download the batch from the market.

Art. 410. (1) in vitro diagnostic veterinary medicinal trading funds is carried out in licensed under this law sites for wholesale and retail trade with VMPS.

(2) trade under para. 1 may be carried out only with registered by the procedure of art. 410 b in vitro diagnostic veterinary medicinal products.

(3) wholesale and retail Traders are required to:

1. to maintain documentation that contains information for each name, the in vitro diagnostic tool veterinarnomedicinsko, quantity supplied, name/name and address/registered office of the supplier and the recipient and batch number on the diagnostic tool;

2. be scrapped and destroy in vitro diagnostic veterinarnomedicinsko a vehicle within 30 days of its expiration date pursuant to the law on waste management.

(4) each consignment must be accompanied by an analytical quality certificate issued by the manufacturer.

Art. 410. In vitro diagnostic veterinary medicinal remedies are stored under the conditions laid down by the manufacturer. "

§ 168. Article 413 is amended as follows:


"Art. 413. (1) a veterinarian or a manager of veterinarnomedicinsko restaurant, which does not fulfil the obligation under art. 39, para. 1, item 1 and 2 and al. 2, item 2, 4, 6, 9, 10 and 14, is punishable by a fine of 200 to 500 BGN, and for repeated infringement – from 400 to 1000 EUR

(2) a veterinarian who does not fulfil the obligation under art. 39, para. 2, item 3, 5, 7 and 8 shall be punishable by a fine of 100 to 300 BGN, and for repeated infringement – from 200 to 500 LEVs. "

§ 169. Art is created. 414:

"Art. 414. (1) a veterinarian who fails to comply with an obligation under a contract under art. 46 or art. 46 (g), is punishable by a fine of 300 to 1000 BGN, and for repeated infringement – from 500 to 2000 BGN.

(2) a veterinarian who fails to comply with the time limits for implementation of measures under art. 46 or art. 46 (g), laid down in the Treaty, is punishable by a fine of 100 to 500 BGN, and for repeated infringement – from 200 to 700 LV.

(3) the veterinarian who submits false information concerning performance of the contract under art. 46 or art. 46 (g) when the Act does not constitute an offence punishable by a fine of 500 to 2000 BGN, and for repeat offenders, from 700 to 3000 BGN.

(4) the veterinarian who in the exercise of veterinary practice does not comply with the animal health requirements is punishable by a fine of 150 to 600 BGN, and for repeated infringement – from 300 to 1500 euro. "

§ 170. In art. 416 is hereby amended as follows: 1. Paragraph 1 shall be amended as follows:

(1) the owner of the farm animals, which do not fulfil the obligation under art. 132, para. 1, item 4, 6, 9, 12, 14, 21-23, is punishable by a fine of 200 to 500 BGN, and for repeated infringement – from 400 to 1000 BGN "

2. in the Al. 2 the words "100 to 300 ' is replaced by ' 500 to 3000" and the words "300 to 500 ' is replaced by ' 1000 to 6000.

§ 171. Article 417 shall be amended as follows:

"Art. 417. (1) the owner of the farm animals, which do not fulfil the obligation under art. 132, para. 1, item 1 – 3, 5, 10, 11, 13, 15-20, is punishable by a fine of 500 to 2000 BGN, and for repeat offenders, from 1000 up to 5000 EUR

(2) when the offence under para. 1 is committed by a legal person or sole proprietor, a penalty payment of 1000 to 3000 BGN, and for repeated infringement – from 2,000 to 10,000 BGN "

§ 172. In art. 419 after the words "the procedure of art. 137 "the comma and added al. 1-9 "and the words" art. 132, para. 2 "are replaced by" article. 137, para. 10. "

§ 173. In art. 420 words "and 14" are replaced by "14 and 16".

§ 174. In art. 425 is hereby amended as follows:

1. In paragraph 8. 1 the words "100 to 200 ' is replaced by ' 300 to 800.

2. in the Al. 2 the words "200 to 400 ' shall be replaced by" 1000 to 5000.

§ 175. Create art. 442 a-442: "art. 442. (1) Where, without being entered in the register under art. 7, para. 3, t. 21, produced or marketed with the means of identification of the animals to be used as official identification of animals is punishable by a fine of 500 to 2500 BGN, and for repeat offenders, from 3000 to 5000 EUR

(2) when the offence under para. 1 is committed by a legal person or sole proprietor, a penalty payment in the amount of 1000 to 5000 BGN, and for repeat offenders, from 5000 to 10 000 LEVs.

Art. 442 (b). (1) in violation of art. 51A or art. 51 (b) produces or trades with non-approved means of identification by BABH of animals to be used as official identification of animals is punishable by a fine of 500 to 2500 BGN, and for repeat offenders, from 3000 to 5000 EUR

(2) when the offence under para. 1 is committed by a legal person or sole proprietor, a penalty payment of 1000 to 5000 BGN, and for repeat offenders, from 5000 to 10 000 LEVs.

Art. 442. the manufacturer or dealer of the means of identification of animals, which is not reflected in the integrated information system of movement of capital BABH identification of animals is punishable by a fine of 300 to 400 BGN, and for repeated infringement – from 500 to 2000 BGN.

Art. 442. That does not remove and/or forward to destroy specified risk material in accordance with the requirements of annex V, point 2, 4 and 8 of Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies, hereinafter referred to as "Commission Regulation (EC) No 999/2001, ' is punishable by a fine of 1000 to 2000 BGN. and, in a repeated infringement – from 2000 to 3000 BGN.

Art. 442 e. (1) That specified risk material placed on the market and/or meat of ruminant animals, of which the specified risk material has not been removed for transmissible spongiform encephalopathies, is punishable by a fine of 1000 to 2000 BGN, and for repeated infringement – from 2000 to 5000 EUR

(2) when the offence under para. 1 is committed by a legal person or sole proprietor, a penalty payment of 2000 to 3000 BGN, and for repeat offenders, from 3000 to 5000 EUR

(3) in the cases referred to in para. 1 and 2 meat and specified risk material has to be seized and opting for destruction in the object for the disposal of animal by-products. The costs of destruction shall be borne by the offender.

Art. 442. (1) a requirement under art. 9 (2) of Regulation (EC) No 999/2001 shall be punishable by a fine of 500 to 1000 BGN, and for repeat offenders, from 1000 to 2000 BGN.

(2) when the offence under para. 1 is committed by a legal person or sole proprietor, a penalty payment of 1000 to 2000 BGN, and for repeated infringement – from 2000 to 3000 BGN.

(3) in the cases referred to in para. 1 and 2, the meat is forfeited and headed for destruction in the object for the disposal of animal by-products. The costs of destruction shall be borne by the offender.

Art. 442 g (1) which is placed on the market of meat from ruminants, which are not tested for transmissible spongiform encephalopathies in accordance with the requirements of annex III, chapter a, to Regulation (EC) No 999/2001 shall be liable to a fine of 1000 to 3000 BGN, and for repeat offenders, from 3000 to 5000 EUR


(2) when the offence under para. 1 was carried out by a sole proprietor or a legal person, the penalty payment from 2000 to 4000 BGN, and for repeat offenders, from 4000 to 6000 EUR

(3) in the cases referred to in para. 1 and 2, the meat is forfeited and headed for destruction in the object for the disposal of animal by-products. The costs of destruction shall be borne by the offender.

Art. 442. the food manufacturer or dealer who violates the provisions of annex II, chapter IX, paragraphs 1-4 of Regulation (EC) No 852/2004, shall be punished with a penalty of 100 to 300 BGN, and for repeated infringement – from 300 to 1000 EUR

Art. 442. (1) Which transports raw materials and foods of animal origin in violation of art. 245, is punishable by a fine of 100 to 300 BGN, and for repeated infringement – from 300 to 500 pounds.

(2) when the offence under para. 1 is committed by a legal person or sole proprietor, a penalty payment of 500 to 1000 BGN, and for repeat offenders, from 1000 to 2000 BGN.

Art. 442 k. Who adopt an animal for slaughter in breach of the requirements of annex II, section II of Regulation (EC) No 853/2004, shall be punished with a penalty of 300 to 500 BGN, and for repeated infringement – from 500 to 2000 BGN.

Art. 442 l. Who adopt an animal slaughtered in an abattoir in casualty slaughter in breach of the requirements of annex III, section I, chapter VI, of Regulation (EC) No 853/2004, shall be punished with a penalty of 200 to 500 BGN, and for repeated infringement – from 500 to 1000 EUR

Art. 442 m. Manufacturer or dealer of foodstuffs of animal origin, who violates the provisions of art. 4 (3) of Regulation (EC) No 852/2004, shall be punished with a penalty of 500 to 1500 EUR and repeated infringement – from 1500 to 5000 EUR

Art. 442. (1) who violates art. 13 of Council Regulation (EC) No 1760/2000 shall be punishable by a fine of 200 to 500 BGN, and for repeated violation of 400 to 800 EUR

(2) where an offence under subsection. 1 is committed by a legal person or sole proprietor, a penalty payment of 500 to 1000 BGN, and for repeat offenders, from 1000 to 3000 BGN.

Art. 442. (1) o who violates art. 1 of Commission Regulation (EC) no 1825/2000 of 25 August 2000 laying down detailed rules for the application of Council Regulation (EC) No 1760/2000 of the European Parliament and of the Council as regards the labelling of beef and beef products, hereinafter referred to as "Commission Regulation (EC) no 1825/2000", is punishable by a fine of 200 to 500 EUR and, in the case of repeated violation 400-to 800 EUR

(2) when the offence under para. 1 is committed by a legal person or sole proprietor, a penalty payment of 500 to 1000 BGN, and for repeat offenders, from 1000 to 2000 BGN.

Art. 442 p. (1) who violates art. 15 of Regulation (EC) No 1760/2000 and article. 2 of Council Regulation (EC) no 1825/2000 shall be punishable by a fine of 200 to 500 BGN, and for repeated infringement – from 500 to 1500 EUR

(2) when the offence under para. 1 is committed by a legal person or sole proprietor, a penalty payment of 500 to 1000 BGN, and for repeat offenders, from 1000 to 3000 BGN.

Art. 442 b. (1) Who contravenes a requirement under art. 83, 84, 85, 86 or is punishable by a fine of 300 to 500 BGN, and for repeated infringement – from 500 to 1000 EUR

(2) when the offence under para. 1 is committed by a legal person or sole proprietor, a penalty payment of 1000 to 2000 BGN, and for repeated infringement – from 1500 to 3000 BGN.

Art. 442 (1) who violates art. 113 (b) of Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (single CMO Regulation) (OJ L 299/1, of 16 November 2007), is punishable by a fine of 200 to 1000 BGN, and for repeated infringement – from 500 to 2000 BGN.

(2) when the offence under para. 1 is committed by a legal person or sole proprietor, a penalty payment of 1000 to 3000 BGN, and for repeated infringement – from 2000 to 7000 EUR "

§ 176. Create art. 449-449 and (d): "art. 449. a Contractor under a contract concluded under art. 137 or 137 (b) who fails to fulfill the obligation under art. 137 c, is punishable by a fine of 200 to 500 BGN, and for repeated infringement – from 500 to 1000 EUR

Art. 449 (b). (1) the Owner of an object, in which animal by-products are received which does not fulfil the obligation under art. 275, para. 1, is punishable by a fine of 200 to 500 BGN, and for repeated infringement – from 500 to 1000 EUR

(2) when the offence under para. 1 is committed by a legal person or sole proprietor, a penalty payment of 500 to 1000 BGN, and for repeated infringement – from 2000 to 5000 EUR

Art. 449. the owner of a site for the disposal of animal by-products, which fails to fulfill the obligation under art. 275, para. 3 shall be punished by a penalty payment of 1000 to 2000 BGN, and for repeated infringement – from 2000 to 5000 EUR

Art. 449. (1) who does not enter into a contract under art. 275, para. 2 and 3 is punishable with a fine of 1000 to 3000 BGN, and for repeated infringement – from 2000 to 5000 EUR

(2) when the offence under para. 1 is committed by a legal person or sole proprietor, a penalty from 3000 to 5000 BGN, and for repeat offenders, from 4000 to 10 000 LEVs. "

§ 177. In art. 450 after the word "produce" a comma and add "store," and after the words "or offers to use" insert "or" store.

§ 178. Create art. 450 – 450 m:

"Art. 450. (1) without a license, Which produces store or carry out trade in active substances, intended for the manufacture of VMPS is punishable with a fine of 2000 to 3500 BGN, and for repeat offenders, from 4000 to 6000 EUR

(2) when the offence under para. 1 is committed by a legal person or sole proprietor, a penalty from 3000 to 5000 BGN, and for repeat offenders, from 4000 to 10 000 BGN.

Art. 450b (1) carrying out retail in violation of art. 372. 1, is punishable by a fine of 500 to 1000 BGN, and for repeated infringement – from 2000 to 3000 BGN.


(2) when the offence under para. 1 is committed by a legal person or sole proprietor, a penalty payment of 1500 to 3000 BGN, and for repeat offenders, from 4000 to 6000 EUR

Art. 450. the holder of a licence to retail with VMPS, who violates the provisions of art. 373, para. 2, is punished with a penalty of 500 to 1000 BGN, and for repeated infringement – from 2000 to 3000 BGN.

Art. 450. Wholesaler with VMPS who violates art. 370, para. 3 shall be punished by a penalty payment of 1000 to 2000 BGN, and for repeat offenders, from 3000 to 5000 EUR

Art. 450 e. wholesaler with VMPS, which disrupt the provision of art. 369, is punishable by a penalty payment of 1000 to 2000 BGN, and for repeat offenders, from 3000 to 5000 EUR

Art. 450. A retailer with VMPS, who violates the provisions of art. 381, is punishable by a penalty payment of 1000 to 2000 BGN, and for repeat offenders, from 3000 to 5000 EUR

Art. 450 g (1) that produces or imports in vitro diagnostic veterinary medicinal remedies without a certificate of registration is punishable by a fine from 2000 to 5000 BGN, and for repeat offenders, from 6000 up to 15 000 LV.

(2) when the offence under para. 1 is committed by a legal person or sole proprietor, having a proprietary sanction from 5000 to 10 000 BGN, and for repeated infringement – from 10 000 to 20 000.

Art. 450. (1) without a license for wholesale or retail with VMPS carry trade or kept in vitro diagnostic veterinary medicinal remedies, or trades, or kept in vitro diagnostic equipment without a certificate of registration is punishable by a fine of 500 to 1000 BGN, and for repeated infringement – from 1500 to 3000 BGN.

(2) when the offence under para. 1 is committed by a legal person or sole proprietor, a penalty payment of 1500 to 3000 BGN, and for repeat offenders, from 4000 to 6000 EUR

Art. 450. Who produces, imports, store and/or carry trade in vitro diagnostic veterinary medicinal remedies which do not comply with the requirements under which the certificate was issued for registration, shall be punished with a proprietary sanction from 1500 to 3000 BGN, and for repeat offenders, from 4000 to 6000 EUR

Art. 450 HP who violates a requirement of the Ordinance under art. in 410, is punished with a penalty of 1500 to 3000 BGN, and for repeat offenders, from 4000 to 6000 EUR

Art. 450 l. A holder of a certificate of registration that does not block, and download from the market batch in vitro diagnostic veterinary medicinal resources in violation of art. 410 g, shall be punished with a proprietary sanction from 1500 to 3000 BGN, and for repeat offenders, from 4000 to 6000 EUR

Art. 450 m. dealer who fails to fulfil an obligation under art. 410 h, para. 3, is punished with a penalty of 1500 to 3000 BGN, and for repeat offenders, from 4000 to 6000 euro. "

§ 179. In art. 452 following amendments and supplements shall be made:

1. In paragraph 8. 1 after the abbreviation "VMPS" is added "or in violation of art. 374, para. 2 issue a prescription ".

2. in the Al. 2 and 3 the words "para. 4 "shall be replaced by" para. 5. "

§ 180. Article 454 shall be amended as follows:

"Art. 454. (1) Who contravenes a provision of art. 359, is punishable by a fine of 1000 to 1500 EUR and repeated infringement – from 2000 to 5000 EUR

(2) when the offence under para. 1 is committed by a legal person or sole proprietor, a penalty payment of 2000 to 5000 BGN, and for repeat offenders, from 5000 to 10 000 LEVs. "

§ 181. Article 455 is hereby repealed.

§ 182. In art. 459 after the words "art. 319 "comma and added al. 1. "

§ 183. In art. 461. 1, the words "or medicated feedingstuffs" shall be deleted, the words "500 to 1000" shall be replaced by "1000 to 3000" and the words "1000 by 2000" shall be replaced by "3000 to 5000.

§ 184. Create new art. 462-468 and art. 468 a – 468 l: "art. 462. Which does not fulfil the obligation under art. 388. 2, is punishable by a fine of 200 to 500 BGN, and for repeated infringement – from 400 to 1000 EUR

Art. 463. A qualified person on the market STATUS in violation of the requirements of art. 353 a, para. 1, item 1 and/or 2, is punishable by a fine from 2000 to 5000 BGN, and for repeat offenders, from 5000 to 10 000 LEVs.

Art. 464. A qualified person of a holder of a license for use of STATUS, which does not fulfill the obligation of art. 295, para. 1, item 1, is punishable by a fine of 500 to 1000 BGN, and for repeat offenders, from 1000 to 2000 BGN.

Art. 465. The holder of the license for use of VMPS, who do not fulfil the obligation under art. 296, para. 1, item 1, 2, 3, 6 and 8 and para. 2 shall be punished by a penalty payment of 1000 to 2000 BGN, and for repeat offenders, from 3000 to 5000 EUR

Art. 466. The holder of a licence for the use of an immunological STATUS, which does not fulfil the obligation under art. 298, is punishable by a penalty payment of 1000 to 2000 BGN, and for repeat offenders, from 3000 to 5000 EUR

Art. 467. The holder of a licence for the manufacture of VMPS, who do not fulfil the obligation under art. 354, para. 1, 2, 3, 4, 6 and 7 shall be punished by a penalty payment of 1500 to 3000 BGN, and for repeat offenders, from 3000 to 6000 EUR

Art. 468. (1) in violation of art. 355 imported VMPS is punishable with a fine of 1000 to 2000 BGN, and for repeated infringement – from 2000 to 4000 EUR

(2) when the offence under para. 1 is committed by a legal person or sole proprietor, a penalty payment of 2000 to 6000 EUR, and for repeat offenders, from 6000 to 10 000 BGN.

Art. 468. Importer of VMPS, who do not fulfil the obligation under art. 360, al. 1 shall be punished by a penalty payment of 1500 to 3000 BGN, and for repeat offenders, from 3000 to 6000 EUR

Art. 468. (b) (1) Whoever in violation of art. 362 transported VMPS and/or active substances is punishable by a fine of 500 to 1000 BGN, and for repeat offenders, from 1000 to 2000 BGN.

(2) when the offence under para. 1 is committed by a legal person or sole proprietor, a penalty payment of 1500 to 3000 BGN, and for repeat offenders, from 3000 to 6000 EUR

Art. 468. the officer under art. 388. 1, which disseminate information obtained in the examination is punishable by a fine of 500 to 1500 EUR and repeated infringement – from 1500 to 3000 BGN.


Art. 468. The holder of the license for use of VMPS, who do not fulfil the obligation under art. 8 and 9 of Regulation (EC) No 1234/2008, shall be punished with a proprietary sanction from 800 to 1500 EUR and repeated infringement – from 1500 to 3000 BGN.

Art. 468 e. The holder of the license for use of VMPS, who do not fulfil the obligation under art. 10 of Regulation (EC) No 1234/2008, shall be punished with a proprietary sanction from 1500 to 3000 BGN, and for repeat offenders, from 3000 to 6000 EUR

Art. 468. A legal person or sole proprietor who place on the market the VMPS, intended for food-producing animals whose active or active substances exceed the maximum residue limit, or STATUS, intended for food-producing species, for which there is no down such values in Regulation (EC) No 37/2010, shall be punished with a proprietary sanction from 2000 to 4000 BGN, and for repeat offenders, from 4000 to 10 000 BGN.

Art. 468 g. Who conducts the treatment or prevention of food-producing animals with VMPS, whose active or active substances exceed the maximum residue limit, or STATUS, intended for food-producing species, for which there is no down such values in Regulation (EC) No 37/2010, is punishable by a fine of 500 to 1500 EUR and repeated infringement – from 1500 to 3000 BGN.

Art. 468 h. veterinarian who violates the requirements under art. 322, para. 1 and/or 2 is punishable by a fine of 600 to 1500 EUR and repeated infringement – from 1500 to 3000 BGN.

Art. 468. The veterinarian who violates the requirements under art. 323, is punishable by a fine of 800 to 2,000 BGN, and for repeated infringement – from 2000 to 4000 EUR

Art. 468 k. Wholesaler with VMPS, who do not fulfil the obligation under art. 371. 1 and/or 2, shall be punished with a proprietary sanction from 1000 to 3000 BGN, and for repeat offenders, from 3000 to 6000 EUR

Art. 468 l retailer with VMPS, who do not fulfil the obligation under art. 380, para. 1 and/or 2, shall be punished with a proprietary sanction from 600 to 1500 EUR and repeated infringement – from 1500 to 3000 pounds. "

§ 185. Art is created. 471: "art. 471. (1) For other violations of this law, as well as of the acts for its implementation shall be imposed a fine of 150 to 1000 EUR, if not provided for more severe punishment.

(2) when the offence under para. 1 is committed by a legal person or sole proprietor, a penalty payment of 500 to 2000 BGN, and for repeated infringement – from 10 000 to 20 000 LV. "

§ 186. In the additional provisions in § 1 are made the following amendments and additions:

1. In paragraph 5, the words "all over generic" and "generic" shall be replaced respectively with "Generic" and "generic".

2. an item 7a:

' 7A. the "veterinary prescription" is a requirement for the granting of STATUS, issued by a registered veterinarian. "

3. point 25 is replaced by the following:

"25." Periodic safety report "is a recording of all the reactions by use of STATUS set out in section VII of the chapter eleven."

4. a t. 27A:

"27A." same STATUS "are products that have the same qualitative and quantitative composition in terms of active substance (s) and are available in one and the same pharmaceutical form, as are permissible differences in secondary substances, if it does not affect the safety and efficacy of the products."

5. Section 29 is repealed.

6. Section 43 is repealed.

7. In paragraph 44, point (b), the words "immune status" shall be replaced by "State immunity".

8. an item 45A: "45." In vitro diagnostic veterinarnomedicinsko tool is a tool that is not applied on animals and represents Kit (set of chemical agents, control material) or reagent for testing the samples of tissues and body fluids, including blood and milk intended solely or mainly for the purpose of obtaining information on:

a physiological or pathological condition), or

b) immune status, or

in therapeutic control) actions.

Products for general laboratory use as reagents, rapid tests and intended for unproductive animals, instruments, apparatus or equipment are not in vitro diagnostic veterinary medicinal products. "

9. In paragraph 49, the words "time interval" shall be replaced by "adequate amount of time", the word "Annex" is replaced by "application", the words ' animal products ' shall be replaced by ' food of animal origin "and finally" is added to the active substances designated in Regulation (EC) No 37/2010 ".

10. an item 52 (a):

"52." Concentration "is the content of the active substances expressed quantitatively per dosage unit, per unit of volume or weight according to the dosage form."

11. In paragraph 54, the word "Sheet" is replaced by "Leaflet for use" and the words "is placed in the outer packaging" shall be replaced by ' accompany ' STATUS.

12. In paragraph 59, the words ' intended for prevention, treatment, restoring, correcting or modifying physiological functions of animals "shall be replaced by the words" prepared for marketing and intended for animals without further processing, which has curative or preventive properties or properties of VMPS as defined under item 9.

13. an item 60 (a):

"60." the name of VMPS "is the name of the STATUS, which may be:

a) trade name;

(b) the common name;)

c) scientific name accompanied by a trade mark or the name of the holder of the license for use of STATUS. "

14. Point 62 shall be replaced by the following:

"62." adverse reaction in animals "is harmful and unexpected reaction occurring in animals after administration of doses of prescribed STATUS under diagnostic, preventive or therapeutic purposes, or to restore, correct or modify a physiological function."

15. In paragraph 63, the word "junk" is replaced by "unexpected".


16. In paragraph 70, after the word "comma" are no ponds and add "sites for feeding of carrion birds".

17. an item 75 (a):

"75." official identification "is placing animals of BABH-approved means of identification by which animal data are entered into the integrated information system of BABH."

18. t. created 90 and 90 (b):

"90." studies related to market surveillance are pharmacologically-epizootologični or STATUS clinical trials conducted under the terms of the license for use with the purpose of identifying and studying the level of safety of the product.

90 b. "placing on the market" means the holding with a view to sale, offering for sale, sale, distribution, as well as any other form of paid and unpaid transfer ownership of objects and/or products subject to veterinary control. "

19. In paragraph 93, the words ' a STATUS ' shall be replaced by "is an original product.

20 section 96 is amended as follows:

"96." serious adverse reaction "is a reaction which results in death, life-threatening condition resulting in severe disability or incapacity, congenital anomaly/birth defect, or which causes permanent or prolonged health deviations in treated animals."

21. a t. 104A:

"104A." substance "means any substance, regardless of its origin, which could be from: a) human origin, for example human blood or blood products;

(b)) animal origin, for example micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products;

in plant origin), such as micro-organisms, plants, parts of plants, vegetable secretions, extracts;

d) chemical origin, for example elements found in nature, chemical materials and products obtained by chemical change or synthesis. "

22. Section 111 shall be amended as follows:

"111." wholesale "STATUS are all activities that include the purchase, sale, export or any other commercial transaction with VMPS, with or without profit, except for:

(a) the delivery by the producer) STATUS, which has been produced by it;

b) retail sale in veterinary medicinal pharmacies. "

23. Section 113 is hereby repealed.

24. Section 122 shall be replaced by the following:

"122." homeopathic "VMPS VMPS is prepared from substances called homeopathic stocks in accordance with a homeopathic manufacturing procedure described in the European Pharmacopoeia or, in the absence of such a procedure – in accordance with the procedure described in the pharmacopoeia of a Member State. The homeopathic VMPS may contain several ingredients. "

Transitional and final provisions

§ 187. (1) on the day of the entry into force of this Act shall terminate the operation of the annual framework contract for implementation of measures under the programmes for the eradication and surveillance of animal diseases and the State preventive program.

(2) individual contracts for the implementation of measures under the State programme and programmes for the prevention, control and eradication of animal diseases retained its action for a period of up to three months from the entry into force of this law.

(3) within the time limit referred to in paragraph 1. 2 owners of farms, the animal accordingly conclude contracts under art. 137 a, according to art. 137 b with the persons under art. 46 is and 46 g.

§ 188. (1) contracts entered into prior to the entry into force of this law between contracts and BABH objects for disposal of animal by-products shall retain the effect before 1 April 2013.

(2) contracts under art. 275, para. 2, 3 and 5 shall be concluded within one month from the entry into force of this Act and shall apply from 1 April 2013.

§ 189. (1) contracts for the use of veterinary stations – State property concluded prior to the entry into force of this Act pursuant to § 1, para. 1 of the additional provisions of the law on professional organization of veterinarians in Bulgaria may maintain action upon agreement of the parties and after the signing of the additional agreement for consideration use at prices determined by a licensed appraiser.

(2) the value of the improvements on the buildings of veterinary stations under para. 1 there shall be deducted from the rental price.

(3) where there is no agreement between the parties or not to enter into an additional agreement under para. 1, within one month from the entry into force of this law the contract shall be considered terminated.

§ 190. (1) the provision of State aid under art. 46, para. 2 and art. 51, para. 11 apply after a positive decision from the European Commission to be compatible with the rules in the field of State aid. The granting of State aid is not allowed until the date of the positive decision of the European Commission.

(2) until a positive decision from the European Commission under para. 1 no expenditure incurred under art. 46, para. 1, the value of the funds and the cost of art. 51, para. 10 are financed with funds from the State budget, the budget of BABH.

§ 191. (1) certificates issued by BABH permits and licenses for use for in vitro diagnostic veterinary funds, retain the action until the expiry of the period for which they are issued.

(2) applications submitted before the entry into force of this law, applications for the issue of a license for use for in vitro diagnostic veterinary medicinal remedies, are dealt with by the order of art. 279.

§ 192. Within one year of the entry into force of this Act, qualified persons with which the holders of a licence for the manufacture of VMPS have contracted, must meet the conditions under art. 353, para. 2-7.


§ 193. In the feed (official SG. 55 of 2006; amend., 36/54 and 100 from 2008, 41/88 and from 2010, issue 8 of 2011 and 83/97 and by 2012) make the following additions:

1. In art. 23, para. 1 in the first sentence, after the word "documents" puts the dash and add "for bulk feedingstuffs" and after the word "product" is placed hyphen and added "for packaged feedingstuffs '.

2. In art. 77 a, para. 1, after the words "the provision of" art "is added. 23 "and a comma.

§ 194. (1) within 6 months from the entry into force of this Act, the Minister of agriculture and food issues the Ordinances under art. 7, para. 2, art. 26, al. 2, art. 51, para. 5 and 9, art. 137, para. 10, art. 284 and 410 in.

(2) within three months of the entry into force of this law the Executive Director affirmed BABH models of documents under this Act.

The law was adopted by 41-Otto National sat 11 Rainier January 2013 and is stamped with the official seal of the National Assembly.

President of the National Assembly Tsetska Tsacheva:

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